Soligenix (OTCBB:SNGX) had its buy rating reiterated by Brean Capital's Jonathan Aschoff on Monday, following the biopharmaceutical company's release of first quarter results last week, which saw "several positive developments" over the period, according to the analyst report. 

The company is set to start a phase 2 randomized, double blind, placebo-controlled study of SGX942 - its lead compound - for oral mucositis in head and neck cancer patients in the second half of this year. 

Meanwhile, in its biodefense business last week, the company inked a collaboration agreement with Intrexon Corp, under which Soligenix licensed Intrexon's antibody discovery, isolation and production technologies to develop a human monoclonal antibody therapy for melioidosis - a biodefense threat and serious infectious disease. 

"We believe the collaboration underscores the capability of the biodefense at Soligenix. In addition, Soligenixpresented its biodefense vaccine programs at the World Vaccine Congress in April 2013, highlighting its ThermoVax technology to produce thermostable RiVax and VeloThrax vaccines that do not require storage at refrigerated temperatures," noted Aschoff in the emailed report on Monday. 

For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations,Soligenix has said that the use of ThermoVax, which has been tested in combination with the company's RiVax and VeloThrax vaccines, can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.

Aschoff also highlighted the submission of a contract proposal to the Biomedical Advanced Research and Development Authority (BARDA) in the first quarter, to support the development of OrbeShield. OrbeShield, also a part of Soligenix's biodefense platform, is being developed by the company to treat gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

"The proposal can potentially lead to a multi-year, multi-million dollar grant from BARDA to support the development program of OrbeShield in GI ARS, which was granted IND clearance, Fast Track Designation, and Orphan Drug Designation from the FDA in January 2013," said the analyst. 

In terms of financials, the company reported grant revenue for the first quarter of $0.9 million, up from $0.6 million in the year-ago period, and a loss per share of 10 cents. Higher grant revenue was mainly driven by reimbursable costs from the government-funded ThermoVax program. 

Brean's Aschoff notes that the most important financial metric for the company at present, however, is that it ended the first quarter with about $2.6 million in cash and equivalents, and has filed to raise capital in the near term. 

Research and development and selling, general and administrative expenses were $0.8 million and $0.7 million, respectively, in the first quarter - in line with Brean Capital's expectations.

Aschoff stood by his $5 target price on the company, which is based on a 5x multiple of the projected 2019 EBITDA of $103 million. 

Shares of Soligenix are currently trading at $1.44 on Monday, up 140 per cent since the start of the year. 

Soligenix (OTCQB:SNGX), a biopharmaceutical company focused on developing products for inflammatory diseases as well as biodefense countermeasures, has seen its share price more than double since the start of the year, and it's easy to see why.  A recent surge in progress and expansion in its pipeline of drugs have been underway at the company, which just recently penned a deal to develop a treatment for melioidosis, an often lethal disease, through a worldwide exclusive collaboration with Intrexon. 

Intrexon, a synthetic biology company, uses its proprietary technologies to provide control over cellular function. Under the agreement between the two parties, Soligenix says it plans to develop and commercialize human monoclonal antibody therapies for new biodefense and infectious disease applications for melioidosis, using Intrexon's isolation and production technologies. 

Melioidosis, which has the potential for widespread dissemination, is endemic in Southeast Asia and Northern Australia, and is considered a high-priority biodefense threat as defined in last year's Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy, established by the U.S. Department of Health and Human Services. 

The disease, for which there is no preventative vaccine or effective immunotherapy, is caused by Burkholderia pseudomallei, a Gram-negative bacteria that is highly resistant to antibiotic treatment, with mortality rates as high as 40 percent in many parts of Southeast Asia, according to recent stats - making melioidosis the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis. 

With the collaboration, Intrexon will develop therapeutic antibody candidates targeting the disease, while Soligenixwill undertake preclinical and clinical development, as well as regulatory and government interactions, and commercialization. 

The companies termed the agreement as "unique" because of their goal to develop a therapy that will treat both a deadly disease, as well as fight a potential "biological weapon". 

"Our collaboration with Intrexon is consistent with our corporate strategy of building shareholder value through continuous evaluation of new product opportunities and acting upon those that meet Soligenix's mission of delivering disease-modifying therapies in areas of high unmet medical need," president and CEO of Soligenix, Dr. Christopher J. Schaber said in a statement.  

"By working with Intrexon we hope to make a potentially life-saving therapy available to patients in endemic regions and include the therapy in the national stockpiling program in case of a biowarfare event."

Other terms of this deal include Soligenix issuing Intrexon 1.034 million shares of its common stock, representing 8.5 per cent of the company's issued and outstanding shares, with Intrexon given the right to participate in future share offerings by Soligenix. 

Soligenix will also pay development milestones and royalties on net sales derived from the products developed from the collaboration.

"Soligenix has the expertise and highly focused mission we look for in all our collaborations," said Randal J. Kirk, founder, chairman and CEO of Intrexon, which just completed a fresh $150 million financing for a whole new slate of collaborations in synthetic biology, with significant contributions from the billionaire founder and his venture fund, Third Security. "Although we are engaging with increasingly larger enterprises in Health, Food, Energy and Environment, we shall continue to explore powerful combinations with smaller, specialized companies that have great teams, grand vision and deep expertise."

Indeed, New Jersey-based Soligenix last week announced its first quarter results, saying revenues for the three months to March 31 were $0.9 million, up from $0.6 million in the year-ago period, while also listing off its accomplishments in the latest period. 

Revenues increased in the quarter due to reimbursable costs from the company's four active government-funded programs - most notably its ThermoVax thermostability technology grant focused on a new method of rendering "aluminum salt adjuvanted vaccines" stable at elevated temperatures. 

For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations,Soligenix has said that the use of ThermoVax, which has been tested in combination with the company's RiVax vaccine, can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.

The company also highlighted the submission of a contract proposal to the Biomedical Advanced Research and Development Authority (BARDA) in the quarter, to support the development of OrbeShield. The award has the potential to be a multi-million dollar contract.

OrbeShield, also a part of Soligenix's biodefense platform, is being developed by the company to treat gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

In addition, in its biotherapeutics segment, the company recently received FDA clearance of its investigational new drug application for SGX942, its lead compound, which is projected to enter phase 2 trials for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. 

In light of the recent progress, shares of Soligenix are currently trading at $1.40 - up 133 per cent since January 2, giving the company a market capitalization of almost $16 million, with 11.2 million shares outstanding. 

Soligenix (OTCQB:SNGX) said Friday that it narrowed its net loss in the first quarter as revenues increased and operating expenses declined, as the company says it continues to make progress in both its biotherapeutics and biodefense businesses. 

The New Jersey-based clinical-stage bipharmaceutical company, which is focused on developing products to treat inflammatory diseases and biodefense countermeasures, said revenues for the three months to March 31 were $0.9 million, up from $0.6 million in the year-ago period. 

Revenues increased due to reimbursable costs from the company's four active government-funded programs - most notably its ThermoVax thermostability technology grant focused on a new method of rendering "aluminum salt adjuvanted vaccines" stable at elevated temperatures. 

For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations,Soligenix has said that the use of ThermoVax, which has been tested in combination with the company's RiVax vaccine, can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.

Net loss for the latest quarter was $1.1 million, or 10 cents per share, versus $1.4 million, or 13 cents per share, for the same quarter last year. Soligenix said Friday in its statement the reduced loss is mainly due to increased government-funded grants, and overall lower operating expenses. 

Indeed, research and development costs for the quarter fell slightly to $0.8 million from $0.9 million, while general and administrative expenses were $0.5 million, down from $0.7 million a year earlier. 

Overall operating decreased by $0.3 million, leaving the company with a cash position of $2.6 million at the end of the quarter. 

"We continue to make steady progress in both our BioTherapeutics and Vaccine/BioDefense business segments," said president and CEO Christopher J. Schaber, in the release today. 

"We have expanded our product pipeline through a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need," he said, also highlighting the submission of a contract proposal to the Biomedical Advanced Research and Development Authority (BARDA) in the quarter, to support the development of OrbeShield.

The award has the potential to be a multi-million dollar contract. OrbeShield is being developed by the company to treat gastrointestinal acute radiation syndrome  (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

Aside from these accomplishments in the period, the company also recieved FDA clearance of its investigational new drug application for SGX942, its lead compound, which is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. 

Shares of Soligenix were inactive Friday, trading at $1.45 - up by more than double since the start of the year. 

After two letters containing ricin were intercepted, one addressed to U.S. President Barack Obama and the other intended for Republican Senator Roger Wicker, shares of Soligenix (OTC:SNGX) surged as traders showed support for its RiVax™ vaccine being developed to protect against disease and death caused by exposure to the deadly toxin. 

According to media supports, the FBI confirmed on Wednesday that the letter addressed to President Obama tested positive for ricin, just a day after a separate letter intended for Senator Wicker also tested positive for the poisonous substance. Both letters were intercepted at off-site facilities.

The Center for Disease Control (CDC) has classified ricin toxin as a Category B biological agent and there are currently no FDA approved therapeutics or vaccines that can be used to protect against ricin exposure or to reverse its effects once exposed. Once exposed to lethal doses of ricin, death is irreversible after four hours and takes three to five days to kill an individual. 

Soligenix has said the RiVax™ vaccine, which recently completed its second human clinical trial, in a Phase 1B clinical study in healthy volunteers was shown to be safe and well tolerated and induce neutralizing antibodies anticipated to protect humans from ricin exposure. These positive results provide a route forward for further development of the vaccine in larger and more definitive trials in humans and provide the additional correlates of protective immunity for pivotal animal studies.

The development of RiVax™ has been funded through a series of grants from the National Institutes of Health (NIH), granted to Soligenix and to the University of Texas Southwestern Medical Center (UTSW), where the vaccine originated. 

Soligenix says it has positioned thermostable RiVax™ for large scale manufacturing and is further establishing correlates of the human immune response in non-human primates. 

The company notes that its process for product development of biodefense products such as RiVax™ is highly dependent on government funding, since the government itself will be the final supplier of the products. 

Currently, Soligenix is operating under a $9.4 million grant award from the National Institute of Allergy and Infectious Diseases (NIAID), which will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines like RiVax™ that are stable at elevated temperatures. 

The thermostabilization technology, called ThermoVax™, is being developed to eliminate the standard cold chain production, distribution and storage logistics required for most aluminum-adjuvanted vaccines.

Last month, Soligenix reported that several preclinical studies have demonstrated that vaccines formulated with ThermoVax™ have the potential for high temperature stability seen for a minimum of six months, and potency stabilization. 

The studies were conducted in a program designed to see if the vaccines could withstand extreme temperatures and other environmental stress conditions. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, Soligenix indicated the use of ThermoVax™ can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.

The company’s shares have rallied as of late, as investors cheer its progress in developing RiVax™ and the ThermoVax™ technology, and more recently ahead of this week’s World Vaccine Congress & Expo, where chief scientific officer, Robert N. Brey, PhD, will discuss the stockpiling of biodefense vaccines.

The clinical stage biopharmaceutical company says Dr. Brey will make his presentation at the Expo today, at the Gaylord National Resort & Convention Center in National Harbor, Maryland.

Soligenix is focused on developing products for serious inflammatory diseases as well as developing several biodefense vaccines and therapeutics.

The New Jersey-based company’s lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. 

Meanwhile, its SGX203 drug for pediatric Crohn’s disease should enter phase 1/2 trials in the first half of 2013.

Soligenix is also developing OrbeShield, a drug for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

Shares of the company closed up 18.57 per cent, or 26 cents, Wednesday, at $1.66. Shares have risen about 177 per cent since December 31, 2012.

Soligenix (OTCQB:SNGX) says that several preclinical studies have shown that vaccines formulated with its ThermoVax technology have the potential for high temperature stability seen for a minimum of six months and increased potency. 

The studies, said the company in a statement Tuesday, were conducted with Soligenix's proprietary ricin toxin vaccine, known as RiVax, and its anthrax vaccine, known as VeloThrax. The program was designed to see if the vaccines could withstand extreme temperatures and other environmental stress conditions. 

Shares of the company rose more than 3.7 percent this morning to $1.40. 

The company is researching the ThermoVax technology with a $9.4 million grant from the National Institute of Allergy and Infectious Disease for biodefense vaccines to prevent ricin toxin and anthrax exposure. 

ThermoVax is being developed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Indeed, when using ThermoVax in the final formulation of vaccines, the results have shown that it is possible for the vaccines to withstand temperatures at least as high as 40 degrees Celsius for a minimum of six months, while also not sacrificing their potency and stability, the company said. 

Recent results, it added, also show that VeloThrax, when formulated with ThermoVax, retained full potency in animals and showed "full structural integrity" when exposed to temperatures as high as 70 degrees Celsius. 

"We are pleased with the progress demonstrated thus far with our vaccines that employ ThermoVax," said the company in a statement on Tuesday, citing president and CEO, Christopher J. Schaber.  

"The ability to engineer vaccines that are able to withstand extreme temperatures and thereby eliminate the cold chain while simultaneously reducing the frequency of vaccinations has the potential to be a significant step forward in vaccine technology."

The chief said that beyond its biodefense applications, ThermoVax has the potential to lead to "major cost savings" in the production, distribution and storage of currently marketed vaccines, and could further facilitate their use in the developing world. 

Soligenix says it has recently initiated discussions with "a number" of vaccine companies and non-profit organizations regarding the potential for collaboration on heat-stable versions of their vaccine candidates. 

Cold chain requirements add considerable cost to the production and storage of conventional vaccines, with the company citing that 98 percent of all vaccines require shipment through cold chain, according to the Biopharma Cold Chain Sourcebook of 2010. 

The World Health Organization also reports that 50 percent of all global vaccine doses are wasted because vaccines are not kept within required temperature ranges.  

For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the use of ThermoVax can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.

The New Jersey-based company focuses on drugs for cancer-supportive care, gastrointestinal disease, and biodefense, and has seen its stock triple in the last six months as investors become more bullish on its developing assets. 

Its lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. Mucositis is the clinical term for damage done to the mucosa by anti-cancer therapies like radiation and chemotherapy.

Soligenix's (OTCQB: SNGX) stock was flat Tuesday after the company announced its full year results for 2012, which was largely spent advancing its programs and expanding its drug pipeline. 

For the year that ended December 31, 2012, net loss was $4.2 million, or 37 cents per share, compared to $2.4 million, or 22 cents per share, in the year-ago period, with the increase due mainly to a receipt of $5.0 million from Sigma-Tau in 2011 for the rights to orBec in Europe. 

This was partially offset by lower research and development expenses related to the company's discontinued phase 3 trial of orBec for Graft-versus-Host disease, for which Soligenix suffered in 2011 due to the study's failure. 

Revenues for the latest year were $3.1 million, down from $7.6 million in the previous year, also a result of the $5.0 million payment from Sigma Tau in 2011.

The New Jersey-based company focuses on drugs for cancer-supportive care, gastrointestinal disease, and biodefense, and has seen its stock more than quadruple in the last six months as investors become more bullish on its developing assets. 

Its lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. Mucositis is the clinical term for damage done to the mucosa by anti-cancer therapies like radiation and chemotherapy.

Soligenix's SGX942 is a key investment catalyst for the company, with a product launch anticipated in early 2017.  In phase 1 trials, it was shown to reduce the severity and duration of oral mucositis and induce anti-inflammatory activity. 

The drug maker is also developing SGX203, an oral BDP for pediatric Crohn’s disease. The phase 1/2 trial of SGX203 should begin in the first half of this year. 

Beyond these two drugs, the company expects to receive additional government grants to pursue other indications of oral BDP and several biodefense therapeutics and vaccines. 

Oral BDP is a topically active corticosteroid that has a local effect on inflamed tissue and is the active ingredient in four of its different product candidates. 

Specifically, it is also being used for the development of OrbeShield for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

In January, the company received an invitation from the Biomedical Advanced Research and Development Authority to submit a contract proposal for the development of OrbeShield, which was submitted in February. 

The submission supports a potential multi-year, multi-million dollar contract to develop OrbeShield for the treatment of GI ARS. 

"Throughout the year, we continued to make progress in advancing a number of our programs utilizing oral BDP, in both our BioTherapeutics and Vaccine/BioDefense business segments, as well as expanding our pipeline with acquired technology," said president and CEO, Christopher Schaber. 

"In December 2012, we were successful in regaining North American and European commercial rights to oral BDP from Sigma-Tau and we expanded our pipeline with the acquisition of a novel innate defense regulator technology known as SGX94. 

"We believe SGX94 is highly synergistic with our existing development pipeline in cancer supportive care and biodefense, and we anticipate the potential for a number of grant funding opportunities for SGX94 across both business segments." 

Schaber said he is also pleased with the momentum the company has built entering 2013, and is "excited" about the opportunities he sees in both of Soligenix's business units. 

At the end of 2012, the company's cash position was $3.4 million, with working capital of $2.7 million. 

Soligenix (OTCQB:SNGX) shares have more than quadrupled in the last three months as it continues to develop its promising pipeline. The drug development company said Friday that its president and CEO, Christopher J. Schaber, will be presenting a corporate update at the 2013 BIO CEO & Investor Conference on Tuesday February 12 at the Waldorf Astoria in New York City. 

The presentation will take place at 3:00pm ET in the Duke of Windsor Room. 

Its stock is changing hands at $1.77, up by $1.33 since early November. 

The New Jersey-based company focuses on drugs for cancer-supportive care, gastrointestinal disease, and biodefense.

Its lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. 

Earlier this week, the company announced a new medical advisory board that will play an important role in the design of the upcoming phase 2 clinical study of SGX942 as well as in the design of further clinical trials and associated communications with regulatory authorities. 

Mucositis is the clinical term for damage done to the mucosa by anti-cancer therapies like radiation and chemotherapy. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. 

The condition affects 500,000 people in the U.S. per year and occurs in 40% of patients receiving chemotherapy, according to recent stats. 

Soligenix's SGX942 is a key investment catalyst for the company, with a product launch anticipated in early 2017.  In phase 1 trials, SGX942 was shown to reduce the severity and duration of oral mucositis and induce anti-inflammatory activity. 

The drug maker is also developing SGX203, an oral BDP for pediatric Crohn’s disease. The phase 1/2 trial of SGX203 should begin in the first half of this year. 

Beyond these two drugs, the company expects to receive additional government grants to pursue other indications of oral BDP and several biodefense therapeutics and vaccines. 

Oral BDP is a topically active corticosteroid that has a local effect on inflamed tissue and is the active ingredient in four of its different product candidates. Specifically, it is also being used for the development of OrbeShield for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

Soligenix (OTCQB:SNGX) says it has formed a medical advisory board to provide strategic guidance to the company as it advances the development of one of its key assets. 

The company is working on developing SGX942 for the treatment of oral mucositis, a complication of cancer therapies. Soligenix said the new medical advisory board will play an important role in the design of the upcoming phase 2 clinical study of SGX942 as well as in the design of further clinical trials and associated communications with regulatory authorities. 

The company noted the board will provide feedback and guidance on clinical strategies and as well as other issues such as health economics and reimbursement. 

Soligenix's stock has seen a slew of share price gains in recent weeks, as it continues to develop its pipeline and receives bullish coverage by analysts. In the last month alone, its stock has almost tripled - currently changing hands at around $2.07 - up almost 1% on Monday. 

The New Jersey-based company focuses on drugs for cancer-supportive care, gastrointestinal disease, and biodefense. Its lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. 

The new medical advisory board will be comprised of Dr. Stephen T. Sonis, a clinical professor of oral medicine at Harvard School of Dental Medicine, as well as senior medical oncologist at Royal Adelaide Hospital Cancer Centre Dr. Dorothy Keefe and Dr. Mark Schubert, a professor in the department of oral medicine at the University of Washington.

"We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board," said president and CEO of Soligenix, Christopher J. Schaber. 

"The initiation of an oral mucositis program marks the first step in the development of our IDR technology platform.  We look forward to working with the MAB and initiating a clinical program in 2013." 

Mucositis is the clinical term for damage done to the mucosa by anti-cancer therapies like radiation and chemotherapy. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. Mucositis affects 500,000 people in the U.S. per year and occurs in 40% of patients receiving chemotherapy, according to recent stats. 

Soligenix's SGX942 is a key investment catalyst for the company, with a product launch anticipated in early 2017.  In phase 1 trials, SGX942 was shown to reduce the severity and duration of oral mucositis and induce anti-inflammatory activity. 

The drug maker is also developing SGX203, an oral BDP for pediatric Crohn’s disease. 

Beyond these two drugs, the company expects to receive additional government grants to pursue other indications of oral BDP and several biodefense therapeutics and vaccines. 

Soligenix (OTC:SNGX) flew higher again Thursday after Brean Capital initiated coverage on the drug developer, calling the company undervalued with "promising drugs" in unmet indications. 

The company has seen a slew of share price gains in recent weeks, as it continues to develop its pipeline and receives bullish coverage by analysts. In the last month alone, its stock has more than tripled - currently changing hands at around $1.87 - up over 12% on Thursday. 

Breane Capital's analyst Jonathan Aschoff started Soligenix off with a buy rating and 12-month target price of $5.00. 

The New Jersey-based company focuses on drugs for cancer-supportive care, gastrointestinal disease, and biodefense. Its lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results in the second half of 2014. 

Aschoff notes that this is a key investment catalyst for the company, with a product launch anticipated in early 2017. "We believe that positive phase 2 results for SGX942 in oral mucositis would be a significant de-risking event for Soligenix."

The analyst adds that current FDA-approved drugs for oral mucositis - a complication of cancer treatments - are either not indicated for head and neck cancer patients, or not effective enough. 

But in phase 1 trials, SGX942 was shown to reduce the severity and duration of oral mucositis and induce anti-inflammatory activity. Given these results, the analyst views "any clear differentiating phase 2 success as sufficient to attract the attention of a suitor."

Assuming a product launch in early 2017, the analyst expects sales from this drug to be about $94 million in 2019.

Soligenix is also developing SGX203, an oral BDP for pediatric Crohn’s disease. 

Beyond these two drugs, the company expects to receive additional government grants to pursue other indications of oral BDP and several biodefense therapeutics and vaccines. 

All compounds are protected by U.S. patents, the analyst notes. Patents with the same claims have also been issued in Mexico and South Africa, and have been filed in Europe, Canada, Australia, and several other countries. 

Oral BDP is a topically active corticosteroid that has a local effect on inflamed tissue and is the active ingredient in four different product candidates.

SGX203 is an oral BDP formulated as two tablets to block inflammation from Crohn’s disease throughout the small and large bowel. 

"It has less toxicity than prednisone and broader use than budesonide, which are two steroids currently used off-label in pediatric Crohn’s disease," Aschoff highlights. 

The phase 1/2 trial of SGX203 should begin in the first half of this year. 

Crohn's Disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. It can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine. Pediatric Crohn's is a subpopulation of around 80,000 patients from 0-19 years of age in the United States. 

"Assuming a product launch in early 2017, we estimate $42 million in SGX203 sales in 2019," the analyst projects. 

Oral BDP is also being used for the development of OrbeShield for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

And through its biodefense division, the company is also developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

"Although we are optimistic about the commercialization of these drugs, to be more conservative, we did not incorporate their revenues in our financial model," notes Aschoff. 

Brean's Capital terminal valuation is based on a 5x multiple of the projected 2019 EBITDA (earnings before interest, taxes, depreciation, amortization) of $104 million.

Soligenix (OTCQB:SNGX) says that its OrbeShield radiation drug has received fast track designation from the U.S. FDA after a series of advances in the development program.

The news comes after the FDA granted orphan drug designation for OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.

OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. Aside from acute radiation syndrome, the company is also developing oral BDP for pediatric Crohn's disease. 

The fast track status announced today is one the FDA reserves for a drug intended to treat a serious or life-threatening condition, and one that shows the potential to address an unmet medical need. 

The designation is designed to fast track the development of the drug, and expedite its review. For example,Soligenix will be eligible to submit a new drug application for OrbeShield on a rolling basis, meaning the FDA can review sections of the application prior to receiving complete submission. 

New drug applications for fast track development programs are ordinarily eligible for priority review, which gives an abbreviated review time of six months.  

"There are no FDA approved therapies for the treatment of GI ARS," said president and CEO, Christopher J. Schaber. 

"The FDA's action in granting fast track designation is a validation of BDP's potential to address this life-threatening, unmet medical need.  

"We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShieldTM development program." 

Earlier this month, the development stage biopharmaceutical company announced that BARDA had called onSoligenix to submit a potential multi-year, multi-million dollar contract proposal to develop OrbeShield.

In pre-clinical studies, the company said that OrbeShield showed a “statistically significant survival advantage” in animals that received the therapy up to 24 hours following exposure to lethal doses of total body irradiation, when compared with placebo control animals. Median survival post exposure in the control group was eight days, compared to 87 days in the OrbeShield treated group.  

Based on this development program and others, Soligenix's stock has been gaining significantly of late. In the last year, its stock more than doubled, and just yesterday, rose nearly 9% to $1.46 on the back of an article in the influential financial markets blog Seeking Alpha, which outlined the "reintroduction" of the company after a "devastating setback" in 2011. 

The article focused on Soligenix as an example of small biotech companies that get defined by lead product candidates, where "a setback or outright failure of the lead program can be catastrophic to the company's share price", with no residual value given to the rest of the pipeline. 

"I believe investments in forgotten gems like these can be profitable as the valuations can become very attractive due to the over-reaction of the marketplace. The downside risk could be minimal and the upside gains could be substantial as the company's developments finally begin attracting investor attention once again," the writer noted.

In 2011, Soligenix's share price suffered due to its phase III clinical trial failure of orBec - an oral formulation of beclomethasone dipropionate (BDP) - for Graft-versus-Host disease. But the company's leaders pushed forward developing the remainder of its platform, to the benefit of its share price. 

Its stock was inactive in premarket trading on Tuesday, but opened up by more than 7.5% to $1.57 in early deals.

Soligenix's (OTC:SNGX) stock soared this morning on the back of an article in the influential financial markets blog Seeking Alpha, which outlined the "reintroduction" of the company after a "devastating setback" in 2011. 

Shares of the biopharmaceutical company were lately up 16 cents, or nearly 12% to $1.50, hitting a high of $1.65 earlier this morning. Its stock price has more than doubled in the last year. 

The article focuses on Soligenix as an example of small biotech companies that get defined by lead product candidates, where "a setback or outright failure of the lead program can be catastrophic to the company's share price", with no residual value given to the rest of the pipeline. 

"I believe investments in forgotten gems like these can be profitable as the valuations can become very attractive due to the over-reaction of the marketplace. The downside risk could be minimal and the upside gains could be substantial as the company's developments finally begin attracting investor attention once again," the writer notes. 

In 2011, Soligenix's share price suffered due to its phase III clinical trial failure of orBec - an oral formulation of beclomethasone dipropionate (BDP) - for Graft-versus-Host disease. 

Meanwhile, the company's leaders pushed forward developing the remainder of its platform. 

"Soligenix has a unique business model that has allowed for a rather diversified development pipeline. It is comprised of 2 business segments, biotherapeutics and vaccines/biodefense. 

"Two key points stand out upon close examination of the product candidates. First, there are 8 development programs. Of these, 6 are being developed either wholly or in part by NIH or FDA funding," the Seeking Alpha entry explains. 

"For long-term investors this is key, as it means their investment dollars need only be utilized for 2 out of the 8 programs," it adds. 

Soligenix's biotherapeutics product line is based on 2 active ingredients, SGX94 and oral BDP. SGX942 is being evaluated for its potential in treating oral mucositis in head and neck cancer, while oral BDP is the active ingredient in three different product candidates aside from orBec.

BDP is the main ingredient in SGX203 to treat pediatric Crohn's disease, SGX201 in the prevention of acute radiation enteritis, and in OrbeShield to treat gastrointestinal acute radiation syndrome (GI ARS).

Earlier in January, the development stage biopharmaceutical company announced that the Biomedical Advanced Research and Development Authority (BARDA) had called on Soligenix to submit a potential multi-year, multi-million dollar contract proposal to develop OrbeShield.

OrbeShield is being developed for the treatment of GI ARS, which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

The news came after the FDA granted orphan drug designation for OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.

Through its biodefense division, the company is also developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

"The heavily government funded Vaccines/Biodefense portion of Soligenix's pipeline is proving to be potentially lucrative not only due to the government aid for their development, but also for the potential contracts that the company could obtain from the U.S. as well as foreign governments," the Seeking Alpha article says. 

For the full article, click here: http://seekingalpha.com/article/1136821-soligenix-the-reintroduction?source=google_news

Shares in Soligenix (OTC:SNGX) have been flying higher so far this year, up more than 12% today alone, with its stock more than doubling since the start of 2013 as investors await the outcome of its recent proposal for a potential multi-million dollar contract to develop its radiation therapy, OrbeShield. 

The company’ stock gained 15 cents on Friday alone, to $1.35. So far this year, its shares have risen 125% and are up over 69% in past 12 months. 

Earlier in January, the development stage biopharmaceutical company announced that the Biomedical Advanced Research and Development Authority (BARDA) had called on Soligenix to submit the potential multi-year, multi-million dollar contract proposal to develop OrbeShield.

OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. Aside from acute radiation, the company is also developing oral BDP for pediatric Crohn's disease and gastrointestinal Graft-versus-Host disease (GVHD).

In pre-clinical studies, the company said that OrbeShield showed a “statistically significant survival advantage” in animals that received the therapy up to 24 hours following exposure to lethal doses of total body irradiation, when compared with placebo control animals.

Median survival post exposure in the control group was eight days, compared to 87 days in the OrbeShield treated group.  

Earlier this month, Soligenix said that the FDA had completed and cleared its review of an investigational new drug (IND) application for OrbeShield “for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS)”.

Clearance of the IND means that the company could initiate its development program, which includes preclinical safety and efficacy evaluations and a phase 1/2 study of OrbeShield in healthy adolescents and young adults.

The program will provide the needed data to inform dose extrapolation from the animal studies to the appropriate dose in humans, the company noted.

This news came after the FDA granted orphan drug designation for OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.

Through its biodefense division, the company is also developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

In December, the company acquired SGX94 - a drug technology that regulates the immune system, and whichSoligenix is planning to develop in both of its key units - namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

At the end of the year, Soligenix had increased its cash position to about $3.3 million after receiving funding from a tax transfer program.

Soligenix stock was on the rise again Tuesday, a day after it gained more than 14 per cent when it said it will submit a proposal for a potential multi-million dollar contract to develop its radiation therapy, OrbeShield.

Its stock closed at 80 cents on Monday, and was lately up by more than 11 per cent, changing hands at around 89 cents as of 1:25pm ET. 

The Biomedical Advanced Research and Development Authority (BARDA) has called on the company to submit a full proposal for a potential multi-year, multi-million dollar contract to develop OrbeShield.

This was in response to a Broad Agency Announcement for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats.

OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. 

In a canine model of GI ARS, the company said that OrbeShield showed a “statistically significant survival advantage” in animals that received the therapy up to 24 hours following exposure to lethal doses of total body irradiation when compared with placebo control animals.

Median survival post exposure in the control group was eight days, compared to 87 days in the OrbeShield treated group.  

Soligenix also last week announced that the FDA had completed and cleared its review of an investigational new drug (IND) application for OrbeShield “for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS)”.

Clearance of the IND means that the company can now initiate its development program, which will include preclinical safety and efficacy evaluations and a phase 1/2 study of OrbeShield in healthy adolescents and young adults.

The program will provide the needed data to inform dose extrapolation from the animal studies to the appropriate dose in humans, the company noted.

This news came after the FDA granted orphan drug designation for OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.

Through its biodefense division, the company is also developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Last month, the company acquired SGX94 - a drug technology that regulates the immune system, and whichSoligenix is planning to develop in both of its key units - namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

***updated with latest share price data***

Soligenix's (OTCQB:SNGX) shares soared this afternoon after it said earlier today that it will submit a proposal for a potential multi-million dollar contract to develop its radiation therapy, OrbeShield.

Its stock rose almost 13 per cent to trade at 80 cents just after 2pm ET on Monday. 

The Biomedical Advanced Research and Development Authority (BARDA) has called on the company to submit a full proposal for a potential multi-year, multi-million dollar contract to develop OrbeShield.

The development stage biopharmaceutical company said it submitted its white paper to BARDA in response to a Broad Agency Announcement for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats.

Following a review of the report, BARDA invited Soligenix to supply a proposal to develop OrbeShield from its current level of technical readiness to FDA approval.

OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. 

"We are very excited by BARDA's invitation to submit a full proposal for development of OrbeShield as a medical countermeasure against GI ARS," said president and CEO Christopher J Schaber. 

"Although there are no guarantees, we believe that we are well-positioned to receive BARDA support for this indication and that the full proposal will allow us to further demonstrate the growing body of compelling scientific evidence supporting OrbeShield’s potential as a countermeasure for GI ARS. 

“We intend to submit our proposal to BARDA in February 2013 and look forward to their response.”

Soligenix will continue to develop OrbeShield following a recent $600,000 Small Business Innovation Research grant to support further GI ARS canine studies.

In a canine model of GI ARS, the company said that OrbeShield showed a “statistically significant survival advantage” in animals that received the therapy up to 24 hours following exposure to lethal doses of total body irradiation when compared with placebo control animals.

Median survival post exposure in the control group was eight days, compared to 87 days in the OrbeShield treated group.  

Soligenix last week announced that the FDA had completed and cleared its review of an investigational new drug (IND) application for OrbeShield “for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS)”.

Clearance of the IND means that the company can now initiate its development program, which will include preclinical safety and efficacy evaluations and a phase 1/2 study of OrbeShield in healthy adolescents and young adults.

The program will provide the needed data to inform dose extrapolation from the animal studies to the appropriate dose in humans, the company noted.

Earlier in the week, the FDA granted orphan drug designation OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.

Last month, it also acquired SGX94 - a drug technology that regulates the immune system. Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

***updated with latest share price data***

Soligenix's (OTCQB:SNGX) shares soared this afternoon after it said earlier today that it will submit a proposal for a potential multi-million dollar contract to develop its radiation therapy, OrbeShield.

Its stock rose almost 13 per cent to trade at 80 cents just after 2pm ET on Monday. 

The Biomedical Advanced Research and Development Authority (BARDA) has called on the company to submit a full proposal for a potential multi-year, multi-million dollar contract to develop OrbeShield.

The development stage biopharmaceutical company said it submitted its white paper to BARDA in response to a Broad Agency Announcement for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats.

Following a review of the report, BARDA invited Soligenix to supply a proposal to develop OrbeShield from its current level of technical readiness to FDA approval.

OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. 

"We are very excited by BARDA's invitation to submit a full proposal for development of OrbeShield as a medical countermeasure against GI ARS," said president and CEO Christopher J Schaber. 

"Although there are no guarantees, we believe that we are well-positioned to receive BARDA support for this indication and that the full proposal will allow us to further demonstrate the growing body of compelling scientific evidence supporting OrbeShield’s potential as a countermeasure for GI ARS. 

“We intend to submit our proposal to BARDA in February 2013 and look forward to their response.”

Soligenix will continue to develop OrbeShield following a recent $600,000 Small Business Innovation Research grant to support further GI ARS canine studies.

In a canine model of GI ARS, the company said that OrbeShield showed a “statistically significant survival advantage” in animals that received the therapy up to 24 hours following exposure to lethal doses of total body irradiation when compared with placebo control animals.

Median survival post exposure in the control group was eight days, compared to 87 days in the OrbeShield treated group.  

Soligenix last week announced that the FDA had completed and cleared its review of an investigational new drug (IND) application for OrbeShield “for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS)”.

Clearance of the IND means that the company can now initiate its development program, which will include preclinical safety and efficacy evaluations and a phase 1/2 study of OrbeShield in healthy adolescents and young adults.

The program will provide the needed data to inform dose extrapolation from the animal studies to the appropriate dose in humans, the company noted.

Earlier in the week, the FDA granted orphan drug designation OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.

Last month, it also acquired SGX94 - a drug technology that regulates the immune system. Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Development stage biopharmaceutical company Soligenix (OTCQB:SNGX) Wednesday said that the FDA has granted orphan drug designation to its radiation therapy, OrbeShield.

The company said in addition to a seven year term of market exclusivity for OrbeShield upon final approval, the FDA’s orphan drug designation also provides leverage to a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive user fees and certain tax credits.

"The FDA's decision to grant oral BDP orphan drug designation signifies an important step for Soligenix as we continue to expand our oral BDP pipeline," said president and CEO Christopher J. Schaber, PhD.  

"The marketing exclusivity that orphan drug designation imparts adds significantly to the existing patent estate surrounding OrbeShield." 

The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. 

OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome, which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.  

There is no established treatment or preventive measure for the gastrointestinal damage that occurs after high-dose radiation, and Soligenix has said there is an “urgent need” to develop specific medical countermeasures against the effects of radiation-induced gastrointestinal injury.

The company noted that BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. 

Soligenix said that oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation such as Crohn's disease and radiation enteritis.

The company last week announced it had regained the North American and European commercial rights to its oral BDP. 

Soligenix is currently developing oral formulations of the drug, including its two-tablet system specifically designed for delivery of BDP throughout the small bowel and the colon.   

Last month, it also acquired SGX94 - a drug technology that regulates the immune system. 

Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Development stage biopharmaceutical company Soligenix (OTCQB:SNGX) Friday said that it has increased its cash position to about $3.3 million after receiving funding from a tax transfer program.

The company said it recently received roughly $521,000 in non-dilutive financing through the State of New Jersey's Technology Business Tax Certificate Transfer Program.  

The program enables approved, unprofitable biotechnology businesses to sell their unused net operating loss carryovers (NOLs) and unused research and development tax credits for at least 80 per cent of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in New Jersey. 

Soligenix noted that the program allows biotechnology businesses with NOLs to turn their tax losses and credits into cash proceeds to fund more research and development, buy equipment and/or facilities, or cover other allowable expenditures.

"As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with the New Jersey Economic Development Authority’s decision to approve our application in this year's program," said president and CEO Christopher J. Schaber, PhD. 

"This NOL funding increases our cash position to about $3.3 million."

Soligenix is focused developing products to treat serious inflammatory diseases. 

On Thursday, the company announced that it has regained the North American and European commercial rights to its oral treatment for inflammatory gastrointestinal disorders. 

The company's oral formulation of beclomethasone dipropionate (BDP), a topically active corticosteroid, is currently in development for pediatric Crohn's disease, acute radiation enteritis, and gastrointestinal Graft-versus-Host disease (GVHD).

Through an amendment of its collaborative agreement with Sigma-Tau Pharmaceuticals, Soligenix said it is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products “with other parties without limitation”.

Soligenix is currently developing oral formulations of the drug, including its two-tablet system specifically designed for delivery of BDP throughout the small bowel and the colon.   

Earlier this month, the biopharmaceutical company also acquired SGX94 - a drug technology that regulates the immune system. 

Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Development-stage biopharmaceutical company Soligenix (OTCQB:SNGX)Thursday said that it has regained the North American and European commercial rights to its oral treatment for inflammatory gastrointestinal disorders. 

The company's oral formulation of beclomethasone dipropionate (BDP), a topically active corticosteroid, is currently in development for pediatric Crohn's disease, acute radiation enteritis, and gastrointestinal Graft-versus-Host disease (GVHD).

Through an amendment of its collaborative agreement with Sigma-Tau Pharmaceuticals, Soligenix said it is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products “with other parties without limitation”.

Oral BDP is a potent, topically active corticosteroid that has a local effect on inflamed tissue. The drug has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma.  

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed toSoligenix, BDP also benefits from several orphan drug designations, the company noted.

Soligenix is currently developing oral formulations of the drug, including its two-tablet system specifically designed for delivery of BDP throughout the small bowel and the colon.   

Earlier this month, the biopharmaceutical company also acquired SGX94 - a drug technology that regulates the immune system. 

The innate defense regulator (IDR) regulates the immune system to reduce inflammation, eliminate infection, and improve tissue healing by binding to the regulatory protein p62. 

Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

The company has acquired all rights to the technology as part of the deal, including composition of matter patents, and preclinical and phase 1 clinical study data. 

SGX94, which Soligenix says is "highly synergistic" with its existing development pipeline, is poised to enter phase 2 clinical testing in humans. 

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Development-stage biopharmaceutical company Soligenix (OTCQB:SNGX) has acquired SGX94 - a drug technology that regulates the immune system. 

The innate defense regulator (IDR) regulates the immune system to reduce inflammation, eliminate infection, and improve tissue healing by binding to the regulatory protein p62. 

Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

The company has acquired all rights to the technology as part of the deal, including composition of matter patents, and preclinical and phase 1 clinical study data. 

SGX94, which Soligenix says is "highly synergistic" with its existing development pipeline, is poised to enter phase 2 clinical testing in humans. 

The company said the drug is active in a wide range of disease models, including life-threatening bacterial infections as well as the severe side-effects of chemo- and/or radiation-therapy.  

Soligenix also noted that since SGX94 targets the host, and not the bacteria, it evades antibiotic resistance mechanisms, and has the potential as both an alternative and an adjunct to antibiotic therapy.  

The drug has proven safe in a phase 1 clinical study in healthy humans, Soligenix said, and is the subject of an open investigational new drug (IND) application by the U.S. FDA. 

Around $40 million has been spent on its development so far, including government grants. 

The acquired technology package by Soligenix also includes other analogs and crystal structures of SGX94, lending potential for a pipeline of additional products to be developed. 

"We are very excited by the acquisition of this cutting edge science which represents a new paradigm for the treatment of tissue injury and infection," said president and CEO of Soligenix, Christopher J Schaber. 

"With SGX94 we will be able to leverage our experience in clinical development of cancer supportive care and biodefense products.  We also anticipate the potential for a number of grant funding opportunities for SGX94 across both segments of our business."

In early November, the company's shares surged as it announced that its program for SGX203, or the oral form of  beclomethasone 17,21-dipropionate (BDP) as a treatment for mild-to-moderate pediatric Crohn's disease, received fast track designation from the US FDA.

In September, the company received a green light from the US FDA to start a clinical program for the drug. The clearance allows it to start a phase 1/2 study of the drug in healthy adolescents and young adults. 

Soligenix is developing proprietary formulations of oral BDP for the prevention and treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec).

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Soligenix (OTCQB:SNGX) reported Wednesday third quarter results that were impacted by license revenue in the year-earlier period, but it said it continued to make "steady progress" in advancing a number of its programs using oral BDP in both its biotherapeutics and biodefense businesses. 

Indeed, last week, the company's shares surged as it announced that its program for SGX203, or the oral form of  beclomethasone 17,21-dipropionate (BDP), as a treatment for mild-to-moderate pediatric Crohn's disease received fast track designation from the US FDA.

The development-stage biopharmaceutical company had previously received orphan drug designation for this indication of SGX203. 

Soligenix will now be eligible to submit a new drug application for SGX203 on a rolling basis, permitting the FDA to review sections of the application prior to receiving the complete submission. Under the fast track program, new drug applications are typically eligible for priority review, which implies a shorter review period of six months. 

In September, the company received a green light from the US FDA to start a clinical program for the drug. The clearance allows it to start a phase 1/2 study of the drug in healthy adolescents and young adults. 

"In the third quarter of 2012 we continued to make steady progress in advancing a number of our programs utilizing oral BDP, in both our BioTherapeutics and Vaccine/BioDefense business segments," said president and CEO, Christopher J. Schaber. 

"We were pleased to receive Investigational New Drug (IND) clearance and Fast Track designation for SGX203 from the U.S. Food and Drug Administration (FDA). 

"We remain committed to enhancing our development pipeline through internal efforts and external strategic alliances. We look forward to reporting on further progress on all programs during the remainder of this year." 

Soligenix's SGX203 contains BDP, a potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed globally since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. 

SGX203 is a two tablet delivery system of BDP, specifically designed for oral use that allows for the delivery of the drug throughout the small bowel and the colon. 

Soligenix is developing proprietary formulations of oral BDP for the prevention and treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec).

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

In August, the company said that phase 1B clinical trials of the aluminum hydroxide adjuvanted formulation of RiVax - designed to improve the immunogenicity of the vaccine - indicated that the adjuvanted vaccine is safe, well tolerated and induces greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax. 

The company also recently formed a scientific advisory board to help in the development of its OrbeShield radiation drug for the treatment of gastrointestinal acute radiation syndrome (GI-ARS).

For the third quarter, revenue amounted to $931,627, compared to $5.8 million a year earlier, when its top line was boosted by license revenue of $5.0 million from Sigma-Tau Pharmaceuticals for rights to orBec in Europe. 

Soligenix said grant revenue actually increased by $135,765 year-over-year, primarily related to increased reimbursable costs from its ThermoVax thermostability grant, which is focused on a new method for rendering aluminum salt adjuvanted vaccines stable at elevated temperatures. 

Net loss for the quarter was $758,966, or 7 cents per share, compared to a profit of $2.2 million, or 20 cents per share, a year ago. This decline was also due to the license revenue seen in the third quarter of 2011. 

Research and development expenses declined sharply, due to a $1.0 million payment in cash and company stock in connection with the Sigma-Tau agreement, and the discontinuation of the phase 3 clinical trial of orBec for Graft-versus-Host disease. 

At the end of the period, Soligenix had $3.7 million in cash, with working capital of $3.1 million. 

Soligenix (OTCQB:SNGX) shares surged Thursday as the company announced that its program for SGX203 as a treatment for mild-to-moderate pediatric Crohn's disease has received fast track designation from the US FDA. 

Shares in the company were lately higher by 16 cents, or 36 per cent, to 60 cents late Thursday morning. 

The development-stage biopharmaceutical company had previously received orphan drug designation for this indication of SGX203, or the oral form of beclomethasone 17,21-dipropionate (BDP).

Fast track designation, which is designed to expedite the review of new drugs, is reserved for a drug intended to treat a serious or life threatening condition, and that shows the potential to address an unmet medical need. 

Soligenix will now be eligible to submit a new drug application for SGX203 on a rolling basis, permitting the FDA to review sections of the application prior to receiving the complete submission. 

Under the fast track program, new drug applications are typically eligible for priority review, which implies a shorter review period of six months. 

"There are no FDA approved corticosteroid therapies for the induction treatment of Crohn's disease in the pediatric population," said president and CEO, Christopher J. Schaber. 

"The FDA's action in granting fast track designation is an indication of SGX203's potential to address this debilitating, unmet medical need.  We look forward to working closely with the FDA to potentially expedite the development and NDA review process." 

In September, the company received a green light from the US FDA to start a clinical program for the drug. The clearance allows it to start a phase 1/2 study of the drug in healthy adolescents and young adults. 

The data from the study will help inform dose selection for phase 2/3 clinical trials that follow. The first trial is expected to be initiated this year. 

Crohn's Disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. It can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine. 

The swelling caused by the disease extends deep into the lining of the affected organ, and can induce pain and cause diarrhea.  People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease, the company noted. 

The disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. Around 30 per cent of people with Crohn's develop symptoms before 20 years of age. 

Pediatric Crohn's is a subpopulation of roughly 80,000 patients from 0-19 years of age in the United States. The disease tends to be both severe and extensive in the pediatric population, and can also stunt growth, delay puberty, and weaken bones. 

The company's drug, SGX203, contains BDP, a potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed globally since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. 

SGX203 is a two tablet delivery system of BDP, specifically designed for oral use that allows for the delivery of the drug throughout the small bowel and the colon. 

Soligenix develops products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain bioterrorism agents. 

Its lead product, orBec, is a locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a life-threatening complication of hematopoietic cell transplantation.

Through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Soligenix (OTCQB: SNGX) said today that results of an animal study of its OrbeShield drug will be presented at a poster session during the 58th annual meeting of the Radiation Research Society. 

The event will be held in San Juan, Puerto Rico from September 30, to October 3. 

In the recently completed study in canines, "statistically significant survival" was seen in dogs that received OrbeShield therapy starting both 2 and 24 hours following exposure to total body irradiation (TBI). 

The company said the program was designed to simulate real world scenarios, in which people exposed to various levels of radiation would not be able to reach care centres immediately after a nuclear event.

In the study, untreated dogs died at a median time of 8 days when exposed to high dose radiation of 10-12 Gray (Gy), even if the dogs were given intensive supportive care such as antibiotics, intravenous fluids and anti-emetics. 

Transplant of autologous bone marrow cells also had no effect on the rate of death of the exposed animals, Soligenix said. 

During the observation period, the company said the survival of dogs was "strongly correlated to the recovery from acute radiation damage to the GI tract." 

The studies were conducted by George E. Georges, MD, at the Fred Hutchinson Cancer Research Center (FHCRC) under a National Institute of Allergy and Infectious Diseases (NIAID) funded grant. 

The OrbeShield program is also the subject of a new $600,000 NIAID Small Business Innovation Research (SBIR) grant.

Gastrointestinal acute radiation syndrome is a potentially life-threatening consequence of exposure to high doses of radiation following a serious nuclear event. 

There is currently no effective therapy approved for the treatment of the condition. 

OrbeShield contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. The treatment is formulated for oral administration. 

BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for  patients with allergic rhinitis and asthma. 

Soligenix (OTCQB:SNGX) said today that it has received the green light from the US FDA to start a clinical program testing SGX203 as a potential treatment for pediatric Crohn's disease - sending shares up more than 7 per cent this morning. 

The company had previously received orphan drug designation for this indication for SGX203, or the oral form of beclomethasone 17,21-dipropionate (BDP).

The clearance of the investigational new drug application allows Soligenix to start a phase 1/2 study of the drug in healthy adolescents and young adults. 

The data from the study will help inform dose selection for phase 2/3 clinical trials that follow. 

The first trial is expected to be initiated in 2012.

"We are very excited to begin the clinical development of SGX203 which we believe may prove to have significant advantages relative to systemic steroids such as prednisone, which are currently administered to the vast majority of newly diagnosed pediatric Crohn's disease patients," said senior VP and chief medical officer of Soligenix, Dr. Kevin Horgan.  

"Our proprietary two-tablet system with immediate and delayed release capabilities allows for comprehensive treatment of a patient's disease regardless of its location in the gastrointestinal tract." 

Crohn's Disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. It can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine. 

The swelling caused by the disease extends deep into the lining of the affected organ, and can induce pain and cause diarrhea. 

People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease, the company noted. 

The disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. Around 30 per cent of people with Crohn's develop symptoms before 20 years of age. 

Pediatric Crohn's is a subpopulation of approximately 80,000 patients from 0-19 years of age in the United States. 

The disease tends to be both severe and extensive in the pediatric population, and can also stunt growth, delay puberty, and weaken bones. 

The company's drug, SGX203, contains BDP, a potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed globally since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. 

SGX203 is a two tablet delivery system of BDP, specifically designed for oral use that allows for the delivery of the drug throughout the small bowel and the colon. 

Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain bioterrorism agents. 

Its lead product, orBec, is a locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a life-threatening complication of hematopoietic cell transplantation.

Through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

Shares of the company rose 7.3 per cent to trade at 44 cents Thursday morning.

Soligenix is a development stage biopharmaceutical company, developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain bioterrorism agents.

In late April, the company announced further progress in the development of ThermoVax, its vaccine thermostabilization technology that allows vaccines that usually need to be refrigerated to maintain their efficacy at higher temperatures.

Soligenix said that progress had been made based on the stability of prototype vaccines that had been kept at elevated temperatures for longer than three months.

The development of ThermoVax is being supported by a $9.4 million National Institute of Allergy and Infectious Disease (NIAID) grant, for biodefense indications against ricin toxin and anthrax exposure.

Soligenix said previous test results had indicated that the company's aluminum-adjuvanted ricin toxin vaccine, known as RiVax, retained effectiveness and potency, while stored at 40 degrees Celsius for one month, when combined with the ThermoVax technology.

Confirmatory results extended these initial observations to more than three months when the vaccine was kept at 40 degrees Celsius, said the company.

ThermoVax is able to produce “stable and potent” vaccine formulations, said Soligenix, by combining precise lyophilization technology with conventional aluminum adjuvants.

The lyophilization process is often employed to extend the shelf life of drugs, by removing the water from the pharmaceutical preparation.

Vaccines that undergo this process often lose their potency, especially if the vaccine is made with aluminum salt adjuvants, as most are.

Soligenix's technology, however, achieves this lyophilization effect but maintains the sensitive material in the vaccine, making the technology especially valuable for biodefense or pandemic situations, where drugs need to be stockpiled for a long period of time.

The underlying technology was developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado, whose team performed the studies along with Dr. Nicholas Mantis of The New York State Department of Health in Albany.

Through its biodefense division, Soligenix is also developing its SGX204 vaccine, which is designed to protect against the lethal effects of exposure to anthrax, in addition to RiVax.

Soligenix is also developing OrbeShield for the treatment of gastrointestinal acute radiation syndrome (GI ARS) and said it has demonstrated "statistically significant" preclinical survival results in a canine model.

Revenues for the quarter that ended March 31 were $647,418 as compared to $808,005 for the first quarter of 2011.

Soligenix said the decrease was related to a reduction in reimbursable costs from its orphan drug grant covering a portion of its phase 3 clinical trial of orBec, in the treatment of acute gastrointestinal graft-versus-host disease.

The company reported a net loss of $1.44 million or 13 cents per share, compared to a wider $1.72 million loss, or 16 cents per share, for the year earlier quarter.

The narrowed loss was due to reduced spending after the stoppage of the orBec trial, Soligenix said. The study was stopped in September 2011,  and the company said it has continued to incur minor costs associated with the close out of the clinical sites, as well as data collection and analysis.

Soligenix's research and development expenses for the quarter were $876,794, down from $1.37 million a year earlier.

General and administrative expenses for the quarter were $655,043, versus $604,010 a year earlier. At the end of the quarter, Soligenix’s cash position was approximately $5.32 million, with working capital of around $4.44 million.

"In the first quarter of 2012 we saw meaningful progress in our vaccine/biodefense business segment particularly with our novel vaccine thermostabilization technology, ThermoVax,” said president and CEO Christopher J. Schaber, PhD.

"We also continue to progress with development efforts of our oral BDP program for pediatric Crohn's disease and plan to initiate a phase 2A clinical trial this year. We remain committed to enhancing our product development pipeline through internal efforts and external strategic alliances.

"We look forward to reporting on further progress this year regarding our Vaccine/biodefense programs."

The company has announced a number of notable operational achievements of late, including promising results from its preclinical study of SGX202 (oral BDP), testing for the treatment of gastrointestinal acute radiation syndrome in dogs.

The study results indicated that dogs treated with SGX202 starting 24 hours after exposure to lethal doses of total body irradiation (TBI) demonstrated "statistically significant" improvement in survival when compared to control dogs.

Soligenix said these results show that SGX202 has the potential to reduce the inflammatory storm induced by the radiation-damaged GI tract.

Also earlier this year, the company unveiled preliminary results from a phase 1/2 clinical trial of SGX201, a time-release formulation of oral BDP for the prevention of acute radiation enteritis.

The study showed that oral administration of SGX201 was safe and well tolerated across all four dose groups.

Acute radiation enteritis is caused by the radiation-induced death of cells in the lining of the bowel.

Soligenix said 16 subjects with rectal cancer scheduled to undergo concurrent radiation and chemotherapy prior to surgery were enrolled in one of four dose groups in the study.

The main goal of the study was to evaluate the safety and tolerability of escalating doses of SGX201, as well as to assess the preliminary efficacy of SGX201 for the prevention of signs and symptoms of acute radiation enteritis.

The company's technology allows vaccines that usually need to be refrigerated to maintain their efficacy at higher temperatures.

Soligenix said Wednesday that progress has been made based on the stability of prototype vaccines that have been kept at elevated temperatures for longer than three months.

Studies are being conducted as part of a continuing program to test the effectiveness of vaccines designed to withstand extremes of temperature and other environmental stress conditions.

The development of ThermoVax is being supported by a $9.4 million National Institute of Allergy and Infectious Disease (NIAID) grant, for biodefense indications against ricin toxin and anthrax exposure.

In February, Soligenix established proof-of-concept for its thermostabilization technology using its aluminum-adjuvant ricin toxin RiVax vaccine. Results from this study showed the vaccine retained effectiveness and potency, while stored at 40 degrees Celsius for one month, when combined with the ThermoVax technology, the company said.

Confirmatory results, Soligenix added, have now extended this initial time frame to more than three months when the vaccine is kept at 40 degrees Celsius.

In contrast, the liquid RiVax vaccine, when stored at 40 degrees Celsius, rapidly degraded and no longer maintained its effectiveness, the company said.  This is because the ricin A chain is typically sensitive to temperature and quickly loses its ability to induce neutralizing antibodies when exposed to higher temperatues than 8 degrees Celsius.

But ThermoVax is able to produce "stable and potent" vaccine formulations, Soligenix said, by combining lyophilzation technology with conventional aluminum adjuvants, secondary adjuvants (for rapid onset of immunity), and protein subunits.

The lyophilization process is often employed to extend the shelf life of drugs, by removing the water from the pharmaceutical preparation. Vaccines that undergo this process often lose their potency, especially if the vaccine is made with aluminum salt adjuvants, as most are.

As a result, most vaccine products must be kept under tightly controlled conditions, as the World Health Organization (WHO) estimates that about half of all global vaccine doses are wasted for not being kept within required temperature ranges.

Soligenix's technology, however, achieves this lyophilization effect but maintains the sensitive material in the vaccine, making the technology especially valuable for biodefense or pandemic situations, where drugs need to be stockpiled for a long period of time.

"We continue to be pleased with the data generated thus far with ThermoVax," said chief scientific officer, Dr. Robert N. Brey.

"The ability of vaccines to withstand extreme temperatures is a significant step forward in vaccine technology.

"ThermoVax may also enable preparation of otherwise difficult multivalent (protective against multiple pathogens) formulations. We plan to apply ThermoVax to other conventional vaccines that require refrigeration."

The underlying technology was developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado, whose team performed the studies along with Dr. Nicholas Mantis of The New York State Department of Health in Albany.

The company said the elimination of the cold chain would also boost the utility of these vaccines for emerging markets, and for other applications requiring but lacking reliable cold chain capabilities, which add considerable cost.

Soligenix is a development stage biopharmaceutical company, developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain bioterrorism agents.

Through its biodefense division, Soligenix is developing its SGX204 vaccine, which is designed to protect against the lethal effects of exposure to anthrax, in addition to RiVax.