Alliance Pharma (LON:APH), which specialises in acquiring the rights to established niche products, continues to see top line growth in the current financial year.

In the company’s annual general meeting (AGM) statement, chairman Michael Gatenby revealed that turnover in the first four months of 2013 was up 6% year-on-year, with sales of £15.1mln. Of this, £1.8mln came through sales of products acquired in 2012.

Adjusting for these acquired products, and for the unavailability of ImmuCyst, sales have shown underlying growth of 5%; production of ImmuCyst has been suspended until late 2013 because of regulatory issues at its manufacturing facility.

"Hydromol sales continue to grow well. There have been reduced sales of Nu-Seals in Ireland although measures to counteract generic competition are helping to mitigate the impact,” Gatenby said.

The company said it continues to pass a number of acquisition opportunities under the microscope, and is confident of completing further transactions in the near future.

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Soligenix (OTCQB:SNGX) shares extended their year-to-date gains on Wednesday after the biopharmaceutical company announced that it has been granted a U.S. patent for its Thermovax vaccine thermostabilization technology. 

The company, which is focused on developing products to treat inflammatory diseases and biodefense countermeasures, says the patent claims encompass composition of matter and methods for the technology, which is exclusively licensed to Soligenix by the University of Colorado. 

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.

This is because the technology allows the production of thermostable vaccines that do not require storage at refrigerated temperatures.

The patent claims granted Wednesday describe methods of preparing an "immunologically-active adjuvant-bound", thermostable, freeze dried vaccine composition, in which the vaccine uses conventional adjuvants comprised of aluminum salts, the company said. 

It added that aluminum salts are commonly used as adjuvants in many vaccines, including those administered to children. 

ThermoVax was developed specifically to overcome the problems that are encountered with freeze-drying vaccines that contain aluminum adjuvants while simultaneously engineering them to withstand extremes of temperature. 

"The granting of the thermostabilization patent is a significant milestone for the ThermoVax program and is a critical component in our commercialization strategy for vaccines that can avoid the increased costs and logistical burdens associated with cold chain storage and distribution," said president and CEO, Christopher J. Schaber, in the release Wednesday. 

"We expect that the introduction of an effective technology for long-term stabilization of vaccines has the potential to be a major advance in the national effort to develop effective countermeasures and therapies for significant biothreats and emerging pathogens."

Schaber also said the company has 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. 

Soligenix is also working to advance its biotherapeutics business, where it 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. In phase 1 trials, it was shown to reduce the severity and duration of oral mucositis and induce anti-inflammatory activity. 

Shares of the company were trading at $1.21 early Wednesday, with its shares more than doubling year-to-date. 

ImmuPharma’s (LON:IMM) £50mln equity draw-down facility has strengthened the company’s hand in negotiations with companies interested in licensing its lead drug candidate, Lupuzor.

The five-year funding package, one of the biggest deals of its kind in London, is to fund the late-stage development of Lupuzor, its breakthrough drug for auto-immune disease lupus.

It will allow ImmuPharma to take its potential blockbuster through phase-III clinical trials as it continues discussions with major drugs companies.

However, chief executive officer Dimitri Dimitriou told Proactive Investors that the funds would also be sufficient for ImmuPharma to go it alone and take the drug all the way to market.

“I’ve said publicly we are in discussions [with potential licensing partners]; we’ve been in discussions for about a year. It is difficult to predict the timeline, but I am confident that at some point a deal will be announced,” Dimitriou said.

Having the option of financing the whole show itself puts ImmuPharma “in a better position”, the chief exec avowed.

It would be unusual, though not unprecedented, for a company of this size to take a drug into the final stage evaluation, never mind all the way to market; usually big pharma is brought in to share the financial burden and the risk.

However, there are a number of factors that count in favour of Lupuzor, which has a unique mechanism that modulates the immune system.

Chief among them is the fact the drug has already been given fast track designation with a Special Protocol Assessment (SPA) by America’s Food & Drug Administration (FDA).

This SPA is an important sign-off on the company’s clinical trial protocols.

The agency is essentially saying that, assuming no unforeseen issues, it will approve the drug if it matches or exceeds certain criteria.

Since this all happens before the data is generated, the FDA tends to be conservative when handing out SPAs.

ImmuPharma has also received sign-off in Europe and Japan that will allow it move into the final clinical trial stage.

Separately, a recent survey of rheumatologists carried out by Decision Research also highlighted Lupuzor as potentially offering substantial improvements over current treatments.

Last month the group signalled it was looking at alternative methods of unlocking the potential of Lupuzor, other than tying up a deal with a large pharma company.

The group previously had a deal with emerging biotech Cephalon before that company was taken out by the generic drug maker Teva and the rights to the treatment were handed back.

ImmuPharma chief executive Dimitri Dimitriou said: "In addition to our ongoing discussions with pharmaceutical companies for another licensing deal such as our previous one with Cephalon, we have been exploring attractive and creative options to advance Lupuzor.

“We are delighted to have obtained the support and funding ability to take Lupuzor to commercialisation.

“This strengthening of our position creates an inflection point with both new institutional investors whose investment criteria is based on phase III compounds and also with pharmaceutical companies that are keen on commercialising late stage compounds."

The five-year funding package will be provided by Darwin Strategic, owned by Henderson Global Investors.

The deal looks well timed, with ImmuPharma’s shares up almost 16% over the last week.

ImmuPharma’s (LON:IMM) £50mln equity funding package agreed with a subsidiary of Henderson Global Investors “mitigates risk” and provides “external validation” for the firm’s plans to take its lead drug into late-stage clinical trials.

This is the conclusion of Panmure Gordon analyst Savvas Neophytou, who has morning restated his ‘buy’ advice and 150 pence a share price target.

The stock was unchanged at 40 pence after it revealed the equity drawdown deal with Darwin Strategic.

The five-year package will allow ImmuPharma to take Lupuzor, a potential blockbuster drug for the treatment of the auto-immune disease lupus, through the phase III clinical trial process, while it continues to talk to potential industry partners.

While not unprecedented, it is unusual for a company of this size to take a drug into the final stage evaluation; usually big pharma is brought in to share the financial burden and the risk.

However, there are a number of factors that count in favour of Lupuzor, which has a unique mechanism that modulates the immune system.

Chief among them is the fact the drug has already been given fast track designation with a Special Protocol Assessment by America’s Food & Drug Administration.

“The dilution impact [of the fundraising] cannot be calculated and may never actually happen if the company finds a licensing partner in coming months, but today's development does provide an external validation of the product's credentials and mitigates financial risk,” said Panmure’s Neophytou.

“Lupuzor could be a significant greenfield opportunity for ImmuPharma investors and we can now begin to look forward to the start of phase III trials. We view this as a significant development particularly as it will be under SPA.”

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China. 

The struggle for any ambitious biopharma group is finding sufficient cash to take a breakthrough treatment to the point where it maximises value for the company and its investors.

For e-Therapeutics (LON:ETX), the Oxford and Newcastle-based pioneer of network pharmacology, the funding silver bullet was fired in March when it successfully concluded a £40mln cash call.

Reflecting a strong interest in the story, the new stock was issued at a modest premium to the prevailing share price, while a number of new blue-chip institutions were ushered onto the shareholder register, including Aviva, which now has just over 16% of the firm.

Of course, those who have followed the e-Therapeutics story will know the group stands out among its peers as having an impressive institutional base, led by Invesco, which holds 49.8%.

The £40mln added to what the group already had in the bank gave it £48mln, and means it can take its lead therapy, cancer treatment ETS2101, through to the conclusion of phase II clinical trials by 2017.

The risk-reward equation suggests this is the optimal point for value creation. There have been examples where hubris has trumped common sense and small firms have shouldered the huge costs of a final stage trial to disastrous effect.

Bringing in big pharma at the successful conclusion of phase II studies mitigates the financial risk as well as potentially replenishing the coffers with significant upfront and milestone payments, as well as possibly a contribution to historic costs. 

For a drug that makes it onto market, royalties can provide a significant income stream for the smaller firm.

This is the way the model should work. However, London’s investors, scarred by past failures (and there have been too many to list), have tended to be very sparing with their investment in the sector and consequently unwilling to bankroll a drug to this value creation sweet spot.

Of course, this has made for a meagre existence for many of the scores of smaller firms trying to eke out enough cash to get them to the next landmark.

And it is why e-Therapeutics’ successful cash call stands out as extraordinary in the current tight equity market.

Whether it signals a change in mind-set is not known, said Dr Daniel Elger, chief financial officer of e-Therapeutics.

But what he, chief executive Malcolm Young and development director Steve Self, were able to deliver was a coherent road map through the clinical trial process – one it is hoped will, ultimately, create significant upside for investors.

“We were fortunate in having very good support from existing investors – Invesco already had a large stake in the business – and we also managed to garner support from important new investors such as Aviva,” said Elger.

“We found there was support for our story – how general that is I don’t know.

“Everyone still says what a tough funding climate it is. But it shows if you have the right story and the right proposition then there is money to support an enterprise.

“I think we had a very clear proposition and rationale that set out what we could achieve if we raised this money.”

The primary goal is to fund the development of cancer treatment ETS2101 through further trials, including a proof-of-concept phase II study in its lead indication of glioma, a type of brain tumour.

Around £25m has been earmarked to pursue the principal glioma indication, together with four to six additional solid tumour indications.

“We had some particularly encouraging pre-clinical data in the brain cancer setting,” said Elger.

“This is a drug we know crosses into the brain and there are a lot of cancer drugs that might work against brain cancer that never get into the brain.”

A phase I trial in the US is currently recruiting up to 24 patients  with brain cancer, while a second trial in the UK is enroling up to  45 patients with a variety of solid tumours.

e-Therapeutics announced some preliminary findings from its trials with its annual results this week, which were hugely encouraging. Key  data on dosing and safety are expected from the US trial in the fourth quarter of this year and from the UK trial in the first three months of 2014.

Much of the balance of the cash raised will be used to propel new drug discovery programmes forward using the company’s network pharmacology platform.

This cutting-edge science underpins a new way to discover compounds, which was designed with the aim of reducing the number of drugs that fail in clinical trials.

As impressive is the ability to find completely new medical uses for products already out on the market, and the potential to derive medicines for diseases that are currently poorly treated or not treatable at all.

According to City research firm Edison, the focus of new drug discovery will be firmly on cancer and central nervous system disorders. 

Overlooked in all of this is ETS6103 for depression, e-Therapeutics’ most advanced drug candidate, which is earmarked to enter phase IIb trials this quarter.

“If the results are positive then we will look to a partnering deal,” said Elger.

However, the fundraising has put the company in the enviable position of being able to choose exactly when it teams with other organizations on ETS6103 or any subsequent drug candidates that trickle out of the pipeline.

While its cornerstone investors are aware of e-Therapeutics’ huge potential, the current share price, even after a decent bump in value, suggests wider market is yet to join the dots. 

Panmure Gordon’s valuation of 70 pence is exactly double the current share price. Analyst Savvas Neophytou concludes: “e -Therapeutics possesses a technology platform that could revolutionise the way the pharmaceutical industry conducts drug development. 

“The platform is increasingly accepted as credible, and the company has intellectual property that puts it in a position of strength, which may necessitate others paying it a licensing fee or, alternatively, result in the company being acquired.”

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

City broker N+1 Singer has raised its valuation of Oxford Pharmascience (LON:OXP) by 33% to reflect the potential of its adaptation of a top selling painkiller.

Its target price rises to 9.2 pence a share, representing a significant premium to the current share price of 3.92 pence.

The upgrade follows pre-clinical data last week that indicated OXPzero ibuprofen could reduce stomach irritation side-effects.

While the study was only conducted on mice, the breakthrough could be significant.

The genetic and biological characteristics of mice are close to those of humans, which is one of the reasons they are so widely used in medical research.

The pharmacological trial showed that Oxford’s OXPzero Ibuprofen material reduces the irritation and ulcerating damage of ibuprofen.

Ibuprofen, along with the likes of aspirin and paracetamol, is one of the main “go-to” pain killers available over the counter today.

It has long been proved to be effective in easing pain and swelling, and is a member of a group of medicines called non-steroidal anti-inflammatory drugs, or NSAIDs for short.

According to the NHS, ibuprofen can cause a number of side effects, including nausea, vomiting, diarrhoea, indigestion and abdominal pain.

“The successful data from the proof of concept pre-clinical trial is a very significant and important step for the group,” said N+1 analyst Sheena Berry.

“The initiation of the NSAIDs programme is very interesting and one that could be very rewarding given the size of the US$12bn NSAIDs market.

“The change in focus to the higher value pharmaceutical market in 2011 is proving to have been a pivotal decision and one, in our view, that has the potential to reap significant benefits.”

Since hitting a low in September last year the stock advanced more than 330%, but is still valued at less than £30mln.

However, analyst Berry remains optimistic on the outlook for the stock.

 “We continue to be extremely upbeat about the group as it continues its drive to become a major player in the re-formulation market,” she added.

e-Therapeutics (LON:ETX) is making encouraging progress on its existing drugs candidates but with a healthy cash position, it is already looking at adding to its development portfolio.

Shares shot up on Tuesday after the group revealed encouraging news from the phase I trial of its lead drug, ETS2101.

Seventeen patients have now been treated in the UK trial of ETS2101, a treatment for cancer. No serious adverse events have been attributed to ES2101, although one patient had severe fatigue after receiving the drug and continued treatment at a lower dose.

A patient with oesophageal cancer has experienced a partial response according to RECIST, a standard method for assessing the impact of treatments on tumour burden.

Chief financial officer Dr Daniel Elger cautioned against getting too carried away, as this is a finding from a single patient, but conceded the news is obviously encouraging.

“It is still too early to draw conclusions from the trials,” he said. “We’re still at an interim stage,” he told Proactive Investors.

As well as the UK trial, which is in patients with solid tumours, there is another phase I trial taking place in the US, on patients with brain cancer.

Both the UK and US studies continue to recruit patients and the company expects key data from the brain cancer trial in the fourth quarter of 2013 and from the solid tumour trial in the first three months of  2014.

The company stands ready to whisk the cancer drug into efficacy trials if phase I trials over the coming year go well.

The group had £48mln in cash and liquid resources at the end of March, following its successful equity placing, which should be enough to fund its business into 2017, including completion of key efficacy trials of ETS2101, its lead cancer drug.

The money is also sufficient to broaden its portfolio through new drug discovery programmes, the company said in a statement announcing results for the year to the end of January 2013.

“Our recent £40 million fundraising leaves us even better placed to pursue our goals, with a cash runway that now extends to a potential partnering deal for our lead cancer drug and resources sufficient to generate a diversified portfolio of assets over the next 3-4 years,” said Elger.

The group will make a decision in the final quarter of this year on which drug to add to the development pipeline, though the group is clearly already mulling its options.

As chief executive Professor Malcolm Young explained to Proactive Investors, the company is looking to pick “real winners”.

“In several of these programmes we have been looking at literally thousands of molecules,” Young revealed.

It is matter of winnowing it down to the most likely prospects.

“The key is quality, something that really sticks out and which solves a key unmet medical need.” he asked.

The company is likely to focus on areas “it already has a bead on,” such as oncology (cancer) and nervous system disorders, and where the company’s research can be used to address other diseases that share the same kind of physiological traits.

In other news, the group has now filed a Clinical Trial Application with the UK’s Medicines and Healthcare Products Regulatory Agency for a phase IIb trial of ETS6103, its anti-depressant.

The group expects to start enrolling patients at or around the end of the second quarter of this year.

The trial will build on an earlier, small phase IIa study that produced encouraging results with ETS6103 in comparison with the approved tri-cyclic anti-depressant amitriptyline.

It will include more patients and a longer period of treatment than originally planned, so results will now probably be published in the second half of 2014.

The filing is an example of the sort of news flow shareholders can expect over the next year or so.

“News flow is now hitting a sweet spot after last year when a lot of the activity was going on below the surface. We’re getting into our stride now,” Young told Proactive.

---ADDS BROKER COMMENT AND UPDATED SHARE PRICE---

e-Therapeutics (LON:ETX) has been encouraged by the first findings of the phase I trial of its lead drug, ETS2101.

The company stands ready to whisk the cancer drug into efficacy trials if phase I trials over the coming year go well.

The group had £48mln in cash and liquid resources at the end of March, following its successful equity placing, which should be enough to fund its business into 2017, including completion of key efficacy trials of ETS2101, its lead cancer drug.

The money is also sufficient to broaden its portfolio through new drug discovery programmes, the company said in a statement announcing results for the year to the end of January 2013.

“Our recent £40 million fundraising leaves us even better placed to pursue our goals, with a cash runway that now extends to a potential partnering deal for our lead cancer drug and resources sufficient to generate a diversified portfolio of assets over the next 3-4 years,” said company chief financial officer, Dr Daniel Elger.

Eleven patients have now been treated in the UK trial of ETS2101. No serious adverse events have been attributed, although one patient had severe fatigue after receiving the drug and continued treatment at a lower dose.

A patient with oesophageal cancer has experienced a partial response according to RECIST, a standard method for assessing the impact of treatments on tumour burden. Both the UK and US studies continue to recruit patients and the company expects key data from the brain cancer trial in the fourth quarter of 2013 and from the solid tumour trial in the first three months of  2014.

The group has now filed a Clinical Trial Application with the UK’s Medicines and Healthcare Products Regulatory Agency for a phase IIb trial of ETS6103, its anti-depressant, in major depressive disorder.

The group expects to start enrolling patients at or around the end of the second quarter of this year.

The trial will build on an earlier, small phase IIa study that produced encouraging results with ETS6103 in comparison with the approved tri-cyclic anti-depressant amitriptyline.

It will include more patients and a longer period of treatment than originally planned, so results will now probably be published in the second half of 2014.

The group, which has no sales revenue at present, saw losses widen slightly last year to £4.2mln from £3.2mln the year before, reflecting increasing investment in drug discovery and development programmes.

Commenting on the results, Professor Malcolm Young, chief executive officer of e-Therapeutics, said: “We have growing momentum in the key areas of our business. Use of our innovative network pharmacology platform to discover new drugs is on track while our most significant product candidate, the cancer drug ETS2101, is making good progress in the clinic.”

The share price advanced 15% to 34.4 pence, valuing the Newcastle-based group at £48mln.

However City broker Panmure Gordon believes the stock has further to go as tweaked its target 3 pence higher to 70 pence a share.

Analyst Savvas Neophytou said: “We had been anticipating safety data from the company’s lead product candidate ETS2101 in the fourth quarter.

“Therefore it was a positive surprise to hear today’s announcement of strong success in the treatment of one particular patient whose tumour was greatly reduced in size.

“This sector is not used to success so the pessimists will scream sample size, chance event and other such instruments of caution.

“They would be right from a purist point of view but the fact remains one particular patient who had ran out of all therapeutic options is still alive as a result of ETS2101 and that is a significant achievement for the company’s first shot at goal.”

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

-- adds broker comment --

Tissue Regenix (LON:TRX) has made significant progress towards commercialisation of its regenerative medical technology over the past year, it said today.

The company, which has a patented technology, dCELL, that allows human or animal tissue to be used again for skin or body part replacement in other patients, added that the market for tissue engineering is large and growing quickly.

In the area of wound repair and following on from a successful chronic ulcer trial in the UK, discussions have begun on initiating a clinical study in the US.

Approval was also received in April for a UK clinical research trial of dCELL dermis matrix in treating acute wounds.

In cardiac, a porcine pulmonary valve is being translated from the work done at the University of Leeds and pre-clinical work is planned for this half-year.

In the vascular area, a pilot study for the AV graft is now in progress and is on course for a pre-clinical study in the second half of this year.

In orthopaedics, regulatory application to start a clinical trial in Europe for its knee cartilage replacement will be submitted in the first half of 2014 when biomechanical testing and refinement of the suturing technique has been completed.

The ligament repair product will be in pre-clinical studies by the end of 2013 with discussions underway with the US Food and Drug Administration over approval requirements for the US market.

Antony Odell, Tissue Regenix’s managing director, added: “We are also moving ahead with our expansion into the US, and are currently in discussions with prospective product manufacturers and distributors, as well as exploring the possibility of clinical trials with major academic institutions and key opinion leaders to support marketing efforts in the US in 2014.

“Tissue Regenix has a portfolio of dCELL Scaffolds, enabling clinicians to get the right tissue for the application area rather than trying to make one tissue type perform a multiplicity of clinical roles that it was not designed to do. 

“As we roll out this portfolio, this clear distinction from other approaches will become an important factor in our future success.”

The group posted a loss of £3.5mln (£2.7mln) in the year to January, with a closing year-end cash position of £24.2mln.

Panmure Gordon said the cash balance was slightly higher than forecast and while the addition of US infrastructure will accelerate cash burn, it demonstrates that Tissue Regenix remains on a good trajectory for growth. 

The company has also received good data on its dermis product, while there is growing evidence of stem cells being attracted to re-populate the company’s dCELL matrix in vascular patches, said the broker.

The marquee product, its heart valve technology that is already on the market in Brazil, now also has eight years worth of supporting data.

Panmure believes that if become Tissue’s technology platform becomes successfully commercialised it will become a bid target.

“It has multiple shots at goal and a strong balance sheet to execute its strategy. Therefore, we remain buyers and re-iterate our price target of 18p,” said the broker.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Vancouver-based Advanced Proteome Therapeutics Corp (CVE:APC) says it has signed an agreement with the Stanford University School of Medicine to test protein conjugates and multimers as part of the company's Foundation Trinity cancer treatment. 

Stanford will be testing Advanced Proteome's protein modifications to determine their effects on tumors in a number of cancer disease states. 

“We are extraordinarily fortunate in having Stanford’s participation in our program involving cancer therapeutics. The School of Medicine’s expertise is unrivaled in APC’s areas of interest," said Advanced Proteome's president and CEO, Dr. Allen Krantz. 

Advanced Proteome has a potential three-in-one cancer treatment that acts as a targeted, combination and homogeneous therapy - all in a single agent. The company's technology is based on a proprietary platform that can be used to attach known therapeutics to specific sites on proteins - in this case, proteins that have shown affinity for specific cancer cells, hence the targeted and combination therapy. 

The attachments are designed to boost the properties of the protein targeted for the specific cancer cells, giving it additional therapeutic abilities. 

The homogeneity aspect of Advanced Proteome's therapy originates from the use of a protein not only as a delivery system, but also as a scaffold on which to attach each anti-cancer entity to its own specific site on the protein, and allows the company to produce single agents, or protein conjugates, bearing multiple therapies. 

The news today of an agreement to test the protein conjugates follows a similar deal with the University of Iowa, inked back in late April, as part of the company's program of preclinical testing of its proprietary protein modifications. 

The first round of testing of the single agents will screen for their ability to target cancer cells specifically, and for any obvious toxic effects on healthy cells. 

Advanced Proteome says it also expects that any promising agents will undergo animal testing in a second round, to determine the potency and toxicity of the therapy.

Investors are indeed tuning into the company's progress and development plans, with its shares having doubled in value since the start of the year, rising 100 per cent to close on Friday at 18 cents per share, up from 8.5 cents at the beginning of January. 

Xenetic Biosciences (LON:XEN) has completed the Phase I, safety trial for its multiple sclerosis (MS) treatment MyeloXen and is now treating patients to establish dosing levels.

The Phase I trial passed without any adverse event on six healthy volunteers and its Russian partner, Pharmsynthez, has now started Phase II where 12 patients will receive escalating dosing levels to establish the safe dose level for MyeloXen.

The final element of the trial will test the dosing range for further safety, surrogate efficacy and mode of action analysis.

MyeloXen has been formulated using Xenetic’s ImuXen liposomal entrapment technology and is one of up to six candidates being investigated under a  Co-Development Agreement between Xenetic and St Petersburg–based Pharmsynthez. The global market for MS treatments is currently estimated to be worth US$20bn.

Scott Maguire, Xenetic’s chief executive, said: "The move to dosing MS patients represents an important milestone in this clinical trial. We now have all our platform technologies as represented by their respective products at least in Phase II clinical trials.

“We are encouraged with the announcement yesterday on the commencement of the ErepoXen Phase III trial for the treatment of anaemia, where our Russian partners are now making significant progress on our collaboration. We expect to make further announcements on additional clinical candidates in due course."

Medgenics (LON:MEDG) aims to  achieve "value creating" milestones in the rest of 2013,  it said, releasing first quarter results.

The company is developing Biopump technology, which uses patients' won tissue to treat a range of chronic diseases including hepatitis and hemophilia.

"During the first quarter we achieved important milestones that strengthened our position in key areas and advanced our strategic and clinical goals," said chief executive and president Andrew Pearlman.

In the period to March 31, the firm raised gross proceeds of around $32 million, reported interim clinical results from its Phase IIa anemia trial in patients with end-stage renal disease and bolstered its board with Joseph J. Grano, Jr - former chairman and chief executive of UBS Financial Services.

Gross research and development (R&D) expenses for the first quarter of 2013 increased to US $2.03 million from US$1.59 million for same period in 2012.

The net loss stood at  US$3.68 million compared with a net loss of $2.71 million in the comparable 2012 period. 

In the quarter, it used US$2.80 million in net cash to fund operating activities, compared with US$2.36 million for the three months last year.

Shares in Oxford Pharmascience (LON:OXP) advanced a further 2% on Thursday and built on Wednesday’s gains as the market continued to digest data on its safer iteration of a top selling painkiller.

OXP’s study indicated its OXPzero Ibuprofen could reduce stomach irritation side-effects.

While the research was only conducted on mice, the breakthrough could be significant.

The genetic and biological characteristics of mice are close to those of humans, which is one of the reasons they are so widely used in medical research.

The pharmacological assessment showed that Oxford’s OXPzero Ibuprofen material reduces the irritation and ulcerating damage of ibuprofen.

Broker N+1 Singer said the results were a “very significant and important” step for the group and added that that OXP product had “remarkable potential”.

“There are over 30 million people consuming NASIDs (non-steroidal anti-inflammatory drugs) every day, generating around US$12 billion in annual sales, providing a very attractive opportunity to the group,” said analyst Sheena Berry.

“We note the impressive share price performance over the last seven months and believe this momentum should continue as the company progresses its programmes through development.”

At 1pm, the shares were changing hands for 4 pence each and their value has increased 150% in the past year.

Xenetic Biosciences (LON:XEN) has dosed the first patient in its phase III trial for ErepoXen, its PSA-EPO treatment for chronic anaemia.

Sufferers have fewer red blood cells or less than the normal quantity of haemoglobin in the blood, which leads to hypoxia (a lack of oxygen) in organs, because haemoglobin, found inside red blood cells, normally carries oxygen around the body.

EPO stimulates the production of red blood cells and is best known as an illegal enhancement used by professional cyclists to boost their endurance levels.

Xenetic said ErepoXen has already demonstrated in over 100 subjects in Phase I and II(a) clinical trials for end stage renal disease patients that it has the potential to be a long-acting EPO, with a likely dosing profile of once per month.

The Phase III study will take place in Russia and involve treatment periods of 24 weeks for 150 male and female patients between 18-75 years of age with established Stage 3 or 4 chronic kidney disease not currently requiring dialysis.

The primary objective is to compare the efficacy of ErepoXen with current market leader Aranesp, which recorded global sales of over US$2bn in 2012.

Scott Maguire, Xenetic’s chief executive, said: "With the commencement of this Phase III trial in Russia, ErepoXen is now the most advanced candidate in our portfolio, and with our double-digit royalty agreement with SynBio, we can now see the potential of a recurring revenue stream.”

Medgenics (LON:MEDG) aims to  achieve "value creating" milestones in the rest of 2013,  it said, releasing first quarter results.

The company is developing Biopump technology, which uses patients' won tissue to treat a range of chronic diseases including hepatitis and hemophilia.

"During the first quarter we achieved important milestones that strengthened our position in key areas and advanced our strategic and clinical goals," said chief executive and president Andrew Pearlman.

In the period to March 31, the firm raised gross proceeds of around $32 million, reported interim clinical results from its Phase IIa anemia trial in patients with end-stage renal disease and bolstered its board with Joseph J. Grano, Jr - former chairman and chief executive of UBS Financial Services.

Gross research and development (R&D) expenses for the first quarter of 2013 increased to US $2.03 million from US$1.59 million for same period in 2012.

The net loss stood at  US$3.68 million compared with a net loss of $2.71 million in the comparable 2012 period. 

In the quarter, it used US$2.80 million in net cash to fund operating activities, compared with US$2.36 million for the three months last year.

. 

Wednesday’s announcement of a successful study indicating OXPzero ibuprofen could reduce stomach irritation side-effects is a step forward in an archetypal Oxford Pharmascience (LON:OXP) low-risk/high-reward programme.

While the study was only conducted on mice, the breakthrough could be significant. The genetic and biological characteristics of mice are close to those of humans, which is one of the reasons they are so widely used in medical research.

The pharmacological study showed that Oxford’s OXPzero Ibuprofen material reduces the irritation and ulcerating damage of ibuprofen.

Ibuprofen, along with the likes of aspirin and paracetamol, is one of the main “go-to” pain killers available over the counter today. It has long been proved to be effective in easing pain and swelling, and is a member of a group of medicines called non-steroidal anti-inflammatory drugs, or NSAIDs for short.

According to the NHS, ibuprofen can cause a number of side effects, including: nausea, vomiting, diarrhoea, indigestion and abdominal pain.

Less common side effects include: headache, inflammation of the stomach (gastritis), duodenal or gastric ulcers.

The results from the tests on mice, if repeated in humans, could see the irritation and ulcerating damage of ibuprofen significantly reduced.

For Oxford Pharmascience this is potentially big news.

“It could increase the number of people able to take ibuprofen, and it could enable existing users to increase the frequency of the dosage,” Oxford’s chief executive officer Nigel Theobald told Proactive Investors.

That could increase the size of the ibuprofen market, estimated to be worth US$12bn in annual sales globally, but more importantly, it could give the UK company a shot at a significant slice of this enormous market.

After all, given a choice between an ibuprofen tablet that is going to upset your tummy and possibly even cause ulcers and internal bleeding, and a product that minimises the prospect of unpleasant side effects, which are you going to choose?

OXPzero has already been used to develop ibuprofen products, including chewable tablets and suspensions, without any irritation or burn in the throat. With products created using Oxford’s technology, Mary Poppins would not need the spoonful of sugar to help the medicine go down.

The latest breakthrough is something different, though.

“This extends the OXPzero proposition beyond taste masking into the area of gastrointestinal side effects,” Theobald stressed.

Theobald said the company would now press ahead with a programme to develop a range of safer NSAIDs that are less likely to cause gastric irritation.

Following a successful fund raising in February, Oxford has the firepower to instigate this programme without having to divert resources from its other programmes, such as the highly promising cholesterol-lowering statin development.

“We’ll be able to develop in parallel, rather than in series, “ Theobald explained.

“It’s a classic example of what we do. It’s what we call re-engineering of everyday drugs that have issues. There’s nothing wrong with ibuprofen, but it has some issues, such as gastrointestinal irritation, so we want to address those.”

By focusing on drugs that have already passed all the regulatory hurdles, Oxford saves itself an enormous amount of time, energy and money. Instead of say, an uncertain journey to market that could take several years, as is the case with a new drug discovery, re-engineering an existing drug offers a safer, shorter journey to market.

“By re-developing existing drugs to make them safer or easier to take, we can access the high value returns associated with new drugs but for a fraction of the cost and with a much quicker timescale," Theobald said.

If all goes well, Oxford should have a full range of safer NSAIDs available to the market by 2016, thereby opening up the huge NSAIDs market to its reformulation technology. By full range, the company means the likes of diclofenac, naproxen and our old friend aspirin.

By any measure, that's news that is easy to stomach.

Tests on laboratory mice have given a big boost to Oxford Pharmacience’s (LON:OXP) OXPzero technology.

As anyone who has read the small print on the back of a packet of Ibuprofen will know, one of the major drawbacks to taking the medicine, and other non-steroidal anti-inflammatory drugs (NSAIDs), is the possibility of gastric irritation (GI).

A recent pharmacological study in mice has demonstrated that OXPZero Ibuprofen material reduces the irritation and ulcerating damage of ibuprofen.

The tests indicate that Oxford’s OXPzero technology may have a bigger future in the lucrative NSAIDs market worldwide than previously thought.

NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day and annual sales of US$12 billion, but the market could be bigger still if a company can crack the problem of GI side effects. These side effects include ulcers and bleeding and lead to significant morbidity and mortality in many patients.

Nigel Theobald, chief executive officer of Oxford Pharmascience commented: "We will now use this breakthrough in our research to begin a programme to develop a range of safer NSAIDs with much lower gastric irritation. OXPzero has already been developed for ibuprofen and will now be incorporated into high dose tablet formats of 400mg and above.”

New versions of other popular NSAIDs such as diclofenac, naproxen and aspirin will also be developed.

One of the advantages of Oxford Pharma’s focus on out of patent or nearly out of patent drugs is that the bulk of the drug development and regulatory hoop-jumping has been done, which means Oxford’s development programmes are comparatively inexpensive and swift. As such, a full range of OXPzero safer NSAIDs could be on the market as early as 2016.

Shares in Oxford Pharmascience shot up 6.2% to 4.01p on the news.

Pivotal Therapeutics (OTCQX:PVTTF) (CNSX:PVO), a specialty pharmaceutical company focused on Omega-3 therapies for cardiovascular disease (CVD), revealed today results from its Vascazen "Reveal" clinical trial, saying the product was "highly effective" in correcting an Omega-3 deficiency. 

The company's product, Vascazen, is an FDA-regulated medical food product developed to lower cardiovascular health risks in Omega-3 deficient cardiac patients, including high triglycerides, or fatty substances in the blood that are associated with coronary disease. 

The 90 percent-pure product, which was introduced in the U.S. in November 2011, provides those suffering from heart disease with levels of the most important Omega-3 fatty acids in fish oil – EPA and DHA – that the company says are ideal, and cannot be achieved just through simple changes in diet alone. Omega 3s are widely known to result in improved blood flow, reduced inflammation, and positive effects on lipid metabolism. 

The main aim of the Reveal trial, which the company says has been met, was to show that cardiovascular disease patients are nutritionally deficient in Omega-3 fatty acids, and through treatment with Vascazen, such deficiency can be corrected - resulting in improved patient lipid profiles, and ultimately reducing risk factors of heart disease. 

Lipid profiles are an entire panel of blood tests that serve as an initial broad medical screening tool for abnormalities in lipids, such as cholesterol and triglycerides. 

After eight weeks of treatment, the company said Tuesday a "statistically significant" increase of 121 per cent in the Omega-Score and 112 per cent in the Omega-Index - both diagnostic tests that measure circulating blood levels of Omega-3 in individuals - was seen in the Vascazen-treated subjects. 

The double blind, placebo-controlled study, which was made up of 110 subjects, analyzed both the placebo and Vascazen-treated groups at baseline and after eight weeks of treatment. 

Pivotal told investors today that the trial also revealed that secondary goals, such as triglyceride reduction, exceeded company expectations. 

It said the median placebo adjusted reduction in triglycerides in the Vascazen treatment group was 48 per cent, a "statistically significant" figure. Levels of HDL, known as the "good cholesterol", actually increased by 9 per cent, without negatively impacting levels of LDL - or the "bad cholesterol". 

The safety profile of the product was found to be similar to placebo, with no treatment-related serious adverse events reported. 

“We are very pleased with the results of the VASCAZEN®-REVEAL trial,” said chairman and chief scientific officer of the company in a statement Tuesday, Dr. George Jackowski, who just last week was awarded the Queen Elizabeth II Diamond Jubilee Medal for his contributions to the Canadian biotech and pharmaceutical industries.

“Both primary and secondary endpoints were met, with the evidence supporting the efficacy of VASCAZEN® in correcting an Omega-3 deficiency and addressing some important CVD risk factors, such as patient lipid profiles. 

"The statistically significant elevation in Omega-3 levels, drop in triglycerides, and the elevation of HDL cholesterol, all in eight weeks, evidences the deficiency is being corrected and patients are seeing results."

He further says that the positive data from the trial, which were presented earlier this month at the American Heart Associationʼs Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions, show that Vascazen could be an important treatment option for correcting an Omega-3 deficiency, "thereby reducing CVD risk factors including high triglycerides in patients who do not meet the current criteria for pharmaceutical treatment targeting high triglycerides.”

Indeed, the dual-listed company says its medical food product has carved out a niche, for the dietary management of patients with cardiovascular disease that are deficient in Omega-3 fatty acids - a much broader market than for Lovaza, the first prescription Omega-3 to market, after which Vascazen followed.  

Lovaza, which is owned by GlaxoSmithKline, is indicated exclusively for the reduction of "very high" - 500 mg/DL- triglyceride levels in adults. 

The Reveal study has also confirmed what Pivotal saw in its earlier open label study in 2011, which identified more than 80 per cent of cardiovascular disease patients as Omega-3 deficient, the company said. 

Vascazen, which avoided the lengthy FDA pre-approval process that is required with drugs, is available with a prescription in all major pharmacies throughout the U.S. Currently, the company's sales reps are focused on the eastern seaboard in the U.S., which contains the highest prevalence of cardiovascular disease-related illness in the nation.

About CS-6

CS-6 belongs to a new class of drug candidates intended to treat most forms of cancer in a comprehensive manner, targeting both cancer cells and their progenitor cells, cancer stem cells.

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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.