Medgenics

Medgenics is developing a unique sustained-action therapeutic protein delivery technology for the treatment of a range of chronic diseases. The technology – called a “Biopump” – is made from the patient’s own skin and is implanted in a simple procedure to work inside the patient’s body, to produce and deliver the active protein steadily over a sustained period to treat the targeted disease. Medgenics believes that this biological approach can replace a major portion of the regular and costly injections of therapeutic proteins patients currently receive.

The Company has demonstrated proof-of-principle of its treatment procedure in a clinical trial using EPODURE in anemic patients. A long-acting version of EPODURE designed to produce and deliver a therapeutic dose of EPO steadily for six months or more began Phase I/II efficacy trials in Israel in mid-2008. Clinical trials with INFRADURE are intended follow in due course.

Beyond this, the Company plans to develop a pipeline of products based on its Biopump technology targeting the large and rapidly growing global $50+ billion protein therapy market, which is expected to grow to some $132 billion per year in 2013.

Medgenics is managed by a highly experienced team of biotechnology and biomedical device experts, and its Board of Directors and Scientific Advisory Board include highly experienced figures in the healthcare industry, in healthcare finance, as well as influential figures from the medical community and academia.

The Medgenics’ Biopump technology is a combination biological/device product.

(a) The first stage is the removal (harvesting) of a sliver of dermal tissue, called a micro-organ (2-3mm diameter x 30-40mm length), from beneath the patient’s skin. This procedure is performed under a local anaesthetic, is intended to be performed in a physician’s office and is minimally invasive, so as to encourage rapid healing with little or no scarring. Generally, more than one micro-organ will be harvested from the patient (typically 4-5).

(b-e) The micro-organ is processed outside the body using a non-immunogenic adeno-viral vector to introduce the appropriate gene into the tissue’s cells and cause the cells to produce the desired protein, thus converting it into a sustained-action Biopump.

(f-i) Tests are performed during processing to determine the daily protein production from each Biopump. The appropriate number of Biopumps is thereby determined and then subcutaneously implanted back into the patient after one to two weeks.  After implantation, Biopumps are designed to maintain protein levels in the blood within the therapeutic window for up to six months or more.

Medgenics believes this technology can be applied across the large and rapidly growing global protein therapy market including the following:

Product Pipeline

Medgenics, Inc.has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is pleased to announce encouraging new results in the Company's ongoing Phase I/II clinical trials with EPODURE to treat anaemia.  As announced on 22 June 2010, two new patients have joined the Company's Phase I/II clinical trial, using Biopumps producing middle dose levels of erythropoietin ('EPO') (40 IU/kg/day). Now, through 4 weeks following treatment, these patients have shown a greater therapeutic response to the higher dose than was obtained in similar patients in the low dose group (20 IU/kg/day).  Although individual patient response to EPO dose varies, comparing the response in the corresponding patients treated with half the dose with the response in these two patients receiving the higher dose shows:

EPODURE

Medgenics has now demonstrated proof of feasibility of long acting protein therapy from a single administration in a Phase I/II dose ranging clinical trial using EPODURE to produce and deliver erythropoietin (EPO) in a steady manner for up to 6 months in anemic patients.  To date, six patients have been treated in the low dose group (20 IU/kg/day) and one patient has been treated in the mid dose group (40 IU/kg/day), and most patients have shown an elevation of their baseline hemoglobin level and a steady maintenance of their hemoglobin levels within the target range. An excellent safety profile has also been demonstrated in all patients, with no adverse events reported.  The hospital ethical committee has declared EPODURE to be safe and effective even at the low dose. The Company's Strategic and Scientific Advisory Board noted that EPODURE is proving its potential as a superior treatment over serial injections for the treatment of chronic renal anemia.

For further information on Epodure please click here

INFRADURE

INFRADURE is Medgenics’ long-acting protein therapy designed to produce a sustained therapeutic dose of interferon-alpha (IFN-α) to treat hepatitis C. INFRADURE is scheduled to commence a Phase I/II trial in Israel during 2011. 

Hepatitis C

Hepatitis C is caused by the hepatitis C virus (HCV) and causes inflammation of the liver, chronic liver disease, cirrhosis and in 1%-5% of chronic cases, liver cancer over a period of 20 to 30 years.

Chronic HCV infection is the leading cause of liver disease in the U.S. and many other western countries. 

Market Size

Worldwide, it is estimated there are 170 million carriers of hepatitis C, with three to four million new infections annually. IFN-α is the leading therapy for chronic hepatitis C infection, but is effective in only 40%-50% of patients, and its administration by periodic injections is routinely accompanied by severe side effects associated with the temporary overdose of each bolus injected. 20%-50% of patients are reported to discontinue treatment as a result of treatment side effects.

In 2005, patients received $2.8 billion worth of IFN-α to treat hepatitis C and some forms of cancer, but there is an unmet need for an IFN-α therapy with greatly reduced side effects.

For more information on Infradure please click here.

Andrew L. Pearlman, Ph.D. 

Chief Executive Officer, President and Director

Dr. Pearlman was appointed to the Board on February 1, 2000 and is the founder and CEO of Medgenics. He has over 25 years experience founding and managing biotechnology and medical device companies, as well as inventing and developing biomedical technology.

Prior to founding Medgenics, Dr. Pearlman founded and served as CEO and chief scientist for TransScan Research & Development Co., Limited, under whose leadership the company's product, the T-scan 2000 breast impedance scanner, was the first new medical imaging method for cancer detection to receive FDA pre-market approval in over 20 years. He has also founded or co-founded several other companies in the fields of diagnosis and patient monitoring.

Dr. Pearlman holds a Ph.D. in biophysics from the University of California, Berkeley, where he completed his doctoral thesis under Nobel Laureates – Professors Melvin Calvin and Donald Glaser.

Eugene Andrew Bauer, M.D. 

Executive Chairman of the Board of Directors 

Dr. Bauer has been a member of Medgenics' Board since March 2001. He has been Chairman of the Board since July 2005, assuming the role of Executive Chairman of the Board in October 2010. He is a Lucy Becker Emeritus Professor in the School of Medicine at Stanford University, having served as Dean of the Stanford University School of Medicine from 1995-2001 and as Chair of the Department of Dermatology at the Stanford University School of Medicine from 1988-1995.

Clarence L. "Butch" Dellio 

Chief Operating Officer

Mr. Dellio joined Medgenics in July 2011. He has been a consultant to a variety of emerging biotechnology and medical technology companies, providing facilities, manufacturing, clinical and regulatory expertise to therapeutics and diagnostics companies. 

Stephen Bellomo, MsME

Chief Operating Officer, Medgenics Medical Israel 

Vice President Product Development and Intellectual Property 

Mr. Bellomo has over ten years of experience in management roles in medical device and biotech industries. Prior to rejoining Medgenics in 2007, he was the CTO for Allium Medical, a urinary and gastrointestinal stent company, where he was responsible for all development and production activities. From 2006 to 2007, Mr. Bellomo was the Director of Special Projects for Glucon Medical, where he led the development of an automated glucose reader to support intensive insulin therapy in critical care applications. Mr. Bellomo held application development and marketing positions at Galil Medical, a cryosurgical device company. 

Ehud Shoshani, M.D.

Vice President of Clinical Affairs

Dr. Shoshani's 13 years' experience in managing clinical trials includes his former position as Chief Executive Officer, Medical Director and Head of Clinical Operations of the Israel division of Quintiles, the international contract research organization. In addition, he has served as Medical Director at Omrix Biopharmaceutical, a blood products company (NASDAQ:OMRI), and at Gamida Cell, a stem cell therapy company.

Phyllis K. Bellin MBA

Director of Finance & Administration 

Ms. Bellin received an MBA from Columbia University, New York and worked at Citibank (member of Citigroup Inc.) before coming to Israel in 1980. Since then, Ms. Bellin has managed finance and administration for several early stage, high-tech ventures in Israel. Most recently, she was a founder and vice president, finance and administration for Gintec Active Safety Ltd. and RoadEye Ltd.

Updated from Medgenics Website 22.05.2012