Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today reported financial results for three and nine months ended September 30, 2012.
Business Highlights of the Third Quarter and Subsequent Weeks
- Received approval from Israel’s Ministry of Health to initiate two Phase I/II studies to assess the safety and efficacy of INFRADURE™ to treat hepatitis C. These will be the first clinical proof-of-concept studies for the INFRADURE Biopump.
- Enrolled the first patients in a Phase IIa trial in Israel with EPODURE™ to treat anemia in patients with end-stage renal disease who are on dialysis, and presented preliminary data at the American Society of Nephrology’s Kidney Week 2012.
- Expanded the executive management team with the addition of Marvin Garovoy, M.D., as Chief Medical Officer. Dr. Garovoy is a biotechnology and pharmaceutical industry executive with considerable drug development experience at Genentech, XOMA, Hyperion Therapeutics, and Arriva Pharmaceuticals.
- Appointed Sol J. Barer, Ph.D. as Chairman of the Board. Dr. Barer is the former Chairman and Chief Executive Officer of Celgene Corporation.
“We made important progress during the third quarter towards our strategic and clinical goals,” stated Andrew L. Pearlman, Ph.D., Chief Executive Officer of Medgenics.“Specifically, we received approval from the Israel Ministry of Health for our Phase I/II trials in hepatitis C, with an objective of enrolling up to 16 untreated patients with hepatitis C genotype 3. This represents the first proof of concept study of INFRADURE in man. We expect to use data from this study to advance our broader INFRADURE hepatitis clinical development program, starting in the U.S., where we have received Orphan Drug Designation for hepatitis D from the U.S. Food and Drug Administration (“FDA”). Hepatitis D is a rare and aggressive form of hepatitis whose standard treatment today consists of weekly injections of interferon-alpha for a year or more, where oral antiviral treatments have not been effective. In addition, we are investigating the application of INFRADURE for hepatitis B towards addressing the emerging need for a practical, shorter treatment alternative to years of expensive oral antivirals. Hepatitis B is the most prevalent form of hepatitis, with an estimated 350 million people infected worldwide, according to the World Health Organization.