In a leap forward for viral medicine no less important than the first studies in HIV decades ago, Medgenics, Inc. (AMEX:MDGN) is set to begin two human clinical trials for its INFRADURE Biopump to test a continuous release of naturally-produced interferon alpha for hepatitis C.
This may, perhaps someday pit it against widely-used PEG-interferon/ribavirin with its host of highly unpleasant side effects such as debilitating flu-like symptoms, depression, bloody diarrhea, and a potential for developing Type 2 diabetes. Israel's Ministry of Health has just approved Medgenics to begin two different clinical trials. One of these studies is comprised of patients that have had no previous treatment for their disease. Those patients will be given Medgenic's Biopump as the first-line of therapy. The special significance for Medgenics is that it is often challenging to persuade regulators to use a new medical modality the first time a patient is being treated, and the Israeli Ministry of Health's agreement to the study's design should be viewed as a testament to the confidence Medgenics is winning from those who will ultimately make the decisions for the treatment's approval. The other study is comprised of a group of patients who have previously been treated for hepatitis C and relapsed.
Timing could not be better for Medgenics. Recently, Bristol-Myers Squibb (NYSE:BMY) yanked its clinical trial of a hepatitis C compound quite far along in the process - a nucleoside inhibitor that caused the death of one patient and the hospitalization of others. Unfortunately, Gilead Sciences (NASDAQ:GILD), Vertex Pharmaceuticals (NASDAQ:VRTX), Identix Pharmaceuticals (NASDAQ:IDIX), and Achillion Pharmaceuticals (NASDAQ:ACHN) all have similar drugs in phased trials. Before Merck & Co. (NYSE:MRK) and Vertex joint-released INCIVEK combination therapy, there had not been a new drug on the hepatitis C landscape for ten years. Even this drug, far from perfect with the addition of a protease inhibitor that carries the side effects of anal rash and vomiting, racked up almost $500 million in sales last year.
It is not surprising, then, that key medical markets such as Israel and the US are moving swiftly to support Medgenics in bringing a potentially better treatment to a disease that affects more than one half of one percent of the world's population and burdens healthcare systems with expenses up to $20 billion per year.
About the Analyst: Sharon di Stefano
Sharon di Stefano has spent 20 years as a healthcare analyst, beginning her career at Smith Barney, Harris Upham & Co. specializing in medical devices, pharmaceuticals, healthcare information technology, and biopharmacology. Ms. di Stefano had also served as Senior Venture Officer for the Edison Innovation Fund, implemented through the New Jersey Economic Development Authority that provided funding for early-stage life sciences companies. Industry experience includes laboratory research for Johns Hopkins Hospital and the Department of Defense.
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