Equity Briefing: Pluristem partners with prestigious Institute for trial of multibillion dollar non toxic alternative to Plavix
A news announcement from Pluristem (PSTI) indicates that those afflicted with peripheral arterial disease, or PAD, may soon have an alternative to Bristol-Myer Squibb`s (BMY) troubled anti-clotting drug Plavix, whose drawbacks prompted the FDA to assign its most severe warning, the `black box label`, two years ago.
No pharma company has yet to market a substitute and patients are obligated to use Plavix throughout their lifetime or the risk of disease returns immediately. Pluristem, allied with the venerable Paul Ehrlich Institute in Germany, long associated with Nobel-quality researchers and counting Pluristem among the first biotechnology companies chosen to conduct cell therapy clinical trials under its sponsorship, will soon start Phase II for intermittent claudication (IC), the painful first sign of PAD. To process clinical trial data, Pluristem has chosen globally recognized Cato Research who had conducted the first cell therapy human studies by Geron Corp. (GERN) and Neuralstem, Inc. (CUR).
Unlike Bristol-Myer`s and Sanofi`s (SNY) bloated studies of Plavix that involved 77,000 patients, Pluristem`s trials will be streamlined to 150 subjects over 11 sites, most in the US, with an endpoint of 12 months based on pain-free walking distance. Like most biologics, the treatment`s safety is not an issue. There were no side effects recorded in Pluristem`s first trial for IC. Plavix, on the other hand, is burdened with a long list of adverse consequences, bleeding being the most frequent that can occur in 5% of users. Severe allergic reactions are not uncommon; neither is difficulty breathing.
The facts about Plavix got worse, however, when the New England Journal of Medicine released a study showing that for sufferers of gastrointestinal problems the risk of bleeding ulcers was 12 times higher for users of the drug compared to aspirin combined with a common heart burn medication. Years later, the FDA warned takers of Plavix that the effectiveness of the drug would be cut in half if taken with Prilosec, a major Proctor & Gamble Co. (PG) product. It is interesting that in a trial size of 77,000 patients gastrointestinal effects, including bleeding ulcers, were not mentioned in the side effect profile.
Class action litigation related to this has been building, with the latest update showing more than 80 new claims filed against Bristol-Myers and Sanofi in New York and Illinois in June. Last year, a mass tort filing consolidation was requested by both companies in response to 40 claims in New Jersey. No mention of these lawsuits, however, appears in Bristol-Myers latest annual SEC filing.
PAD is pervasive - it affects over 5% of the American population; expensive - hospital stays account for 75% of its economic burden; efficacy is limited - up to 14% of PAD sufferers do not respond to Plavix; and there are interactions with key drugs often needed by PAD patients. With competition wide open, it`s not hard to imagine doctors and patients choosing Pluristem`s non-toxic, fast-acting, treatment-friendly muscular injections over the drudgery of lifelong pill therapy with the ever-present risk of dangerous side effects.
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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