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Biotech / Medical : T/FIF, a New Plateau -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (2010)	5/23/2003 12:29:06 PM
From: JMarcus	Read Replies (2) \| Respond to of 2243

<<Pitch away. Not much discussion of gene therapy companies here. We can use it, thanks.>> Shamelessly, I put just put my pitch (summary of yesterday's stockholders meeting) on Yahoo. Here it is (or as much as I'll do before the weekend when I have time to review my notes): <<I've attended each of the last 5 annual meetings. The CEO, John Monahan, seemed more serene than I'd ever seen him before. A good sign, I think. Or maybe he’s just become philosophical after all the ups and downs of the last several years. He seemed quite confident that they would soon be restarting the Coagulin-B trials soon (the 10K said “by the middle of 2003,” so he seems to be sticking to that estimate). If I understood correctly, one of the "working hypotheses" (his term) for the sudden drop-off in FIX levels that one patient experienced in week 4 of the trial (something never before encountered in human or animal trials with Coagulin-B) was that the particular patient had at sometime before the trial received a bad batch of FIX and had developed an immune response to it. A change in the clinical trial protocol might be to test for FIX antibodies before beginning treatment with Coagulin-B and pretreat the patient as necessary to reduce those antibody levels before administering Coagulin-B. The real excitement seemed to be the IND for the Parkinson’s gene therapy, still on-track for 3Q03. They expect a Phase I trial size of 18 patients. Their research indicates that they should have no problem enrolling the entire cohort of patients here in the SF Bay Area. Enrollment should go very quickly. They will treat and follow the patients for an entire year, but by the time of next year’s stockholders’ meeting they’d hope to be reporting the initial findings. Although the method of administration of the Parkinson’s vector seems alarming to a lay person, the procedure need only take about 30 minutes (during the Phase I trials, they’ll probably take a full hour, just to be cautious) and the patient remains conscious the entire time. Because Parkinson’s patients have such a problem with trembling, the patient’s head must be stabilized in a vice of some sort that fits around the jaw and cheeks. Then a hole the diameter of a needle is drilled into the skull so that a syringe may inject the vector into the precise location in the brain where it is needed: the striatum. I was told that the before and after videos of primates that have undergone the treatment are most impressive. Before treatment, the Parkinson’s afflicted primates are in a pathetic state of constant trembling. After treatment (once the vector has had time to work its magic), they look and behave like a healthy primate. The Coagulin-B product is the only one Avigen has partnered. It owns virtually 100% of the rights to Coagulin-A, the PD vector, and the rest. The company has no debt and $120M in the bank. Enough for at least 4 years. No fundraising is needed or planned in the near future. At $4/share, the market cap is equal to about 2/3ds of the cash in the bank. No one has yet produced a safe and effective gene therapy product. This is cutting edge stuff. So it is slow going, but the upside, once all the hurdles are cleared, ought to be stupendous. The biotech market has lately been more receptive of such models. I think this stock could really take off once the Coagulin-B trial is resumed and the IND for the PD vector is announced.>> messages.yahoo.com