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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

To: Izzy who wrote (3349)	12/16/1997 7:42:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 6136

Izzy, The active ingredient in LGND's gel treatment for KS is 9-cis retinoic acid, the first non-polypeptide hormone discovered in over 25 years. LGND calls it Panretin because it is a retinoid that binds to all six known receptors (3 RARs and 3 RXRs). When an RAR binds a retinoid, the cells generally differentiate and stop dividing. When an RXR binds a rexinoid, the cells undergo apoptosis (prgrammed cell death) and self destruct. I'm not sure which receptor type is on the surface of KS cells, but Panretin will either make them stop dividing or self destruct. The gel only works in about 1/2 of the patients. Some patients saw improvemet in the protocol's 12 weeks, while some took a bit longer. The gel has a very favorable safety profile and is only for cutaneous lesion. At the doses used, it does not generate a systemic response. LGND is testing the oral form and those tests are in phase II. There is some eveidence that the oral treatment also improves immunological parameters. It is in a trial run by the AIDS consortium and has met the minimum requirements for expanding the study. If immunological parameters are improved, the the treatment would have applications for all HIV+ patients. Panretin is in advanced trials for APL (acute promyelocytic leukemia, where it is particularly effective (even in refractory cases) because one of the RAR is involved in a chromosomal translocation and the hybrid protein causes the disease (and the retinoid blocks the transformation). Those trials are in Phase III and oral Panretin is expected to be approved in 1999. Topical Panretin is slated for an NDA next quarter. It has been used on over 500 patients and has succesfully completed 2 pivotal phase III trial (the International trial was halted early because the results were so positive -42% of Panretin patients responded compared to 7% of the palcebo group - the International was not expected to be complete in time for the US filing - now US and Eurpean applications will be submitted in early 1998 and results from both Phase III trials will be included).