Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: chirodoc who wrote (453)	12/16/1997 10:22:00 AM
From: Sector Investor	Read Replies (1) \| Respond to of 887

Yes there was - I missed a section. Most of report was Chiron specific * Phase III Data Show Significant Improvement In Time To Progression - A poster describing data from the Phase III trial in 61 patients with neoplastic meningitis from solid tumors was presented at ASH. The data, previously released, show a statistically significant improvement over standard therapy in time to clinical progression of disease (a median of 58 days for DepoCyt vs. 30 days for methotrexate). In addition, the DepoCyt- treated group achieved a higher number of complete responses (26% vs. 20%) and improved survival (105 days vs. 78 days, higher for patients who achieved complete responses); these endpoints did not reach statistical significance. Lack of statistical significance on several endpoints would ordinarily be worrisome. However, the investigator with whom we spoke stressed that the FDA stated during protocol discussions that the trial did not have to achieve statistical significance to be successful, likely because neoplastic meningitis is a difficult disease in which to conduct clinical trials and there are limited treatment options. Indeed, CHIR/DEPO's Phase III trial, while small, is the largest neoplastic meningitis trial conducted to date. Not sure if this next is part of the same thing. * Improved Dosing V. Standard Therapy A Help -- An improved dosing schedule (once every two weeks vs. 2X/week with methotrexate), better neurological status (which could impact quality of life), and a side effect profile that does not confer a significantly higher incidence of grade 3 and 4 neurological toxicity and arachnoiditis (fever, headache, nausea) are other pluses. Thus, we believe the FDA panel will view the trial outcome as positive and that the drug will be approved.