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Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (69)	5/20/2002 12:48:25 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 130

[farnesyl transferase inhibitor in GI cancer] Johnson & Johnson Pharmaceutical Research and Development Announces Results from Phase III Trials for R115777 ORLANDO, Fla., May 20 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (PRD) today announced results of two Phase III clinical trials of R115777 in gastrointestinal cancers. These results were presented at the American Society of Clinical Oncology (ASCO) annual meeting. The first trial compared gemcitabine (GEM) and R115777, a developmental farnesyl transferase inhibitor, to GEM and placebo among patients with locally advanced or metastatic pancreatic cancer. This pivotal, randomized, double-blind trial enrolled 688 participants previously untreated with systemic therapy from 133 centers worldwide. The primary endpoint of the study was median overall survival and researchers observed no statistically significant differences in survival between patients receiving GEM and R115777 and a control group of patients receiving GEM and placebo (median overall survival, 193 vs. 182 days respectively [p=0.75]). The second trial compared R115777 to placebo among patients with advanced refractory colorectal cancer who had failed on two or more prior chemotherapy regimes for metastatic disease. This randomized, double-blind, placebo-controlled trial enrolled a total of 368 participants in 65 centers in 18 countries. The primary endpoint of this study was overall survival. Researchers observed the median overall survival of patients receiving R115777 was 5.7 months versus 6.1 months for those receiving placebo [p=0.396]. "We are disappointed that these studies in gastrointestinal cancers did not achieve their primary endpoints," said Mary Ellen Rybak, Vice President, Oncology, Johnson & Johnson Pharmaceutical Research and Development. "However, results from studies in other tumor types also are being presented at ASCO and are encouraging. Based on the results of these trials and other Phase II trials, we are committed to continuing a balanced clinical development program to explore the utility of R115777 across multiple tumor types." Based in Raritan, New Jersey, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (PRD) conducts pharmaceutical research and development for the pharmaceutical companies of Johnson & Johnson. R115777 was discovered and is being developed by PRD. Ortho Biotech Products, L.P. and its worldwide affiliates would be responsible for marketing R115777 upon approval.