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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (142)	11/20/2001 11:31:44 AM
From: tuck	Read Replies (1) \| Respond to of 447

>>MELVILLE, N.Y., Nov 20, 2001 (BUSINESS WIRE) -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP chart, msgs), announced today that its global partner Roche has initiated a Phase III clinical trial evaluating the use of Tarceva(TM) (OSI-774) in combination with gemcitabine (Gemzar(R)) / cisplatin (Platinol(R)) for non-small cell lung cancer (NSCLC). Tarceva(TM) is a small molecule, anti-epidermal growth factor receptor (EGFR) drug candidate that has demonstrated encouraging anti-cancer activity in single agent, open label Phase II studies in NSCLC, head and neck cancer and ovarian cancer. Tarceva(TM) is being developed as a three way alliance between OSI, Genentech and Roche. The multi-center, 1,000 patient study, to be run by Roche, is one of two randomized, controlled Phase III trials in NSCLC to be conducted by the OSI/Genentech/Roche alliance that will assess the value of adding Tarceva(TM) to two of the most commonly utilized front-line combination chemotherapy regimens for NSCLC. The study has improvement in patient survival as the primary end-point. The second Phase III front-line combination study combining Tarceva(TM) with carboplatin (Paraplatin(R)) and paclitaxel (Taxol(R)) was initiated by Genentech in July. Since the alliance's inception in January, several clinical studies have been initiated with Tarceva(TM), including three NSCLC Phase III studies, a Phase III pancreatic study, a Phase II metastatic breast cancer trial, and several Phase 1b trials which are to determine the safety, tolerance and pharmacokinetics and preliminary anti-cancer activity of escalating doses of Tarceva(TM) in combination with various chemotherapies. "This trial is the third registration oriented study to be initiated for NSCLC and we are pleased that the alliance has successfully initiated this program several months ahead of schedule," stated Colin Goddard, Ph.D., Chairman and Chief Executive Officer of OSI Pharmaceuticals. Non-small cell lung cancer, the most common form of lung cancer, afflicts approximately 150,000 people in the U.S. alone every year. A high proportion of these patients express the EGFR gene, a protein-tyrosine kinase strongly implicated in human cancer. Additional lung cancer patients are known to have a mutant form (EGFRVIII) of this gene. OSI also announced the initiation of a Phase 1b trial evaluating Tarceva(TM) in combination with docetaxel (Taxotere(R)) and capecitabine (Xeloda(R)) in patients with advanced breast cancer who have relapsed after initial chemotherapy treatment. The study, conducted by Roche, will take place in Spain and in the UK. "We are very excited about the potential of Tarceva(TM) to improve outcomes for patients in a number of different solid tumors," stated Dr. Jose Baselga, lead investigator for the breast cancer study in Spain, from the Department of Medical Oncology, Vall d'Hebron University Hospital in Barcelona. Breast cancer is the leading cause of death in women aged 35-55, and the second leading cause of death in women of all ages. In Europe alone breast cancer is estimated to claim over 165,000 lives each year.<< snip Cheers, Tuck