To: David Culver who wrote (48 ) 12/3/1998 7:32:00 PM From: Spiney Read Replies (1) | Respond to of 94
FDA submission completed for cancer drug trial IGT Pharma Inc IGT Shares issued 8,340,914 Dec 2 close $0.65 Thu 3 Dec 98 News Release Mr. Bruce Schmidt reports IGT has been informed by the protocol office of the Roswell Park Cancer Institute in Buffalo, New York, that the phase 1 human clinical trial application for the new cancer drug, Anhydrovinblastine (AVLB), has been forwarded to the U.S. Food and Drug Administration. This will now activate a 30-day review period during which the FDA can comment on the content of the submission. Subject to no deficiencies being identified, the clinical trial process will start early in the new year. The purpose of the clinical trial is to test the safety profile and dosing parameters for AVLB, a new drug for the treatment of non-small cell lung cancer. Involving over 150,000 new cases every year, lung cancer is the most common form of cancer in the United States with over 75 per cent of those cases being the non-small cell type. Currently the five-year survival rate is approximately 10 per cent with only a limited range of therapies available. AVLB represents a potentially, better approach to the treatment of non-small cell lung cancer having shown in preclinical studies to have superior effectiveness and lower toxic side effects compared to a range of other drugs. Up to 30 cancer patients will be involved in the trial. Further to the status of the Canadian clinical trial application, management has concluded a series of discussions with Health Canada which has led to the resubmission of the original application for further review. (c) Copyright 1998 Canjex Publishing Ltd. canada-stockwatch.com