To: dale w ruckle who wrote (40 ) 8/5/1998 11:32:00 AM From: Stan Greene Read Replies (1) | Respond to of 86
Found this in the inbox this morning.... SUBMISSION FILED FOR PHASE I CLINICAL TRIAL FOR CANCER The Company has received confirmation from its regulatory consultants that an Investigational New Drug application (IND) has been filed for the new cancer drug, Anhydrovinblastine (AVLB). The receipt and review of the application by the Bureau of Pharmaceutical Assessment of the Health Protection Branch (HPB), in Ottawa, will provide the necessary data and rationale to allow the start of clinical trials for the treatment of certain lung cancers in humans. Should no deficiencies in the application be identified by the HPB, authorization will be received within 60 days to allow the human clinical trials to proceed. The IND submission is a standard document required by any pharmaceutical company wishing to begin the approval process for a new drug. The IND process involves an extensive set of investigations that include manufacturing standards, clinical protocols, and pre-clinical biological studies. The latter studies were conducted at the British Columbia Cancer Agency (BCCA) in Vancouver and Roswell Park Cancer Institute (RPCI) in Buffalo, New York, the results of which have provided pharmacology and toxicology data relating to the use and characteristics of AVLB as a cancer therapeutic. The reports indicate no adverse factors that would preclude a safe clinical trial of AVLB in humans. The Medical Oncology Department at the BCCA will be conducting the Phase I trial at the clinical site in Vancouver, British Columbia later this summer. The clinical investigation team have been appointed consisting of three clinical oncologists and one medical oncology investigator. A new drug in clinical trials is in itself significant as only a small percentage of inventions ever achieve that level of development. In striking contrast to the traditional power of the multi-national pharmaceutical companies AVLB is very much a "B.C.", development having been discovered at the University of British Columbia, tested by the B.C. Cancer Agency andlicensed and developed by IGT Pharma. IGT Pharma is a Vancouver based bio-pharmaceutical drug discovery company focused on the development of innovative solutions for the treatment of cancer and disorders of the central nervous system. On behalf of the board of directors of IGT Pharma Inc. Bruce Schmidt, President The Vancouver Stock Exchange has not reviewed and does not accept responsibility for the accuracy of this News Release.