The National Cancer Institute (NCI) will sponsor phase III trials to test the efficacy of AE-941/Neovastat, an angiogenesis inhibitor developed by AEterna Laboratories Inc., a Canadian biotechnology corporation, in the treatment of cancer. The studies include a multicenter phase III, double-blind, placebo-controlled trial in which AE-941/Neovastat, a liquid shark cartilage extract, will be administered to several hundred cancer patients in hospitals and institutions across the United States and Canada. Pending regulatory review, the trials are scheduled to begin in early 1999.
Phase III trials are designed to formally evaluate the efficacy and safety of drugs in development on a large number of patients. Such studies are of great importance for medical oncologists to evaluate the value of an antiangiogenic agent like AE-941/Neovastat in the treatment of cancer in combination with conventional therapies, stated Dr. William Evans, medical director and CEO of the Ottawa Regional Cancer Centre and a member of AEternas Scientific Advisory Board.
The NCIs involvement in the clinical development program of AE-941/Neovastat is important for AEterna because it moves the project closer to the submission of a new drug application (NDA). We are privileged to have been chosen by the National Cancer Institute. This is a unique opportunity to validate our development program with the Cancer Therapy Evaluation Program of the National Cancer Institute, said Dr. Eric Dupont, president and CEO of AEterna Laboratories.
Previous Trials Have Shown Drugs Safety at All Dose Levels
AE-941/Neovastat has been tested in over 450 patients with advanced cancer in the United States and Canada. Phase I/II clinical trials in patients with lung and prostate cancer have established the drugs excellent safety and tolerability profile at all dosage levels tested and have indicated preliminary signs of efficacy. In fact, no drug-related serious adverse events have been reported to date, which allows the phase III trials to proceed at the highest dose.
In our work to date with patients, AEternas AE-941/Neovastat has demonstrated to be an interesting angiogenesis inhibitor for the treatment of cancer. AE-941/Neovastat is administered orally and is very well tolerated by our advanced cancer patients, which is exciting for an anti-cancer drug candidate, stated Dr. Dilip Patel, medical oncologist and chief, Haematology Department, North Shore-Long Island Jewish Health System, New York.