Hello,
Finally, some more news from IGT...
U.S. CLINICAL TRIAL OPPORTUNITY - I.N.D. SUBMISSION TO F.D.A.
IGT has been informed by its regulatory consultants that the Canadian Health authority, Health Canada, is still processing IGT's Investigational New Drug Application (I.N.D.) for a Phase I human clinical trial for the new cancer drug, Anhydrovinblastine. These trials for lung cancer were planned to start in the month of October but it is now obvious that they will start later than anticipated. The delay in the processing of this application by Health Canada is
unfortunately not under IGT's control.
In contrast to the Canadian delay, a positive development has surfaced recently in an offer from the Roswell Park Cancer Institute in Buffalo, New York, to conduct a United States F.D.A. clinical trial for the same drug.
It is generally recognized within the pharmaceutical industry that clinical trials in the United States are the most important
type of approval as, in the case of cancer therapy, over 50% of the world market exists in the United States.
IGT's management has therefore decided to immediately pursue an I.N.D. application with the F.D.A.. It is therefore possible that IGT would not proceed with a Canadian trial however the final decision will be reserved pending further information from Health Canada. The current time frame for approval in the U.S. would be late 1998 or early 1999.
IGT also reports that the Directors have adopted a new stock option plan to replace the existing plan which has been fully utilized. The new plan calls for a maximum of 1,320,000 shares to be offered as incentives to directors, management and employees. Effective today, the company has granted 445,000 of these options at an exercise price of $0.65. These options will vest over a period of 2 years and will expire October 7, 2001. Both the stock option plan and the granting of options are subject to approval by the shareholders of the company and the Vancouver Stock Exchange.
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. |
