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Inex Pharmaceuticals Files Regulatory Application with FDA to Begin ONCO TCS Phase II/III Pivotal Clinical Trial

VANCOUVER, BRITISH COLUMBIA
SEPTEMBER 30, 1999

Inex Pharmaceuticals Corporation (TSE: IEX) has submitted an application with the United States Food and Drug Administration (FDA) for permission to evaluate the company's lead product Onco TCS in a Phase II/III pivotal human clinical trial as a treatment for second-relapsed aggressive non-Hodgkin's lymphoma (NHL), the company announced today.

"Today's announcement means we have met our objective of filing this application with the FDA during the Third Quarter of 1999," said David J. Main, INEX's President and CEO. "Pending FDA approval of this Investigational New Drug (IND) application, we could start the pivotal trial before the end of the year. This trial is designed to provide sufficient data to seek marketing approval in 2001."

Main said the Phase II/III pivotal trial will enroll approximately 100 patients at up to 12 medical centres across North America. The regulatory application to conduct the pivotal clinical trial at centres in Canada will be filed within 30 days.

The Phase II/III pivotal trial follows the successful completion of patient enrolment in a Phase IIa physician-sponsored clinical trial at The University of Texas M .D. Anderson Cancer Center in Houston. Interim results from the Phase IIa trial demonstrated that Onco TCS is effective against relapsed NHL. A full evaluation of the Phase IIa data is now under way and will be presented to the meeting of the American Society of Hematology in New Orleans in December.

Onco TCS is a proprietary drug comprised of the off-patent cancer drug vincristine encapsulated in the company's patented drug delivery technology, Transmembrane Carrier Systems (TCS).

NHL is the most common form of lymphoma. It is the sixth leading cause of cancer deaths and has the second fastest-growing mortality rate of all cancers in the United States. Approximately 55,000 new cases were diagnosed in 1997 in the United States with 240,000 people currently suffering from the disease. Of the newly diagnosed cases, approximately 50% are categorized as the aggressive form of NHL.

INEX is a Canadian biopharmaceutical company that utilizes proprietary drug delivery systems and therapeutic compounds to increase the effectiveness and reduce the side-effects of anti-cancer therapies. INEX is focused on commercializing products for unmet needs of the oncology market.

Company Contact
Ian Mortimer, Investor Relations,

Media contact:
Karen Cook Boas

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