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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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