Message 17015020
Tuesday February 12, 8:30 am Eastern Time
Press Release
SOURCE: Inex Pharmaceuticals Corporation
Inex announces new Onco TCS Phase II trial for Hodgkin's disease
INEX GIVES SCHEDULE FOR RELEASING DATA FROM ONGOING TRIALS
VANCOUVER, Feb. 12 /PRNewswire-FirstCall/ - Inex Pharmaceuticals Corporation (``INEX''; TSE: IEX) has expanded the clinical development program for its lead anticancer product Onco TCS to include a new phase II clinical trial evaluating Onco TCS as a treatment for patients with relapsed Hodgkin's disease, the company announced today.
David Main, INEX's President and CEO, said the Hodgkin's disease trial will generate preliminary safety and efficacy data in a maximum of 35 patients. ``The phase II trial is a logical extension of the Onco TCS clinical program as Hodgkin's disease is often treated with combination therapy that contains vincristine, the active agent in Onco TCS, and there is no standard agent to treat relapsed patients.''
The trial is being conducted by Dr. Andre Goy, Assistant Professor in the Department of Lymphoma and Myeloma, at The University of Texas M. D. Anderson Cancer Center.
``We are continuing to expand the commercialization potential for Onco TCS. Our objective is to commercialize Onco TCS as a product that can be used to treat a number of cancers as a stand-alone therapy or in combination with other drugs'' Main said. ``We will also be releasing a significant amount of clinical data during 2002, beginning later this quarter and continuing throughout the year.''
Main said the pivotal phase II/III trial for relapsed aggressive non- Hodgkin's lymphoma (NHL) has enrolled 92 patients and expects to reach the target of a minimum of 100 patients in the next few weeks. ``Enrollment in December and January was slower than we anticipated, but we are on schedule to analyze and release the data during the fourth quarter and to file the New Drug Application to the U.S. Food and Drug Administration (FDA) during the first quarter of 2003.''
In addition to the new phase II trial for Hodgkin's disease and the pivotal phase II/III trial, Onco TCS is being evaluated in seven phase II trials: As a treatment for small cell lung cancer, as part of first-line combination treatment for aggressive NHL, as a treatment for relapsed pediatric malignancies, in two pilot studies as a treatment for relapsed lymphoma in combination with the approved cancer drug Rituxan® (rituximab), and in two pilot studies as a treatment for NHL in combination with the approved cancer drug etoposide.
INEX expects to release, during the first half of the year, interim results from the small cell lung cancer trial and for the first-line combination therapy lymphoma trial, and during the second half of the year, results from the pivotal phase II/III trial and from some of the other ongoing phase II trials.
About Hodgkin's disease
Hodgkin's disease is a cancer of the lymph system. The Canadian Cancer Institute and the American Cancer Society estimate there will be approximately 8,000 new cases of Hodgkin's disease diagnosed and 1,500 deaths from Hodgkin's disease in the two countries in 2002.
About Onco TCS
Onco TCS is a proprietary drug comprised of the widely used off-patent cancer drug vincristine encapsulated in the company's patented drug delivery technology, Transmembrane Carrier Systems (TCS). The TCS technology provides prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are designed to increase the effectiveness and reduce the side effects of the encapsulated drug.
About INEX
INEX is a Canadian biopharmaceutical company commercializing proprietary drugs and drug delivery systems that improve the treatment of cancer. INEX has a corporate partnership with Elan Corporation, plc for the development of its lead anticancer drug Onco TCS and with GlaxoSmithKline for the development of its second anticancer drug Topotecan TCS.
INEX's common shares are traded on the Toronto Stock Exchange under the trading symbol ``IEX''.
INEX contact: Media contact:
Ian Mortimer Maria LoScerbo
Director, Investor Relations James Hoggan & Associates Inc.
Inex Pharmaceuticals Corp. Tel: 604-739-7500
Tel: 604-419-3200 Email: mloscerbo@hoggan.com
Email: info@inexpharm.com
Website: www.inexpharm.com
SOURCE: Inex Pharmaceuticals Corporation |
