VANCOUVER, Dec. 8 /PRNewswire-FirstCall/ -- Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) announced today that it released results from three separate clinical trials that indicate the company's lead anticancer product Onco TCS is able to reduce the size of tumors in lymphoma patients with advanced disease.
The results were reported on December 6 and 7 at the Annual Meeting of the American Society of Hematology (ASH) in San Diego, California.
INEX released the final results from its pivotal phase II/III trial evaluating Onco TCS as a single agent treatment for relapsed aggressive non- Hodgkin's lymphoma (NHL). This data was previously released by INEX in June 2003. INEX also released interim results from a phase II trial evaluating Onco TCS as a single agent treatment for relapsed Hodgkin's disease and interim results from a phase II trial evaluating Onco TCS in combination with Rituxan(R) as a treatment for relapsed large B-cell lymphoma.
Relapsed non-Hodgkin's lymphoma
Dr. Jane N. Winter of the Feinberg School of Medicine at Northwestern University in Chicago, Illinois presented results from a pivotal phase II/III multicenter trial of 119 patients with relapsed aggressive non-Hodgkin's lymphoma (NHL) who were enrolled after receiving an average of four prior treatment regimens. The patients had not responded to their previous therapy or had responded then relapsed. After treatment with Onco TCS, the overall response rate was 25%, including eight patients (7% of patients) whose tumors were completely eliminated and 22 patients (18% of patients) whose tumor volume was reduced by more than 50%. An additional 31 patients (26% of patients) had their disease stabilized while being treated with Onco TCS.
Also included in the presentation were subgroup analyses, which included a 46% response rate in patients with cancer that had responded to their last therapy (sensitive disease), a 20% response rate in patients with resistant disease and a 26% response rate in patients who had failed prior bone marrow transplant. Onco TCS was well tolerated in this heavily pretreated population.
These pivotal results form the basis of a New Drug Application (NDA) which is currently in the process of being submitted to the United States Food and Drug Administration (FDA).
Relapsed Hodgkin's disease
Interim results were presented from a phase II trial conducted at the University of Texas M. D. Anderson Cancer Center in Houston of 15 patients with Hodgkin's disease who were enrolled after not responding to previous therapy or after responding to previous therapy then relapsing. Patients had received a median of four prior treatment regimens and 60% of patients had failed prior bone marrow transplants. After treatment with Onco TCS, the overall response rate was 33%, including three patients (20%) whose tumors were completely eliminated and two patients (13%) whose tumors were reduced by more than 50%. This trial is continuing and will enroll up to 35 patients.
Relapsed B-cell lymphoma
Interim results were presented from a phase II trial conducted at University of California in San Francisco and at the University of Leeds in the United Kingdom of 18 patients with diffuse large B-cell lymphoma who were enrolled after not responding to previous therapy or after responding to previous therapy then relapsing. The median age of patients was 70 years old. Patients had received a median of four prior treatment regimens. After treatment with Onco TCS, in combination with the approved cancer drug Rituxan(R) (rituximab), the overall response rate was 56%, including four patients (22%) whose tumors were completely eliminated and six patients (33%) whose tumors were reduced by more than 50%.
Rituxan(R) and Onco TCS are logical drugs to combine together to treat relapsed lymphoma as the two drugs have different mechanisms of action and have relatively low and manageable side effect profiles.
About Onco TCS
Onco TCS is a proprietary drug comprised of the widely used off-patent cancer drug vincristine encapsulated in INEX's TCS (liposomal) drug delivery technology. 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.
INEX has filed two of three major sections in its "rolling submission" of an NDA to the FDA seeking marketing approval for Onco TCS for the treatment of relapsed aggressive NHL. The NDA filing will be completed during the first quarter of 2004 with the third submission being data and analysis from human clinical trials.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer.
There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects," and similar expressions. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, INEX's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market INEX's products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
Company contact: Media contact:
Ian Mortimer Karen Cook Boas
Director, Investor Relations James Hoggan & Associates Inc.
Inex Pharmaceuticals Corporation Tel: 604-739-7500
Tel: 604-419-3200 Email: kcook@hoggan.com
Email: info@inexpharm.com
Website: http://www.inexpharm.com/
INEX's common shares are traded on The Toronto Stock Exchange under the trading symbol "IEX".
Inex Pharmaceuticals Corporation