For immediate release: May 17, 2005
VANCOUVER - Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) announced today results from clinical studies indicating its lead anticancer drug, Marqibo™, has shown anti-tumor activity in patients with relapsed non-Hodgkin’s lymphoma (NHL), Hodgkin’s disease and pediatric malignancies.
David Main, President and CEO of INEX said, “The data presented from these clinical studies continue to demonstrate the activity of Marqibo in a variety of different cancers. Our current focus for Marqibo is finalizing the design of phase 3 clinical trials in non-Hodgkin’s lymphoma and acute lymphoblastic leukemia in order to file Special Protocol Assessments with the United States Food and Drug Administration as well as continue our discussions with potential development and commercialization partners. ”
The following are summaries of two posters presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 13-17, 2005 and one poster presented at the American Society of Pediatric Hematology/Oncology (ASHPO) Annual Meeting being held May 14-16, 2005 in Washington, DC.
Relapsed non-Hodgkin’s lymphoma
Combined results from two different clinical trials were presented at ASCO in Orlando, Florida on May 17, 2005.
These combined results are from a phase 2a clinical trial conducted at M. D. Anderson Cancer Center in Houston, Texas and a pivotal phase 2b multi-center clinical trial. Both trials evaluated Marqibo as a single-agent treatment for patients with relapsed aggressive NHL.
A total of 211 patients were treated in the combined trials. The median age of the patients was 62 and the median number of prior treatment regimens was three. Two-thirds of patients were resistant to their last therapy.
The overall response rate was 28% (59 patients), of which 7% (15 patients) had complete responses. The time to progression was approximately four months and overall median survival was approximately 8.5 months.
The investigator presenting the combined data concluded that the single-agent treatment of Marqibo in this heavily pre-treated population demonstrated a clinically meaningful rate of response for patients with multiply relapsed aggressive NHL.
Hodgkin’s disease
On May 17, 2005 follow-up data was presented at ASCO for a phase 2 study conducted at M.D. Anderson Cancer Center of Marqibo as a single-agent treatment for patients with relapsed or refractory Hodgkin’s disease.
The data were reported on 29 patients with a median age of 34 and a median of four prior chemotherapy treatments. Twenty-eight patients were evaluable for response with an overall response rate of 36% (ten patients).
The therapy was well tolerated, with mostly mild to moderate toxicities, despite the number of prior therapies. The investigator concluded that this study supports further investigation of Marqibo in this disease.
Pediatric malignancies
On May 14, 2005, clinical investigators from the M. D. Anderson Cancer Center presented a poster at the ASHPO Annual Meeting in Washington, DC.
The data was from a phase 2 clinical study of Marqibo as a single-agent treatment in pediatric patients who had relapsed after receiving standard therapy. The trial was designed to determine the response rate, the progression-free survival rate, and the safety of Marqibo in pediatric patients.
The data from this trial in 30 patients with a variety of pediatric malignancies indicate that the drug was well tolerated with side effects being mild to moderate in severity and that Marqibo can be used for prolonged periods of time. Marqibo showed promising activity in pretreated patients with soft tissue sarcomas. The investigator concluded that Marqibo warrants further study in combination regimens to treat pediatric cancers.
About Marqibo™
Marqibo (sphingosomal vincristine) is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in INEX’s sphingosomal drug delivery technology. This technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness while reducing the side effects of the encapsulated drug.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about INEX and Marqibo can be found at www.inexpharm.com.
Forward Looking Statements
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.
Contact Information
Investors
Ian Mortimer
Vice President, Finance and Chief Financial Officer
Phone: 604-419-3200
Email: info@inexpharm.com
Website: www.inexpharm.com
Media
Karen Cook Boas
James Hoggan & Associates Inc.
Phone: 604-739-7500
Email: kcook@hoggan.com
