INEX Expands Onco TCS Clinical Program to Include Phase I/II Trial for Acute Lymphoblastic Leukemia
VANCOUVER, Aug. 15 /CNW/ - Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) announced today that it has expanded the clinical development program for its lead anticancer product Onco TCS to include a new Phase I/II human clinical trial evaluating Onco TCS in combination with dexamethasone as a treatment for patients with relapsed acute lymphoblastic leukemia (ALL).
David Main, INEX's President and CEO, said the ALL trial is part of the strategy to continue 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. In addition to generating safety and efficacy data in a new cancer indication, this trial will also generate important information on a different dosing schedule for Onco TCS in combination with another drug."
One of the first-line treatment regimens for ALL is a combination of the drugs vincristine, cyclophosphamide, doxorubicin and dexamethasone.
The new ALL Phase I/II clinical trial will evaluate Onco TCS in combination with dexamethasone in a maximum of 64 patients whose disease has relapsed after treatment with first-line therapy or has not responded to first- line therapy. The trial is being conducted by Dr. Deborah A. Thomas, Assistant Professor of Medicine in the Department of Leukemia, at the University of Texas M. D. Anderson Cancer Center.
The Phase I stage of the trial will evaluate the safety of Onco TCS and dexamethasone in a maximum of 20 patients at escalating Onco TCS doses beginning at 1.0 mg/m2 and going to 2.25 mg/m2. Onco TCS will be given weekly for 4 weeks and dexamethasone will be dosed at 40 mg, given orally, on Days 1- 4 and Days 11-14. Phase II will evaluate the effectiveness of the treatments at the maximum tolerated Phase I dose in a maximum of 44 patients.
In addition to the ALL trial, Onco TCS is being evaluated in nine human clinical trials for several cancers. The most advanced trial is a pivotal Phase II/III clinical trial designed to provide data to support an application for marketing approval as a treatment for relapsed aggressive non-Hodgkin's lymphoma. Data from this trial will be available in the fourth quarter of 2002 and INEX plans to file in the first quarter of 2003 for marketing approval.
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 System (TCS). The TCS technology permits the loading of a high concentration of an anticancer drug into a lipid carrier that provides extended circulation in the bloodstream and accumulation at tumor sites. The drug is then released from the carrier over an extended period of time, thereby increasing the drug's effectiveness.
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia is a rapidly progressing cancer in which excessive amounts of immature white blood cells interfere with the production of normal marrow cells. This results in low numbers of red blood cells, platelets and normal white blood cells in the blood stream, leading to anemia, excessive bruising, excessive bleeding from injuries, and recurrent skin and ear infections. Most cases of ALL occur in children under age 10, but it can appear in all age groups. The American and Canadian cancer societies estimate that there will be approximately 4,200 new cases of ALL diagnosed and 1,600 deaths in the two countries from ALL in 2002.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems that improve the treatment of cancer.
INEX's lead product, Onco TCS, is being developed with Elan Corporation, plc and a second product candidate, Topotecan TCS, is being developed with GlaxoSmithKline. |
