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IRX Therapeutics Enrolls First Patients in IRX-2 Phase II Head and Neck Cancer Study

Posted on: Monday, 17 October 2005, 09:00 CDT

IRX Therapeutics, a privately-held company dedicated to the development and commercialization of novel drugs for the treatment of cancer and viral diseases, today announced the first patients in its IRX-2 Phase II head and neck cancer clinical trial have been enrolled and treated.

Approximately 25 patients suffering from late-stage head and neck cancer will be recruited for IRX Therapeutics' Phase II trial. The Phase II trial involves clinical sites in the United States and in Mexico. This study will seek to confirm the response results obtained in earlier studies, which suggest the effectiveness of IRX-2 in improving survival. IRX-2 received Fast Track designation by the Food and Drug Administration in November 2003.

"More than 40,000 people in this country are diagnosed with head and neck cancer each year," said John T. Spitznagel, Chairman of IRX Therapeutics' Board of Directors. "For patients with late-stage head and neck cancer, there is an "unmet medical need" for which the IRX-2 therapy is being studied."

An earlier open-label Phase II clinical trial in late-stage head and neck cancer patients demonstrated statistically significant improvement in the treatment group. After forty-eight months, the overall survival of IRX-2 treated patients was 61% versus 32% for the case-matched control group. Results of earlier Phase II trials suggest that the treatment stimulates T-cell mediated anti-tumor activity. In these studies, IRX-2 appeared to be well tolerated with no reported serious product-related adverse events.

"We appreciate the support of our Medical Advisory Board, which includes many of the leaders in the field of head and neck cancer," said John W. Hadden II, Chief Operating Officer. "As a result, this Phase II trial will be available on an outpatient basis in several cancer centers across the U.S. and in Mexico."

In order to be eligible for this study, patients must have locally advanced head or neck cancer that has not spread to other areas of the body. Patients who have undergone surgery, radiation therapy, or chemotherapy for this cancer are not eligible to participate. The IRX-2 therapy is administered over 21 days prior to surgery. More information about this Phase II trial can be found at http://www.clinicaltrials.gov.

About IRX Therapeutics

IRX Therapeutics is a privately held immunotherapy company focusing on the development and commercialization of treatments for advanced cancer and viral diseases. Founded in 1994 by John W. Hadden, M.D., a pioneer in the field of Immunopharmacology,

IRX Therapeutics is developing an innovative approach that stimulates a coordinated cellular immune response to treat human diseases. The Company's product pipeline includes IRX-2, a therapeutic cancer treatment that seeks to stimulate a cellular immune response in the host to destroy tumor cells. Other products in development similarly seek to stimulate a cellular immune response for the treatment of other cancers and viral diseases. This immune response is essential for the eradication of most viruses and tumors, and relies on the effective functioning of dendritic cells, macrophages, and T-cells.

For more information on IRX Therapeutics, please visit the Company's website at http://www.irxtherapeutics.com.

Source: Business Wire

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