IRX Therapeutics Announces Results of Phase 2 Study for IRX-2

NEW YORK--(BUSINESS WIRE)--Jul 22, 2008 - IRX Therapeutics, a privately-held company dedicated to the discovery and development of proprietary therapies for the treatment of cancer and viral diseases, today announced preliminary findings from its Phase 2 clinical trial of IRX-2, the Company's investigational immunotherapy for head & neck cancer.

The preliminary results of the study suggest that IRX-2 is safe and well tolerated and survival data show promising results when compared to historical controls. The findings were presented during a symposium at the American Head and Neck Society's 7th International Conference on Head and Neck Cancer.

John W. Hadden II, President and Chief Executive Officer of IRX Therapeutics, summarized, "We are encouraged by the Phase 2 study results and, consequently, are busy preparing to launch the INSPIRE trial, our pivotal Phase 3 study." He added, "We believe that IRX-2 has the potential to alter the course of treatment for patients with advanced head and neck cancer and are very pleased by the interest and support shown in the INSPIRE trial by the head and neck community."

Study Details and Results

In this multi-center study, twenty seven newly diagnosed head and neck cancer patients were treated with the IRX-2 regimen as a neoadjuvant therapy prior to curative cancer surgery. The vast majority of patients had locally advanced disease, Stage III or IVa. The preoperative IRX-2 regimen was associated with significant changes in immune cells consistent with an anti-tumor immune response, with some patients showing tumor shrinkage after treatment. At 18 months of follow-up in the Stage IVa cohort, thirteen of sixteen patients, 81%, of IRX-2 treated patients were alive. The IRX-2 regimen was well tolerated by all patients and had a good safety profile.

Gregory T. Wolf, M.D., F.A.C.S., the Principal Investigator for the Phase 2 trial of IRX-2 concluded, "The IRX-2 regimen is safe and well tolerated. Short-term disease free and overall survival rates of IRX-2 regimen patients studied compared with historic matched controls are excellent and support further testing in a randomized Phase 3 clinical trial."

Dr. Wolf is the Professor and Chair, Department of Otolaryngology and Head and Neck Surgery at the University of Michigan as well as Director of the University of Michigan Head and Neck Oncology SPORE Program.

Theresa L. Whiteside, Ph.D., a recognized expert in immune biology and immunotherapy in head and neck cancer, concluded that, "Ex vivo pre-treatment of T-cells with IRX-2 immunotherapy may be beneficial in preserving the integrity of the immune system by protecting anti-tumor effector T-cells from tumor-induced apoptosis. As a result, utilizing IRX-2 in cancer biotherapies might significantly improve anti-tumor effects."

Dr. Whiteside is Professor of Pathology, Immunology and Otolaryngology and is Director of the Immunologic Monitoring and Cellular Products Laboratory at the University of Pittsburgh School of Medicine.

Arlene A. Forastiere, M.D., a major contributor to the development of combined modality therapy and in establishing standards of care for management of advanced head and neck cancer, noted, "Current treatment options for locally advanced head and neck cancer provide a opportunity for the IRX-2 pre-operative immunotherapy."

Dr. Forastiere is Professor of Oncology, Otolaryngology, Head and Neck Surgery and Radiation Oncology at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University.

About Head and Neck Cancer

Head and neck cancer is a deadly disease that often goes undiagnosed until it is at an advanced stage. There are over 500,000 new cases worldwide each year, with about 45,000 new cases in the United States. Head and neck cancer is associated with high rates of recurrence and mortality and is understood to be highly immunosuppressive. The current standard of care for newly diagnosed head and neck cancer is primarily curative surgery followed by radiation therapy or, in some cases, chemoradiation. For patients indicated for curative surgery, there is no approved neoadjuvant therapy. The immunosuppressive nature of head and neck cancer creates a potential role for immunotherapy as a neoadjuvant intervention in the treatment of this disease.

About IRX Therapeutics

IRX Therapeutics is a privately-held immunotherapy company founded by John W. Hadden, M.D., a pioneer in the field of Immunopharmacology. The Company's product platform seeks to restore an effective cellular immune response for the treatment of advanced cancers and viral diseases by correcting both dendritic cell and T-cell defects. An effective immune response is essential for the eradication of viruses and tumors.

The Company's lead product, IRX-2 (citoplurikin), received Fast Track designation by the Food and Drug Administration. Phase 1/2 and Phase 2 clinical trials in late-stage head and neck cancer patients have been completed.

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

Contact

IRX Therapeutics
R. Breck Denny, 212-582-1199 (office)
rbdenny@irxtherapeutics.com
216-789-1522 (mobile)

Posted: July 2008

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