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

Data Presented at 7th International Conference on Head and Neck
Cancer
NEW YORK--(Business Wire)--
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.

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

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