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Avaxia Biologics Awarded Phase I SBIR Grant to Develop Antibody Therapeutic for Oral Mucositis

Collaboration with Biomodels facilitates development of novel drug product

BURLINGTON, Mass., Sept. 16 /PRNewswire-USNewswire/ -- Avaxia Biologics, Inc., a biotechnology company developing oral antibodies for disease targets accessible via the GI tract, announced today that it has been awarded a Phase I SBIR grant from the National Institute of Dental and Craniofacial Research to support the development of a novel antibody therapeutic for oral mucositis.

Avaxia is developing a polyclonal anti-TNF antibody to be administered to the oral cavity of patients suffering from mucositis. The antibody is designed to reduce the pain and ulceration associated with this serious side effect of cancer treatment. The grant will fund key pre-clinical studies of the antibody in a well-established animal model of radiation-induced oral mucositis.

"We are delighted to have been awarded this grant from the NIH," said Barbara S. Fox, Avaxia's founder and CEO. "Our preliminary data indicate that an anti-TNF antibody, delivered topically to a damaged mucosal membrane, will limit the severity of the inflammatory response induced by ionizing radiation. The support of the NIH provides both the funding we need to advance the development of this much needed therapeutic, and critical scientific validation of our approach."

Avaxia is carrying out the grant-funded research in collaboration with Biomodels LLC, a Watertown-based pre-clinical drug research organization. Biomodels specializes in animal models of toxicities associated with chemotherapy and radiation therapy used for the treatment of cancer and is a world leader in the study of cancer treatment-related mucosal injury (mucositis) .

"We are looking forward to working closely with Avaxia Biologics scientists in developing and testing a drug that could lead to an effective therapy for oral mucositis, a debilitating side effect that impacts virtually every patient who undergoes aggressive cancer treatment," said Edward Fey, managing partner of Biomodels.

Avaxia and Biomodels anticipate extending their productive collaboration to other therapeutic areas, including inflammatory bowel disease and GI enteritis and fibrosis.

ABOUT ORAL MUCOSITIS. Oral mucositis is a serious side effect of cancer chemotherapy and radiation therapy. According to a 2008 report from the National Comprehensive Cancer Network, mucositis has "emerged as the most significant adverse symptom of cancer therapy reported by patients." Mucositis is associated with severe pain and risk of infection, necessitating the use of systemic narcotics and the insertion of a feeding tube to provide nutrition. Most significantly, when mucositis develops, the dose and frequency of cancer treatment is often reduced, leading to a significant decrease in both short-term efficacy and long-term disease-free survival. There are no approved medications for the treatment of mucositis associated with most forms of cancer treatment.

ABOUT AVAXIA BIOLOGICS, INC. Avaxia Biologics ( is an early stage company developing orally-delivered antibody therapeutics. The antibodies are designed to treat both diseases of the GI tract and systemic diseases where the disease targets are accessible in the GI tract. Avaxia has a proprietary antibody platform and is developing products for oral mucositis, inflammatory bowel disease, and diabetes and obesity.

ABOUT BIOMODELS LLC. Biomodels (, a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases.

The company specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has particular expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels' studies enable organizations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success. Biomodels is headquartered in Watertown, MA.

SOURCE Avaxia Biologics, Inc.
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