Biotech Firm Synedgen Reports Promising Research Findings on New Treatment for Radiation Damage to the Digestive Tract and Radiation-Induced Mucositis

Federal agencies are highly concerned about potential dangers to the US population by radiation exposures such as the nuclear incident in Japan or the threat of a terrorist dirty bomb

June 7, 2012– (Claremont CA) – Federal agencies are highly concerned about potential dangers to the US population by radiation exposures such as the nuclear incident in Japan or the threat of a terrorist dirty bomb. Synedgen has already demonstrated success in reducing severe oral ulcerations and inflammation in a model of radiation-induced oral mucositis and reducing damage and inflammation in the GI tract after chemical or bacterial insult. Because of these results, the Army asked Synedgen to test its proprietary polysaccharide, SYN01, in reducing mortality following exposure to lethal doses of ionizing radiation.

In an independent, validated study, mice were subject to a total body radiation dose with 80 percent mortality (LD80) of ionizing radiation. Treatments were given as a single oral dose daily and in the drinking water. Because patients typically would not receive immediate treatment for radiation exposure, the treatments began at 24 hours post radiation.

The SYN01 oral treatment prevented significant lethality in mice that received treatment relative to vehicle treated animals. In fact, 88% of the treated animals survived while only 19 % of the untreated animals survived.

This research is a continuation of Synedgen’s ongoing efforts to evaluate the effects of SYN01 on different types of injury to mucosal and dermal surfaces. Other studies indicate that Synedgen’s lead candidate SYN01 has remarkable ability to enhance healing, restore bowel integrity, and possibly reduce systemic complications of bowel injury following chemical or bacterial infection.

“These encouraging results suggest that this treatment could be a potential treatment for radiation-induced gastrointestinal injury,” stated Dr. Stephen T. Sonis, Chief Scientific Officer at Biomodels and a Clinical Professor of Oral Medicine at Harvard.

There is no effective treatment for acute radiation bowel injury; patients receive supportive care. Although radiation therapy is a key therapeutic component of cancer treatment, side effects of radiotherapy include painful oral lesions, gastric and intestinal tissue damage, and severe diarrhea, which can inhibit completion of the full treatment protocol. Patients undergoing bone marrow transplants or other transplants may also receive high doses of radiation as part of their program, and also are subject to these painful effects. While these medical populations are small, their needs are acute. However, the largest potential threat is a nuclear accident or terrorist event.

“We are excited about the potential of SYN01 to safely provide a promising new approach to treating the effects of radiation exposure from both medical and non- medical exposures,” stated Synedgen President Shenda Baker. “Future studies are planned to further quantify the impact of SYN01 on the GI tract and to provide additional insight into its protective mechanisms.”

Synedgen recently presented its recent findings to the National Institute of Dental and Craniofacial Research at the National Institutes of Health, who supports the oral mucositis studies and the National Institute of Allergy and Infectious Disease Radiation countermeasures group, also at the National Institutes of Health. The total body radiation study was supported by a grant from the US Army Medical Research Acquisition Activity (USAMRAA).