Synedgen Awarded National Cancer Institute Funding for Promising New Treatment for Medical Radiation-induced Bowel Injury

Treatment designed to reduce pain and inflammation associated with radiation therapy to the lower bowel

September 26, 2014–Claremont CA—Synedgen announced today the award of a competitive Small Business Innovation Research (SBIR) Phase I contract from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to demonstrate proof-of-concept activity of Synedgen’s proprietary treatment for radiation proctitis, a condition that causes painful tissue damage to the lining of the gastrointestinal (GI) tract caused by radiotherapy.

With this award, Synedgen will complete efficacy studies for its proprietary formulation of it’s polymer-based pharmaceutical, SY513, to alleviate radiation proctitis following medical radiotherapy often used to treat prostate cancer, ovarian cancer and tumors originating in the pelvic region.

Radiation proctitis impacts as much as 75% of patients treated by radiotherapy in the lower bowel area and can cause both short term and chronic pain. In some cases, acute radiation proctitis is so serious that the intensity of the radiotherapy has to be reduced, ultimately jeopardizing the patient’s prognosis for successful cancer treatment.

Synedgen has developed formulations of its proprietary high molecular weight polymer therapeutics to reduce radiation or chemical damage to the oral cavity and the entire length of the GI tract. Synedgen’s orally delivered GI treatments have shown a remarkable ability to reduce local and systemic inflammation, reduce cell death and improve tissue regeneration associated with radiation-induced damage in the large and small intestines in animal models that mimic conditions seen in human therapies.

“This award helps further expand our growing portfolio of oncology supportive care products. Our surface-active polymers have broad mechanism of action, which are designed to reduce inflammation and tissue damage due to chemical or radiation damage. Based on our previous positive research findings, we anticipate this formulation and delivery directly to the affected area will limit the damage of radiation therapy, and allow more aggressive treatment of prostate and other pelvic cancers that are currently limited by radiation proctitis,” stated Synedgen president Shenda Baker.

“Acute radiation-induced injury to the GI mucosa occurs in virtually all patients undergoing radiation therapy. Clearly, there is a need for new agents to reduce the short and long-term side effects of radiotherapy and minimize tissue damage. We are optimistic that this research will result in improved survival of and quality of life for cancer patients,” added CEO William Wiesmann M.D.

This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, and Department of Health and Human Services under Contract No. HHSN261201400011C.This NCI is fully funding $196,707 for the specific project costs under the contract.