BEDFORD, Mass.--(BUSINESS WIRE)--Augmenix, Inc., a medical technology company that develops, manufactures and sells proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy, today announced positive results from the first prospective clinical trial evaluating the efficacy of its SpaceOAR® System in protecting the rectum in men undergoing high dose stereotactic body radiation therapy (SBRT*) for the treatment of low- to intermediate-risk prostate cancer. Results from the multi-institutional Phase 2 study were presented today as a late-breaking clinical trial at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO 2017) in San Diego.

Researchers have long known that higher radiation doses (dose escalation) are more effective at killing tumors. However, the amount of radiation safely delivered to the prostate is limited by the rectum proximity, and concerns of creating long-term rectal injury and associated side effects. Physicians at the University of Texas Southwestern Medical Center and Memorial Sloan Kettering Cancer Center recently evaluated 44 men receiving SpaceOAR Hydrogel followed by dose-escalated (45 Gray) SBRT. The data show that SpaceOAR Hydrogel significantly reduces rectal injury in men undergoing high-dose SBRT for prostate cancer. Specifically, 13.6 percent of treated men had rectal mucosal injury in the study, all of which were mildly symptomatic and completely healed within six months following treatment. These findings are significant, as prior clinical research found that 90 percent of non-SpaceOAR Hydrogel patients treated with the same SBRT regimen experienced similar radiation-induced mucosal injury due to higher rectal wall radiation doses. None of the patients exhibited signs of biochemical cancer recurrence in the 12-month follow up period.

“Hypofractionated approaches are gaining momentum in the treatment of prostate cancer, and in our experience, high-dose regimens have provided exceptionally high rates of biochemical control, but at the cost of an increased risk of rectal complications associated with the rectal wall dose,” said Michael Folkert, MD, radiation oncologist and brachytherapy specialist at University of Texas Southwestern Medical Center in Dallas. “Our new study demonstrates that use of the perirectal hydrogel spacer gets us the 'room' we need to safely deliver the most potent therapeutic doses to patients, which may ultimately lead to the optimal cancer control while significantly reducing the risk of treatment related complications.”

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