PROVIDENCE – A potential cancer-treating therapy developed in partnership with Brown University Health has received clearance from the U.S. Food and Drug Administration to move onto human clinical trials.
The drug, named ACM-CpG, is designed to treat patients with peritoneal carcinomatosis: a condition which occurs when cancer spreads to the membrane lining the internal organs, known as the peritoneum. Peritoneal carcinomatosis can cause abdominal swelling, pain and digestive complications, according to Brown Health’s Aug. 19 announcement.
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ACM-CpG is a collaborative effort between Brown Health and Arcamyra Therapeutics Inc., an oncology subsidiary of Singapore-based ACM Biolabs. The duo received the green light from the FDA after the federal agency approved their Investigational New Drug Application, which affirms clinical trials won’t subject humans to unreasonable risk, according to the FDA’s website.
“Peritoneal carcinomatosis remains one of the most challenging disease settings we treat, and patients need new options,” Dr. Khaldoun Almhanna, principal investigator of the study and professor of medicine at Brown University, said in the release.
Administered directly through the abdominal cavity, the drug aims to activate the body’s immune system to target cancer cells.
According to the study’s ClinicalTrials.gov post, clinical trial participants will receive at least one dose of the therapy on the first day of a 28-day treatment cycle, possibly receiving up to two additional injections. Participants will be required to visit the clinic seven times for checkups and tests. The trial will administer CT scans or MRIs every eight weeks, with subsequent scans every following 12 weeks.
“This FDA clearance marks an important step for Arcamyra and for patients with peritoneal carcinomatosis, a disease with few effective treatment options,” Madhavan Nallani, CEO and co-founder of Arcamyra, said in the announcement. “We are pleased to advance ACM-CpG into this Phase 1 trial with Dr. Almhanna and the teams at Brown University Health and The Warren Alpert Medical School of Brown University, whose experience in gastrointestinal oncology and peritoneal disease will be essential to this work.”
Mica Kanner-Mascolo is a PBN staff writer. She can be reached at kannermascolo@pbn.com.
