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High-risk gastric cancer drug enters phase 2 testing
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Cancer Prevention Pharmaceuticals Inc. launched a phase 2 clinical trial to assess CPP-1X, a therapy for the treatment of gastric cancer previously given orphan drug designation from the FDA, in patients with precancerous gastric lesions, according to a press release.
“Currently, there are no agents for the prevention of gastric cancer in patients with precancerous conditions of the stomach,” Keith T. Wilson, MD, Thomas F. Frist Sr. Chair in medicine and professor of medicine in the division of gastroenterology, hepatology and nutrition at Vanderbilt University Medical Center, said in the release.
In collaboration with Vanderbilt University Medical Center, the National Cancer Institute-funded trial will evaluate whether the drug can improve DNA damage in patients with premalignant atrophic gastritis or intestinal metaplasia. Researchers will perform a randomized, double-blind, placebo-controlled trial of 300 patients enrolled to receive daily treatment of CPP-1X for 18 months.
CPP-1X received orphan drug designation for treating gastric cancer including cancer of the gastroesophageal junction, and for familial adenomatous polyposis and neuroblastoma in the U.S. and European Union.
“Our mission is to develop new therapeutics that focus on the prevention of cancer and its recurrence,” Jeffrey Jacob, CEO of Cancer Prevention Pharmaceuticals said. “We are pleased to collaborate with the NCI and leaders in gastric cancer prevention at Vanderbilt University to evaluate the potential of CPP-1X in reducing the progression of precancerous lesions in high-risk patients, and thereby help prevent gastric cancer.”
Disclosure s: Healio Gastroenterology was unable to confirm any relevant financial disclosures at the time of publication.