Tucson-based drug startup Cancer Prevention Pharmaceuticals Inc. has announced the launch of a Phase 2 clinical trial at Vanderbilt University Medical Center to test the company’s flagship drug candidate for preventing gastric cancer.
The drug, CPP-1X, will be studied in patients with precancerous gastric lesions who are at high risk for gastric cancer, the company said Monday.
The trial is funded by the National Cancer Institute and run in collaboration with gastroenterologists Dr. Keith T. Wilson and Dr. Douglas R. Morgan of the Vanderbilt University School of Medicine and the Vanderbilt-Ingram Cancer Center.
Currently, there are no treatments for the prevention of gastric cancer in patients with precancerous conditions of the stomach, Wilson said.
The American Cancer Society estimates the incidence of stomach cancer in the United States in 2015 was about 24,590 cases. About 10,720 people will die from this type of cancer this year, the company said.
The trial will enroll 300 patients for 18 months of treatments as an initial step in a program to determine if CPP-1X can prevent gastric cancer, the company said.
CPP-1X already is in late-stage clinical trials as a preventive treatment for colon cancer in combination with a second drug. It also is the subject of clinical trials as a standalone treatment for a type of pediatric brain cancer and in preclinical studies as a treatment for early onset Type I diabetes.
The company is developing CPP-1X under “orphan drug” status granted by the U.S. Food and Drug Administration for the treatment of gastric cancer and by the FDA and the European Union for treatment of familial adenomatous polyposis, a precursor to colon cancer, and for neuroblastoma.
French drug giant Sanofi formerly manufactured CPP-1X, also known as eflornithine, as a treatment for African sleeping sickness and hirsutism.
Cancer Prevention Pharmaceuticals, which is led by University of Arizona alumnus Jeff Jacob as CEO, has licensed its drug technology from the UA and the University of California-Irvine.
The company was co-founded by retired UA professor and Arizona Cancer Center member Eugene Gerner and Dr. Frank Meyskens Jr., an oncologist and former Arizona Cancer Center member who is now associate vice chancellor of health sciences at UC-Irvine.