US-based Cancer Prevention Pharmaceuticals (CPP) has initiated a Phase II clinical trial of CPP-1X for the treatment of precancerous gastric lesion patients who are at high gastric cancer risk.
CPP-1X is an anti-proliferative agent currently being developed to inhibit the ornithine decarboxylase (ODC) enzyme.
Sponsored by the National Cancer Institute (NCI), the randomised, double-blind, placebo-controlled pharmaco-prevention trial is being conducted in partnership with Vanderbilt University School of Medicine, Vanderbilt University Medical Centre and the Vanderbilt-Ingram Cancer Centre.
The trial is designed to assess efficacy of the investigational candidate to ameliorate DNA damage in premalignant atrophic gastritis or intestinal metaplasia patients.
CPP CEO Jeffrey Jacob said: “Our mission is to develop new therapeutics that focus on the prevention of cancer and its recurrence.
“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.”
The US Food and Drug Administration (FDA) has granted orphan drug designation for CPP-1X in 2015 to treat gastric cancer and cancer of gastroesophageal junction.
CPP-1X also received orphan designation for familial adenomatous polyposis (FAP) and neuroblastoma in both the US and the European Union (EU).
With a focus on cancer therapeutics, CPP develops medicines for multiple therapy areas, including cardiovascular, neurovascular and infectious diseases.
The firm is also performing a Phase III trial in colon cancer survivors and another Phase III trial in familial FAP patients with CPP-1X combination product, CPP-1X / sulindac.