Cancer Prevention Pharmaceuticals, Inc., (CPP) announced today the launch of a Phase III colon cancer prevention trial in collaboration with the National Cancer Institute (NCI) and SWOG, an NCI-supported clinical trials group. The Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) trial is a Phase III trial testing CPP’s prevention therapy product CPP-1X/sul (eflornithine/sulindac) in 1340 colon cancer survivors—each of whom will receive daily treatment for three years to prevent the recurrence of cancer or high-risk polyps.
In an earlier trial, people who had had adenomas removed from their colon who then took daily eflornithine and sulindac for three years lowered their risk of developing another adenoma during the following three years to less than one third of what it was for those who did not take the drugs. And they lowered their chances of developing a high-risk adenoma during that time by 90 percent.
The PACES trial is being conducted under CPP’s IND, supported by the NCI, and primarily managed by SWOG. “This is a huge milestone for all of us today,” said Jeffrey Jacob, CEO of Cancer Prevention Pharmaceuticals. “We have worked collaboratively with the NCI, SWOG, and the US Food and Drug Administration (FDA) for over three years to get this pioneering trial up and running.”
CPP has agreements in place with both SWOG and the NCI providing CPP exclusive access to the data from this trial for commercial and regulatory purposes. The Company is also considering supplementing this trial with a parallel study in Europe or Asia. Jacob said, “CPP was created to pave a regulatory pathway so that others in the industry would consider cancer risk-reduction therapy—the prevention of cancer before it occurs—as a viable product development model that the Company believes holds the key to reducing death rates from cancer.”
About Colon Adenoma Therapy (CAT)
Polyps begin in the cells of glandular structures lining the colon. Most polyps are benign, but one kind is the cause of greater concern—the Colon Adenomatous Polyp (adenoma). This growth is associated with DNA changes in the lining of the colon. Up to 10% of these polyps can become cancerous within a 10 year period if undetected or ignored. For individuals with multiple polyps, the chance of at least one of these polyps becoming cancerous is very high. However, if malignant polyps are detected early, 90% of patients survive at least five years.
Some individuals have a genetic tendency to develop polyps. Individuals age 50 or older have a higher risk of developing Colon Adenomatous Polyps. In addition to genetic factors, these polyps are associated with a diet high in fat and beef and low in fiber. Another risk factor is a lack of exercise resulting in weight gain. To prevent polyps from becoming cancerous, they must be removed.