Our Phase 3 PACES Trial is being conducted on colon cancer survivors.
The trial is recruiting patients to participate in an important trial of its lead combination therapy product, CPP-1X/sul, to minimize the occurrence and/or recurrence of colon adenomas in colon cancer survivors. There are currently no other effective treatments available to reduce the risk of recurrent colon cancers.
The Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) trial is testing CPP’s prevention therapy product CPP-1X/sul (eflornithine/sulindac) in 480 colon cancer survivors—each of whom will receive daily treatment for three years to prevent the recurrence of cancer or high-risk polyps.
The PACES trial is funded by the NCI in collaboration with SWOG, part of the nation’s oldest and largest publicly funded cancer research network.
In an earlier trial, people who had had adenomas removed from their colon who then took daily CPP-1X/sul for three years lowered their risk of developing a high-risk adenoma during that time by over 90%. And they lowered their chances of developing any adenoma during that time to less than one-third of what it was for those who did not take the drugs.
About Colon Adenomas
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 high-risk polyps, the chance of at least one of these polyps becoming cancerous is significantly increased.
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.
Currently to prevent polyps from becoming cancerous, they must be removed surgically. CPP is developing, in concert with the NCI, a Colon Adenoma Therapy (CAT) meant to prevent occurrence and recurrence of colon cancers.