According to results recently presented at the 2006 Gastrointestinal Cancers Symposium, the addition of CoFactor™ (ANX 510) appears to significantly enhance the activity of the chemotherapy agent 5-fluorouracil (5-FU) in the treatment of metastatic colorectal cancer.
The colon and rectum comprise the final parts of the large intestine. Colorectal cancer is the second leading cause of cancer-related deaths in the U.S. Metastatic colorectal cancer refers to cancer that has spread from its site of origin to distant sites in the body, often invading vital organs. Standard treatment for metastatic colorectal cancer often includes chemotherapy, targeted therapy, surgical removal of cancer (if possible), and possibly radiation therapy.
5-FU is a commonly used chemotherapy agent in the treatment of colorectal cancer; it is administered as a single agent or in combination with other therapeutic agents. The agent leucovorin is used in combination with 5-FU to enhance its anticancer activity. Researchers are now evaluating the agent referred to as CoFactor, which is still in clinical trials, to further enhance the anticancer activity of 5-FU as well as reduce side effects caused by the agent.
CoFactor is an agent that maintains a stable bond between 5-FU and its target-a bond that would typically be degraded through biological processes. This allows for enhanced cancer-killing effects. CoFactor also bypasses the chemical pathway necessary for leucovorin use, which ultimately reduces side effects caused by treatment.
Researchers conducted a study to evaluate the effects of CoFactor in patients with metastatic colorectal cancer. This trial included patients who had not received prior therapy and were treated with CoFactor plus 5-FU.
- Clinical benefit (decrease in cancer size or stabilization of cancer) was achieved in 85% of patients.
- 35% of patients had a reduction of more than 50% of total cancer size.
- Median time to cancer progression was over 5.4 months.
- Median duration of survival has not yet been reached.
- There were no serious hematologic (blood) or gastrointestinal side effects reported.
The researchers concluded that the addition of CoFactor to 5-FU provides impressive responses, as well as delays progression. Longer follow-up will help determine overall survival. A phase III trial (final phase of trial prior to FDA review) evaluating CoFactor has been planned, and patient enrollment will begin shortly.
Patients diagnosed with metastatic colorectal cancer who are not eligible for combination chemotherapy may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating CoFactor or other novel therapeutic agents. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (www.cancer.gov) and www.cancerconsultants.com.
Reference: AdventRX Pharmaceuticals.ADVENTRX Announces Positive Efficacy and Safety Results from CoFactor Phase II Clinical Trial. Available at: http://ir.adventrx.com/phoenix.zhtml?c=75414&p=irol-newsArticle&ID=809773&highlight=. Accessed January 2006.