Promising Results After Successful Patient Enrollment In Clinical Trial
A new treatment for platinum-resistant ovarian cancer has been granted Fast Track status to the CA4P drug, developed by OXiGENE, Inc. Fast Track designation opens up wider access and communications with the FDA, and can later shorten the standard FDA review timeline from 10 to 6 months by allowing the drug to be submitted for priority review of the New Drug Application.
CA4P (combretastatin-A4 phosphate or fosbretabulin) is a vascular disrupting agent (VDA) that targets existing tumor blood vessels. By quickly binding to the tumor blood vessels, the tumors become compromised due to ischemia (insufficient blood flow) and necrosis (tissue death). Cancer cell death then occurs in the central region of the tumor. When used alone, CA4P has shown that tumor regrowth may appear after the treatment course. So, OXiGENE has focused on a combination therapy, combining CA4P with bevacizumab.
CA4P’s Phase II Clinical Trial
In a randomized controlled Phase II trial, CA4P showed to improve response rates and progression-free survival in patients with recurrent ovarian cancer. By combining CA4P with bevacizumab, an existing combination anti-vascular therapy drug, these results showed to be especially evident in patients with platinum-resistant ovarian cancer.
Regarding the Fast Track status, William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE, stated, “The FDA’s granting of Fast Track status to CA4P is a significant acknowledgement of the potential for CA4P to provide a new and better treatment option for women with platinum-resistant ovarian cancer. I am pleased that we now have the opportunity to work closely with FDA to expedite our CA4P development program in ovarian cancer, as we seek to bring this promising product candidate to patients.”
This April or May will see a new Phase II/III study with 436 enrolled subjects. The primary endpoint is a progression-free survival for over at least 12 months, with the study completion date to be estimated for July 2018.
Next Steps: Patient Enrollment
This new clinical trial is huge news in the fight against ovarian cancer. With that said, in order to see whether or not this fast track status will ultimately lead to an FDA approval, OXiGENE will need to yield positive results from their phase II/III clinical trials; and in order to accomplish this, they will need to obtain a significant sample size from patient enrollment and people willing to participate in clinical research trials. Only time will tell if CA4P can provide a better treatment option for women with platinum-resistant ovarian cancer, and we will continue to monitor this case as it progresses.