2012.3.5 Patient Advocates Encouraged That Ovarian Cancer Trial Will Advance, Thanks to FDA Approval to Re-Import Doxil®
Washington, DC—Endocyte, Inc. announced today that is has received approval from the Food and Drug Administration (FDA) to re-import supplies of Doxil® from Europe for use in the company’s PROCEED Phase 3 trial. The PROCEED trial is a clinical trial for women with folate-receptor positive platinum resistant ovarian cancer. Enrollment in the trial had stopped due to the ongoing, worldwide shortage of Doxil. More information about the PROCEED trial is available at www.clinicaltrials.gov.
Amanda Davis, a spokeswoman for the Ovarian Cancer National Alliance, commented on the announcement: “The good news today is that research on ovarian cancer will continue. We are pleased that this clinical trial can move forward, potentially giving women with the disease another treatment option.”
“While today’s announcement is good news for a few women, it will only affect those who can enroll in the PROCEED trial,” Ms. Davis noted. “Hundreds more women have been affected by shortages of Doxil and other chemotherapy drugs in the past year. As the foremost advocate for women with ovarian cancer, the Ovarian Cancer Nation Alliance is working vigorously with the FDA, drug manufacturers and other stakeholders to find solutions to this ongoing crisis.”
The Ovarian Cancer National Alliance is the foremost advocate for women with ovarian cancer in the United States. To advance the interests of women with ovarian cancer, the organization advocates at a national level for increases in research funding for the development of an early detection test, improved health care practices, and life-saving treatment protocols. The Ovarian Cancer National Alliance educates health care professionals and raises public awareness of the risks and symptoms of ovarian cancer. The Ovarian Cancer National Alliance is a 501 (c) (3) organization established in 1997.