We are enthusiastic about receiving FDA clearance to start this important clinical trial and with the opportunity it affords us to collaborate with CTCA
Chicago, IL (Vocus) May 30, 2008
Cancer Treatment Centers of America (CTCA), a leading provider of innovative cancer care for patients living with complex and advanced-stage disease, has begun accepting patients for an ovarian cancer vaccine clinical trial. The Phase I/II study, recently reviewed and cleared by the U.S. Food and Drug Administration (FDA), will evaluate the safety and efficacy of the unique ovarian cancer vaccine therapy for up to 42 patients with chemotherapy-resistant, advanced stage ovarian cancer.
The study will be conducted exclusively at CTCA at Midwestern Regional Medical Center in suburban Chicago. Eligible participants will be CTCA patients who have stage III or IV ovarian cancer and have tumor progression despite at least one, but no more than two, chemotherapy regimens. Participants in this clinical trial must first receive surgery at CTCA at Midwestern Regional Medical Center and localized chemotherapy infused directly into the abdomen (intraperitoneal chemotherapy), a standard of cancer care available to many CTCA patients. Patients become eligible for the ovarian cancer vaccine trial when it is determined that enough tumor cells can be harvested from the debulked tumor to create the ovarian cancer vaccine and the vaccine has passed rigid quality control testing.
CTCA will work with AVAX Technologies, Inc., to create a personalized ovarian cancer vaccine, using each patient's tumor cells that have been surgically removed at CTCA. These cells will be modified in the AVAX laboratories and will be designed to produce an immunologic response to treat the patient's ovarian cancer.
"The use of a systematic vaccine to sensitize the patient's immune system to fight their own tumors following localized, high-dose chemotherapy has not been attempted before," said Donald Braun, Ph.D, CTCA vice president for clinical research. Braun and Dr. Sybilann Williams, gynecologic oncologist and surgeon at CTCA along with Dr. David Berd, chief medical officer of AVAX, will serve as investigators.
"CTCA offers a powerful combination of traditional and innovative therapies provided by a team of cancer experts who work with each patient individually, to determine the appropriate combination of therapies to fight cancer," Dr. Williams said. "Ovarian cancer is a very complex disease that is often resistant to chemotherapy, radiation and surgery. CTCA will offer our patients the opportunity to be involved in another ground-breaking step in the fight against ovarian cancer."
The American Cancer Society ranks ovarian cancer as the eighth most common cancer among women, and it is the fifth leading cause of cancer-related deaths in women. It is estimated that there will be 21,650 new cases of ovarian cancer in the U.S. in 2008 and 15,520 cancer-related deaths. Ovarian cancer occurs in about one out of every 69 women, according to the Ovarian Cancer National Alliance.
"We are enthusiastic about receiving FDA clearance to start this important clinical trial and with the opportunity it affords us to collaborate with CTCA," stated AVAX's Dr. Berd. "Clearly, better treatments for ovarian cancer are needed and we hope the vaccine will eventually find its place as a relatively non-toxic therapeutic alternative for these patients."
More information about the vaccine trial, ovarian cancer, and ovarian cancer treatment can be found at CancerCenter.com. Patients interested in the clinical trial may contact a CTCA Oncology Information Specialist at 877-98-TRIAL
About Cancer Treatment Centers of America:
Founded in 1988, Cancer Treatment Centers of America (CTCA) is a network of cancer treatment hospitals and community oncology programs in Illinois, Oklahoma, Pennsylvania and Washington - with a future location in Arizona scheduled to open in early 2009. CTCA provides a comprehensive, patient-centered treatment model that fully integrates conventional, state-of-the-art medical treatments with scientifically-supported complementary therapies such as nutrition, naturopathic medicine, psychological counseling, physical therapy and spiritual support to meet the special, whole-person needs of cancer patients with complex and advanced-stage disease. CTCA encourages patients and their families to participate in treatment decisions through its Patient Empowerment MedicineSM model. For more information about Cancer Treatment Centers of America, go to cancercenter.com.
About AVAX Technologies, Inc.:
AVAX Technologies, Inc. is a biotechnology company with operations in the United States and Europe. The company is engaged in the research, clinical and commercial development of biological products and cancer therapeutics. In addition, the company performs contract-manufacturing services for biological products for other pharmaceutical and biotechnology companies.