OvaRex® MAb for Patients with Advanced Ovarian Cancer May Extend Remission Following Favorable Surgery and Chemotherapy
U.S. Researchers Seeking New Standard of Care for Advanced Ovarian Cancer
BOSTON (April 4, 2005) - For the majority of patients with advanced ovarian cancer, the current standard of care and front-line treatments - surgery and chemotherapy - are not enough to control the high recurrence rate. Researchers at clinical centers throughout the United States are further evaluating OvaRex® MAb (oregovomab), an investigational therapy, to determine the extent of remission in patients who have a favorable response to surgery and chemotherapy.
They are also assessing survival, quality of life, immune response, and safety. Women with stage III or IV ovarian cancer, who qualify to participate in the ongoing clinical research, must begin taking the study medication within four to 12-weeks of completing their last dose of initial chemotherapy. For more information and pre-screening, visit www.OvarianCancerStudy.com.
According to the American Cancer Society (ACS), ovarian cancer causes more deaths than any other cancer of the female reproductive system. Because it is usually detected at an advanced stage, the disease is difficult to treat and most patients relapse within two years of front-line treatment.
"The biggest challenge we face with advanced ovarian cancer is the recurrence rate," says Dr. Carolyn Runowicz, director of the Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, president-elect of the ACS, and an investigator on the OvaRex® study. "In order to make progress in treating this very aggressive disease, we must conduct a variety of research studies. In turn, patients with advanced ovarian cancer must understand that participating in a clinical trial, to supplement their current standard of care, is far better than doing nothing."
Results of the most recently completed OvaRex MAb clinical study were published in the September 2004 issue of the Journal of Clinical Oncology (JCO). In a study of 145 women with advanced ovarian cancer, researchers identified a subset of 67 patients who responded more favorably to surgery and chemotherapy. These were patients with remaining tumors of two centimeters or less, following surgery, who had no conclusive evidence of disease during and after chemotherapy. Within this "successful front-line treatment" group, patients who received OvaRex MAb experienced a longer period of remission - double the time - when compared with those patients who did not receive the investigational treatment.
"Weve learned so much about OvaRex MAb but we now need to confirm these observations with new clinical data," said Dr. Jonathan S. Berek, a gynecological oncologist at UCLAs Jonsson Comprehensive Cancer Center and a lead researcher of the study published in the JCO. "This biological therapy is in a class of investigational treatments, known as monoclonal antibodies, which hold promise as the next important incremental advance for the disease."
More than 80 percent of all ovarian cancers release excessive quantities of a surface protein, or antigen, called CA125 into the bloodstream. Researchers developed the OvaRex MAb infusion to act with CA125, stimulate the bodys immune system, attack the protein, and kill the tumors.
"If you can imagine the classic arcade game, it helps the immune system act like Pac-Men eating the foreign proteins and fighting the tumors," said Dr. William McGuire, director of the Harry and Jeanette Weinberg Cancer Institute in Baltimore. "Thats the best way to visualize how this therapy could potentially help patients with advanced ovarian cancer," continued Dr. McGuire.
The Phase III research study is enrolling at more than 60 medical centers throughout the United States. More than 350 women, 18 years of age or older, with stage III or IV ovarian cancer may be eligible to participate in one of two independent and identical clinical studies of OvaRex MAb. Qualified participants will receive best standard supportive care plus OvaRex MAb or placebo (an inactive agent). Two thirds of enrolled patients will be randomized to receive OvaRex MAb. The study medication will be administered by 20-minute infusions, once a month for three consecutive months, followed by quarterly doses for up to five years. All participants will be followed for relapse and survival status for a period of up to seven years.
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