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Investigational New Drug Application Submitted for Paclitaxel Poliglumex

SEATTLE, July 7 /PRNewswire-FirstCall/ -- The Gynecologic Oncology Group (GOG) submitted an IND with the U.S. Food and Drug Administration (FDA), including a Special Protocol Assessment (SPA) package, for a pivotal trial examining the ability of XYOTAX(TM) to maintain remission and prolong the survival of patients with ovarian cancer. The GOG is a National Cancer Institute-sponsored research group of more than 250 affiliate and member institutions that has established the standards of care in ovarian cancer since the 1970s. In March, the GOG entered into a clinical trials agreement with Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) to sponsor and conduct a phase III clinical trial of XYOTAX(TM) in patients with ovarian cancer. The GOG plans to initiate the trial later this year following FDA review of the IND and SPA and expects to enroll approximately 1550 patients over 18-24 months.

"Our objective is to prolong the survival of patients with advanced ovarian cancer, ultimately making this a curable disease," stated Larry Copeland, M.D., Department of Obstetrics and Gynecology Chair, James Cancer Hospital, Ohio State University and Vice Chair of the GOG. "The potential for maintaining a complete remission by using chronically administered maintenance doses of chemotherapy is well established in blood-related cancers. A prior study of maintenance paclitaxel demonstrated the potential benefit in ovarian cancer, however, chronic treatment with paclitaxel is limited by side effects, which can often be severe like nerve damage and which impair the patients' quality of life. We believe that XYOTAX(TM) may provide a safer, potentially more effective alternative to paclitaxel and allow patients to maintain a good quality of life while being treated."

The trial will investigate the safety and efficacy of XYOTAX(TM) (175 mg/m2), administered over approximately 10 minutes once a month for 12 months, compared to no maintenance therapy to assess progression free survival (PFS) and overall survival (OS) in patients with ovarian cancer who have achieved a complete remission following front-line chemotherapy. Paclitaxel (175mg/m2) will also be investigated as a third treatment arm to assess the potential quality of life advantages of XYOTAX(TM) by measuring differences in toxicity and tolerability between treatment groups. These differences will constitute secondary endpoints of the trial.

According to a recent market survey, approximately 60 percent of patients (20,000 in 2003 in the U.S.) receive surgery followed by chemotherapy for newly diagnosed advanced ovarian cancer. The standard front-line regimen consists of paclitaxel (175mg/m2) and carboplatin (AUC 6) for up to six cycles. Approximately 70 percent of patients will achieve a complete response with front-line therapy and would be eligible for treatment on the XYOTAX(TM) pivotal trial.

About The Gynecologic Oncology Group
The GOG is a national non-profit organization dedicated to clinical research in the field of gynecologic cancer. The purpose of the GOG is to improve the treatment of gynecologic cancer. These goals are addressed through research encompassing surgery, radiation therapy, chemotherapy, pathology, immunology and/or gynecologic nursing. To promote this mission, the GOG receives support from the National Cancer Institute (NCI) of the National Institutes for Health. The GOG has a history of establishing treatment standards for ovarian cancer, demonstrating improved survival with platinum therapy in the early 1980s and again with the combination of paclitaxel and platinum in the mid-1990s.

About XYOTAX(TM)
XYOTAX(TM) (paclitaxel poliglumex) is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. This polymer technology results in a new chemical entity, designed to selectively deliver higher and potentially more effective levels of active chemotherapeutics to tumors. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX(TM) is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. Because more of the chemotherapy is targeted to the tumor and the levels of chemotherapy delivered to normal tissue are reduced, XYOTAX(TM) may be more effective and have less severe side effects than currently available chemotherapeutics.

Source: Cell Therapeutics, Inc.

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