Cell Therapeutics Announces Data Safety and Monitoring Board Recommendation to Continue the GOG-0212 Phase 3 Clinical Trial of OPAXIOTM as Maintenance Therapy in Ovarian Cancer First Planned Interim Survival Analysis Passes Futility Boundary
SEATTLE, Jan. 31, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the Gynecologic Oncology Group (GOG) informed CTI that an independent Data Safety Monitoring Board (DSMB) recommended continuation of the GOG-0212 Phase 3 clinical trial of OPAXIOTM (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a planned interim survival analysis. CTI remains blinded to the interim analysis results. GOG-0212 is the largest maintenance study in this setting, having enrolled approximately 1,000 of the planned 1,100 patients. Enrollment is expected to be completed in 2013.
The trial is being conducted and managed by the GOG, which is one of the National Cancer Institute's (NCI) funded cooperative cancer research groups focused on the study of gynecologic malignancies.
"This is an important milestone for our OPAXIO clinical development program and potentially for women with advanced ovarian cancer," noted Steve Benner, M.D., Chief Medical Officer of CTI. "GOG-0212 seeks to address an important question on the role OPAXIO may play in maintenance therapy for ovarian cancer and potentially other solid tumors."
The GOG-0212 study is a randomized, multicenter, open label Phase 3 trial of either monthly OPAXIO or Taxol® for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy. For purposes of registration, the primary endpoint of the study is overall survival of OPAXIO compared to surveillance. Secondary endpoints are progression-free survival, safety and quality of life. The statistical analysis plan calls for four interim analyses and one final analysis, each with boundaries for early closure for superior efficacy or for futility. The Company expects the next interim analysis to occur in the second half of 2013.Additional information about GOG-0212 may be found at www.clinicaltrials.gov, study ID NCT00108745.
In September 2006, CTI and Novartis entered into a worldwide licensing agreement to grant Novartis a right to develop and commercialize CTI's OPAXIO and an option to negotiate a license to pixantrone.
About Ovarian Cancer
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide. Annually, over 220,000 women will be diagnosed with ovarian cancer around the world and approximately 140,000 will die from the disease.1 In 2012, it was estimated that 22,280 new cases of ovarian cancer would be diagnosed in the U.S. and 15,500 deaths would result. Ovarian cancer is the most lethal of the gynecologic malignancies. Treatment for ovarian cancer usually involves advanced surgery and chemotherapy.2
OPAXIO™ (paclitaxel poliglumex, CT-2103), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue's exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as OPAXIO. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel. Unlike standard radiosensitizing agents, OPAXIO appears tumor selective and does not appear to enhance radiation toxicity to normal tissues.
About the Gynecologic Oncology Group
The Gynecologic Oncology Group (GOG) is a not-for-profit organization of more than 300 member institutions with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of the Group's processes is utilized in order to constantly improve the quality of patient care. To promote this mission, the GOG receives support from the National Cancer Institute of the National Institutes for Health. The GOG is the only group that focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus, and cervix. The GOG is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, basic scientists, quality of life experts, data managers, and administrative personnel.
Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.
OPAXIO is a trademark of Cell Therapeutics, Inc. All other trademarks are the property of their respective owners.
- WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008
- American Cancer Society Fact Sheet, http://tinyurl.com/b35gtwb, Accessed January 27, 2013
This press release includes forward-looking statements that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of OPAXIO include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with OPAXIO in particular, including, without limitation, the potential failure of OPAXIO to prove safe and effective for the treatment of patients with , either ovarian cancer or in combination regimens, as determined by the U.S. Food and Drug Administration and/or the European Medicines Agency ; that OPAXIO may not satisfy a medical need not currently addressed with existing ovarian cancer treatments; that the GOG-0212 clinical trial of OPAXIO may not occur as planned; that 1,100 patients may not enroll in the GOG-0212 clinical trial; that CTI may not be able to successfully implement its plans, strategies and objectives related to the development of OPAXIO; CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling CTI's product candidates; and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
SOURCE Cell Therapeutics, Inc.