Randomized Study Comparing Cell Therapeutics’ OPAXIO (Paclitaxel Poliglumex) and Radiotherapy to Standard of Care Temozolomide and Radiotherapy Treatment Open for Enrollment
SEATTLE, Aug. 18, 2011 /PRNewswire/ — Cell Therapeutics, Inc. (“CTI”) (NASDAQ: CTIC and MTA: CTIC) announced that enrollment has opened for a randomized phase II clinical study comparing the combination of OPAXIO (paclitaxel poliglumex, PPX) and radiation (“RT”) to the combination of temozolomide (“TMZ”) and RT for patients with newly diagnosed glioblastoma, a high-grade malignant brain tumor.
The objectives of the study are to determine if OPAXIO and RT improve progression free survival (“PFS”) and overall survival (“OS”) compared to TMZ and RT as well as to evaluate neuro-cognitive function and toxicities of these therapies. If positive, results from the study could be used to plan a phase III study of OPAXIO added to standard radiation therapy for approval in this disease.
Glioblastoma is the most common and deadliest type of primary brain tumor in adults. It is estimated that 17,000 primary brain tumors are diagnosed each year in the U.S., 60% of which are gliomas with glioblastoma being the most prevalent. The prognosis for the great majority of patients with glioblastoma is poor with less than 25% of patients surviving two years with current therapies.
In a recent study, treatment with OPAXIO added to standard therapy with TMZ and RT resulted in a median PFS of 13.5 months in the subset of patients with GBS (n=17). Median OS has not yet been reached with 50% of patients having at least 22 months of follow-up since completing therapy. The study was presented in June 2011 by Drs. Suriya Jeyapalan, Heinrich Elinzano and Mark Goldman, Assistant Professors of Neurology and Neurosurgery, Brown University Oncology Group at the 2011 American Society of Clinical Oncology Annual Meeting. Additional survival data are expected to be presented at the Society of Neuro-Oncology annual meeting later this year.
“The data from the earlier OPAXIO study with an overall survival not yet reached at a median follow-up of 22 months led us to quickly initiate this study. Only patients with glioblastomas without MGMT methylation will be eligible for this new study. Approximately half of all patients with glioblastomas have unmethylated MGMT and these patients have particularly poor prognosis with standard treatment with temozolomide and radiation so there is a serious unmet medical need — particularly for MGMT-positive patients,” commented Howard Safran, M.D., head of the Brown University Oncology Group. “There was strong interest in participating in this study based on those data and we hope to be able to enroll this trial on schedule.”
The study is expected to enroll 60 patients. Patients in the OPAXIO arm will receive OPAXIO once every week plus RT for six weeks. Patients in the TMZ arm will receive daily oral TMZ plus RT for six weeks. After completion of initial therapy, both arms will receive TMZ on day 1-5 and then every 28 days up to 12 cycles for a total of 48 weeks.
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in TaxolÃ‚®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue’s exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. 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 the paclitaxel chemotherapy.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com/.
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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 trading 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 and/or less toxic and effective for the treatment of newly diagnosed high-grade malignant brain tumors such as GBM, including when combined with TMZ and RT, the potential failure of OPAXIO when combined with TMZ and RT to provide PFS and OS responses to newly-diagnosed high-grade malignant brain tumors such as GBM, that the results of the new OPAXIO study may not be positive or be used to plan a phase III study of OPAXIO for approval for use in treating newly diagnosed GBM, that CTI cannot predict or guarantee the pace of patient enrollment in the phase II clinical study comparing OPAXIO to TMZ, Brown and 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 such as OPAXIO, and the risk factors listed or described from time to time in CTI’s filings with the U.S. 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.
Lindsey Jesch Logan
Medical Information Contact:
SOURCE Cell Therapeutics, Inc.