SEATTLE, March 27, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) announced that the University of Washington's ("UW") School of Medicine, Departments of Neurology and Neurosurgery, Division of Neuro-Oncology has begun enrolling patients in a randomized phase II clinical study comparing the combination of OPAXIO™ (paclitaxel poliglumex, PPX, CT-2103) and radiation therapy ("RT") to the combination of temozolomide ("TMZ") and RT for patients with newly-diagnosed glioblastoma multiforme ("GBM"), which is a poor-prognosis high-grade malignant brain tumor with an active gene called MGMT. MGMT is active in more than half of patients with glioblastoma and it substantially decreases the effectiveness of standard therapy with TMZ. This study is a multicenter trial initiated and led by the Neuro-Oncology department of the Brown University Oncology Research Group ("BrUOG") in Providence, Rhode Island. The first patient at UW recently has been enrolled.
Dr. Maciej Mrugala, Associate Professor of Neurology, Neurological Surgery and Medicine at UW's School Of Medicine and Affiliate Investigator at Fred Hutchinson Cancer Research Center is leading the study at the UW site.
"Patients with glioblastomas are rarely cured, although current standard therapy with RT and TMZ has been shown to prolong survival. A Phase I/II study of paclitaxel poliglumex and TMZ with RT, performed by BrUOG, showed encouraging results with median progression free survival of 13.5 months. Two of the 4 patients tested retrospectively found to express MGMT had progression free survivals of greater than 16 and 18 months as of June 2011," said Dr. Mrugala. (Jepayalan et al, ASCO 2011).
"The current Phase II Trial randomizes patients 2:1 between paclitaxel poliglumex and standard of care and will only enroll patients with active (unmethylated) MGMT who are less likely to benefit from TMZ. I brought this study protocol to the attention of my colleagues in the Neuro-Oncology Program because the results of the BrUOG study were intriguing and there is a serious unmet medical need," Dr. Mrugala concluded.
The study objective is to determine whether paclitaxel poliglumex and RT are likely to improve progression-free survival ("PFS") and overall survival ("OS") compared to TMZ and RT. This study will also 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 paclitaxel poliglumex added to standard RT in this disease.
According to the National Cancer Institute, glioblastoma is the most common and deadliest type of primary brain tumor in adults. It is estimated that there will be 10,000 new cases of GBM diagnosed in the US this year. The prognosis for the great majority of patients with glioblastoma is poor, with less than 25% of patients surviving two years with current therapies.
About the Study
The study is expected to enroll 60 patients. Patients in the paclitaxel poliglumex arm will receive paclitaxel poliglumex 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 for up to 12 cycles for a total of 48 weeks.
Patients interested in participating in this study or wanting more information can call Sandra Johnston, PhD, RN at (206) 616-7117.
OPAXIO™ (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX™, 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, 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 paclitaxel poliglumex 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. Paclitaxel poliglumex enhances the anti-tumor potency of radiation therapy in preclinical animal models and is being tested as a radiosensitizer in patients with esophageal cancer, brain cancer, and head and neck cancer.
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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About Brown University Oncology Research Group (BrUOG)
The Brown University Oncology Research Group (BrUOG) was created in 1994 to coordinate clinical cancer research for Brown's affiliated hospitals and Warren Alpert Medical School faculty. Since that time more than 3,000 Rhode Islanders have been treated on BrUOG trials at area hospitals. BrUOG's main mission is to improve cancer care through the implementation of innovative, multidisciplinary cancer clinical trials. Before BrUOG was founded, there was no unifying body for such research through which Brown's myriad scientists and physicians could share their ideas on the treatment of cancer. The trials sponsored by BrUOG investigate novel, cutting-edge applications of chemotherapeutic agents, biologic agents, and other cancer treatments.
Today besides the 5 Rhode Island main member hospitals, Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital, Roger Williams Hospital and Memorial Hospital, BrUOG studies are also implemented in 8 other states nationwide.
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, UW's and CTI's ability to continue to raise capital as needed to fund this study and 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.
Clinical Trial Enrollment Contact:
Sandra K. Johnston, PhD, RN
Medical Information Contact:
SOURCE Cell Therapeutics, Inc.