About OPAXIO™ as a radiosensitizer
OPAXIO is a highly potent radiosensitizer that selectively enhances the anti-tumor potency of radiation therapy in preclinical animal models and has demonstrated excellent tumor sensitization during clinical trials of locally advanced lower esophageal cancer. In addition to the study in patients with GBM, is also being tested as a radiosensitizer in patients with locally advanced head and neck cancer in combination with cetuximab.
About Cell Therapeutics, Inc.
, 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
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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 receive regulatory approval from the FDA, 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, and/or the treatment of locally advanced lower esophageal cancer, the potential failure of OPAXIO when combined with TMZ and/or RT to provide progression free survival and overall survival responses to newly-diagnosed high-grade malignant brain tumors such as GBM, that the results of the randomized 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 clinical trial comparing OPAXIO to TMZ, that CTI cannot guarantee or predict whether or not orphan-drug designation of OPAXIO will provide a substantial benefit to CTI, the CTI cannot guarantee that even if OPAXIO is approved by the FDA that CTI will receive seven years of market exclusivity for OPAXIO, fee waivers and/or tax incentives, 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