European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.’s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application
“We are pleased that the EMEA has agreed to an in person oral explanation in September allowing the Company and its lung cancer experts adequate time to prepare a thorough review for the Co-rapporteurs in support of our MAA for OPAXIO in non-small cell lung cancer,” said
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 Taxol(R), 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. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
About Cell Therapeutics, Inc.
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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 our securities. Specifically, the risks and uncertainties include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with OPAXIO and pixantrone in particular, including, without limitation, the potential for OPAXIO and pixantrone to be proved safe and effective the treatment of the indications noted in this press release or any other indication, determinations by regulatory, patent and administrative governmental authorities (including the FDA and EMEA), CTI’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling OPAXIO and pixantrone, CTI’s ability to sell OPAXIO and pixantrone and otherwise receive any revenue 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.
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SOURCE Cell Therapeutics, Inc.