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 Pixuvri include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Pixuvri in particular including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the U.S. Food and Drug Administration, that CTI may not market and commercialize Pixuvri in the E.U. as planned, that CTI may not launch Pixuvri in the E.U. this year as planned, that CTI may not be able to complete the PIX306 clinical trial of Pixuvri-rituximab compared to gemcitabine-rituximab in patients who have relapsed after 1 to 3 prior regimens for aggressive B cell NHL and who are not eligible for autologous stem cell transplant by June 2015 or at all as required by the EMA or have the results of such trial available by June 2015 or at all, that CTI may not be able complete a post-marketing study aimed at confirming the clinical benefit observed in the PIX301 trial, that the conditional marketing authorization for Pixuvri may not be renewed, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled, that CTI's average net operating burn rate may increase and CTI's ability to continue to raise capital as needed to fund its operations in general, and, including, without limitation, competitive factors, technological developments, costs of developing, producing, and selling Pixuvri, 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, 8-K, and 10-Q. 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.
References
1) European Cancer Observatory, Cancer Fact Sheets, 2008
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3) Pettengell R, Coiffier B, Narayanan G et al. Lancet 2012. Published online
May 30th 2012. DOI:10:1-16/S1470-2045(12)70212-7
4) Cavalletti E, Crippa L, Mainardi P et al. Invest New Drugs 2007;25:187-95
5) Hagemeister FB. Cancer Chemother Pharmacol 2002;49(suppl 1):S13-20
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7) Friedberg ASH Education Book 2011;1:498-505
Media Contact:
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E: invest@ctiseattle.com
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