Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials. CTI has exclusive marketing and co-development rights to Chroma Therapeutics Ltd.'s drug candidate tosedostat in North, Central, and
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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 market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of Pixuvri, pacritinib, or tosedostat include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Pixuvri, pacritinib or tosedostat in particular including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory non-Hodgkin's lymphoma and/or other tumors as determined by the U.S. Food and Drug Administration (the "FDA"), that Pixuvri may not be immediately available to patients in the EU, that CTI may not market and commercialize Pixuvri as planned, that CTI may not launch Pixuvri in the EU this year, 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, the potential that phase III studies of pacritinib might not begin in the fourth quarter of 2012, or failure of a pacritinib to prove safe and effective for
primary myelofibrosis ("MF") and MF secondary to other myeloproliferative neoplasms ("MPN")
, the potential failure of tosedostat to prove safe and effective for the treatment of elderly patients with newly-diagnosed AML or high-risk myelodysplastic syndrome ("MDS") (including when administered in combination with cytarabine or decitabine) as determined by the FDA and/or the EMA, the potential failure of combination studies of tosedostat with hypomethylating agents in treating AML and/or MDS, that the studies of tosedostat may not achieve their primary and/or secondary objectives, that tosedostat may not be approved by the FDA and/or the EMA,, 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 re-alignment of its resources and re-prioritization of its product pipeline may not result in reducing CTI's operating expenses from $6.5 million per month to an average of $4.5 million per month or by more than 30% or at all, 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.
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Lindsey Jesch Logan
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