SEATTLE, Jan. 8, 2015 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced an overview of recent progress for its drug portfolio in addition to several anticipated key objectives for 2015.
"We ended a productive 2014 and have entered a promising 2015 stronger and more focused than we have been in recent years," said James A. Bianco, M.D., CTI BioPharma's President and Chief Executive Officer. "In the latter part of 2014, we entered into a global development and commercialization collaboration for PIXUVRI®; reported on data highlighting pacritinib's potential therapeutic utility in blood-related cancer indications beyond myelofibrosis, such as AML, MDS, CMML and CLL; and secured worldwide rights to tosedostat, a first-in-class aminopeptidase inhibitor. We look forward to building on this momentum, as we set our near-term focus on reporting top-line results from the first Phase 3 trial in myelofibrosis later in the first quarter of 2015 and advancing pacritinib towards an NDA submission."
Recent Progress Update
- In December 2014, researchers presented data showing treatment with pacritinib, a next generation oral multikinase inhibitor in Phase 3 development, preferentially killed acute myeloid leukemia (AML) cells with FLT3 mutations, overcame stromal protection and suppressed leukemic outgrowth from stroma adherent AML cells in both medium-term (7-14 days) and long-term (5-6 weeks) assays. In addition, significant synergy resulted with a combination treatment of pacritinib and cytarabine or a MEK inhibitor. In a separate presentation, researchers showed pacritinib demonstrated a unique kinome profile that supports potential role in modulating tumor microenvironments in blood-related cancers, including AML, myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and chronic lymphocytic leukemia (CLL).
- In September 2014, CTI BioPharma entered into an exclusive license and collaboration agreement with Servier to develop and commercialize PIXUVRI (pixantrone) in a transaction valued at up to approximately €103.0 million (approximately $133.5 million) if all milestones are achieved. Under the agreement, CTI BioPharma retains full commercialization rights for PIXUVRI in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the United Kingdom and the United States, while Servier has exclusive rights to commercialize PIXUVRI in all other countries.
- In October 2014, CTI BioPharma acquired worldwide rights to tosedostat, a late-stage oral targeted therapy for patients with AML and MDS and eliminated the potential for $209 million in development and sales milestone payments to Chroma Therapeutics Ltd.
Corporate and Financial
- In December 2014, CTI BioPharma announced receipt of a $15 million milestone payment from Teva Pharmaceutical Industries Ltd. related to the achievement of sales milestones for TRISENOX® (arsenic trioxide).
- CTI BioPharma plans to provide 2015 financial guidance in its fourth quarter and year-end 2014 results announcement.
2015 Key Objectives
- Report topline results. CTI BioPharma expects to unblind and report top-line data from the PERSIST-1 pivotal Phase 3 trial of pacritinib for patients with myelofibrosis late in the first quarter of 2015.
- Complete enrollment for PERSIST-2. CTI BioPharma anticipates completing enrollment in our ongoing second Phase 3 trial, PERSIST-2, in mid-2015.
- Start rolling submission. CTI BioPharma plans to begin submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 2015.
- Initiate trial in second indication. CTI BioPharma intends to advance a pacritinib development program in other hematologic malignancies in collaboration with Baxter in the second half of 2015.
- Grow E.U. sales. CTI BioPharma intends to focus on PIXUVRI for multiply relapsed or refractory aggressive relapsed B-cell non-Hodgkin lymphoma (NHL) and generate E.U. sales to achieve a net positive contribution margin by year-end 2015, excluding royalties or product sales outside CTI BioPharma territories.
- Complete enrollment in PIX306. CTI BioPharma expects to complete enrollment in the post-marketing commitment Phase 3 study of PIXUVRI in the fourth quarter of 2015, which, if positive, CTI BioPharma expects would convert conditional to full marketing authorization and extend label to second-line combination therapy.
- Initiate additional studies. CTI BioPharma and Servier plan to collaborate to support the initiation of multiple investigator-sponsored combination trials in other indications.
- Report top-line Phase 2 results. CTI BioPharma anticipates reporting top-line results from an investigator-sponsored randomized Phase 2 trial of tosedostat in combination with low-dose cytarabine in older patients with AML or high-risk myelodysplastic syndrome (MDS).
- Define registrational path. Based upon the clinical data for tosedostat in AML and MDS, CTI BioPharma plans to consult with the FDA and the European Medicines Agency (EMA) regarding a registrational strategy for this product candidate. If positive, these discussions could enable the start of a pivotal program in AML in early 2016.
About CTI BioPharma Corp.
CTI BioPharma Corp. (NASDAQ and MTA: CTIC) is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a commercial presence in Europe and a late-stage development pipeline, including pacritinib, CTI BioPharma's lead product candidate that is currently being studied in a Phase 3 program for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington, with offices in London and Milan under the name CTI Life Sciences Limited. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.
This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to 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 BioPharma's securities. Such statements include, but are not limited to, statements regarding CTI BioPharma's expectations with respect to the development of CTI BioPharma and its product and product candidate portfolio, and expectations concerning the benefits of our recently expanded rights to tosedostat, the anticipated reporting of top-line results from a Phase 2 trial of tosedostat, the development of a registrational strategy and development program for tosedostat, the anticipated completion of enrollment in PERSIST-2 in mid-2015, potential release of top-line data from PERSIST-1 late in the first quarter of 2015, the potential submission of a rolling NDA to the FDA for pacritinib in late 2015, the advancement of a pacritinib development program in other hematologic malignancies in the second half of 2015, enrollment projections and expected outcome of the PIX306 post-marketing commitment study, liquidity and expense projections, the anticipated achievement of partner-related milestones and product and geographic sales, initiation of investigator-sponsored trials, the potential commencement of a pivotal program for tosedostat in early 2016, and the release of 2015 financial guidance. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI BioPharma and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI BioPharma cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI BioPharma cannot predict or guarantee the outcome of preclinical and clinical studies, that CTI BioPharma may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI BioPharma may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing pacritinib and CTI BioPharma's other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI BioPharma may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI BioPharma may not achieve previously announced goals and objectives as or when projected, that CTI BioPharma's average net operating burn rate may increase, that CTI BioPharma will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI BioPharma's most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI BioPharma does not intend to update any of the statements in this press release upon further developments.
Currency Exchange Rate
Under the license and collaboration agreement with Servier, monetary amounts are generally denoted in euros, while the corresponding U.S. dollar amounts are based upon conversion on September 12, 2014.
PIXUVRI is a registered trademark of CTI BioPharma Corp.
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SOURCE CTI BioPharma Corp.