Cell Therapeutics Readies Commercial Launch of Pixuvri® in EU; Re-Alignment of Resources and Portfolio Priorities Reduces Burn Rate by more than 30%
Pixuvri® Market Research Supports Potential Attractive Market in EU
Prioritizing Resources to Accelerate Advancement of Pacritinib into Phase 3 in Q4 2012
Re-prioritization Results in Reduction in Operating Burn Rate by more than 30%
Steven E. Benner M.D., M.H.S., Appointed Chief Medical Officer to Lead Cancer Drug Development
SEATTLE, June 20, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that it is re-aligning its resources and re-prioritizing its product development pipeline to focus on the launch of Pixuvri in the EU and accelerate the advancement of pacritinib, CTI's recently-acquired, highly-selective JAK 2 inhibitor, into phase III clinical trials. As a result, CTI's operating burn rate will be reduced from an average of $6.5 million per month to an average of $4.5 million per month.
"In-market research across the five largest EU markets confirms significant physician interest in product adoption in the target patient population. With the potential to generate meaningful Pixuvri® product sales, coupled with the recent acquisition of pacritinib and investigator interest in participating in its pivotal studies, we believe that focusing our resources on the Pixuvri launch and accelerating the start of pacritinib phase III studies is the best deployment of our limited resources to build near-term shareholder value," said James A. Bianco, M.D., Chief Executive Officer of CTI.
"We are re-evaluating the tostedostat phase III clinical trial design and are considering both studies in a refractory setting and in front line treatment," said Steven E. Benner, M.D., M.H.S, CMO of CTI. "With two ongoing phase II investigator-sponsored trials examining the activity of combining tosedostat with hypomethylating agents (HMAs), we should have adequate data to make an evidence-based decision on the trial design with the highest probability of both regulatory and commercial success by early next year."
About Pixuvri (pixantrone)
Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds, Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.
In May 2012, Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply-relapsed or refractory aggressive NHL. The benefit of Pixuvri treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/community-register/html/h764.htm#ProcList.
CTI is currently accruing patients into a Phase III trial comparing pixantrone and rituximab with gemcitabine and rituxan in the setting of aggressive B-cell Non-Hodgkin Lymphoma. European sites will be participating in this study later this year.
Pixuvri is currently available in the EU through Named Patient Programs.
Pixuvri does not have marketing approval in the United States.
About Conditional Marketing Authorization
Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.
The European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use ("CHMP") has accepted PIX306, CTI's ongoing randomized controlled phase 3 clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.
Pacritinib is an oral, once a day, tyrosine kinase inhibitor (TKI) with dual activity against JAK2 and FMS-like tyrosine kinase 3 ("FLT3"). Mutations in these kinases have been shown to be directly related to the development of a variety of blood related cancers including MPN, leukemia, and lymphoma. Pacritinib has demonstrated encouraging results in phase I and II studies for patients with myelofibrosis and a phase III study is planned for this disease.
FLT3 is a commonly mutated gene found in acute myeloid leukemia ("AML") patients and its activating mutations have been proven to be a negative prognostic marker for clinical outcome suggesting a possible future role for treatment of AML.
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 South America
About Cell Therapeutics, Inc.
Headquartered in Seattle, 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 http://www.celltherapeutics.com/.
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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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