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Cell Therapeutics (CTIC)

Q3 2013 Earnings Call

October 30, 2013 4:30 pm ET


Monique M. Greer - Senior Vice President of Corporate Communications and Investor Relations

James A. Bianco - Principal Founder, Chief Executive Officer, President and Executive Director

Matthew J. Plunkett - Executive Vice President of Corporate Development

Jack W. Singer - Co-Founder, Executive Vice President of Global Medical Affairs & Translational Medicine and Executive Director


Kimberly Lee - Janney Montgomery Scott LLC, Research Division

Robert Cummins Hazlett - Roth Capital Partners, LLC, Research Division



Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Cell Therapeutics Third Quarter 2013 Financial Results Conference Call. [Operator Instructions] This call is being recorded today, October 30, 2013. I would now like to turn the conference over to Monique Greer, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead, ma'am.

Monique M. Greer

Thank you, George. Good afternoon, everyone, and thank you for joining us today for our third quarter 2013 financial results conference call. Following formal remarks by management, the conference call will be open for questions.

With me today are Jim Bianco, President Chief Executive Officer; Matt Plunkett, Executive VP of Corporate Development; and Lou Bianco, Executive VP of Finance and Administration.

A press release was issued after market close today, a copy of which can be found on our homepage and in the Investors section of our website at celltherapeutics.com.

Before we begin, please note that during the course of this call, we will be making forward-looking statements based on current expectations. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Additional information concerning these risks and uncertainties is contained in the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended September 30, 2013, and in the company's other periodic reports and filings with the Securities and Exchange Commission.

I will now turn the call over to Jim.

James A. Bianco

Thanks, Monique. Good afternoon, everyone. For those of you that maybe new to CTI, we're a biopharmaceutical company with one marketed oncology drug and a promising late-stage pipeline. Our focus is to become a leader in the treatment of blood-related cancers.

Our foremost investigational agent in Phase III development is pacritinib, which is an oral JAK inhibitor that inhibits 2 important activating mutations, JAK2 and FLT3. As you may know, the JAK pathway is important in many biological processes, including the regulation of immune function and the formation and development of blood cells.

Activating mutations of JAK2 is implicated in a spectrum of blood-related cancers, such as myeloproliferative neoplasms, leukemia and surface solid tumors. FLT3 is a commonly mutated gene found in patients with acute myeloid leukemia. In myelofibrosis, myelosuppression, particularly thrombocytopenia or a relative decrease in platelets in blood, it's both a consequence of the disease and has emerged as a limiting treatment-related side effect of JAK1/JAK2 inhibitors.

While normal platelet counts in adults ranges from 150,000 to 450,000 platelets per microliter of blood, thrombocytopenia refers to a platelet count lower than 150,000. As myelofibrosis progresses, platelet production decreases and thrombocytopenia develops, thereby resulting in a high-risk population in patients with MF who have a normal platelet count. Approximately 37% of patients with myelofibrosis have thrombocytopenic, with platelet counts below 150,000.

Now although pacritinib has the potential to benefit all patients with myelofibrosis, we believe the benefit will also be clearly demonstrated in those patients with low platelet counts, a patient population that was not studied in randomized trials utilizing other JAK2 inhibitors.

At the recent European Hematology Association Congress held in June, an integrated safety analysis of the 4 completed Phase I and Phase II studies were presented, totaling 191 patients who were treated with pacritinib for myeloid, primarily myelofibrosis or lymphoid malignancies to quantify clinical toxicities with a specific focus on hematologic side effects.

Now other JAK2 inhibitors have been associated with treatment-related anemia and thrombocytopenia, and this was not observed in patients on pacritinib. The integrated safety data analysis suggested that regardless of initial platelet counts, pacritinib does not cause further myelosuppression. Even patients with initial platelet counts less than 50,000, a high-risk population, tolerative therapy and maintaining stable blood and platelet counts and did not require dose reduction for thrombocytopenia.

A great 1 or 2 gastrointestinal events, particularly diarrhea, were the most adverse events and can be controlled by early administration of standard anti-motility agents.

We believe pacritinib could effectively address an unmet medical need, particularly for patients living with myelofibrosis who either face treatment-emergent thrombocytopenia on marketed JAK1 and JAK2 inhibitors, or who have disease-related thrombocytopenia that is being sub-optimally managed on low doses of currently improved agent. As such, pacritinib may offer patients with myelofibrosis an effective therapy but a safety profile that could allow for longer-term management of their disease than with currently approved agents or other agents in development.

In October, we reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment or SPA, for the PERSIST-2 pivotal study. As you may know, a SPA is a written agreement between CTI and the FDA regarding the design, end points and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application. We believe this is the only JAK2 inhibitor that is being studied under an SPA.

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