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Cell Therapeutics Receives Fast Track Designation for Pixantrone for the Potential Treatment of Aggressive Non-Hodgkin’s Lymphoma

SEATTLE, July 12 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato: CTIC) received fast track designation from the U.S. Food and Drug Administration (FDA) for pixantrone, a novel anthracenedione, being investigated for the potential treatment of relapsed, aggressive non-Hodgkin's lymphoma (NHL). The FDA granted fast track designation because relapsed aggressive NHL in the third-line or subsequent recurrence is a life threatening disease and responses have been noted in phase 2 trials in patients with relapsed, aggressive NHL. Preliminary experience in phase I/II studies of pixantrone has shown a complete remission rate ranging from 20 percent as a single-agent to 59 percent in a variant of the standard front-line combination therapy CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), where pixantrone replaces doxorubicin. In addition, pixantrone is easier to administer than standard anthracyclines and, to date, has not displayed the same risk of severe cardiac damage.

"The complete remission rates of single-agent pixantrone and in combination with other agents in phase I and phase II clinical studies are quite remarkable. As there are currently no approved therapies for third-line aggressive non-Hodgkin's lymphoma (NHL) we expected to obtain 'fast track' designation for this product," stated Jack W. Singer, M.D., Chief Medical Officer of CTI. "The pivotal trial is well-designed and if successful, the efficacy and cardiac safety profile along with the drug's administration advantages may make pixantrone an important therapeutic for the potential treatment of aggressive NHL."

"Fast track designation for pixantrone is an important step in the development of this product candidate and may help us bring this potentially life-saving drug to patients more quickly," stated James A. Bianco, M.D., President and CEO of CTI.

Pixantrone is presently being studied as a single-agent and in combination in several phase I and II clinical studies for the potential treatment of aggressive or indolent NHL. In the United States, it is estimated that more than 30,000 patients each year receive salvage therapy for salvage NHL (greater-than-or-equal-to third-line) with more than 60,000 patients receiving multi-agent chemotherapy for front-line or second-line treatment of NHL.

Fast Track Designation

Fast track designation provides the FDA with mechanisms to help facilitate the development and expedite the review of a new drug that is intended to treat a serious or life-threatening condition and demonstrates the potential to address an unmet medical need. Due to the nature of these types of products, new drug applications (NDAs) filed with Fast track designation are eligible for priority review, which provides for review of the NDA within six months.

About pixantrone

Pixantrone (pronounced pick-san-troan) is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplified administration compared to the currently marketed anthracyclines.

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.cticseattle.com/.

This announcement 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. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with development of pixantrone in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of non-Hodgkin's lymphoma, the potential failure of pixantrone to receive priority review, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q.

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