SEATTLE, Feb. 10 /PRNewswire-FirstCall/ -- Cell Therapeutics (CTI) today announced that they have executed a definitive collaborative agreement with IDIS to manage its investigational drug pixantrone on a named patient basis in Europe. Pixantrone will be supplied by IDIS to healthcare professionals for the treatment of individual patients with relapsing aggressive non-Hodgkin's lymphoma. This program is expected to be initiated by second quarter of 2009.
"Under the named patient program, CTI will be able to provide pixantrone to European patients in need at the prescriber's request while moving it through the approval process in the United States," noted Craig Philips, President of CTI. "With the announcement of preliminary results showing significantly higher rate of complete remission and improvement in progression-free survival for patients receiving pixantrone compared to standard chemotherapeutic agents, we expect to receive a number of requests for pixantrone to treat specific patients."
"Pixantrone is an important new treatment with impressive remission and progression-free survival data," said Dr. Raul Herbrecht of Strasbourg University Hospital in France. "This drug is also important because it meets an unmet medical need for this group of patients. I have been impressed by the good tolerance and efficacy of pixantrone since the first clinical trial we had with this drug in our department. We obtained excellent results in salvage therapy of non-Hodgkin's lymphoma in heavily pretreated patients and several years later some of our patients are still in complete response. These positive results have been confirmed in further studies," Dr Herbrecht added.
The EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician.
"We are pleased to be working with Cell Therapeutics to ensure that those patients with non-Hodgkin's Lymphoma who do not respond to current available therapies have access to pixantrone through a named patient program," said Natalie Douglas, CEO, IDIS. "CTI's potentially life-saving medicine can offer these patients renewed hope for remission. We are deeply committed to work in partnership with pharmaceutical and biotechnology companies to give physicians and their patients access to new and innovative medicines through regulated and responsible channels."
CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (CR/CRu+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). In January, 2009 CTI announced preliminary results that show patients treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. PFS, CR/CRu and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety information is not yet available for the study, however, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee and no serious concerns were raised.
The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has received fast track designation for this indication.
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
IDIS is the world leader in the development and implementation of named patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. IDIS supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named patient basis to medical professionals worldwide. For more information on IDIS please visit our website at http://www.idispharma.com.
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 www.celltherapeutics.com.
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. 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 pixantrone in particular including, without limitation, the results of complete safety information, the ability of the company to initiate named patient sales by the second quarter of 2009, the failure to receive anticipated number of requests for pixantrone to treat specific patients, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the company's ability to continue to raise capital as needed to fund its operations, 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. 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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