Updated Safety data presented at BIO International Convention in Atlanta
ATLANTA, May 19 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) released updated safety data today from its pixantrone phase III 301 EXTEND trial demonstrating the effectiveness of pixantrone in patients with relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) for whom anthracycline-related drugs are typically not to be used due to the increased risk of cardiac failure.
As noted during the presentation of Craig Philips, President of CTI, "The standard chemotherapy regimen (CHOP) for this disease exposes patients to less than or equal to 300mg/m2 of doxorubicin, a dose at which 5.6% of patients are expected to develop congestive heart failure (CHF). At cumulative doses of doxorubicin in excess of 600mg/m2, 48% of patients develop CHF."
"With these background statistics, we examined the occurrence of CHF from any cause among PIX 301 recipients who received prior treatment at standard doxorubicin doses (<=300mg/m2) along with those pixantrone recipients who had received extensive prior doxorubicin treatment compared to historically reported rates when treated with standard doxorubicin," stated Mr. Philips. "Despite patients receiving a median total cumulative doxorubicin equivalent dose of 535mg/m2, the frequency of CHF among PIX 301 recipients was non-dose dependant and was markedly lower than that reported for doxorubicin at similar levels of treatment."
At a cumulative total doxorubicin equivalent exposure of > 600mg/m2, the frequency of CHF among PIX 301 recipients was 4% compared to 48% reported for doxorubicin.
Incidence Clinical CHF- related or unrelated to drug Dose (mg/mg2 doxorubicin Doxorubicin(1) Pixantrone equivalents) N=620 N=70 <=300 mg/m2 5.6% 2/68 500 mg/m2 15% 2/43 600 mg/m2 32% 0/36 >600 48% 1/25 (1) Cancer 97: 2869, 2003
The EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed, aggressive NHL 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.
CTI previously announced that its pivotal phase III (PIX 301) EXTEND trial had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) 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) with no patients in the standard chemotherapy arm achieving a confirmed complete remission.
Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever or documented infections, or severe vomiting or diarrhea. Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between pixantrone and the control arm. The pixantrone patients had a higher incidence of leucopenia and neutropenia. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).
CTI will be presenting additional new efficacy and safety data at the upcoming American Society of Clinical Oncology Annual Meeting to be held from May 29 to June 2, 2009 in Orlando, Florida.
In April 2009, CTI began a rolling submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission this quarter and will request priority review, which if granted could lead to an approval decision from the FDA in Q4 2009.
Pixantrone is also now available in Europe on a named-patient basis.
Pixantrone (BBR 2778), is a novel major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anti-cancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
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.
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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. 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 potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that pixantrone could cause cumulative heart damage, the possibility that the New Drug Application submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, 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, 10-Q, and 8-K. 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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