Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkin's Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based TherapyPositive interim results prompt request for meeting with FDA
SEATTLE, July 11, 2007 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) announced today that interim results of its phase II/III trial comparing CPOP-R, in which pixantrone is substituted for doxorubicin in standard CHOP-R first-line treatment of patients with aggressive non-Hodgkin's lymphoma (NHL), resulted in essentially all patients on both arms achieving a major objective anti-tumor response (complete response or partial response). The preliminary results showed that patients who received pixantrone had a reduction in severe (grade 3/4) side effects when compared to patients treated with standard doxorubicin-based therapy. The Company intends to report data from this trial, known as RAPID, at the American Society of Hematology (ASH) annual meeting in December.
Despite pixantrone patients receiving more treatment cycles, a three-fold reduction in the incidence of severe heart damage (LVEF decline >15 percent) was seen as well as clinically significant reductions in infections and thrombocytopenia. In addition a significant reduction in febrile neutropenia was also observed. Febrile neutropenia is a life-threatening complication of chemotherapy which often requires hospitalization and antibiotic therapy and may lead to death from infection while the patient's infection-fighting white blood cells are low due to neutropenia. The RAPID study is expected to complete enrollment in 2008.
"We are excited by these results demonstrating that pixantrone is living up to the promise of preventing the severe cardiac damage that accompanies the use of standard doxorubicin treatment while retaining the potent anti-lymphoma activity of this class of drug," said James A. Bianco, M.D., President and CEO of CTI. "Pending results from this and other studies, these findings could have major implications for treating patients with breast cancer, lymphoma, and leukemia, where debilitating cardiac damage from doxorubicin might be prevented. We look forward to discussing these results and our planned interim analysis of the PIX301 (EXTEND) pivotal trial with the FDA. We believe the RAPID data coupled with the EXTEND data may provide sufficient clinical information for review of pixantrone in aggressive NHL."
Details of the RAPID Trial
The RAPID (Replacing Adriamycin with Pixantrone to Improve Safety in NHL Disease) trial is a 280-patient randomized controlled phase II/III combination study investigating whether the substitution of pixantrone for doxorubicin in the first-line treatment of patients with advanced aggressive NHL can provide a comparable major response rate while reducing known doxorubicin-related toxicities. This multi-center international trial randomizes newly diagnosed patients to either the standard of care regimen CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab) or an investigational regimen which replaces doxorubicin with pixantrone, CPOP-R (cyclophosphamide, pixantrone, vincristine, prednisone, and rituximab) monthly for six cycles. Patients are evaluated for response to therapy every two cycles and evaluated every two months following completion of therapy.
Cardiac function, as determined by serial multi-gated nuclear scans (MUGA), is evaluated prior to initiation of therapy and then at the completion of every two cycles of therapy. Thus far, routine prophylactic administration of G-CSF was utilized equally across treatment arms in approximately half of study participants. The interim analysis was conducted after approximately 60 patients completed at least four cycles of therapy to determine if the dose of pixantrone (150 mg/m2) was adequate to induce major objective responses comparable to the doxorubicin arm as well as to evaluate potential differences in major toxicities.
Pixantrone in Clinical Studies
There are currently two clinical studies of pixantrone in aggressive NHL patients, RAPID and a phase III single agent trial, known as EXTEND. The EXTEND trial explores the role of single-agent treatment as a salvage regimen in patients with relapsed aggressive NHL who have failed at least two prior treatment regimens. Patients are randomized to receive either pixantrone or another single-agent drug of the physician's choice currently used for the treatment of this patient population. An interim look for the EXTEND trial is planned for later this year.
The Company is awaiting feedback from the FDA on the design of a new phase III trial of pixantrone for patients with indolent NHL. The trial, PIX303, will examine the complete remission rates and time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have received at least one prior treatment for NHL. The trial is expected to enroll 300 patients.
Pixantrone 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 permit 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 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 the final results of the RAPID clinical study of pixantrone to have the same or similar results to the interim analysis, or the potential failure of pixantrone to prove safe and effective for treatment of non-Hodgkin's lymphoma or other cancers, 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. Except as may be required by Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter
its forward-looking statements whether as a result of new information, future events, or otherwise. Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 Susan Callahan T: 206.272.4472 F: 206.272.4434 E: http://www.cticseattle.com/media.htm Investors Contact: Leah Grant T: 206.282.7100 F: 206.272.4434 E: http://www.cticseattle.com/investors.htm Medical Information Contact: T: 800.715.0944 E:email@example.com firstname.lastname@example.org email@example.com
CONTACT: Dan Eramian, +1-206-272-4343, cell, +1-206-854-1200, or SusanCallahan, +1-206-272-4472, fax, +1-206-272-4434, , orinvestors, Leah Grant, +1-206-282-7100, fax, +1-206-272-4434,, of medical, 1-800-715-0944, , all ofCell Therapeutics, Inc. firstname.lastname@example.org email@example.com firstname.lastname@example.org
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Posted: July 2007