SEATTLE, March 25 Cell Therapeutics, Inc. (CTI)(Nasdaq: CTIC; MTA) announced today that enrollment is complete in the phaseIII EXTEND (PIX301) clinical trial of pixantrone (BBR2278) for patients withrelapsed diffuse large B cell non-Hodgkin's lymphoma (NHL). An analysis of thedata is expected in the second half of 2008. Based on prior discussions withthe U.S. Food and Drug Administration (FDA) the data could provide aregistration path for pixantrone if final study results are adequate forsubmitting a New Drug Application (NDA) with the FDA in early 2009 with apotential approval in 2009. A total of 140 patients were enrolled in thestudy, 97 patients are currently evaluable according to Histological Intent toTreat, or HITT, criteria and will be included in the final analysis of thestudy.
"PIX301 examines the effectiveness of pixantrone in patients with relapsedand refractory diffuse large B cell lymphoma, a population where currenttherapies seldom induce complete remissions," said Jack W. Singer, ChiefMedical Officer at CTI. "Based on a blinded current independent assessment ofevents in the trial we believe we have an adequate sample size of eligiblepatients to meet the primary objective of the trial."
About the EXTEND (PIX301) Clinical Trial
The EXTEND clinical trial is a phase III single agent trial of pixantronefor patients with relapsed, aggressive non-Hodgkin's lymphoma who received twoor more prior therapies and who were sensitive to treatment withanthracyclines. The trial was conducted at 130 sites in 17 countries. Patientswere randomized to receive either pixantrone or another single-agent drugcurrently used for the treatment of this patient population and selected bythe physician. The trial was designed to examine the complete response (CR) orunconfirmed complete response (uCR) rate, time to tumor progression, andoverall survival. The study was powered based on a CR rate assumption of lessthan 5 percent for the control arm and a greater than 10 percent improvementin CR rate for the pixantrone arm. The study was conducted under a SpecialProtocol Assessment from the U.S. Food and Drug Administration (FDA) andpixantrone has received fast track designation for this indication.
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that containsan aza-anthracenedione molecular structure, differentiating it fromanthracycline chemotherapy agents, was discovered by our scientists in Bresso,Italy. It is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracyclinechemotherapy agents. A new chemical compound for the treatment of non-Hodgkin's lymphoma (NHL), and various other hematologic malignancies, solidtumors, and immunological disorders, pixantrone is being developed by CTI toimprove the activity and safety in treating cancers usually treated with theanthracycline family of anti-cancer agents. Anthracyclines have been shown tobe very active clinically in a number of tumor types, such as lymphoma,leukemia, and breast cancer. For these diseases, anthracycline-containingchemotherapy regimens are effective in first-line (initial) treatment.However, they may cause cumulative heart damage that limits lifetime dosageand does not allow for retreatment. Pixantrone has been designed to reduce thepotential for heart damage compared to currently available anthracyclines oranthracenediones without a loss in anti-tumor or immunomodulatory activities.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed todeveloping an integrated portfolio of oncology products aimed at making cancermore treatable. For additional information, please visithttp://www.celltherapeutics.com.
This press release includes forward-looking statements that involve anumber of risks and uncertainties, the outco