CTI withdraws European Marketing Authorization Application (MAA) for non-inferiority indication in non-small cell lung cancer

Pivotal Registration Trial of OPAXIO Maintenance Therapy in First-Line Ovarian Cancer Reaches Enrollment Milestone of 600 patients, Cell Therapeutics and the Gynecologic Oncology Group Discuss Potential for Early Interim Analysis

Posted by Nathan Solomon | 21 September 2009, 9:16 pm

CTI withdraws European Marketing Authorization Application (MAA) for non-inferiority indication in non-small cell lung cancer

Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that it will re-focus its resources on the approval of OPAXIO(TM) for its potential superiority indication in maintenance therapy for ovarian cancer. The Gynecologic Oncology Group (GOG) is conducting an ongoing phase III trial that evaluates the use of 12 months of OPAXIO therapy versus an untreated control arm. To date, 600 patients have been enrolled in this trial. CTI has discussed with the GOG, several strategies for conducting an interim analysis which could potentially result in an earlier registration. In addition, given the encouraging results of treatment of advanced esophageal cancer with OPAXIO to be reported at the upcoming International Society of Gastrointestinal Oncology Annual Meeting, CTI plans on meeting with the Food and Drug Administration (FDA) to discuss an additional registration study utilizing OPAXIO as a radiation sensitizer in the treatment of advanced esophageal cancer.

CTI has notified the European Medicines Agency (EMEA) of its decision to withdraw its Marketing Authorization Application (MAA) for a non-inferiority indication in non-small cell lung cancer (NSCLC).

"Given that we have reached a milestone in the ovarian cancer trial enrollment coupled with the reservations the Committee for Medicinal Products for Human Use (CHMP) expressed about the control arm activity in the NSCL cancer study we believe it makes best sense for CTI to focus its efforts with OPAXIO on superiority applications like the first-line ovarian cancer trial as well as the exciting new potential application as a radiation sensitizer," noted Craig W. Philips, President of CTI. "Both of these studies would be landmark trials and first in class for this novel bioengineered taxane. We look forward to continuing to work with the GOG and ultimately the FDA on a registration pathway for OPAXIO."

"We believe focusing on ovarian maintenance, and radiosensitization, not only address areas of unmet medical need, but are in the best long term strategic interest of CTI. With the FDA review of the NDA for pixantrone in relapsed/refractory non-Hodgkin's lymphoma well underway and the phase III Ovarian trial of OPAXIO progressing nicely we are pleased with the advancement and future potential of these novel treatments," said James A. Bianco, M.D., CEO of CTI.

CTI has an existing license and co-development agreement with Novartis for OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which also provides Novartis with an option to enter into an exclusive worldwide license to develop and commercialize pixantrone based upon agreed terms.  - PR Newswire

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