Key Developments For Cell Therapeutics, Inc.
Cell Therapeutics, Inc. (CTIC.O) (Consolidated Issue listed on NASDAQ Capital Market)
Cell Therapeutics, Inc. (CTI) Wins Federal Appeal To Pursue $22.8 Million Claim Against The Lash Group
Cell Therapeutics, Inc. (CTI) announced that the Ninth Circuit Court of Appeals reversed a U.S. District Court order and ruled that CTI should be allowed to pursue all of its claims against The Lash Group, sending the case back to the District Court for trial. CTI filed a complaint against The Lash Group, CTI's former third-party reimbursement consultant for CTI's product TRISENOX, in 2007 seeking $22.8 million in damages for expenses already incurred related to the investigation, defense and a settlement of claims by the U.S. government concerning Medicare reimbursement for TRISENOX and other business losses.
Cell Therapeutics, Inc. (CTI) Announces Appointment of Stonefield Josephson, Inc. as New Auditor
Cell Therapeutics, Inc. (CTI) announced the Stonefield Josephson, Inc. as was appointed the Company's independent auditor for the fiscal year December 31, 2009.
Cell Therapeutics, Inc. (CTI) Announces Positive Results from OPAXIO Study
Cell Therapeutics, Inc. (CTI) announced that patients with cancer of the lower esophagus demonstrated a high rate of complete remission (CR) when given OPAXIO (paclitaxel poliglumex), a biologically enhanced paclitaxel, when administered in combination with standard cisplatin and concurrent radiation. The phase II study enrolled 40 patients with pathologically-confirmed, locally-advanced adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction with no evidence of distant metastasis. The patients received weekly paclitaxel poliglumex (50mg/m2) and cisplatin 25mg/m2 for six weeks with concurrent 50.5Gy of radiation. Of the first 28 patients undergoing surgery, all with adenocarcinoma, eight of 28 (28.5%), have achieved a pathologic CR. No patients required a feeding tube. There were no grade four hematologic toxicities; grade three hematologic toxicity included neutropenia (two) and anemia (one). Four of 35 patients experienced grade four non-hematologic toxicities, which included electrolyte abnormalities, glucose intolerance, hypersensitivity reaction and thromboembolus. Eleven of 35 patients had grade three non-hematologic toxicities including electrolyte abnormalities (five), nausea (three), dysphagia (two), fatigue (two), glucose intolerance (two), and hypersensitivity reaction (one). Grade tree anorexia was reported in only one patient who subsequently was given total parenteral nutrition. No patients developed neuropathy.
Cell Therapeutics, Inc. (CTI) Applies For European Orphan Drug Designation For Pixantrone In Aggressive Non-Hodgkin's Lymphoma (NHL)
Cell Therapeutics, Inc. (CTI) announced that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL. CTI anticipates the formal Marketing Authorization Application (MAA) filing in 2010, following approval of the pediatric investigation plan which was submitted to the EMEA earlier this month. CTI would be granted 10 year market exclusivity in Europe if the MAA is approved. In the United States, the pixantrone New Drug Application (NDA) for the treatment of relapsed or refractory aggressive NHL is currently under review for approval by the Food and Drug Administration (FDA).
Cell Therapeutics, Inc. (CTI) Finalizes Asset Sale and Closure of Italian Branch
Cell Therapeutics, Inc. (CTI) announced that it has finalized the closing its Bresso, Italy operations and will receive approximately $1.1 million from the sale of assets. The Company expects the closure to save approximately $20 million in annual operating expenses in 2010 and beyond based on current exchange rates. The Bresso facility was used for pre-clinical research and was underutilized due to the Company's focused business model preparing for commercial launch of pixantrone and other phase III development stage products.
