PRINCETON, N.J., Sep 21, 2011 (BUSINESS WIRE) -- Celator Pharmaceuticals today announced that U.S. Patent No. 8,022,279 was issued by the United States Patent and Trademark Office on September 20, 2011 and that two related patents in Japan have been granted as well. These patents add to the intellectual property surrounding Celator's lead anti-leukemia drug, CPX-351.
U.S. Patent No. 8,022,279 covers the key composition features of CPX-351, a liposome formulation that co-encapsulates cytarabine and daunorubicin at a synergistic 5:1 molar ratio. In addition to this patent, Celator has also been notified that patent claims broadly covering the CombiPlex(R) method of developing drug combinations as well as claims covering the Company's metal-based drug loading technology have been allowed by the Japanese Patent Office. Both of these patents also provide protection of CPX-351 and were previously allowed in the United States.
Cytarabine and daunorubicin have been a standard of care for the treatment of patients with acute myeloid leukemia (AML) for more than thirty years, and CPX-351 has demonstrated marked improvements in efficacy versus the conventional administration of the same two drugs in a randomized phase 2 clinical study in elderly patients with newly diagnosed AML.
"We're pleased to receive these patents which increase the depth of intellectual property protection for CPX-351 in the United States and expand the protection of Celator's broader technology platforms into Japan," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "The positive results for CPX-351 in a previously reported phase 2 clinical trial have supported the planning for a pivotal phase 3 registration trial. With the Patent Term Adjustment, the U.S. patent provides protection until September 2027 which, should we be successful in gaining regulatory approval, significantly extends market exclusivity for CPX-351 in the United States."
CPX-351 (cytarabine:Daunorubicin) Liposome Injection represents a new approach to developing combinations of drugs in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by the U.S. Food & Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). CPX-351 is currently in phase 2 clinical development for the treatment of AML. Celator has completed a successful randomized, phase 2 study comparing CPX-351 to the standard "7+3" regimen of cytarabine:daunorubicin in patients 60-75 years of age with newly diagnosed AML and has completed enrollment in a randomized, phase 2 study of CPX-351 versus intensive salvage therapy in patients 18-65 years of age with AML in first relapse. The second study is supported by The Leukemia & Lymphoma Society.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Princeton, NJ, and Vancouver, BC, is a privately held pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex(R), the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two Phase 2 products; CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage compound, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. Based on the applications of CombiPlex and the proprietary nanoparticle prodrug delivery platform, Celator is positioned to advance a broad pipeline of cancer therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at www.celatorpharma.com . Information on ongoing trials is available at www.clinicaltrials.gov .
SOURCE: Celator Pharmaceuticals, Inc.