Celator Pharmaceuticals announced that US Patent No. 8,022,279 was issued by the United States Patent and Trademark Office (USPTO) 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-leukaemia drug, CPX-351.
“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”
US 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 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 Leukaemia (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 II 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 II clinical trial have supported the planning for a pivotal phase III registration trial. With the Patent Term Adjustment, the US 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-tumour 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 US Food & Drug Administration (FDA) for the treatment of AML. CPX-351 is currently in phase II clinical development for the treatment of AML. Celator has completed a successful randomized, phase II 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 II 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 Leukaemia & Lymphoma Society.
Celator Pharmaceuticals, Inc. is a privately held pharmaceutical company developing new and more effective therapies to treat cancer.