Celsion Corporation a leading oncology drug development company, announced that the Japan Patent Office (JPO) has granted the Japanese counterpart of the “Needham” composition of matter patent, “Temperature-Sensitive Liposomal Formulation,” which is issued in various regions around the world, including the US and European Union. Celsion holds a license agreement with Duke University under which the Company received exclusive worldwide rights to the Needham Patent Family, covering products, such as Celsion's phase III product candidate, ThermoDox, which are developed using Duke's temperature sensitive liposome technology.
Celsion sublicensed its rights within Japan to Yakult Honsha Co., Ltd, the company's Japanese development partner for ThermoDox. The new patent, Japan Patent No. 4691253, provides patent protection for 20 years from the international filing date, which was June 9, 1999. Celsion has an additional divisional patent in the Needham Patent Family pending in Japan and continues to pursue various avenues, including patent term extensions, to maximize the company's intellectual property protection in Japan and other territories.
“This patent, along with the expertise of Yakult Honsha, a leading Japanese pharmaceutical company, provide the resources for making ThermoDox a commercial success in Japan,” said Michael H Tardugno, Celsion's president and CEO. “We continue to pursue a deliberate and comprehensive global intellectual property strategy aimed at maximizing the value of our drug delivery platform.”
ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the HEAT Study, ThermoDox is administered intravenously in combination with RFA. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumour.
For primary liver cancer, ThermoDox is being evaluated in a 600 patient global phase III study at 76 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox in combination with Radio Frequency Ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is Progression-Free Survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT study is complete and 190 PFS events are realized in the study population.
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumour cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 700,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries.
The standard first line treatment for liver cancer is surgical resection of the tumour; however 90% of patients are ineligible for surgery. Radio Frequency Ablation (RFA) has increasingly become the standard of care for non-resectable liver tumours, but the treatment becomes less effective for larger tumours. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumour-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems.