The US Patent and Trademark Office (US PTO) has issued key patent covering the tumour-targeting conjugate INNO-206 linker platform technology and INNO-206 pharmaceutical compositions to CytRx Corporation, a biopharmaceutical company specializing in oncology.
“We now have broad patent protection for the linker platform technology, which is exclusively licensed to CytRx from the Tumor Biology Institute in Freiburg, Germany. This technology is in essence its own pipeline with blockbuster drug potential and for which we hold exclusive worldwide rights. It has proven affinity to couple with multiple chemotherapeutic agents beyond doxorubicin, which is the formulation we are currently evaluating. We now have patent protection covering the linker technology with epirubicin, daunorubicin, and idarubicin, any of which could be incorporated into our future clinical development plans,” said Steven A Kriegsman, president and CEO, CytRx.
This linker technology consists of a single molecule that, when attached to a chemotherapeutic agent, binds within minutes to albumin in the bloodstream and delivers the agent to the tumour site, thus allowing for greater drug concentration within the tumour. The Company believes that greater drug delivery to the tumor site could improve effectiveness while avoiding the side effects associated with the broader systemic delivery of most toxic agents.
The patent, US Patent No. 8,153,581, entitled "Process for Producing an Injectable Medicament Preparation," claims pharmaceutical compositions comprising a class of pro-drugs characterized by having an active agent, such as anthracyclines or other cytostatic agents, linked through a cleavable spacer to a protein-binding molecular residue, such as albumin. Certain claims of the patent also specifically cover pharmaceutical compositions of INNO-206.
CytRx has completed enrollment of a phase I b/II clinical trial with the doxorubicin conjugate formulation of INNO-206 in patients with advanced solid tumors (primarily soft tissue sarcomas), and has initiated an international phase II b clinical trial in patients with soft tissue sarcomas, comparing the efficacy and safety of INNO-206 to doxorubicin, a standard treatment for soft tissue sarcomas. The phase I b/II clinical trial results will be presented by a premier soft tissue sarcoma expert at the American Society of Clinical Oncology (ASCO) meeting in early June. The company also has announced plans in the second quarter of 2012 to begin a phase II trial with INNO-206 in an undisclosed solid tumor indication. INNO-206 has been shown to have increased efficacy compared to either placebo or native doxorubicin in breast, ovarian, pancreatic, renal and lung cancers, as well as in multiple myeloma human tumour xenograft models in mice.