(NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today announced that the European Patent Office (EPO) has issued a patent covering the Company’s tumor-targeting linker platform technology and pharmaceutical compositions. CytRx also unveiled aldoxorubucin as the new generic name for INNO-206, the conjugate comprised of the protein-binding linker technology and the commonly prescribed chemotherapeutic drug doxorubicin.
“We now have broad intellectual property exclusivity for our protein-binding linker technology in the U.S. and the European Union,” said CytRx President and CEO Steven A. Kriegsman. “This is particularly exciting coming on the heels of our recent presentation at the American Society of Clinical Oncology (ASCO) conference of favorable results from our aldoxorubicin Phase 1b/2 clinical trial in patients with advanced sarcomas whose tumors had progressed after receiving other chemotherapies. These results increase our confidence in the linker technology’s ability to deliver doxorubicin in substantially higher concentrations to the tumor, while avoiding many of the severe side effects associated with the systemic delivery of unconjugated doxorubicin.”
CytRx holds the exclusive worldwide rights to the single-molecule linker technology, which is licensed from the Tumor Biology Institute in Freiburg, Germany. The linker is directly conjugated to a chemotherapeutic agent and when injected into the bloodstream binds to circulating albumin within minutes. The albumin-bound conjugate concentrates at the tumor site where the chemotherapeutic agent then is released from the linker.
“The technology can be used with multiple chemotherapeutic agents, making it in effect its own potential drug pipeline with blockbuster possibilities,” added Mr. Kriegsman.
Results from a Phase 1b/2 clinical trial showed clinical benefit (defined as partial response and stable disease of more than four months) following treatment with aldoxorubicin in 10 of 13 (77%) evaluable patients with relapsed or refractory soft tissue sarcoma. The trial data were presented earlier this month at the ASCO conference. CytRx is currently conducting an international Phase 2b clinical trial comparing aldoxorubicin with native doxorubicin as a first-line therapy in patients with soft tissue sarcomas, and is entering patients with advanced pancreatic ductual adenocarcinomas in a Phase 2 trial to evaluate treatment with aldoxorubicin. The Company plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial for aldoxorubicin as therapy for patients with soft tissue sarcomas who have relapsed after or were refractory to chemotherapy.