CytRx Corporation (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.
About CytRx CorporationCytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: aldoxorubicin (formerly known as INNO-206), tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, recently initiated a Phase 2 trial for patients with advanced pancreatic ductual adenocarcinomas, and plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a Phase 2 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about the Company, visit www.cytrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties related to the outcome, timing and results of CytRx's clinical trials for aldoxorubicin, the risk that aldoxorubicin might not show greater efficacy than doxorubicin notwithstanding the administration of higher doses than the standard of care, the risk that additional longer-term dosing of aldoxorubicin might cause adverse events not seen to date in CytRx's preclinical or clinical testing, uncertainties regarding whether aldoxorubicin effectively targets doxorubicin to tumors, uncertainties regarding regulatory approvals for current and future clinical testing of aldoxorubicin and the scope of the clinical testing that may eventually be required by regulatory authorities for aldoxorubicin, the significant time and expense that will be incurred in developing any of the potential commercial applications for aldoxorubicin, including soft tissue sarcomas, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in animals, risks related to CytRx's ability to manufacture its drug candidates, including aldoxorubicin, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.