LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a key patent covering the tumor-targeting conjugate INNO-206 linker platform technology and INNO-206 pharmaceutical compositions.
“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 CytRx President and CEO Steven A. Kriegsman.
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 tumor site, thus allowing for greater drug concentration within the tumor. 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, U.S. 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 1b/2 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 2b 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 1b/2 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 2 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 tumor xenograft models in mice.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, is completing its ongoing Phase 1b/2 clinical trial primarily in the same indication, and plans to initiate a Phase 2 trial for an undisclosed solid tumor indication in the first half of 2012. 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 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company is evaluating 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 INNO-206, the risk that INNO-206 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 INNO-206 might cause adverse events not seen to date in CytRx's preclinical or clinical testing, uncertainties regarding whether INNO-206 effectively targets doxorubicin to tumors, uncertainties regarding regulatory approvals for current and future clinical testing of INNO-206 and the scope of the clinical testing that may eventually be required by regulatory authorities for INNO-206, the significant time and expense that will be incurred in developing any of the potential commercial applications for INNO-206, including for soft tissue sarcomas, the risk that any future human testing of INNO-206 might not produce results similar to those seen in animals, risks related to CytRx's ability to manufacture its drug candidates, including INNO-206, 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 INNO-206, 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.