Strengthens overall intellectual property for potent, orally available synthetic retinoid compound
Patent coverage for the tamibarotene capsule formulation will extend to 2028
CytRx Announces Allowance of U.S. Patent Application for Tamibarotene Capsule
<0> Investor RelationsLegend Securities, Inc.Thomas Wagner800-385-5790 x152718-233-2600 x152 </0>
(NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance for a patent application with claims covering a pharmaceutical composition of tamibarotene in capsule form. Tamibarotene is an orally available, rationally designed, synthetic retinoid compound that was designed to be more potent than the chemotherapeutic agent all-trans retinoic acid (ATRA), while avoiding several of ATRA’s toxic side effects by selectively binding to specific molecular receptors. The U.S. patent issuing from this application on the tamibarotene capsule formulation will have a term that expires in 2028.
CytRx is currently conducting a Phase 2b global clinical trial with tamibarotene as a first-line treatment for non-small-cell lung cancer (NSCLC) and a Phase 2 clinical trial with tamibarotene as a treatment for acute promyelocytic leukemia (APL). CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC and APL, and retains an option to expand its licenses for the use of tamibarotene in other fields in oncology.
“We are highly optimistic about tamibarotene’s prospects for improving the treatment of certain cancers, and strengthening the intellectual property position for this oncology asset is clearly in our best interest,” said CytRx CEO Steven A. Kriegsman. “Last month we announced a major milestone in our late-stage clinical trial with tamibarotene in NSCLC. An approval to market tamibarotene for this indication alone could represent a blockbuster opportunity for CytRx.”
In late June the Data Safety Monitoring Board recommended moving forward with CytRx’s Phase 2b clinical trial with tamibarotene as a first-line treatment for NSCLC. This recommendation indicated that no significant safety issues had been seen at that time with tamibarotene even in trial patients with advanced disease. CytRx expects to report clinical data from the Phase 2b trial in 2013.
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: , and . 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 in patients with soft tissue sarcomas who have relapsed or not responded to prior chemotherapies. 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 .
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 or uncertainties related to the outcome, timing and results of CytRx's planned Phase 2b clinical trial for tamibarotene as a treatment for NSCLC, uncertainties regarding regulatory approvals for current and future clinical testing of tamibarotene and the scope of the clinical testing that may eventually be required by regulatory authorities for tamibarotene, the significant time and expense that will be incurred in developing any of the potential commercial applications for tamibarotene, including for NSCLC, the risk that any future human testing of tamibarotene for NSCLC might not produce results similar to those seen with ATRA, risks related to CytRx's ability to manufacture its drug candidates, including tamibarotene, 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 tamibarotene, 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.