Yesterday, CytRx 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 the drug tamibarotene in capsule form. CytRx is currently conducting a Phase 2b global clinical trial with tamibarotene.
CytRx is focused on research and development that specializes in oncology, and currently has three programs in their pipeline that are in clinical development for cancer indications: aldoxorubicin (formerly known as INNO-206), tamibarotene, and bafetinib. Furthermore, CytRX has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, completed its Phase 1b/2 clinical trial primarily in the same indication, and recently initiated a Phase 2 trial for patients with advanced pancreatic ductual adenocarcinomas. CytRx plans to meet with the FDA in the second half of 2012 to discuss potential Phase 3 trials.
Tamibarotene has been designed to be more potent than the chemotherapeutic agent ATRA (all-trans retinoic acid), with the benefit of avoiding some of ATRA’s toxic side effects by selectively binding to specific molecular receptors. The drug is included in a Phase 2b global clinical trial, as a first-line treatment for non-small-cell lung cancer (NSCLC). It is also in a Phase 2 clinical trial 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. The U.S. patent from this application on the tamibarotene capsule formulation will expire in 2028.
Steven A. Kriegsman, CytRx CEO, said, “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. 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.”
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