Thursday, February 28, 2013

CytRx Corp. (CYTR) Hits Patient Enrollment Target in Phase II Clinical Trial for Tamibarotene


CytRx is a biopharmaceutical research and development company specializing in oncology. The company’s current oncology pipeline includes two programs in clinical development for cancer indications, aldoxorubicin, and tamibarotene. It also completed evaluation of a third drug candidate, bafetinib, and is seeking a partner for further development of the drug.

The company reported today that enrollment of 140 evaluable patients has been completed in its global Phase 2b clinical trial with CytRx’s oral retinoid compound tamibarotene in combination with chemotherapeutic agents. Tamibarotene was developed to be superior to ATRA, an FDA-approved retinoid, by binding to its molecular target more selectively.

The combination will be used as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC). Patients with stage IIIb or IV squamous or adenocarcinoma NSCLC who had not received prior non-adjuvant chemotherapy have been enrolled in this double-blind Phase 2b trial at sites in the United States, Mexico, India, Russia, Bulgaria, and the Ukraine.

The main goal of the clinical trial is progression-free survival. Secondary goals include response rate, overall survival, and RAR beta expression, a potential biomarker for responders.

The market for this type of cancer is decent-sized. By 2015, it is projected to be $13.3 billion. So if the trials are successful, it will be good news for CytRx, which holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC. Tamibarotene is currently marketed in Japan for a rare form of leukemia.

For additional information about Cytrx Corporation, tamibarotene, and its entire portfolio of drug candidates, visit www.cytrx.com

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