Journal of Clinical Oncology publishes CytRx tamibarotene Phase 2b trial results in APL

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced the publication of a case report in the peer-reviewed Journal of Clinical Oncology documenting the use of tamibarotene in the successful treatment of a patient with recurrent advanced-stage acute promyelocytic leukemia (APL). The case report provides further evidence of the biological activity of tamibarotene, which data indicate is 10-times more potent and less toxic than with all trans retinoic acid (ATRA). The announced results, which highlight the activity of tamibarotene in this patient, support CytRx's Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC).

The case report documents the total elimination of a unique and deadly form of APL called promyelocytic sarcoma from a patient who was diagnosed with APL at age 25 in 2004. Tamibarotene was first administered in December 2009 under a compassionate use protocol to treat this particularly aggressive form of APL following multiple failures with approved therapies, including ATRA, the current first-line APL standard of care, arsenic trioxide (ATO), the current second-line APL standard of care, as well as anthracycline chemotherapy, cytotoxic antibody therapy and a blood stem cell transplant. Treatment with orally available tamibarotene eradicated 20 tumors located in the abdomen, chest, deep muscles and subcutaneous tissues, and was well tolerated by the patient. At one-year following initiation of treatment, the patient continued to be cancer-free and is continuing therapy with tamibarotene indefinitely.

The case report, "Successful Treatment of Relapsed and Refractory Extramedullary Acute Promyelocytic Leukemia with Tamibarotene," (April 13, 2011) was coauthored by Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer, in conjunction with researchers at the University of Texas Southwestern in Dallas. "We have seen several patients respond dramatically to tamibarotene after failing multiple standard treatments for their APL. The total response of these leukemic solid tumors to tamibarotene in the patient reported in this article was astounding.

"We are very optimistic about the potential of tamibarotene in combination with chemotherapeutic agents in the treatment of NSCLC, since our clinical trial is based on statistically significant clinical results obtained from an ATRA/chemotherapy combination in patients with stage 4 disease," said Dr. Levitt.