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CytRx Announces the Publication of a Peer-Reviewed Case Report Documenting Tamibarotenea?s Successful Elimination of Recurrent

^{Published on 2011-04-18 05:36:01 - Market Wire}
 

LOS ANGELES--([ BUSINESS WIRE ])--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 CytRxa™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).

"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"

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, aSuccessful Treatment of Relapsed and Refractory Extramedullary Acute Promyelocytic Leukemia with Tamibarotene,a (April 13, 2011) was coauthored by Daniel Levitt, MD, Ph.D., CytRxa™s Chief Medical Officer, in conjunction with researchers at the University of Texas Southwestern in Dallas. aWe 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.

aWe 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,a said Dr. Levitt.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: bafetinib, tamibarotene and INNO-206. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), a pharmacokinetic clinical trial in brain cancer and the PROACT Phase 2 clinical trial in advanced prostate cancer. With its tumor-targeting pro-drug candidate INNO-206, CytRx is conducting a safety trial with plans to initiate Phase 2 proof-of-concept clinical trials as a treatment for soft tissue sarcomas and pancreatic cancer. CytRx's pipeline also includes tamibarotene, which it is testing in patients NSCLC and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit [ http://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 relating to possible reappearance of cancer in the patient described in this press release, the failure of other patients to response to our drug candidate or possible unreported cases of adverse patient outcomes, the ability to obtain regulatory approval for clinical testing of tamibarotene, including additional clinical trials for patients with APL, the scope of clinical testing that may be required by regulatory authorities and the timing and outcome of further clinical trials, the risk that any future human testing of tamibarotene might not produce results similar to those seen in animals, risks related to CytRx's ability to manufacture tamibarotene and its other drug candidates 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.