CytRx Corporation's Tamibarotene Receives Positive Opinion from the Committee for Orphan Medicinal Products in the European Union for Treatment of APL

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (NASDAQ: CYTR - News), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that its lead drug candidate tamibarotene has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of acute promyelocytic leukemia (APL). The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register. This favorable opinion for tamibarotene in the European Union (EU) is in addition to the Orphan Drug Designation for APL and Fast Track Designation for the treatment of adult patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide granted by the U.S. Food and Drug Administration (FDA) in October 2007.

"We believe that the positive opinion by the COMP reflects the potential therapeutic value of tamibarotene as a treatment for European patients suffering from APL, especially for those who currently lack an effective third-line therapy for their disease. We consider this positive opinion important as it supports our ability to pursue marketing approval for tamibarotene in the EU in addition to our ongoing U.S. clinical program," said Steven A. Kriegsman, CytRx President and CEO.

CytRx Chief Scientific Officer Jack Barber, Ph.D., commented, “The granting of orphan medicinal product status for tamibarotene will provide us with an improved communications mechanism with the European Medicines Agency (EMEA) and other EU regulatory officials going forward as we pursue EU approval. Added interaction between the EMEA and CytRx during the regulatory process could assist us in obtaining marketing approval for tamibarotene for the treatment of APL in the EU.”

The European Commission grants orphan medicinal product status to promote the innovation of drugs that are developed to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU. With this designation, CytRx will have market exclusivity in the EU for 10 years in the event that tamibarotene receives marketing approval. The designation also provides for special benefits, including research support, eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development, or at the time of application for marketing approval.

About Acute Promyelocytic Leukemia

Acute promyelocytic leukemia (APL) is a subtype of acute myelogenous leukemia, a cancer of the blood and bone marrow. In APL, an abnormal accumulation of immature granulocytes called promyelocytes in the bone marrow results in a reduction in the production of normal red blood cells and platelets, resulting in anemia and thrombocytopenia. Either leukopenia (low white cell count) or leukocytosis (high white cell count) may be observed in the peripheral blood. Symptoms include fatigue, weakness, shortness of breath from anemia, easy bruising and bleeding from thrombocytopenia and coagulopathy, and fever and infection from lack of normal white blood cells.

About Tamibarotene

CytRx holds the North American and European rights to tamibarotene as a treatment for APL. Tamibarotene is an orally available, rationally designed, synthetic retinoid compound designed to potentially avoid toxic side effects by binding to its molecular target more selectively than all trans-retinoic acid (ATRA), the current first-line treatment for APL. The FDA has granted Orphan Drug Designation for APL and Fast Track Designation for the treatment of adult patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide. There are currently no third-line treatments for APL approved in the U.S. or Europe.

A Special Protocol Assessment (SPA) is in place with the FDA for a Phase 2 registration clinical trial, known as STAR-1, which is evaluating the efficacy and safety of tamibarotene as a third-line treatment for APL. The STAR-1 trial is ongoing and currently includes seven clinical sites in the U.S. CytRx believes that successful data from the STAR-1 trial and supporting studies, in conjunction with data from the Japanese clinical trials, will form the basis for a New Drug Application (NDA). CytRx recently reported that, of the 11 patients enrolled in the STAR-1 trial to date, 5 patients, or 45%, achieved a morphologic leukemia-free state, or MLFS. Of those, two patients have achieved durable complete response and one has achieved morphologic leukemia-free state, or MLFS, but withdrew from the trial to receive a bone marrow transplant before the durable complete response could be confirmed. One patient achieved a complete response, but did not maintain MLFS for the required 28 days to be considered a durable complete response. Another patient achieved a durable MLFS, but did not have the necessary increases in blood cells to be considered a durable complete response.

The efficacy of orally administered tamibarotene was demonstrated in two Phase 2 studies conducted in Japan in a total of 63 Japanese subjects with APL. The overall complete response rate in these subjects was 60%. In subjects experiencing their first relapse, the overall complete response rate was 81%. Tamibarotene is currently approved in Japan as a treatment for relapse APL.

CytRx also retains an option to expand its licenses for the use of tamibarotene in other fields in oncology, including multiple myeloma, myelodysplastic syndrome and certain solid tumors in the U.S., and multiple myeloma, myelodysplastic syndromes and solid tumors other than hepatocellular carcinoma in Europe. Tamibarotene also has showed statistically significant anti-tumor activity in animal trial for multiple myeloma, an incurable malignant tumor of the plasma cells of bone marrow.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII - News). For more information on the Company, visit 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 the timing, outcome or results of any clinical testing of tamibarotene as a third-line treatment for APL in the United States or Europe, risks related to CytRx’s ability to manufacture its drug candidates, including tamibarotene, in commercial quantities in compliance with stringent regulatory requirements, the risk that the results from clinical testing of tamibarotene might not be sufficient to accelerate regulatory approval for the drug candidate or permit the Company to reduce the total number of patients ultimately enrolled in the trial, risks related to CytRx’s ability to enter into partnerships or other transactions to advance the clinical development of its portfolio of drug candidates, or commercialize any of CytRx’s current drug candidates or initiate commercial operations through the acquisition of any newly identified drug candidates, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, risks related to the future market value of CytRx's investment in RXi and the liquidity of that investment, 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.

Contact:

Legend Securities, Inc.Thomas Wagner800-385-5790 x152718-233-2600 x152twagner@legendsecuritiesinc.com

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