CytRx Files Report with the FDA in Response to the Partial Clinical Hold on its Phase 2b Arimoclomol ALS Trial
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LOS ANGELES--(Business Wire)-- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, has filed a report with the U.S. Food and Drug Administrations (FDA) in response to the Agency`s partial clinical hold on the Company`s Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig`s disease). "We have been working closely with the FDA throughout this process and we are confident that the information included in this report, including results from a detailed animal toxicology study, sufficiently addresses the Agency`s concerns," said Steven A. Kriegsman, President and CEO of CytRx. "Given the timing of this submission, we anticipate that the FDA will review the report during the third quarter of this year. Again, we emphasize that the FDA`s partial clinical hold was unrelated to data generated by human studies and arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events." "We were diligent in our design and implementation of a highly detailed animal toxicology study that specifically responded to the issues raised by the FDA to support the lifting of the partial clinical hold," said Jack Barber, Ph.D., CytRx`s Chief Scientific Officer. "We remain optimistic about the prospects of arimoclomol as a treatment for the devastating consequences of neurodegenerative diseases such as ALS, and continue to work towards a potential partnership to help with further development." Arimoclomol is an orally administered molecular chaperone regulator drug candidate that is being considered as a treatment for ALS and stroke recovery. Molecular chaperone regulator drugs are believed to function by regulating a normal cellular protein repair pathway through the activation or inhibition of "molecular chaperones." Molecular chaperones detect proteins that are misfolded, and have the ability to refold those proteins into the appropriate, non-toxic shape. In February 2009, CytRx announced the commencement of a Phase 2/3 adaptive clinical trial, sponsored by the ALS Association and the FDA`s Office of Orphan Products Development OOPD, to study arimoclomol in a subset of patients with the inherited or familial form of ALS. In March 2009, the Company reported that arimoclomol had demonstrated statistically significant neurorestorative results in a preclinical embolic stroke trial. This data supported previous preclinical results indicating improvement in stroke recovery following oral arimoclomol administration up to 48 hours post-stroke. About ALS ALS is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement. ALS is a common neuromuscular disease, affecting an estimated 120,000 people of all races and ethnic backgrounds worldwide. Over a period of months or years, ALS causes increasing muscle weakness, inability to control movement and problems with speaking, swallowing and breathing. According to the ALS Association more than 5,600 people in the U.S. are diagnosed with ALS annually and an estimated 30,000 Americans have ALS at any given time. According to the National Institute of Neurological Disorders and Stroke, most ALS patients die within three to five years after the onset of symptoms. 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. The Company owns and operates a research and development facility in San Diego. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). 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 the risk that the animal toxicology data submitted to the FDA will not sufficiently address the Agency`s concerns expressed in their clinical hold on the Company`s Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis, uncertainties related the timing and ability to resume that clinical testing at the desired dosage of arimoclomol, the risk that any requirements imposed on the Company's planned clinical trial designs for ALS by the FDA as a result of the original concerns expressed in their clinical hold of the Company's ALS program might adversely affect the Company's ability ultimately to demonstrate that arimoclomol is efficacious in treating ALS, risks relating to the timing, outcome or results of future clinical testing of arimoclomol, 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. Legend Securities, Inc. Thomas Wagner 800-385-5790 x152 718-233-2600 x152 twagner@legendsecuritiesinc.com Copyright Business Wire 2009
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