Rochester,NY 7/8/2009 11:05:44 PM
Mid Morning Movers - CYTR - CytRx Files Report with the FDA in Response to the Partial Clinical Hold on its Phase 2b Arimoclomol ALS Trial - Sourced WhisperFromWallStreet.com
CytRx Corporation
Mid Morning Movers - CYTR - CytRx Files Report with the FDA in Response to the Partial Clinical Hold on its Phase 2b Arimoclomol ALS Trial - Sourced WhisperFromWallStreet.com
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CytRx Corporation, CYTR
After Hours: 0.8869 -0.09 (-9.50%) 11:46am ET
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.”
About
CytRx Corporation, a biopharmaceutical research and development company, engages in the development of human therapeutics. Its product pipeline includes Tamibarotene, a synthetic retinoid in Phase II clinical development to treat acute promyelocytic leukemia; INNO-2006, a pro-drug for doxorubicin in Phase II clinical development for the treatment of cancer; Bafetinib, a drug in Phase I clinical development to treat chronic myeloid leukemia; Arimoclomol, an orally-administered small-molecule product candidate in Phase IIb clinical development for the treatment of amyotrophic lateral sclerosis; and Iroxanadine, an orally-administered small-molecule product candidate in Phase I clinical development to treat diabetic ulcers. The company also engages in developing treatments for neurodegenerative and other disorders based on its small-molecule molecular chaperone amplification technology; and new-drug discovery research utilizing its master chaperone regulator assay technology. The company was founded in 1985 and is headquartered in Los Angeles, California.
Last Trade: 0.89
Day's Range: 0.87 - 0.97
52wk Range: 0.23 - 1.21
Volume: 401,240
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