CytRx Files Report With The FDA In Response To The Partial Clinical Hold On Its Phase 2b Arimoclomol ALS Trial
"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.
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.
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