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In a release, the Company noted that the decision follows receipt of an anticipated written letter from the U.S. Food and Drug Administration (FDA) regarding the arimoclomol Phase IIb clinical trial. Under its guidelines, the FDA will have 30 days following CytRx's planned protocol submission to respond. CytRx expects that the revised protocol will result in the lifting of the clinical hold in the fourth quarter of this year.
"We are delighted with the FDA's letter, which we believe opens a viable pathway for continued development of arimoclomol for ALS and represents a significant step in its advancement as a potential treatment for this debilitating disease," said CytRx's President and CEO Steven A. Kriegsman. "We are addressing the FDA's letter by formulating a Phase IIb clinical trial protocol that will, among other modifications, include escalating dosing of orally administered arimoclomol up to the 400 milligrams, three times daily as originally planned in the previous protocol. As expected, the FDA letter did not indicate a need for additional animal toxicology studies or other studies prior to the revised protocol submission.
"We expect this positive development to support our pursuit of strategic alternatives, including potential partnerships, for the further development of arimoclomol. We are also continuing to evaluate possible clinical development of arimoclomol for stroke recovery and neuropathy, which were not directly affected by the FDA's prior letter relating to the Phase IIb clinical trial for ALS. Those two major therapeutic markets present additional opportunities for CytRx to create significant value for our stockholders." he added.
Arimoclomol is a molecular chaperone regulator drug candidate that is being considered as a treatment for ALS, stroke recovery and other diseases. 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.
((Comments on this story may be sent to health@closeupmedia.com))
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