CytRx Receives Letter From FDA

CytRx has received letter from the 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.

Arimoclomol is a molecular chaperone regulator drug candidate that is being considered for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), stroke recovery and other diseases.

Steven Kriegsman, president and CEO at CytRx, said: “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.

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,” added Mr Kriegsman.