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CytRx arimoclomol begins Phase II

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

CytRx is initiating a Phase II trial of its amyotrophic lateral sclerosis treatment arimoclomol, the firm says Sept. 22. CytRx received notification from FDA Sept. 21 regarding a clinical hold on the development program for the molecular chaperone activator announced last July (1Pharmaceutical Approvals Monthly August 2005, In Brief). The double-blind, placebo-controlled trial will enroll 80 patients from eight to ten U.S. centers. Primary endpoints are safety and tolerability; secondary endpoints include the revised ALS Functional Rating Scale. A second Phase II trial in 300 patients is slated to begin "soon after completion" of the present trial. CytRx announced FDA's decision to grant arimoclomol fast-track status Sept. 26...
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