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news.Curemark, a drug R&D company, has reported that the FDA has cleared the company's investigational new drug application to initiate its pivotal Phase III clinical trial of CM-AT for the treatment of autism.
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The company expects to begin Phase III clinical trials at multiple sites across the US in the second quarter of 2009. As part of this investigational new drug (IND) application, the FDA has agreed that Curemark may proceed directly into pivotal Phase III clinical trials in patients with autism.
The FDA has reviewed the quality, safety and efficacy data generated by Curemark in pediatric patients with autism. In addition, the FDA has provided written guidance on the trial protocol.
Joan Fallon, CEO of Curemark, said: “The FDA clearance of the CM-AT IND for the pivotal Phase III trial is an important milestone for Curemark. With one in 150 children diagnosed with autism, we have children who are suffering. We are very excited about the opportunity to enter a Phase III trial for this ever-growing population of children.”