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news.CytRx Corporation has filed an investigational new drug application for arimoclomol for the treatment of amyotrophic lateral sclerosis with the FDA. The company expects to initiate a phase II clinical trial for arimoclomol in June.
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CytRx has assembled a team of renowned neurologists throughout the US to conduct the planned phase II clinical trial.
The company announced in May that arimoclomol was granted orphan drug status designation for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease). Receipt of orphan designation holds numerous potential benefits, including opportunities for grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, seven years of US market exclusivity should the FDA grant marketing approval for the drug and an added mechanism for more frequent communication with the FDA.
“Filing an investigational new drug application (IND) represents a significant milestone in our efforts to combat this deadly neurodegenerative disease,” said Steven Kriegsman, president and CEO of CytRx.
“We are hopeful that, due to the lack of an effective therapeutic treatment for this fatal disease and the recent designation of arimoclomol by the FDA as an orphan drug, the completion of a successful phase II program demonstrating efficacy in Lou Gehrig’s disease might be sufficient to enable us to submit a new drug application for the marketing of arimoclomol.”