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news.CytRx Corporation has submitted a protocol to the FDA detailing its plans to expand its ongoing phase II clinical trial evaluating its investigational drug, arimoclomol, for the treatment for amyotrophic lateral sclerosis, otherwise known as AML or Lou Gehrig's disease.
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CytRx plans to provide all patients who complete the ongoing phase II trial with the opportunity for treatment with arimoclomol at the highest dose level three times daily for an additional six months.
In the currently underway 80 patient, phase II study, patients are receiving either placebo or one of three dose levels of arimoclomol capsules three times daily for a period of 12 weeks.
The extension trial is designed to provide additional safety and tolerability data in combination with the current phase II trial.
“It is not surprising that patients enrolled in our trial have expressed high interest in an open-label extension option with arimoclomol for the treatment of ALS. Currently, there are no effective therapeutic treatments available for those suffering from this devastating neurodegenerative disease that carries an average life expectancy of 18 months following diagnosis,” said Steven Kriegsman, CytRx’s president and CEO.
CytRx expects to report final data from its ongoing phase II trial with arimoclomol for ALS in the third quarter of this year, followed by initiation of a pivotal phase IIb clinical trial subject to FDA review and acceptance. The company believes that successfully demonstrating safety and efficacy in this latter phase II clinical trial could be sufficient to support product registration with the FDA.