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www.fdanews.com/articles/90854-receptopharm-begins-study-of-drug-for-rare-genetic-disorder

RECEPTOPHARM BEGINS STUDY OF DRUG FOR RARE GENETIC DISORDER

January 30, 2007

Nutra Pharma announced that its subsidiary ReceptoPharm had commenced its Phase IIb clinical trial of subjects with adrenomyeloneuropathy, a genetic disorder that affects the nervous system.

RPI-78M is ReceptoPharm's lead drug candidate for the treatment of neurological disorders. The company announced regulatory approval to begin its Phase IIb trial in April 2006, but was later delayed by the UK's Medicines and Healthcare Products Regulatory Agency's (MHRA) request for certification of the clinical drug batch prior to starting the trial.

"We are pleased that the MHRA feels comfortable with our safety data and has given us the final endorsement to begin our trial," Rik Deitsch, chairman and CEO of Nutra Pharma, said.

RPI-78M is also being developed for the treatment of multiple sclerosis. The company is considering testing the drug as a treatment for other neurological disorders, including myasthenia gravis and amyotrophic lateral sclerosis. The drug contains anticholinergic peptides that recognize the same receptors as nicotine (acetylcholine receptors) but have the opposite effect.

There is currently no approved treatment for adrenomyeloneuropathy, according to the company. ReceptoPharm has applied for orphan drug status in the U.S. and intends to do so in Europe.