A board to discuss future MS therapies in early stage (Phase I or II) trials.


Postby dignan » Tue May 09, 2006 7:28 pm

Sounds like they are going to be starting a phase I/II MS trial soon.

Nutra Pharma Announces Approval to Start Late Phase II Human Trials in England

05/09/2006 -- Nutra Pharma Corp., a biotechnology company that is developing drugs for HIV and Multiple Sclerosis, has announced that their holding, ReceptoPharm, has received approval from the Medicines Health and Regulatory Agency (MHRA) for its application of human clinical trials for the treatment of Adrenomyeloneuropathy (AMN). The MHRA is the medical regulatory agency within the British Department of Health.

"Receiving this approval from the MHRA is extremely important for Nutra Pharma and ReceptoPharm," explained Dr. Paul Reid, CEO of ReceptoPharm. "Not only will it allow us to pursue human clinical trials for the treatment of AMN, it also allows us to gather additional safety data in support of other trials. We expect the study to commence by the end of the summer," he added.

Adrenomyeloneuropathy (AMN) is a rare inherited metabolic disorder characterized by the loss of the fatty covering (myelin sheath) on nerve fibers within the brain (cerebral demyelination) and the progressive degeneration of the adrenal gland (adrenal atrophy). Neurological disability in AMN is slowly progressive over several decades. AMN interests the wider neurologic community because of its similarities to Multiple Sclerosis (MS). There is currently no approved treatment for AMN. Additionally, the disease's rarity designates it as an orphan drug candidate both in Europe and the U.S. ReceptoPharm's drug, RPI-78M, was assessed in a placebo-controlled, double-blind study in the UK in 2003. The trial, published in the journal NEUROLOGY, represented the first controlled study of RPI-78M. The therapy was proven to be safe and well tolerated.

"In addition to this late phase II human trial in AMN, we are also moving forward with the plans to obtain regulatory approval from the FDA to begin Phase I/II studies in subjects with MS, a disease that affects as many as 2.5 million worldwide," commented Rik J. Deitsch, Chairman and CEO of Nutra Pharma Corporation. "The case for using the drug in subjects with MS is far stronger than that for AMN," he concluded.

http://www.marketwire.com/mw/release_ht ... _id=127931
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