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.
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). The approval to begin a late Phase II clinical trial for the treatment of AMN should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.