Nutra Pharma Corp., a biotechnology company that is developing drugs for HIV and Multiple Sclerosis, has announced that ReceptoPharm, has received Ethics Committee approval in the UK to begin its Phase IIb human clinical trial for the treatment of Adrenomyeloneuropathy (AMN). ReceptoPharm, the drug-discovery holding of Nutra Pharma, is currently studying the effectiveness of Cobra Venom and Cobratoxin as treatments for Multiple Sclerosis, HIV, Adrenomyeloneuropathy (AMN), Pain and Rabies.
"This approval from the London Ethics Committee will allow us to start the in-depth study of RPI-78M for the treatment of AMN," explained Paul Reid, CEO of ReceptoPharm, Inc. "We feel confident that if successful, our treatment will help those suffering from this devastating disease," 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 in the U.S. The Company has applied for Orphan drug status in the U.S. and intends doing so for the EU.
RPI-78M is ReceptoPharm's lead drug candidate for the treatment of neurological and autoimmune disorders. The drug has already completed pre-clinical testing and a Phase I/IIa human trial in AMN.
"For over five years, one patient with AMN using RPI-78M under the compassionate release laws of the United Kingdom has maintained an improved quality of life that provides us with quiet confidence for this new study," commented Rik Deitsch, Chairman and CEO of Nutra Pharma Corporation. "We expect this trial to be the first in a series of Phase II human clinical trials anticipated to begin over the next several months," he concluded.
The AMN Phase IIb human clinical trial is expected to begin within this quarter.
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"). e UK Ethics Committee approval of the AMN trial 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.