Nutra Pharma Corp., a biotechnology company that is developing drugs for HIV and Multiple Sclerosis has today announced that ReceptoPharm had commenced its Phase IIb clinical trial in subjects with Adrenomyeloneuropathy (AMN).
“The AMN trial is important for ReceptoPharm, as its protocol will also allow us to assess the potential effects of RPI-78M in Multiple sclerosis,” explained Paul Reid, CEO of ReceptoPharm, Inc. “We are happy it is underway and, given our prior clinical experiences, we are very positive about the future outcome of this trial,” he added.
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 contract drug fillers and the British Medicines and Health Regulatory Agency’s (MHRA) need 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,” commented Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. “The commencement of this trial provides the foundation for initiating several additional clinical trials that we have scheduled for 2007,” he concluded.
There is currently no approved treatment for Adrenomyeloneuropathy. Additionally, the disease's rarity designates it as an orphan drug candidate both in Europe and in the U.S. ReceptoPharm has applied for Orphan drug status in the U.S. and intends doing so for the EU.
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 start of the ReceptoPharm Phase IIb human clinical trial for the treatment of Adrenomyeloneuropathy 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.