Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy, HIV and Multiple Sclerosis, has announced today that its wholly-owned drug discovery subsidiary, ReceptoPharm, will provide RPI-78M under compassionate release to patients previously enrolled in the Phase IIb/IIIa clinical study of Adrenomyeloneuropathy (AMN). RPI-78M is ReceptoPharm’s leading drug candidate for treating neurological and autoimmune disorders.
In July, Nutra Pharma announced the completion of ReceptoPharm’s Phase IIb/IIIa clinical study of RPI-78M for treating AMN. The last patient’s visit occurred in August 2008 and currently, the data from the trial are being prepared for analysis, with results expected during early 2009.
“This is an exciting time for Nutra Pharma as we await the clinical findings from our recent study,” said Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. “While the data from this trial is being reviewed and cleaned for analysis, we are pleased to be able to provide RPI-78M, under compassionate release to those patients who were enrolled in the trial and wish to remain on the drug,” he added.
Adrenomyeloneuropathy (AMN) is a rare inherited metabolic disorder that affects approximately 30,000 people worldwide. The disorder is 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.
There is currently no approved treatment for AMN. The disease's rarity designates it as an orphan drug candidate both in Europe and in the U.S.
“We want to complete the data quality control before the database is closed and the results are analyzed and before releasing the results from the trial,” explained Paul Reid, CEO of ReceptoPharm. “We are planning for success and subject to favorable clinical data from the current trial, we are preparing to initiate a subsequent study and also preparing to request a meeting with the European regulatory agency to discuss licensing strategy,” 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"). Providing RPI-78M under compassionate release to patients enrolled in the Adrenomyeloneuropathy (AMN) clinical study 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.