Nutra Pharma Corp., a biotechnology company that is developing drugs for HIV and Multiple Sclerosis (MS), has today announced that its drug discovery arm, ReceptoPharm, has successfully completed its six-month patient crossover in the Phase IIb/IIIa clinical trial for the treatment of Adrenomyeloneuropathy (AMN).
The six-month patient crossover occurred when patients enrolled in the study switched from using a placebo to RPI-78M and those patients currently taking RPI-78M began using a placebo. RPI-78M is ReceptoPharm's lead drug candidate for the treatment of neurological and autoimmune disorders.
“This is an important milestone in our clinical development process, as successful completion of this crossover acts as an early indication that our trial is running smoothly,” explained Paul Reid, CEO of ReceptoPharm, Inc. “As we move into the second-half of our trial, we will continue to monitor patients closely to determine efficacy of our treatment,” 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.
“We’re confident in what we’ve seen in previous patient trials. But because this is a double-blind, placebo-controlled study, we will not know patient results until the trial is fully-completed,” commented Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. “As the study progresses, we will continue to provide relevant information about this trial to our shareholders and to the public,” 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 6-month Adrenomyeloneuropathy clinical trial crossover 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.