Newton, Massachusetts – February 19, 2008
NeuroHealing Pharmaceuticals, a private, clinical stage company developing drug treatments for individuals with neuro-rehabilitation needs, today announced the initiation of a Phase II clinical trial of NH004 for the treatment of sialorrhea (uncontrolled drooling) in Parkinson’s disease (PD) patients. The first patients have been enrolled, and dosing was initiated last week. Subject to recruitment, results are expected to be available by the end of the second quarter of 2008. The clinical trial is a phase II, double-blind, placebo controlled, dose response, Latin-square crossover study to evaluate the efficacy and safety of NH004 for the treatment of PD patients suffering from sialorrhea. Up to 36 patients will be randomized to receive treatment with three doses of NH004 and placebo. NH004 is an intra-oral muco-adhesive thin film for the control of sialorrhea and has demonstrated promising responses in exploratory studies. This trial is being funded by The Michael J. Fox Foundation for Parkinson’s Research. The trial is being conducted at the FLENI Hospital in Buenos Aires, Argentina. Marcelo Merello, M.D., Ph.D., an internationally recognized Parkinson’s disease researcher is the principal investigator. Dr. Merello commented, “We are excited about this clinical study of NH004 in patients with sialorrhea. It’s important that physicians have new options for the management of sialorrhea.” Daniel Katzman, NeuroHealing’s president and a co-investigator in this trial said, “Initiating this trial is a milestone that recognizes the completion of several significant tasks including film manufacturing and pre-clinical pharmacology studies.” He further added, “These efforts will help bring NH004 closer to the market.”
Sialorrhea (drooling or uncontrolled salivation) is a major non-motor complaint in many patients suffering from various neurological impairments including Parkinson’s disease (PD), cerebral palsy, ALS, stroke and other motor disorders. Sialorrhea is often described as the single most disabling social problem for many PD patients. It is a frequent, awkward and embarrassing condition, affecting up to 75 percent of patients with advanced PD. Depending on its degree, drooling can result in social and medical disability, impaired speech, or serious feeding difficulties. Unable to manage oral secretions, affected persons are at an increased risk of aspiration pneumonia, skin maceration, and infection.
NH004 is an intra-oral, slow-dissolving film containing a fast acting anticholinergic agent to control the symptoms of sialorrhea, and the accompanying embarrassment and frustration to patients. The drug is embedded in a muco-adhesive film that is placed in the mouth and provides a slow, localized delivery of the medication while minimizing systemic exposure to the drug. This drug delivery is designed for effectiveness, safety and convenience. The film design makes it ideal for unobtrusive use in a social environment. NH004 is designed to provide both supportive care and to improve the quality of life.
About The Michael J. Fox Foundation
The Michael J. Fox Foundation for Parkinson’s Research is dedicated to ensuring the development of a cure for Parkinson’s disease through an aggressively funded research agenda. To date, the Foundation has funded $115 million in research.
About NeuroHealing Pharmaceuticals
NeuroHealing Pharmaceuticals, Inc. is a clinical stage private company developing therapies to improve the neuro-rehabilitation process and functional outcome for patients who have suffered debilitating injuries to the central nervous system. Clinical stage programs include: NH001 (phase II), a dopaminergic agent to help post traumatic brain injury patients to emerge from a coma, vegetative or minimally consciousness state; NH004 (phase II), an anticholinergic agent in a convenient intra-orally muco-adhesive dissolving film to help treat motor neuron disease patients who suffer from sialorrhea (drooling); and NH02D, a novel mechanism compound to accelerate the rehabilitation outcomes of stroke patients who remain with chronic motor and cognitive disabilities.