Newton, Massachusetts – December 13, 2007
NeuroHealing Pharmaceuticals, a private, clinical stage company developing drug treatments for individuals with neuro-rehabilitation needs, today announced that the Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded the company a grant to advance the clinical development of NH004, a novel treatment for sialorrhea (uncontrolled drooling). This grant will be used to support a double blind, placebo controlled Phase II study testing NH004 in 36 Parkinson’s disease (PD) patients suffering from sialorrhea. NH004 is an intra-oral muco-adhesive film for the control of sialorrhea and has demonstrated promising responses in exploratory studies. “This is a rewarding milestone and an important accomplishment for the company,” commented Neal M. Farber, Ph.D., CEO of NeuroHealing. “We are very pleased to receive this support from the Michael J. Fox Foundation. It demonstrates the need for a treatment to control sialorrhea in PD patients and represents a nice validation of the promise of NH004 therapy.” Marcelo Merello, M.D., Ph.D., the principal investigator of the NH004 Phase II trial, is co-director of the Neuroscience Department at the FLENI Hospital in Buenos Aires, Argentina, a member of the International Executive Committee of the Movement Disorders Society and a world recognized Parkinson’s researcher. The clinical trial has already received authorization to begin from the FLENI ethics committee and from the ANMAT (FDA equivalent in Argentina). Dr. Merello commented, “It is an honor to receive the Clinical Discovery Program award from the Michael J. Fox Foundation,” and added, “There are no effective therapies to control the symptoms of drooling,” and, “We are excited about the NH004 films due to the fact that the drug is delivered locally into the oral mucosa, minimizing possible drug interactions with patients who are already receiving many medications.”
Sialorrhea (drooling or uncontrolled salivation) is a major non-motor complaint in many patients suffering from various neurological impairments including Parkinson’s disease (PD). Sialorrhea is often described as the single most disabling social problem for many PD patients. It is a frequent, awkward and embarrassing, but often not discussed, 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. Numerous approaches have been attempted to treating sialorrhea in PD patients; however, they are not satisfactory.
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 NEUROHEALING PHARMACEUTICALS INC. 617.331.4111 – WWW.NEUROHEALING.COM 50 UNDINE RD, UNIT #1 – NEWTON, MA 02135 2 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 FLENI Hospital
The FLENI Hospital, also known as the Raul Carrea Institute for Neurological Research, is a wellrespected hospital and leading research center in Buenos Aires, Argentina specializing in the neurosciences. The FLENI’s rehabilitation and therapeutic education center serves patients with acquired brain injury, stroke, spinal cord, orthopedic, cardiovascular and respiratory diseases.
About the Michael J. Fox Foundation and the Clinical Discovery Program
The Michael J. Fox Foundation for Parkinson’s Research (MJFF) 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 $100 million in research directly or through partnerships. The MJFF Clinical Discovery Program is an annual program that seeks well-designed clinical research proposals focused on potentially high-impact approaches to the field of Parkinson’s disease. If successful, projects funded under this program could lead to improved treatment of PD within five years and have an immediate impact on patients’ lives. The MJFF launched the Clinical Discovery Program in 2004 and has awarded approximately 17 projects under the initiative to date. The Foundation particularly seeks projects that explore new neuroprotective treatments, improvements on existing therapies, and development of treatments for unmet symptoms of PD.
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.