Newton, Massachusetts, May 3, 2011.
NeuroHealing Pharmaceuticals Inc., a private, clinical stage company announced today the dosing of the first patient in a Phase II/III study to test the efficacy of NH001 in accelerating the recovery and improving the outcome of patients in an altered state of consciousness following a severe traumatic brain injury (TBI). The NH001-2 clinical trial is a double-blind, placebo-controlled, multi-centered, randomized study of the safety and efficacy of NH001 in improving the functional outcome of patients in a vegetative state or minimally conscious state following a severe TBI (clinicaltrials.gov identifier NCT00761228). Subjects who have not responded in the NH001-2 study after 28 days may be eligible to participate in an open-label extension study NH001-3. These clinical studies build on the encouraging findings of a completed NH001 Phase IIa trial (Fridman, et al. Brain Injury 2010). The NH001-2 study was initiated at the Spaulding Rehabilitation Hospital, a Harvard Medical School affiliate, in Boston, Massachusetts. Dr. Ross Zafonte, Earle P & Ida S Charlton Chair of the Department of Physical Medicine & Rehabilitation at Harvard Medical School and Vice President of Medical Affairs for Spaulding Rehabilitation Hospital, is the principal investigator of this study. “The team at the Spaulding Rehabilitation Hospital is extremely excited to work with NeuroHealing in this first clinical trial in the United States evaluating NH001,” said Dr. Zafonte. “There is a need for a validated and approved drug therapy for low functioning TBI patients and we believe that NH001 is a promising possibility.” NH001 obtained Orphan Drug designation from the FDA and the NH001-2 study is funded in part by a three-year clinical grant from the FDA’s Office of Orphan Drug Products.
NH001 is a potent dopaminergic agonist with well-established human safety data, appropriate pharmacokinetic profile and route of administration. It is a direct acting dopamine agonist at both D1 and D2 dopamine receptors. It rapidly crosses the blood brain barrier and reaches a concentration in the brain eight times higher than that in plasma. Because dopaminergic function appears to be of importance in executive central nervous system function, such as arousal and memory, NH001 has been designed to help regain consciousness, accelerate recovery and improve the functional outcome of patients from a coma, vegetative or minimally conscious state following a traumatic brain injury.
About Coma, Vegetative State and Minimally Conscious State
Each year in the U.S. 25,000 to 50,000 patients survive a severe TBI but remain in an altered consciousness state – such as coma, vegetative state or minimally conscious state – for an extended period of time. These ‘altered consciousness states’ are characterized by the lack of awareness and lack of interaction with the environment. Diffuse axonal injury, a neural pathology occurring in post-TBI patients, is associated with a disruption of dopamine pathways. There is evidence suggesting that 2 NEUROHEALING PHARMAC EUTICALS INC. 617.331.4111 – WWW.NEUROHEALING.CO M 50 UNDINE RD, UNIT #1. NEWTON, MA 02135 dopamine agonists may have a role in regaining consciousness, facilitating rehabilitation and improving outcome. In the acute stage, the main medical efforts are focused on stabilizing vital signs, internal homeostasis and intra-cranial pressure. After the patient reaches stability, current therapy is based on sensory stimulation. There are no approved drug treatments for post-traumatic patients who remain in a vegetative state or minimally conscious state.
About NeuroHealing Pharmaceuticals
NeuroHealing Pharmaceuticals, Inc. is a clinical stage private company developing innovative treatments for specialty indications based on repositioning neurologically active compounds. 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 patients suffering from sialorrhea (drooling); and NH02D, a neurologically active compound to treat premature ejaculation.
About Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital, a member of Partners HealthCare, is the flagship facility of the Spaulding Rehabilitation Network, which includes the Spaulding main campus, a 196-bed facility, located in Boston, MA, Spaulding Hospital Cambridge, Rehabilitation Hospital of the Cape and Islands, Shaughnessy-Kaplan Rehabilitation Hospital, three skilled nursing facilities: North End Rehabilitation and Nursing Center, Boston Center for Rehabilitation and Sub-Acute Care, and the Clark House, as well as sixteen outpatient sites throughout the Greater Boston area. Spaulding is a teaching hospital of Harvard Medical School as well as the official rehabilitation hospital of the New England Patriots.