Newton, Mass., March 12, 2007
NeuroHealing Pharmaceuticals Inc., a a clinical stage private company developing products for individuals with chronic brain injuries, today announced that it had presented new clinical data for its coma recovery compound, NH001, at the American Society for Experimental NeuroTherapeutics (ASENT) 9th annual meeting, held in Washington, DC from March 7-10, 2007.
NH001 is a dopaminergic agent designed to accelerate the recovery and improve the functional outcome of patients from a coma, vegetative or minimally conscious state following a traumatic brain injury. The findings presented include the response to NH001 treatment of eight patients with a traumatic brain injury who were in a vegetative or minimally conscious state for 1-4 months and neurologically stable for weeks prior to beginning of NH001 treatment. Seven of the eight patients had previously received, and failed to respond, to commonly used stimulant drugs, such as l-dopa, amantadine and bromocriptine.
The responses to NH001 treatment were rapid and observed in the first 2-4 weeks. Five of seven patients showed a progressive and continuous improvement with clinically significant changes in consciousness, functional recovery and reached an independent walking ability. The responses were maintained after NH001 discontinuation. NH001 was well tolerated; adverse were anticipated based on literature reports and were transient.
Patients fared better than expected historic outcomes. Consistent with previously released clinical data, these new data provide further support that NH001 may be a safe and an effective treatment to accelerate the emergence of consciousness following a TBI.
Dr. Ben-Zion Krimchansky, Principal Investigator of the clinical site in Israel noted that “patients who had tried and failed to respond to the standard medications, responded promptly to the NH001 treatment and their outcomes were surprisingly better than predicted considering the severity of the brain damage.”
About Coma, Vegetative State and Minimally Conscious State
Each year in the U.S. 50,000 to 75,000 patients survive a severe TBI but remain in an altered consciousness state – such as coma, vegetative state (VS) and minimally conscious state (MCS) – 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 some evidence suggesting that 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 limited to sensory stimulation. Presently, there is no approved treatment for post-traumatic patients who remain in a vegetative state or minimally conscious state.
NeuroHealing’s proprietary therapy NH001 is a potent dopaminergic agonist with well-established human safety data, appropriate pharmacokinetic profile and convenient route of administration. It is a direct acting dopamine agonist on both D1 and D2 receptors, and has been reported to stimulate post-synaptic dopamine receptors independent of pre-synaptic dopamine synthesis or stores. 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 may stimulate recovery from a coma.
NeuroHealing has received authorization from the FDA to begin a double-blind Phase II clinical trial, under an open IND. NH001 is eligible for fast track approval at the FDA.
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.