Newton, Mass., January 17, 2006
NeuroHealing Pharmaceuticals Inc., a private company developing products for individuals with chronic brain injuries, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a 76-patients, Phase II clinical trial with NH001. The study is entitled “A Double-Blind, Placebo-Controlled, 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 Traumatic Brain Injury.”
“The clearance of our first IND is an important step forward for NeuroHealing. We continue to observe encouraging clinical results with NH001 in sites outside of the U.S., which suggest that the product may be an effective treatment for patients with impaired consciousness following a traumatic brain injury.” stated Elkan Gamzu, head of clinical trials for NeuroHealing.
About Coma, Vegetative State and Minimally Conscious State
Advances in the acute management of traumatic brain injury have led to increased survival of severely brain-injured patients. Each year 50-75,000 patients in the US survive severe brain injury but remain in an altered consciousness state. Patients that remain in prolonged coma usually evolve to a persistent vegetative state or a minimally conscious state, characterized by the regaining of arousal but with little capacity for awareness, attention or the ability for independent living.
In the acute stage the main medical efforts are focused on stabilizing the vital signs, internal homeostasis and intracranial pressure. Presently, there is no approved pharmaceutical treatment for post-traumatic patients who remain in a vegetative state or minimally conscious state. After the patient reaches stability, current therapy is limited to sensory stimulation.
NeuroHealing’s proprietary therapy NH001 is a potent dopaminergic agonist with well-established human safety data, an appropriate phamacokinetic profile and a convenient route of administration. It is a direct acting dopamine agonist at 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 develops and commercializes novel therapeutics based on new formulation strategies to treat the needs of post-acute neuro-rehabilitation patients, including disorders such as traumatic brain injury, stroke, Parkinson’s disease and other motor neuron diseases.