Newton, Mass., August 31, 2005 — E-Worldwire
NeuroHealing Pharmaceuticals Inc., a private company developing products for individuals with chronic brain injuries, announced today the submission of an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to initiate a 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 Principal Investigator of the study will be Dr. Ross Zafonte, chairman and tenured professor of the Department of Physical Medicine and Rehabilitation at the University of Pittsburgh Medical School. Additional clinical sites are being recruited.
“The affected population is comprised of mostly young patients who remain with long-lasting disabilities. Current approaches to help patients emerge from a vegetative state are sub-optimal and based only on anecdotal evidence. The clinical application of dopaminergic agents holds great promise for post-TBI patients. Given the preliminary clinical observations treating TBI patients with NH001, a double blind clinical trial is warranted to fully evaluate the promising potential of NH001,” stated Dr. Zafonte.
“The submission of our first IND is a significant milestone for NeuroHealing. The early clinical results on NH001 in sites outside of the US are encouraging and suggest that the product may be an effective treatment. We look forward to working closely with the FDA to meet the requirements necessary to bring this therapy to the market,” stated Elkan Gamzu, head of clinical trials for NeuroHealing.
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 (seven days or more) 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 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 phamacokinetic 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 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.