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Read More...Friday 25th August 2006
NeuroMedix produces large-scale amounts of cGMP grade Minozac for human clinical studies
TORONTO, Aug. 25 /CNW/ - NeuroMedix Inc. ("NeuroMedix") (TSXV: NMX) today announced that it has produced its first kilogram-scale batch of clinical grade cGMP (current Good Manufacturing Practice) Minozac for late stage pre-clinical toxicology studies and for human safety Phase I studies.
"This represents the achievement of a significant milestone for NeuroMedix as promised to our investors," said Mark L. Pearson, Chief Executive Officer of NeuroMedix. "The production of cGMP Minozac, the grade of material which will be used in human clinical trials, puts us one step closer to entering Phase I safety trials."
NeuroMedix in collaboration with scientists at Northwestern University and a contract chemical manufacturing organization has developed two scalable synthetic procedures to produce Minozac under cGMP conditions. Each of the synthetic procedures involves five synthetic steps, starting with a readily available intermediate and finishing with conversion of the base form of Minozac to a dihydrochloride salt. The synthetic yields and purity are very good. NeuroMedix expects to complete two additional batches by early December 2006. This first batch of cGMP material will be used to initiate the cGLP (current Good Laboratory Practice) repeat dose toxicology and safety pharmacology studies in two species of animal. The later batches will be used for formulation development and manufacturing of the solid dosage form that will be used for clinical Phase I studies.
Minozac, NeuroMedix's lead compound, acts to reduce brain inflammation, to protect neuronal cells, and to prevent the loss of cognitive function in an Alzheimer's disease animal model in mice. It has also been shown to reduce brain inflammation and prevent loss of cognitive function in mice suffering traumatic brain injury. NeuroMedix expects to submit a regulatory filing for the initiation of a Phase I clinical trial by the end of calendar 2006.
About NeuroMedix:
NeuroMedix is a biotechnology company focused on the development of therapeutic agents for the treatment of degenerative and inflammatory diseases of the central nervous system, such as Alzheimer's disease, traumatic brain injury, neuropathic pain, age-related macular degeneration and multiple sclerosis. Our therapeutic drug candidates are based on research from a team of leading experts in the field of neuroinflammation at Northwestern University and have been demonstrated to reduce brain inflammation, to protect neuronal cells, and to prevent the loss of cognitive function in an Alzheimer's disease animal model in mice. Our lead candidate, Minozac has also been shown to reduce inflammation and prevent loss of cognitive function in mice suffering traumatic brain injury. Based on these findings, NeuroMedix is pursuing the development of its lead compound for Alzheimer's disease and traumatic brain injury in humans. NeuroMedix's shares are listed on the TSX Venture Exchange under the symbol "NMX".
For further information: visit www.neuromedixinc.com or contact:
Mark Pearson, PhD.
Chief Executive Officer
NeuroMedix Inc.
(425) 503-5156
mark@neuromedixinc.com
or
Catherine Auld, CA
Chief Financial Officer
NeuroMedix Inc.
(416) 673-8190
cathy@neuromedixinc.com
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties, which may include but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

