Healthcare Industry News:  schizophrenia 

Biopharmaceuticals Neurology

 News Release - April 21, 2009

NeuroScience Pharmaceuticals Launches in Research Triangle Park

RESEARCH TRIANGLE PARK, N.C.--(HSMN NewsFeed)--NeuroScience Pharmaceuticals Inc. has been launched in Research Triangle Park with the help of a North Carolina Biotechnology Center loan. The pharmaceutical company is developing treatments for brain disorders, utilizing technology licensed from Duke University and Durham Veterans Affairs Medical Center (VA).

Dr. Gabriel Cipau, President and CEO of the new clinical-stage company, said it will be focused on the development of neurosteroid drugs. Neurosteroids are potent brain substances that play a role in controlling anxiety and depression. NeuroScience’s lead product, Pregnenolone, is being tested for the treatment of schizophrenia in two fully funded Phase II clinical trials. Each study will involve 88 patients and enrollment is expected to start in the next two months.

“Multiple characteristics of Pregnenolone support its potential efficacy for the treatment of cognitive and negative symptoms in schizophrenia. Pregnenolone has multiple mechanisms of action supported by an extensive preclinical literature and emerging clinical data. Phase I clinical trials have indicated that Pregnenolone has the potential to effectively address schizophrenia symptoms with a favorable side effect profile”, said Dr. Cipau. The trial results were announced in a recent publication: Marx CE et al. Proof-of-Concept Trial with the Neurosteroid Pregnenolone Targeting Cognitive and Negative Symptoms in schizophrenia, Neuropsychopharmacology (2009), 1-19.

“We look forward to efforts by Neuroscience Pharmaceuticals to bring this promising compound through the development process and, ultimately, to the clinic,” said Dr. Brandy Salmon, Associate Director, The Office of Licensing and Ventures at Duke University. “This new company will focus on advancing compounds for the treatment of various psychiatric and neurological disorders in which patients are currently underserved by available therapies.”

Dr. Cipau said he expects NeuroScience to pursue other potential therapeutic applications for Pregnenolone, including cognitive impairment, Alzheimer's disease, post-traumatic stress disorder, depression, and addiction. The future product pipeline also includes a variety of delivery mechanisms and second generation neurosteroid compounds.

Dr. Cipau is a former Wellcome PLC executive and was CEO of several pharmaceutical and biotechnology companies including Nippon Wellcome, Catalytica Pharmaceuticals, Copley Pharmaceuticals, Biolex and PhaseBio.

Dr. Christine Marx serves as an unpaid scientific advisor/board member. She is an Associate Professor of Biological Psychiatry at Duke University Medical Center and the Durham VA Medical Center and directs the Interventions and Metabolomics Core of the VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center. Her efforts are at the leading edge of research investigating neurosteroids.

The NC Biotechnology Center approved a $50,000 low-interest Company Inception Loan to NeuroScience – the latest in a series of loans made by the Biotechnology Center to support start-up biotech firms.

“NeuroScience Pharmaceuticals represents the kind of investment in our state’s future that has been the Biotechnology Center’s hallmark for nearly 25 years,” said John Richert, Vice President of business and technology development for the Biotechnology Center. “This inception loan helps pay for basic activities related to the formation of the company, making it possible for NeuroScience to find the necessary funding for Phase III clinical trials from investors. And if the company grows as we anticipate, it will add to our increasingly important statewide base of more than 500 biotech companies employing more than 56,000 people.”

NeuroScience Pharmaceuticals is currently seeking series A investment to continue the clinical development of the lead product, Pregnenolone, develop new forms of delivery and extend the use to other indications. The company is also seeking partners for clinical development and development of new delivery technologies.

Source: NeuroScience Pharmaceuticals

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