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DarPharma, Inc.'s DAR-0100 To Be Evaluated In First-in-Class Clinical Proof-of-Concept Trial For Working Memory Deficits In Schizophrenia

10/19/2005 5:10:42 PM

CHAPEL HILL, N.C., Aug. 24 /PRNewswire/ -- DarPharma announces that enrollment has begun for a trial of DAR-0100 for the treatment of working memory and cognitive deficits associated with schizophrenia. This is the first ever clinical trial of a dopamine D1 receptor full agonist in treating working memory deficits. The trial is sponsored by The Stanley Medical Research Institute (SMRI), the largest private source of funding for research into schizophrenia and bipolar disease.

"SMRI is dedicated to finding ways to improve the quality of life of people with schizophrenia and bipolar disorder," said Dr. Michael Knable, Executive Director of SMRI and a member of DarPharma's Board of Directors. "This is a rare opportunity to take the exciting science done by Professors Richard Mailman [University of North Carolina, Chapel Hill] and David Nichols [Purdue University] and promising, related science conducted by other investigators throughout the world and translate it into a clinical study that may open new horizons for therapy. We at SMRI are very pleased that we could support this study."

An expert consensus panel convened by the National Institute of Mental Health last year selected D1 agonists as the most promising way to treat working memory deficits in schizophrenia, a major medical problem with significant social and economic costs.

"This is the first clinical study to address the conclusions of the NIMH experts," said Dr. Prabhavathi Fernandes, President and CEO of DarPharma. "Professors Mailman and Nichols have invested years towards developing D1 agonists and bringing DarPharma to this point. This trial of DAR-0100 for treating cognitive deficits is a landmark in mental health research."

The trial will enroll patients with schizophrenia who are currently stabilized on existing medications, and will evaluate the effect of DAR-0100 on brain activation using a technique called fMRI, or functional magnetic resonance imaging. The Medical University of South Carolina is the primary site for the trial. Results are expected in the first quarter of 2005.

About DarPharma, Inc.

Launched in July 2001, DarPharma's primary goal is to bring to the market dopamine D1 receptor full agonists as therapeutics for numerous CNS conditions, including the cognitive deficits and negative symptoms associated with schizophrenia. Their large intellectual property portfolio includes multiple drug candidates for dopamine receptors and other targets. DarPharma's lead compound, DAR-0100, is in a Phase II study in schizophrenia patients and a Phase I/IIa clinical trial in late-stage Parkinson's disease patients.

For further information, please contact Mr. Michael Dombeck, Director of Business Development.

DarPharma, Inc. 215 Cloister Court Chapel Hill, NC 27514 Voice: (919) 403-4348 Fax: (919) 403-4369

DarPharma, Inc.

CONTACT: Michael Dombeck, Director of Business Development of DarPharma,Inc., +1-919-403-4348, or fax, +1-919-403-4369

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