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Old 02-06-2007, 03:08 AM
aftermathman aftermathman is offline
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Join Date: Sep 2006
Location: Evesham, England
Posts: 598
15 yr Member
aftermathman aftermathman is offline
Member
 
Join Date: Sep 2006
Location: Evesham, England
Posts: 598
15 yr Member
Default Is this the first neuroprotective drug ...

to enter phase 3. I know everything is supposed to have neuroprotective qualities, (Azilect, all dop ags, l-dopa etc, my brain will live forever!) however from memory this may be the first "neuroprotective only" drug to have got this far.

I'm probably wrong though

http://sev.prnewswire.com/health-car...5022007-1.html

"Avicena Completes Dose-Escalation Portion of Chronic Toxicology Study of Parkinson's Disease Drug Candidate PD-02
Results Pave Way for Phase III Study in Parkinson's Disease

PALO ALTO, Calif., Feb. 5 /PRNewswire-FirstCall/ -- Avicena Group, Inc. (OTC: AVGO) (BULLETIN BOARD: AVGO) , a biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today the completion of the dose-escalating portion of a chronic toxicology study of PD- 02, its lead Parkinson's disease drug candidate. Results, which demonstrated that PD-02 is safe and well-tolerated, will allow Avicena to proceed with patient enrollment in a Phase III Parkinson's disease study.

"We are encouraged by the results to date, and our next step is to initiate patient enrollment for the Phase III trial," stated Belinda Tsao- Nivaggioli, Avicena's chief executive officer. "We are eager to pursue our clinical program to evaluate the potential of PD-02 as a treatment option for patients with Parkinson's disease."

The Food and Drug Administration (FDA) approved a Phase III study design for PD-02 in April 2006, and requested a dose-escalating chronic toxicology study of PD-02 prior to patient enrollment. This Phase III study is designed to evaluate PD-02's potential to slow the progression of Parkinson's disease and will be funded by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institute of Health. The trial's lead investigators are Karl Kieburtz, M.D., M.P.H., of the University of Rochester in New York, and Barbara C. Tilley, Ph.D., of the Medical University of South Carolina in Charleston.

ABOUT PD-02

PD-02 is Avicena's proprietary therapeutic that has demonstrated the potential to improve neurological function in patients with Parkinson's disease. In preclinical studies, PD-02 has demonstrated significant neuroprotective properties including protection of the dopaminergic cells which are affected in Parkinson's disease".

Aftermathman.
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