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Prima BioMed Receives Regulatory Scientific Advice on CVac Phase III Trial
Date:2/18/2011

SYDNEY, Feb. 18, 2011 /PRNewswire/ -- Australian health care company Prima BioMed Ltd (ASX: PRR) (Prima) announced today that there has been an agreement for strategy and design of the Phase III clinical registration trial for the CVac™ immunotherapy therapeutic ovarian cancer vaccine.

The agreement comes after the European regulator, the European Medicines Agency (EMA) advised that Scientific Advice for the Phase III trial had successfully been granted.

Receiving Scientific Advice is a significant milestone in the timeline progression for CVac's global registration. Prima can now move forward and begin preparations for patient enrollment into international, registration directed trial.

The international CVac™ Phase III trial will provide statistically powered endpoints for progression free survival and also for overall survival.

Scientific Advice was granted after the EMA reviewed extensive data was analysed on the study design and endpoints. Evaluation of the ovarian cancer patient needs, the CVac™ dosing regimen, along with manufacturing and safety data from past clinical and preclinical data was compiled in order to allow the regulator to make a positive determination on the strategy and design of the upcoming clinical trial that will allow for registration.

The trial will be conducted on 750 patients in a double blind placebo controlled study randomized 1:1 of CVac vs. Standard of Care (currently there is no approved maintenance therapy for ovarian cancer), across multiple sites in Europe, the US and Australia. This will include the world renowned centres of Charite University Hospital in Berlin, Germany, under leadership of Prof Dr Jalid Sehouli, Bonn University, Germany under the leadership of Prof Dr Kuhn, Stanford Medical Centre in Palo Alto, California under world leading gynaelogical expert Dr Jonathan Berek, and Austin Hospital in Melbourne, Australia, under the leadership of Dr. Paul Mitchell The
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