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

enrollment process is expected to begin in mid 2011 and will reach full enrollment in by end of 2012. Interim data in relation to the Phase III clinical trials is expected to be available in end of 2012 /early 2013, which will provide the first opportunity to observe statistical analysis of progression free survival. Full information on the study including key dates is available in the clinical appendix further below.

The patient population will be randomised to the CVac™ treatment arm vs. a standard of care observation arm. The objective of the trial is to further confirm the ability of CVac to reduce the instance of relapse in ovarian cancer patients, control the metastases of the cancer and increase the life expectancy of patients. Patient quality of life and patient immunological markers will also be measured.

In conjunction with the current Phase IIb trial with the US Food and Drug Administration (FDA), this trial will seek to add to the positive efficacy results from CVac's Phase IIa trial on a larger patient population. The Phase IIa trial was conducted on 28 patients in Australia and was completed in 2007.

If statistical endpoints are successfully reached in the Phase III trial, we anticipate CVac™ becoming the world's first ovarian cancer immunotherapy treatment.

Prima BioMed chief executive Martin Rogers said: "The Company is delighted that the Scientific Advice for CVac™'s Phase III Trial has been successfully received from the European regulators. With regulatory agreement for strategy and design in place, we look forward to progressing through the next important development stages. If this critical trial is successful it will provide a new paradigm for patients and oncologists globally."

Conference Call to be Hosted Tuesday, February 22nd, 2011 at 11:00 a.m. Australian EST/ Monday, February 21st, 2011 at 7:00 p.m. United States ETDr Jonathan Berek from Stanford Medical Centre, Dr Neil Frazer and J
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SOURCE Prima BioMed Ltd
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