Feb 19 2011
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 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."
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