its official - ann. out

ASX/Media Release
21 February 2011
REGULATORY SCIENTIFIC ADVICE on CVac PHASE III TRIAL
Scientific Advice agreement with European Medicines Agency
Prima to Host an Expert Call w
22(US time Monday, February 21)
Australian health care company Prima BioMed Ltd (
today
clinical registration trial for the CVac
vaccine.
The agreement comes after the European regulator, the European Medicines
Agency (EMA) advised that Scientific Advice for the Phase III
been
Receiving
CVac?s global registration. Prima can now move forward and begin preparations for
patient enrollment into
The international CVac
for progression free survival and also for overall survival.
Scientific Advice was
on the
the CVac
clinical and preclinical data was compiled in order to allow the regulator to make a
positive determina
will allow for registration.
The trial will be conducted
randomized 1:1 of CVac vs
maintenance therapy for ovarian cancer),
Australia. This will include the world renowned centres of Charite University Hospital
in Berlin, Germany, under leadersh
Germany
Alto, California
Austin Hospital in
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 opportu
Prima BioMed Ltd
that there has been an agreement for strategy and design of the Phase III
granted.
Scientific Advice is
study design and endpoints. Evaluation of the ovarian cancer patient needs,
? dosing regimen,
under the leadership of of Prof Dr Kuhn, Stanford Medical Centre in
Ph: +61 (0) 3 9824 5254 Fax: +61 (0)
international, registration directed
?
granted
determination on the strategy and design of the upcoming
under world leading gynaelogical expert Dr Jonathan Berek, and
Melbourne,
Ltd, Suite 1, 1233 High St, Armadale, VIC 3143
www.primabiomed.com.au
ABN: 90 009 237 889
with Dr. Jonathan Berek
a significant milestone in the timeline progression
Phase III
after the EMA reviewed
along with manufacturing and safety data from past
tion on 750 patients
Standard of Care (currently there is no approved
Australia
, ith CVacTM immunotherapy therapeutic ovarian cancer
trial will prov
in a double blind placebo controlled study
across multiple sites in Europe,
leadership of Prof Dr Jalid Sehouli, Bonn University
Australia, under th
3 9822 7735
ASX: PRR) (Prima)
trial.
provide statistically powered endpoints
extensive data
, the leadership of Dr. Paul Mitchell
on Tuesday, February
trial had successfully
ide c
e announce
rial was analysed
clinical trial that
the US and
Palo
opportunity to
announced
for
rial University,
The
nity
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
standard o
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
In conjunction with the current Phase IIb
Administration
CVac
conducted on 28 patients in Australia and was completed in 2007.
If statistical endpoints are successfully reached
CVac? becoming
Prima BioMed chief executive Martin Rogers said: ?The Company is delighted that
the Scientific Advice for CVac
the
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
Prima BioMed Ltd
of care observation arm. The objective of the trial is to further confirm the
life and patient immunological markers will also be measured.
CVac?s Phase IIa
European regulators. With regulatory agreement for st
globally?