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 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 ET
Dr Jonathan Berek from Stanford
Medical Centre, Dr Neil Frazer and
Jason Kolbert head analyst from
National Securities US will host a conference call on Tuesday, February 22, 2011 at 11:00 a.m. Australian
EST/Monday, February 21, 2011 at
7:00 p.m. United States ET to provide updates and
commentary around the phase III study of CVac™, the unmet medical
need of ovarian cancer patients and relevance for the medical
oncology profession.
Date: Tuesday,
February 22, 2011(United States date is Monday, February
21)
|
|
Time: 11:00 a.m. Australian EST
/ 7:00 p.m. United States ET / 4:00 p.m. United States
PT
|
|
Dial-in: 1-800-4626-6666 (Toll-Free
Australia)
|
|
+1 877-407-0778 (Toll Free
US)
|
|
+1 201-689-8565
(International)
|
|
|
Webcast: www.primabiomed.com.au (homepage and investor
relations section)
A recorded broadcast will be available for interested parties
unable to participate in the live conference call by dialing +1
877-660-6853 Toll Free in the US or +1 201-612-7415 for
International callers. ; the Account # is 286 and the conference ID
number is 367779. The replay will be available until 11:59 p.m. ET on Monday,
March 21. In addition the webcast will be archived for
on-demand listening at www.primabiomed.com.au.
For further information please
contact:
|
|
|
Mr Martin Rogers
|
James Moses
|
|
Chief Executive
Officer
|
Investor and Media
Relations
|
|
Prima BioMed
|
Mandate Corporate
|
|
Ph: +61 0 428 268 357
|
Ph: +61 0 420 991 574
|
|
E: martin.rogers@primabiomed.com.au
|
E: james@mandatecorporate.com.au
|
|
W:
www.primabiomed.com.au
|
|
|
|
|
|
US Investor
Relations
|
|
|
Ms Danielle Spangler
|
|
|
Investor Relations
|
|
|
The Trout Group
|
|
|
Ph: +1 (646) 378-2900
|
|
|
E: dspangler@troutgroup.com
|
|
|
|
|
About CVac™ Ovarian Cancer Treatment
CVac™ is Prima BioMed's lead product. It is of key
importance as there is a large un-met medical need for new
treatments for ovarian cancer which has a very high morbidity rate.
CVac™ is a maintenance therapy administered post-surgery and
post-chemotherapy to delay relapse and control metastases.
There are currently no products available as maintenance based
therapies for ovarian cancer and the global market for ovarian
cancer therapeutics was valued at US$2.1b in 2007 and is expected to total
US$3.6b by 2010.
Regulatory approval and commercialisation of CVac™ is the
core focus for Prima.
About Prima BioMed
Prima BioMed is an ASX listed Australian health care company.
The Company is focused on technologies in the fields of cancer
immunotherapy and immunology. Prima's lead product is the CVac™
ovarian cancer therapy treatment. It has completed two successful
clinical trials and is progressing toward eventual
commercialisation in the United
States, Australia,
Europe, and globally.
The Company's broader, long term goal is to develop commercial
cancer treatment technologies and programs for global markets.
Clinical Appendix
Study Title
CAN-004: A Randomized, Double-Blinded, Placebo-Controlled Phase
2/3 Trial of CVac™ (Autologous Dendritic Cells Pulsed with
Recombinant Human Fusion Protein [Mucin1-Glutathione S Transferase]
Coupled to Oxidized Polymannose) as Maintenance Treatment in
Patients With Epithelial Ovarian Cancer (EOC) Following Optimal
Debulking Surgery and First-line Chemotherapy
Study Design
This is a randomized, double-blinded, placebo-controlled Phase
2/3 trial of CVac as maintenance treatment in patients with EOC
following optimal debulking surgery and first-line chemotherapy.
The initial planned enrollment is 750 patients. The primary
analysis of irPFS is planned to be conducted after 350 irPFS events
(confirmed immune-related progressive disease [irPD] or death) have
occurred. The primary analysis for OS is planned to be conducted
after 468 deaths.
An independent Data and Safety Monitoring Board (DSMB) will
assess blinded safety measures and demographics at regular
intervals throughout the study or as determined by the DSMB chair.
The DSMB will also review interim irPFS data, unblinded at the
group level, after 200 irPFS events. At the time of interim sample
size review, the DSMB may recommend changes to the sample size or
early termination of the study for efficacy or safety reasons as
detailed in the protocol.
Key Dates
First patient recruited Q3 2011
Interim data analysis* Q4 2012 - 1Q 2013
Final data analysis * Q4 2013 - 1Q 2014
*As an event driven study with adaptable design to have the
flexibility after interim analysis to adjust patient size and study
duration. Precise timelines are driven by these events of study
patient progression free survival and/or overall survival and this
can only be indicative.
Study Summary
The purpose of this study is to determine whether CVac™ is
effective in the treatment of Patients With Epithelial Ovarian
Cancer (EOC) Following Optimal Debulking Surgery and First-line
Chemotherapy as assessed by progression free survival or overall
survival.
Endpoints
Primary Objectives
- To assess the efficacy, in terms of immune-related
progression-free survival (irPFS), of CVac™ as compared with
placebo for maintenance treatment in patients with epithelial
ovarian cancer (EOC) following optimal debulking surgery and
first-line chemotherapy
- To assess the efficacy, in terms of overall survival (OS), of
CVac as compared with placebo for maintenance treatment in patients
with EOC following optimal debulking surgery and first-line
chemotherapy.
Secondary Objectives
- To assess the safety and tolerability of CVac™ as compared with
placebo
- To assess health-related quality of life (QoL) related to CVac
treatment as compared with placebo.
Exploratory Objectives
- To investigate the utility of various biomarkers as predictors
of irPFS and/or OS
- To investigate histopathology of tumor samples for potential
markers of predictive clinical efficacy of CVac
SOURCE Prima BioMed Ltd