Prima BioMed Receives Regulatory Scientific Advice on CVac Phase III Trial

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.

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.

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

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