BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Prima Biomed (PRR.AX) First Quarter Report, Management Conference Call and CVac Program Update


11/4/2013 9:03:36 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

SYDNEY, AUSTRALIA--(Marketwired - Oct 31, 2013) - Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (ISIN: US74154B2034) ("Prima", the "Company") yesterday released its Appendix 4C - Quarterly Report for the first quarter of financial year 2014, the three month period ending 30 September 2013.

The Company ended the quarter with approximately A$31.37 million in cash and term deposits.

Webcast and Conference Call Information

Prima's management will hold a conference call to discuss first quarter financial results and provide a thorough update of its clinical development plans on November 7, 2013 at 9:00am (Sydney local time). This corresponds to Wednesday, November 6, 2013 at 5:00pm U.S. Eastern standard time. The Conference call dial-in numbers are as follows:

Australia Toll Free 1 800 131 617

Australia Alternate Toll Free 1 800 838 758

USA & Canada 1 855 237 2970

Germany 0800 189 9369

The call will also be audio webcast with additional supplemental slides available via http://services.choruscall.com/links/primabiomed131106.html. Before launching the webcast, it is recommended to click on the link and then on "test your systems configuration."

A replay and a transcript of the teleconference will be available through Prima's website following the live event.

Operational Highlights of the First Quarter

Share purchase plan "shortfall" placement. Proceeds of approximately A$6.8 million were received during July and August 2013 as a result of share purchase plan "shortfall" placements to sophisticated investors.

CAN-003 analysis and the ovarian cancer clinical research program. On September 18, 2013, Prima reported top-line analysis of the CAN-003 phase 2 study evaluating the effects of CVac, as compared to an observation-only control arm, in epithelial ovarian cancer patients in complete remission after first or second line treatment. Prima's management delivered a presentation of the top-line analysis via webcast and teleconference on October 2.

As advised, Prima will continue monitoring patients from the CAN-003 trial for overall survival data. It is expected that this data will be mature enough for evaluation by approximately the end of calendar year 2014. Further detailed analysis of immune monitoring is ongoing.

To date, the intracellular cytokine staining data indicate that CVac increases T cell activity directed at mucin 1. Prima believes that stimulating mucin 1-specific T cells will result in clinical benefit for ovarian cancer patients. A strong trend of improved progression-free survival in second remission patients was observed; although in the combined data of all patients on the trial, there was no observed PFS improvement.

CAN-004 ("CANVAS") clinical trial. Because the phase 2/3 CANVAS trial was designed to evaluate progression-free survival as the primary endpoint, Prima suspended enrollment of new patients on to this trial as of September 18. As of that time, 113 patients had been screened at 34 sites in seven countries. Of those patients, 76 patients had met all study criteria, had been randomized, and are in various stages of their first-line treatment. According to the trial design, patients should complete first-line therapy and achieve complete remission prior to entering the dosing stage of the trial. Thirteen patients have completed their first-line therapy and moved on to the dosing part of the CANVAS trial.

Termination of Oncothyreon Inc. License. As of October 2, Prima and Oncothyreon Inc. (previously Biomira, Inc.) agreed to terminate a License and Development Agreement, and all subsequent amendments thereto (collectively "Agreements"), related to a purported license of mucin 1 technology for use in CVac. The now terminated Agreements could have been construed as requiring Prima to pay up to US$8.5 million in research milestones and continued royalties on commercial sales of CVac. The termination clarifies that Prima has no ongoing obligations to Oncothyreon Inc.

In the event that CVac would be approved for sale in the United States prior to 2018, when certain patents related to mucin 1 controlled by Oncothyreon Inc. expire, Prima may need to obtain a license from Oncothyreon Inc. related to use of mucin 1. Mucin 1 patents expire in Canada in 2014 and are already expired in all other countries.

About Prima BioMed

Prima BioMed is a globally active leader in the development of personalized immunocellular therapeutic products for the treatment of cancer. Prima is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Prima's lead product is CVac™, an autologous dendritic cell- based product currently in clinical trials.

Contact Information

For further information please contact:

USA Investor/Media:

Ms. Jessica Brown

Prima BioMed Ltd.

+1 (919) 710-9061

Australia Investor/Media:

Mr. James Moses

Mandate Corporate

+61 (0) 420 991 574

Europe Investor/Media:

Mr. Axel Muhlhaus

edicto GmbH

+49 (0) 69 905505-52

Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES