excellent safety data

ASX/Media Release 1 February 2011

FIRST COHORT SAFETY DATA REVIEW SUCCESSFUL
IN CVac PHASE IIb TRIAL

Safety review of first CVacTM Phase IIb trial patient group complete Excellent safety data Another step forward with important US FDA components of manufacturing Randomised component of trial now open
Australian health care company Prima BioMed Ltd (ASX: PRR) (Prima) is pleased to announce that the first seven patients in its Phase IIb Trial for the CVacTM immunotherapy ovarian cancer vaccine have now successfully completed the first treatment cohort with the vaccine. No safety data concerns were expressed by the Data Safety Monitoring Board.
An initial cohort of seven subjects who met the Phase IIb Trials eligibility criteria have completed their first injection of the CVacTM vaccine, in an open label fashion. Post the treatment, this patient group have been monitored for a period of (at least) 28 days to assess any treatment-related adverse effects.
The Company can now advise that the initial patient group has not suffered any therapy related adverse effects and, on January 31, received confirmation from the Data Safety Monitoring Board that the Phase IIb Trial was safe to proceed. This was based on a detailed review of patients safety laboratory measures of blood, serum and urine chemistry, vital signs, and any reported study agent effect (or adverse events reported to date).
As a result, patient enrollment into the randomised component of the Phase IIb Trial (a further 54 patients) is now open. This patient cohort will be tracked on either standard of care versus treatment with CVacTM. The trial is open in five premier sites in Australia and 15 sites across the US. This includes Stanford Medical Centre, under the leadership of world leading gynealogical expert Dr Jonathan Berek.
The successful completion of the treatment of the first patient group in the CVacTM Phase IIb Trial is a significant achievement for the Company. It not only marks the treatment of the first group of trial subjects, but the uneventful safety review of this group now paves the way for the enrollment of the balance of patients for the trial.
Prima BioMed Managing Director Martin Rogers said: We are delighted to complete the first cohort of CVac treatment in the initial patient group in the Phase IIb Trial. Importantly, no safety concerns were raised by the Data Safety Monitoring Board and the patient group has experienced no adverse effects from the treatment. We now look forward to expanding patient enrollment in the trial to its full 60 patient complement.
ENDS
Prima BioMed Ltd, Suite 1, 1233 High St, Armadale, VIC 3143
Ph: +61 (0) 3 9824 5254 Fax: +61 (0) 3 9822 7735
www.primabiomed.com.au
ABN: 90 009 237 889
For further information please contact:
Mr Martin Rogers Mr James Moses Chief Executive Officer Investor and Media Relations
Prima BioMed Ltd Mandate Corporate Ph: +61 0 428 268 357 Ph: +61 0 420 991 574 E: [email protected] E: [email protected]
W: www.primabiomed.com.au
US Investor Relations
Ms Danielle Spangler
Investor Relations
The Trout Group
Ph: +1 (646) 378-2900
E: [email protected]
About CVac Ovarian Cancer Treatment
CVac is Prima BioMeds 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 was expected to total US$3.6b in 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. Primas 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 Companys broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.