us fda preind meeting request submitted for cv

ASX Release Stock Code: PRR
Monday, 25 August 2008
US FDA preIND MEETING REQUEST SUBMITTED FOR CVac™ CANCER TREATMENT
Meeting with US FDA to take place within 60 days
Australian cancer treatment development company Prima BioMed (Prima) (ASX: PRR) is pleased to announce that it has submitted its formal request for a pre-Investigational New Drug Application (preIND) meeting with the US Food and Drug Administration (FDA) for the company’s CVac™ ovarian cancer treatment.
The submission of the preIND meeting request is a major milestone in Prima’s commercialising process for CVac™, and under the terms of US FDA process the meeting will now take place within 60 days of the submission of the formal meeting request.
Prima’s aim is to secure the grant of a Investigational New Drug Application (IND) from the US FDA for the CVacTM cancer treatment as part of the Company’s broader and long term goal of developing commercial cancer treatment technologies and programs.
CVac™ is a therapy treatment for ovarian cancer administered post-surgery and post-chemotherapy to delay relapse and control metastases. There is a large un-met medical need for new treatments for ovarian cancer which has a very high morbidity rate, and there are currently no maintenance based therapy products available.
Prima management have worked extremely hard over the year to date to finalise the preIND meeting request. This has been done in conjunction with the Fred Hutchinson Cancer Centre in Seattle in the USA, which is a leading world class cancer centre with three Nobel Laureates on staff.
A preIND meeting is a major step in the commercialiastion of any new drug application, and Prima is delighted to be on the cusp of this milestone for CVac™.
Prima chairman Mr Ata Gokyildirim said that the submission for the preIND meeting was the result of a lot of hard work and persistence from the Prima team, and had been a long time coming but the elements had finally come together.
“We are delighted to be in a position to take this milestone step with our CVac™ ovarian cancer treatment, and are of the view that its eventual commercialiastion has the potential to add major material value to the Company,” Mr Gokyildirim said.
ENDS
For further information please contact:
Mr Martin Rogers James Moses Director Partner Prima BioMed Fortbridge Consulting Ph: 02 9232 4420, 0428 268 357 Ph: 0420 991 574 E: [email protected] E: [email protected]
Website: www.primabiomed.com.au
About Prima BioMed
Prima BioMed is an Australian biotechnology company. The Company is focused on technologies in the fields of cancer immunotherapy and immunology. Prima’s lead product, CVac™ has completed Phase IIa clinical development in Ovarian Cancer and is working to a path of US FDA IND approval.
About CVac™ Ovarian Cancer Treatment
CVac™ is Prima’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. CVacTM 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 of CVac™ over the next 6-9 months is the core focus for Prima.
For further information, visit www.primabiomed.com.au
This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing and results of clinical trials, interpretation and implications of such results, availability or adequacy of financing, the sales and marketing of commercial products or the efficacy of products. Although the Company believes that the forward - looking statements contained herein are reasonable, it can give no assurance that the Company’s expectations are correct. All forward - looking statements are expressly qualified in their entirety by this cautionary statement.
Prima BioMed Ltd, Suite 1705, 109 Pitt St, Sydney NSW 2000 AUSTRALIA
www.primabiomed.com.au Ph:+61 2 9232 4420 Fax:+61 2 9232 4450
ABN: 90 009 237 889