Prima hires Progen for vaccine manufacture
Friday, 10 October, 2003
Brisbane's Progen Industries (ASX:PGL) will take on production of an anti-cancer therapeutic vaccine for Prima Biomed's (ASX:PRR) Cancer Vac subsidiary.
The agreement initially involves the scale-up manufacture of the therapeutic for Cancer Vac's planned Phase II clinical trial in patients with ovarian and kidney cancer.
Prima Biomed chief executive Marcus Clark said the trial was expected to commence in the first quarter of next year, pending hospital ethics committee approval.
"We are pleased that Progen will undertake the scale-up activities to produce a Good Manufacturing Practice grade of therapeutic vaccine," Clark said. "It is essential this activity be performed according to Therapeutic Goods Administration regulatory standards so it will also meet FDA requirements, and essential element of our licensing package into North America."
Clark said the company looked within Australia and overseas to find a suitable manufacturing partner for its vaccine.
"Progen was the company of choice because they have got a lot of experience in the production of recombinant proteins as well as giving a competitive quote and having the ability to deliver on time," he said.
The agreement will be milestone-based and divided into a development and production phase, with the timeline for supply being the first quarter of 2004.
Clark could not reveal the value of the manufacturing agreement or whether Progen would have any ongoing involvement in the Cancer Vac project.
Once ethics approval for the Phase II trial is gained, the Austin Hospital and Austin Research Institute will collaborate with lead oncologists to recruit patients.
The trial will involve earlier stage cancer patients than in the initial trials and will focus on kidney and ovarian cancers as opposed to multiple tumour types.
Clark said the Phase II patients will have had first line surgery and chemotherapy before receiving Cancer Vac's immunotherapy.
The aim of the trial will be to demonstrate clinical activity and follows on from a Phase Ib trial, which showed significant results in terms of immunogenicity and safety.
At the time of writing, Prima's shares were up 3.3 per cent at 33 cents each while Progen was 1.2 per cent higher at $1.68.
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