PRIMA MEETS FDA FOR CANCER VACCINE APPLICATION
August 27th 2008 12:27
Monday August 25, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS UP: PROTEOME UP 22%, NOVOGEN DOWN 7%
* PRIMA TO MEET FDA FOR CVAC CANCER TREATMENT APPLICATION
* CELLESTIS POSTS $2.25m MAIDEN PROFIT; SALES REVENUE UP 77%
* ASTRAZENECA ADOPTS BIOTA’S MEDIMMUNE RSV LICENCE
* RELENZA ROYALTY TUMBLE TURNS BIOTA’S PROFIT TO LOSS
* MEDICAL DEVELOPMENTS PROFIT DOWN 26% ON REVENUE UP 24%
* LABTECH PROFIT DOWN 25% TO $271k ON REVENUE DOWN 36%
* CSL SHARE PLAN OFFER TO RAISE UP TO $96m
* PROTEOME PLACEMENT RAISES $2.5m
* KARMELSONIX SECURES $7m FUNDS FACILITY
To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
PRIMA BIOMED
Prima has submitted a “formal request for a pre-investigational new drug application meeting” with the US Food and Drug Administration for its CVac ovarian cancer treatment.
Prima said the meeting request was “a major milestone in Prima’s commercializing process for CVac” and the meeting would take place within 60 days.
The company said it intended to secure an investigational new drug application from the FDA for the CVac cancer treatment as part of its “broader and long term goal of developing commercial cancer treatment technologies and programs”.
Prima said CVac was a therapy treatment for ovarian cancer administered post-surgery and post-chemotherapy to delay relapse and control metastases.
The company said there was 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 announced qualified efficacy results for CVac but the company to find funding to continue its operations.
In 2006, the company announced that 21 percent of 21 patients in the phase IIa trial at Melbourne’s Austin Hospital had either a clinical response to treatment or stabilization of their disease (see Biotech Daily; May 16, 2006)
On October 16, 2007 Martin Rogers was appointed a director of Prima and began and review and renewal of the company (see Biotech Daily of that date).
Earlier this year Prima said it had a new board, cash in the bank and a planned pivotal phase II/III trial of the ovarian cancer vaccine.
Mr Rogers told Biotech Daily at that time the company had raised $2.3 million, had $1.5 million cash in the bank with a cash burn rate of $100,000 a month (see Biotech Daily; May 14, 2008).
Prima said management had finalized the pre-IND meeting request in conjunction with the Fred Hutchinson Cancer Centre in Seattle, Washington.
The company said the meeting was “a major step in the commercialization of any new drug application, and Prima is delighted to be on the cusp of this milestone for CVac”.
Prima chairman Ata Gokyildirim said that the submission for the pre-IND 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 commercialization has the potential to add major material value to the company,” Mr Gokyildirim said.
Prima was untraded at 0.9 cents.
subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
| 10 |
| Vote |
Shared on
Add To: 
Subscribe to this blog
