The US Food and Drug Administration (FDA) has awarded orphan drug status to BioSante Pharmaceuticals for its GVAX pancreas vaccine to guard against pancreatic cancer.
The Orphan Drug Act (ODA) allows for special grant status to be awarded to drugs with the potential to treat rare diseases or conditions, which are usually costly to develop.
The ongoing GVAX Pancreas Vaccine trials are designed to determine the safety, overall survival and response to GVAX Pancreas Vaccine combined with various anti-cancer agents, compared to those agents on their own or in combination with other agents.
BioSante’s president & CEO Stephen M Simes said that this is the first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines in October 2009.
“It is our intention to find ways to continue the development of our GVAX Pancreas Vaccine using the benefits conferred by gaining orphan drug designation,” Simes said.
Patients with pancreatic cancer have sone of the poorest survival rates for any form of cancer, with median survival after diagnosis around three to six months.
