Tuesday, January 27, 2009
DelSite Biotechnologies, Inc., its wholly-owned subsidiary, received the approval from the FDA of the Investigational New Drug (IND) application to initiate a Phase I clinical study of the Company's lead product candidate GelVac(TM) nasal powder H5N1 (bird flu) influenza vaccine.
It is preservative-free, adjuvant-free and can stabilize vaccines at room temperature for a long period of time. The vaccine requires no cold chain and allows needle-free administration.
Dr. Yawei Ni, Chief Scientific Officer of DelSite Biotechnologies, said, "The GelVac is a very innovative and effective powder platform; besides deliverable as a nasal powder, GelVac powder vaccines can be reconstituted and administered using classical needle technology. Using this route of administration a strong antigen-sparing effect, i.e., increasing numbers of vaccine doses, is created by a classical depot effect. We believe the paradigm shift under way as to how vaccines are to be stored, shipped and administered will be accelerated by the GelVac platform."
This vaccine candidate is believed to be the only nasal powder vaccine under development that, if approved, could be shipped without refrigeration to peoples' homes and self-administered in the event of a pandemic outbreak of avian bird flu.
After administering one or two doses to test subjects at the highest dose tested,
testing results showed the vaccine is safe and nontoxic. I for one would still like a break down of what is in the vaccine.
Of course far more research will be done in the clinical studies, but DelSite is thrilled at the FDA approval of Phase I.
Whether or not this approval will help DelSite Biotechnologies get more funding is still yet to be seen, for now they have discontinued manufacturing operations.
It is preservative-free, adjuvant-free and can stabilize vaccines at room temperature for a long period of time. The vaccine requires no cold chain and allows needle-free administration.
Dr. Yawei Ni, Chief Scientific Officer of DelSite Biotechnologies, said, "The GelVac is a very innovative and effective powder platform; besides deliverable as a nasal powder, GelVac powder vaccines can be reconstituted and administered using classical needle technology. Using this route of administration a strong antigen-sparing effect, i.e., increasing numbers of vaccine doses, is created by a classical depot effect. We believe the paradigm shift under way as to how vaccines are to be stored, shipped and administered will be accelerated by the GelVac platform."
This vaccine candidate is believed to be the only nasal powder vaccine under development that, if approved, could be shipped without refrigeration to peoples' homes and self-administered in the event of a pandemic outbreak of avian bird flu.
After administering one or two doses to test subjects at the highest dose tested,
testing results showed the vaccine is safe and nontoxic. I for one would still like a break down of what is in the vaccine.
Of course far more research will be done in the clinical studies, but DelSite is thrilled at the FDA approval of Phase I.
Whether or not this approval will help DelSite Biotechnologies get more funding is still yet to be seen, for now they have discontinued manufacturing operations.
Labels: avian flu, FDA, press release, vaccines
1:59 PM
0 comment(s)!
:: share it 
strange
Name: Christy ManneringAppreciating and dancing around to all types of music. Movie mania! Reading fiend!
See my complete profile
Bring it on and BRING ME UP!
webRoll
Physical
Mental
Emotional
the archive
support a cause
the latest reads
search the site
be in the know