Posted: Mon Sep 21, 2009 8:19 am Post subject: All Vaccines Under Development
All the following information can be found here on our forum
* BioCryst's IV Peramivir: Neuraminidase inhibitor ~ Clinical trials that are finished have given positive results. FDA has proceeded with a pre-Emergency Use Authorization (EUA) review of peramivir, and if an order is placed for the Strategic National Stockpile, BioCryst has the manufacturing supplies it needs to finish the product and make large quantities available.
* NexBio Inc.'s drug Fludase (DAS181): A novel broad-spectrum drug candidate for prophylaxis and treatment of respiratory infections by all variations of influenza viruscand may fight strains of virus that have evolved resistance to Tamiflu. The Phase 1 study showed the drug was well tolerated at all dose levels.
* Medicago's VLP-based H5N1 vaccine: VLP vaccines can be manufactured within 4 weeks of obtaining the genetic sequence of a pandemic strain. Health Canada granted approval to commence a Phase I human clinical.
* BioSante Pharmaceuticals' BioVant: Intranasal adjuvant for various flu vaccines ~ showed good restults in animal studies.
* Biota's laninamivir (CS-8958): Long-Acting Inhalable Neuraminidase Inhibitor ~ Asian Phase III clinical trials were successful. Daiichi Sankyo is seeking approval from the Japanese regulatory authority to market laninamivir in Japan, with submission anticipated by March 2010. A clinical study for prophylaxis of influenza is expected to commence in Japan in late 2009.
* CEL-SCI's L.E.A.P.S: Ligand Epitope Antigen Presentation System ~ preclinical studies have demonstrated that vaccines utilizing its proprietary technology potentially induce protection against illnesses such as the swine influenza.
* Protein Sciences' Insect-based flu vaccine: Genetically engineered flu vaccine made from yellow striped caterpillars ~ testing during the 2004-2005 influenza season gave positive results. The govt. awarded the company funding and has made its first 100,000 doses of a vaccine against the new swine flu.
* Avir Green Hills' H5N1/nH1N1 Influenza Vaccine: Reverse genetics intranasal vaccine, is produced in cell cultures (vero cells) ~ animal studies show intensive immune response and long sustainable protection against different varieties of the virus. Clinical evaluations of their pandemic and seasonal vaccine candidates are already in progress.
* Hemispherx's Ampligen® (poly I:poly C12U): Adjuvant for intranasal inoculation ~ well tolerated in clinical trial; testing in the US and abroad.
* Antigenics' QS-21 Stimulon: Adjuvant ~ under study and exhibits synergy with other adjuvants. Partners with Glaxo, Wyeth, Aventis Pasteur and others.
* Virginia Tech's FLU CYT-IVAC: New technology using cell culture based systems... these "killed vaccines," which Roberts' has dubbed FLU CYT-IVACs (for FLU CYTokine bearing Inactivated VACcine), still retain the bioactivity of cytokines ~ still in the mouse study stage.
* Novavax's VLP Vaccine: Produced in insect cells, the recombinant H1N1 VLP vaccine was made up of the hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins from 1918 Spanish influenza virus strains ~ preclinical study results showed that the investigational VLP vaccine protected against both the Spanish flu and a highly pathogenic H5N1 avian influenza strain.
* Vical's Vaxfectin: DNA vaccine candidate (bird flu vax) ~ The preliminary results from this Phase 1 trial indicate for the first time that an adjuvanted DNA vaccination against H5N1 influenza is well-tolerated and can induce impressive antibody responses even against this relatively weak immunogen _________________ https://twitter.com/mixin1771
One recombinant subunit formula, Protein Sciences Corp.'s FluBlok, has completed phase 3 trials and has been submitted to the FDA in a biologics license application. Novavax has completed a phase 2 trial in Mexico of a vaccine containing virus-like particles and has enrolled 467 participants in a phase 2a trial in the United States.
(Separately today, NIAID announced that it has completed enrollment of 20 participants in a phase 1 safety trial for a DNA vaccine for pandemic H1N1 flu, developed at NIH's Vaccine Research Center.)
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