AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
FDA clears IND for anthrax vaccine candidate.
2003 JUL 2 - (NewsRx.com & NewsRx.net) -- VaxGen, Inc., (VXGN) announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its candidate anthrax vaccine.
The effective IND allows VaxGen to begin clinical development of the investigational vaccine with the goal of producing an emergency stockpile for the U.S. government and licensing the product for commercial sales.
The next step in this process will be the initiation of a phase I human clinical trial involving approximately 100 volunteers at four leading medical centers: Baylor College of Medicine in Houston, Emory University School of Medicine in Atlanta, Johns Hopkins University in Baltimore and Saint Louis University Health Sciences Center.
The trial will evaluate the safety and immunogenicity of VaxGen's candidate vaccine compared to those of the existing licensed anthrax vaccine. The vaccine candidate's efficacy will be established by comparing the immune responses in humans to those shown to protect animals from inhalation of anthrax spores.
The phase I trial is being funded through VaxGen's contract, N01-AI-25494, with the National Institute of Allergy and Infectious Disease (NIAID), a component of the National Institutes of Health. The purpose of the project is to develop an anthrax vaccine that is safe in humans, efficacious in animal inhalation challenge studies and requires no more than three injections, compared to the six injections required with the existing licensed anthrax vaccine.
The contract calls for the vaccine to be made from recombinant Protective Antigen (rPA), a protein known to induce antibodies that neutralize anthrax toxins. Achieving full licensure will depend on the results of current and planned studies designed to satisfy the standard requirements for FDA vaccine licensure, with the exception that the demonstration of efficacy will be in animals according to the FDA's "Animal Rule," published in the Federal Register on May 31, 2002.
"The ability to begin phase I clinical trials advances our ultimate goal of supplying the next-generation anthrax vaccine to the U.S. and foreign governments, as ...
- FDA clears IND for anthrax vaccine candidate.
- Newspaper article from: Genomics & Genetics Weekly July 4, 2003 700+ words
...the existing licensed anthrax vaccine. The vaccine candidate's efficacy will be...development of an rPA anthrax vaccine candidate. Deliverables under...contract. VaxGen's anthrax vaccine candidate is based on the pioneering...
- FDA Clears VaxGen's IND for Anthrax Vaccine Candidate; Clinical Development to...
- Press release article from: PR Newswire May 27, 2003 700+ words
...the existing licensed anthrax vaccine. The vaccine candidate's efficacy will be...development of an rPA anthrax vaccine candidate. Deliverables under...contract. VaxGen's anthrax vaccine candidate is based on the pioneering...
- NIAID to Fund Development of Emergent BioSolutions' Advanced Anthrax Vaccine...
- Press release article from: Business Wire September 30, 2009 700+ words
...of bioterrorism." The anthrax vaccine candidate is composed of the double...Vaccine - a recombinant anthrax vaccine candidate, which is composed of...dmPA7909) - a recombinant anthrax vaccine candidate, which is composed of...
- NIAID Award to Fund Development of Emergent BioSolutions' Advanced Anthrax...
- Magazine article from: Health & Beauty Close-Up October 7, 2009 700+ words
...of Emergent's anthrax vaccine candidates known...that the novel vaccine candidate is designed to...for an advanced anthrax vaccine such as the potential...noted that the anthrax vaccine candidate is composed of...
- VaxGen Awarded $80.3 Million NIAID Contract for Advanced Development of Anthrax...
- Press release article from: PR Newswire October 1, 2003 700+ words
...development of its anthrax vaccine candidate, rPA102. The...contract. VaxGen's anthrax vaccine candidate is based on the...anthrax toxins. The vaccine candidate cannot cause anthrax...the need for an anthrax vaccine that has an improved...
- Biopharm company awarded $80.3M contract for anthrax vaccine candidate.
- Newspaper article from: Drug Week October 31, 2003 700+ words
...development of its anthrax vaccine candidate, rPA102. The...contract. VaxGen's anthrax vaccine candidate is based on the...anthrax toxins. The vaccine candidate cannot cause anthrax...the need for an anthrax vaccine that has an improved...
- Phase I clinical trial results of anthrax vaccine candidate reported.
- News wire article from: Bioterrorism Week March 29, 2004 700+ words
...AVA), the anthrax vaccine currently...Antigen (PA) Anthrax Vaccine (rPA102...administration of the vaccine candidate at each dose...models. The vaccine candidate cannot cause...need for an anthrax vaccine with an improved...
- VaxGen Reports Phase I Clinical Trial Results of Anthrax Vaccine Candidate.
- Press release article from: PR Newswire March 2, 2004 700+ words
...AVA), the anthrax vaccine currently...Antigen (PA) Anthrax Vaccine (rPA102...administration of the vaccine candidate at each dose...models. The vaccine candidate cannot cause...need for an anthrax vaccine with an improved...