FDA News

DOR BioPharma Announces $940,000 FDA Orphan Products Grant for Clinical Development of RiVax

(July 30, 2007)-- DOR BioPharma, announced that the Office of Orphan Products Development (OOPD) of the Food and Drug Administration (FDA) has awarded a development grant for the further clinical evaluation of its vaccine for ricin toxin, RiVax. The grant has been awarded to UT Southwestern Medical Center, one of the Company's academic partners in the development of RiVax. The Principal Investigator for the project is Ellen S. Vitetta, PhD, Director of the Cancer Immunobiology Center at UT Southwestern. The award totals approximately $940,000 for three years and is to be used for the evaluation of an adjuvant for use with the vaccine. Typically, awards made by the OOPD are to support clinical trials for development of products that address rare diseases or medicines that would be used in numerically small populations.

RiVax was evaluated in a small dose escalating Phase 1 clinical trial in human volunteers conducted at UT Southwestern. It was shown to be well tolerated and immunogenic especially at the highest dose levels of the vaccine given three times at monthly intervals. The vaccine induced antibodies that were correlated to protection from toxin exposure, including the capacity to neutralize the toxin. Further, the functional activity of the antibodies was established by demonstrating that transfer of serum globulins from the vaccinated individuals to mice resulted in their survival subsequent to ricin toxin exposure. The results of that confirmatory trial underpin the current effort to develop an adjuvant form of the vaccine, which is intended to enhance human antibodies' responses to the vaccine and increase their durability and rapidity of onset.

RiVax is a recombinant subunit of one of the components of ricin toxin and has been genetically detoxified. The subunit is produced in recombinant bacterial hosts, purified, and formulated with an adjuvant.

"The Phase 1 clinical trial was done to establish that we had inactivated the toxin sufficiently to remove any possible local toxicity that could be associated with intramuscular injection," said Dr. Vitetta. "Having confirmed the fundamental immunogenicity in humans, we are ready to test the immunogenicity and safety of the vaccine with an adjuvant that we expect to induce long-lasting antibodies with lower doses of the vaccine."

The Company has been developing RiVax in a consortium effort between academic and industrial partners under several separate NIAID grants totaling approximately $14 Million. In addition to UT Southwestern, development partners include, Stanford Research Institute (SRI International), the University of Kansas, Lonza Baltimore, and the Wadsworth Center of the New York State Department of Health in Albany. Complementing the current OOPD grant, Dr. Ellen Vitetta has also separately been awarded a grant for $2.2 million over 5 years to conduct research in fundamental areas to develop novel vaccine formulations and characterize immune responses in small animals. The outcome of that novel research will help support ongoing development of RiVax.

Share or bookmarklet this web page at: