DOR BioPharma Announces $9.4 Million NIH Grant Award to Develop Thermostable and Rapidly Actin...(through a series of overlapping challeng...),Health

Date:9/21/2009

through a series of overlapping challenge grants (UC1) and cooperative grants (U01) from the NIH, granted to DOR and to the University of Texas Southwestern Medical Center (UTSW) where the vaccine originated. The second clinical trial is being supported by a grant to UTSW from the US Food and Drug Administration Office of Orphan Products Development. DOR and UTSW have collectively received approximately $15 million in grant funding from the NIH for RiVax(TM).

Results of the first Phase 1 clinical trial of RiVax(TM) established that the immunogen was safe and induced antibodies anticipated to protect humans from ricin exposure. The outcome of the study was published in the Proceedings of the National Academy of Sciences (Vitetta et al., 2006, PNAS, 105:2268-2273). The second trial, sponsored by UTSW, is currently evaluating a more potent formulation of RiVax(TM) anticipated to result in higher antibody titers of longer duration in human subjects. DOR has adapted the original manufacturing process for the immunogen contained in RiVax(TM) for large-scale manufacturing and is further establishing correlates of the human immune response in non-human primates.

About Ricin Toxin

Ricin toxin is thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. It is second only to botulinum toxin as the most lethal natural toxin. Exposure to ricin results in general organ failure leading to death within several days of exposure. Ricin is highly toxic to humans and other mammals because it has the ability to enter virtually any type of cell and affect any organ in the body. Exposure to small amounts, especially by inhalation, leads to irreversible lung damage. The potential use of ricin toxin as a biological weapon of mass destruction has been highlighted in an FBI Bioterror report released in 2007 entitled Terrorism 2
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SOURCE DOR BioPharma, Inc. Copyright©2009 PR Newswire. All rights reserved

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