DOR BioPharma, Inc. announced that it has successfully completed its cGMP (current Good Manufacturing Practices) milestone for the production of RiVax, DOR's vaccine against ricin toxin. The milestone was achieved in the performance of a Challenge Grant totalling $6.4 million previously awarded to DOR in September 2004 by the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health. The safety and immunogenicity of RiVax has recently been evaluated in a Phase I clinical trial in healthy volunteers, and the results were published earlier this year in the Proceedings of the National Academy of Sciences.

DOR and its manufacturing partner, Cambrex BioSciences Baltimore, Inc., have developed a robust and reproducible manufacturing process for the large-scale production of RiVax. The completion of cGMP manufacture of RiVax forms one of the crucial milestones in the performance of the work conducted under the NIH grant. Based on the release and further toxicology testing of the cGMP batches, the company is planning to test the vaccine in further clinical trials.

These trials will examine the influence of an immunological adjuvant formulation and vaccination regimen on the human immune response. These studies will be directed towards providing safety and immunogenicity data needed for licensure of the vaccine by the FDA. Further animal testing is also planned to provide correlation of antibody levels in human serum with protection against ricin exposure in animal models. Because vaccine efficacy for exposure of humans to ricin toxin can only be tested in animals, the FDA has established a two animal rule. Under this rule, the FDA can permit human licensure of a vaccine by relying on results from animal trials when human trials cannot ethically evaluate efficacy.

"We are pleased that we have achieved this critical milestone and are encouraged that we will have a means to manufacture RiVax™ at the scale necessary for potential future immunization programs of civilian or military personnel,'' stated Michael T Sember, president and CEO of DOR BioPharma. "We are well on the pathway to successful development of RiVax as we continue work on this important biodefense countermeasure. We will continue to work closely with our partners and NIAID to propel the vaccine through the next phase of clinical studies."

Ricin toxin is a potential bio-terror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. Exposure to small amounts, especially by inhalation, can lead to lung damage, nausea, fever, abdominal pain, and death within several days. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. Currently there are no FDA approved vaccines or therapeutics against ricin toxin.

DOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical countermeasures.