DOR BioPharma, Inc., Is The Only Company In The World Able To Produce A Ricin Vaccine In Scale That Meets The FDA' S GMP Standards

Main Category: Bio-terrorism / Terrorism
Article Date: 08 Sep 2007 - 1:00 PDT

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Ricin toxin is a bioterror threat that is extremely deadly in small doses and can lead to lung damage and general organ failure leading to death within several days. Evidence is mounting that al Qaeda is experimenting with manufacturing ricin for the purposes of using it as a bioterror weapon. There are currently no vaccines available to prevent ricin poisoning or medical treatments to care for poisoning victims. Ricin can be easily produced, is stable over long periods of time, is toxic by several routes of exposure and thus has the potential to be used as a biological weapon against military and civilian targets.

DOR BioPharma, Inc. (OTC BB: DORB) has developed a proprietary vaccine, RiVax™, to protect against exposure to ricin toxin. RiVax™ is the first ricin toxin vaccine ever to be clinically tested in humans. DOR's ricin vaccine development program, through University of Texas Southwestern, is led by the world-renowned Ellen Vitetta, PhD, Director of the Cancer Immunobiology Center at University of Texas Southwestern Medical Center at Dallas (UT Southwestern).

According to the Center for Disease Control and Prevention, threats to U.S. citizens are categorized by threat level. Category A consists of agents that are easily disseminated and may cause the highest mortality, category B includes those agents that are easily disseminated and can cause moderate morbidity and low mortality include, while category C includes agents that contain emerging pathogens with potential for high morbidity and mortality. Until recently, ricin has been categorized as a B-level threat. Recent results from additional animal testing of RiVax™ at the University of Texas Southwestern Medical Center "…indicates pure ricin toxin is 2000 fold more toxic by the oral route than previously described," said Ellen Vitetta, PhD, Director of the Cancer Immunobiology Center at UT Southwestern. These developments will likely shift ricin from threat level B to threat level A.

DOR has announced positive Phase I clinical trial results for RiVax™ which demonstrated that the vaccine is well tolerated and induces antibodies in humans that neutralize the ricin toxin. 15 volunteer participants were administered RiVax™ in rising doses over a 1.5 year period. The trial resulted with the desired end point of "Safety" met.

The vaccine can induce protection against mortality and tissue damage from both aerosol and oral toxin exposure; the most likely routes to be used in a ricin toxin biological attack.

DOR is the only company in the world able to manufacture a ricin vaccine in scale (in large quantities easily) and meet the FDA's Good Manufacturing Practice (GMP) guidelines which requires documentation of every aspect of the process activities operations involved with drug and medical device manufacture. GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported functions.)

http://www.dorbiopharma.com