DOR's Ricin Vaccine "RiVax" to Enter Human Clinical Trials
RiVax Represents the First Ricin Vaccine to Enter Human Clinical Trials
Tuesday, November 30, 2004
MIAMI--(BUSINESS WIRE)--Nov. 30, 2004--DOR BioPharma, Inc. ("DOR" or the "Company") (AMEX:DOR) announced today that its academic partner, The University of Texas Southwestern Medical Center at Dallas (UT Southwestern), plans to proceed with the first phase of human clinical testing of RiVax(TM), a genetically engineered vaccine against ricin, a deadly Category B toxin.
The Phase I clinical trial is intended to assess the safety and immunogenicity of RiVax(TM) at doses that induce ricin-neutralizing antibodies. The trial will be conducted by Dr. Robert Munford, Professor of Internal Medicine and Microbiology at UT Southwestern. Volunteers for the trial are currently being recruited.
"Dr. Ellen Vitetta at UT Southwestern and DOR have worked extremely hard in our efforts to advance RiVax(TM) to the clinic," said Gregory J. Davenport, Ph.D., President of DOR's BioDefense Division. "We are very pleased with the progress we have made with our BioDefense vaccines, and remain focused on meeting the needs of the U.S. Government and other potential purchasers of safe and effective BioDefense countermeasures."
RiVax(TM) was developed by Dr. Ellen Vitetta and her collaborators at UT Southwestern several years ago after discovering that two key sites in the enzymatically active A chain of ricin toxin can be simultaneously altered to eliminate toxicity. RiVax(TM) has been shown to be safe in every animal study so far conducted and induces immune responses that protect against lethal exposure to ricin. During the past year, Dr. Vitetta and her group have produced under cGMP (current Good Manufacturing Processes) guidelines and tested highly purified RiVax(TM) for the upcoming clinical trials. DOR has an exclusive worldwide license to RiVax(TM) from UT Southwestern.
To date, funding to support the development of RiVax(TM) has originated with direct funding from DOR to UT Southwestern through a sponsored research agreement and with the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), which awarded Dr. Vitetta and UT Southwestern $2.6M to develop and test the vaccine in August 2003. In September of this year, NIAID also awarded a $5.2 million grant to DOR for process development, scale up and cGMP manufacturing of RiVax(TM) for further clinical testing.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of biodefense vaccines and therapeutics for areas of unmet medical needs. Through its BioDefense Division, DOR is currently developing vaccines to protect against exposure to ricin toxin and botulinum toxin for potential U.S. Government procurement pursuant to the Project BioShield Act of 2004.
In September of this year, DOR BioPharma completed the treatment phase of its pivotal Phase III clinical trial of orBec(R) (oral beclomethasone dipropionate) for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a severe, life-threatening form of gastrointestinal inflammation. DOR expects to announce top-line results from this study before the end of the year. OrBec(R) has been granted fast track status by the FDA for the treatment of iGVHD. For further information regarding DOR BioPharma, please visit the Company's website located at http://www.dorbiopharma.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma's current expectations about its future results, performance, prospects and opportunities. Where possible, DOR BioPharma has tried to identify these forward-looking statements by using words such as "anticipates," "believes", "intends", or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR BioPharma cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that, product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.