DOR Dor Biopharma

DOR BioPharma, Inc. (AMEX: DOR) ("DOR" or the "Company"), announced today positive interim results from its ongoing Phase I clinical trial of RiVax(TM), its vaccine against ricin toxin. The Phase I clinical trial of RiVax(TM) represents the first ricin toxin vaccine ever to be clinically tested in humans and is being conducted by DOR's academic partner, a group led by Dr. Ellen Vitetta at the University of Texas Southwestern Medical Center at Dallas. In the rising dose, open label trial, three cohorts of 5 normal volunteers each have been dosed three times with 10, 33 and 100 micrograms. These interim data are from the first two lower dose cohorts of volunteers. Early results demonstrate that the vaccine is safe and immunogenic after immunization with three monthly injections of vaccine, with volunteers developing antibodies. This is the first indication that a ricin toxin vaccine elicits immune responses and predicts that humans can be protected against ricin exposure. Antibody data from all three cohorts is expected in the next several months. RiVax(TM) is a form of ricin that consists of a fragment of the toxin that has been proven in pre-clinical studies to be non-toxic but retains the capacity to elicit protective immunity. Ricin toxin is relatively easy to produce and exposure to small amounts, especially by inhalation, can lead to lung damage, nausea, fever, abdominal pain, and death within several days. "We are very encouraged that we have demonstrated safety and seen antibody responses in the blood samples of the volunteers," said Dr. Vitetta. "We are looking forward to a complete analysis of the data as the trial continues." "We are very pleased with these promising interim results which so far corroborate our preclinical evaluation of RiVax(TM)," commented Michael T. Sember, President and Chief Executive Officer of DOR. "These data, combined with significant progress by our manufacturing partner Cambrex, are evidence of our leading position in the development of a vaccine against the deadly threat of ricin toxin." In 2003, the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), awarded Dr. Vitetta and UT Southwestern $2.6M to develop and test the vaccine. In September of 2004, NIAID also awarded a $5.2 million grant to DOR for process development, scale up and cGMP manufacturing of RiVax(TM). The total amount of this grant has recently been increased to $6.4 million. This grant supports manufacturing and process development work being carried out by Cambrex. About DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of therapeutic products and biomedical countermeasures for areas of unmet medical need. Our lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other gastrointestinal disorders characterized by severe inflammation. We intend to file a new drug application (NDA) with the FDA for orBec(R) for the treatment of iGVHD later this year. Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(TM), is currently the subject of a Phase I clinical trial in normal volunteers. We have also recently announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design. 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, including statements regarding the potential use of orBec(R) for the treatment of iGVHD and the prospects for regulatory filings for orBec(R). 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, including orBec(R), 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 (including that the results of its Phase I clinical trial of RiVax(TM) will demonstrate acceptable safety and immunogenicity/efficacy), 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, that it will be able to maintain its listing on the American Stock Exchange, or that its business strategy will be successful. Important factors which may affect the future use of orBec(R) for iGVHD include the risks that: because orBec(R) did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBec(R) approvable based upon existing studies, orBec(R) may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR BioPharma expects or may never gain approval; Dor BioPharma is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; or orBec(R) may not gain market acceptance; and others may develop technologies or products superior to orBec(R). 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.