DOR Dor Biopharma

DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company") today announced results of a Phase I clinical trial of RiVax(TM), a recombinant vaccine against ricin toxin, that has been completed by investigators at the University of Texas Southwestern Medical Center (UT Southwestern) led by Dr. Ellen Vitetta, director of the Cancer Immunobiology Center at UT Southwestern. The results of the Phase I safety and immunogenicity dose-escalation study indicate that the vaccine is well tolerated and induces antibodies in humans that neutralize ricin toxin. The outcome of the study will be published this week in the online edition of the Proceedings of the National Academy of Sciences. The pilot Phase I dose escalation clinical trial of RiVax(TM) marks the first time a ricin toxin vaccine has ever been clinically tested in humans. The trial enrolled 15 volunteers in groups of 5 who were vaccinated with three successive monthly injections of the same dose level of RiVax(TM). Three dose levels of RiVax(TM) were evaluated. The vaccine was prepared without an adjuvant to determine whether the subunit itself was immunogenic and safe. Even without an adjuvant, RiVax(TM) induced antibodies in all five of the individuals who received the highest dose, four out of five who received the intermediate dose, and one out of five who received the lowest dose levels. The vaccine was well tolerated in all individuals with only mild side effects that are typical of reactions to vaccines injected intramuscularly. These side effects included mild transient headaches and sore arms. Despite the absence of an adjuvant, antibodies were present in the blood of several volunteers for as long as 127 days after their last vaccination. The functional activity of the antibodies was confirmed by transferring serum globulins from the vaccinated individuals along with active ricin toxin to sensitive mice, which then survived the treatment. "The fact that the animals survived in the presence of antibodies from the vaccinees shows that the antibodies were functionally active," stated Dr. Vitetta. "Based on the levels of antibodies made by the volunteers, we expect that the human volunteers would be protected against ricin toxin exposure. We are currently conducting studies in mice to determine whether the vaccine protects them against ricin administered by aerosols or orally instead of by injection. Preliminary results are encouraging." "We have had an excellent opportunity to work with UT Southwestern and appreciate the efforts of Dr. Vitetta and her team," stated Michael T. Sember, President and CEO of DOR. "These data, combined with steady progress in efficacy testing, process development and formulation by our collaborators, further demonstrate our leading position in the development of a vaccine against the deadly threat of ricin toxin." During the past decade, the Department of Defense (DOD) has identified the development of a safe and effective ricin vaccine as one of its eight top development priorities and is currently exploring the feasibility of available technologies to address that need. Under the BioShield I Act, the government can authorize, purchase, and use these vaccines as early as Phase I clinical testing, before a vaccine is fully licensed by the Food and Drug Administration (FDA). The next steps for the development of RiVax(TM) will include extensive evaluation to correlate protection against ricin exposure in animals to immune responses in vaccinated humans. Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. Exposure to small amounts can lead to rapid lung damage if inhaled, rapid onset of nausea, fever, and abdominal pain if ingested, and general organ failure leading to death within several days. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. There currently is no FDA approved vaccine against ricin toxin. DOR has licensed the underlying technology and pending patent for RiVax(TM) for commercial development from UT Southwestern. DOR is in the process of implementing the transition of the vaccine to large scale development and is also working with the National Institutes of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), under the auspices of a $6.4 million Challenge grant to assure a smooth and timely progression. About DOR BioPharma, Inc. 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. 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 GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec(R) for the treatment of iGVHD in the first quarter of 2006. In November we announced that we entered into a binding letter of intent to acquire Gastrotech Pharma A/S, a Danish biotech company developing therapeutics based on peptide hormones to treat cancer and gastrointestinal diseases and conditions. 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), has successfully completed a Phase I clinical trial. We have also announced the initiation of a 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, 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 ("AMEX") by completing a transaction which will provide it with shareholders' equity of at least $6 million, 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). DOR BioPharma's business strategy has been revised to include the issuance of its securities to acquire companies or assets. DOR BioPharma presently is involved in negotiations which could result in the issuance of a significant number of shares of its equity securities, thereby diluting the equity interests of present stockholders. 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.