DOR BioPharma Initiates New Botulinum Toxin Therapeutic Program; Complements DOR's BT-VACC ``Oral Botulinum Toxin Vaccine'' Program.

MIAMI -- DOR BioPharma Inc. ("DOR" or the "Company") (AMEX:DOR) announced today that it has initiated a rational drug design program to identify oral, small molecule drugs to counter the deadly effects of Botulinum toxin exposure. Botulinum toxin is generally regarded as the most poisonous natural substance known to man, and has been used as a bioterror agent in the past. Currently, there are no clinically acceptable drugs that either slow or reverse the effects of Botulinum toxin.

Capitalizing on research focused on structure/function relationships of Botulinum toxin done by Lance Simpson, Ph.D., Director, Center for Research on Bioterrorism and Biodefense, Thomas Jefferson University Philadelphia, the inventor of DOR's oral Botulinum toxin vaccine, BT-VACC(TM), and a world recognized leader in Botulinum toxin research, DOR has entered into an agreement with Blue Dolphin, LLC, a firm specializing in rational drug design, to apply computer-aided design to the discovery of new drug leads against Botulinum toxin.

Under the agreement, Blue Dolphin will propose novel drug-like inhibitors of Botulinum toxin by targeting a new site on the toxin's structure identified by Dr. Simpson. Millions of candidate molecules will be modeled for structural and chemical fit to the target site on the toxin using computer aided discovery techniques. The best fitting molecules will be experimentally tested by Dr. Simpson for their effectiveness in treating Botulinum toxin exposure. By focusing on the structure of the Botulinum toxin, as opposed to derivatives of previously known inhibitors, this "virtual screening" will allow DOR to target new parts of the toxin with new candidate inhibitors.

"I am eager to begin screening drugs utilizing new targets in Botulinum toxin," stated Dr. Simpson, "I believe it is essential for national security that we begin the process of finding new post-exposure countermeasures against the deadly and easily weaponizable Botulinum toxin."

"This agreement further demonstrates DOR's commitment to biodefense and specifically being a leader in Botulinum toxin prevention and therapy," said Michael Sember, President & CEO of DOR BioPharma. "Development of Botulinum toxin countermeasures is a top priority for the US government as they have allocated $1.7 Billion to establish and stockpile them under Project BioShield. They also qualify for the FDA's abbreviated review process. We have made significant progress with BT-VACC(TM), our orally administered botulinum vaccine, and are excited to enter into this agreement with Blue Dolphin to identify new small molecule inhibitors for post-exposure treatment to these deadly toxins."

"We are looking forward to working with DOR on the Botulinum toxin project," said John Irwin, Ph.D., VP of Chemistry for Blue Dolphin. "We have extensive experience with the computational and modeling aspects of this project. Our collaborators at DOR are introducing us to a new biological application against this class of potent bio-warfare toxins."

Botulinum toxin is an extremely potent neurotoxin synthesized by three strains of bacteria (Clostridium botulinum, Clostridium butyricum and Clostridium beratii). The toxin is known to exist in seven different serotypes, designated A to G, but only three (A, B and E) account for almost all human cases of disease. The Centers for Disease Control and Prevention (CDC) has classified Botulinum toxin as a Category A biothreat because of its extreme potency and lethality, its ease of production, transport and misuse, and the potential need for prolonged intensive care of affected persons. Exposure to Botulinum toxin in the nanogram range results in blockage of peripheral nerve function and descending flaccid paralysis ultimately leading to death. Botulinum toxin has been previously used in a number of documented incidents. Subsequent to the 1991 Persian Gulf War, Iraq admitted to the United Nations inspection team to having produced 19,000 liters of concentrated Botulinum toxin, with approximately 10,000 liters loaded into military weapons.

Current treatment for Botulinum toxin exposure in adults consists of supportive care and post-exposure passive immunization with equine antitoxins. These antitoxins include a bivalent and monovalent antitoxin that consist of neutralizing antibodies which are in limited supply from the CDC and have been associated with serious adverse reactions. Passive immunotherapy with antitoxins is only effective if administered within a narrow window of time post-exposure (18-36 hours) before the onset of symptoms.

DOR's vaccine against botulinum neurotoxin, BT-VACC(TM), is an orally administered vaccine based on the pioneering work of Dr. Lance Simpson and colleagues at Thomas Jefferson University that protects against exposure to botulinum neurotoxins. BT-VACC(TM) may be formulated as a multivalent, solid oral dosage form. The oral formulation may be sufficiently stable for stockpiling and storage, which is ideal for rapid distribution and vaccination for military use or civilian vaccination in response to bio-terrorism. Oral administration of BT-VACC(TM) for serotype A produces protective antibodies that afford protection or prolonged survival of treated animals against 30,000 times the lethal dose of Botulinum toxin serotype A. Initial studies of BT-VACC(TM) for serotype B are ongoing and both the antibody response and protection data are very encouraging.

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 developing bioengineered vaccines designed to protect against the deadly effects of ricin and botulinum toxins for potential U.S. Government procurement. DOR's lead therapeutic product, orBec(R) (an oral formulation of beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a severe, life-threatening form of gastrointestinal inflammation. DOR recently announced top line results of its pivotal Phase III clinical trial of orBec(R) in iGVHD in which orBec(R) demonstrated a highly statistically significant reduction in mortality during the prospectively defined Day 200 post-transplant period and positive trends on its primary endpoint. DOR will meet with the FDA in the coming months to determine the appropriate next steps for the development of orBec(R).

For further information regarding DOR BioPharma, please visit the Company's website located at http://www.dorbiopharma.com.

About Blue Dolphin, LLC

Blue Dolphin is a contract research organization that works with drug discovery organizations to find novel, biologically active small molecules using virtual screening and other structure-based methods. Founded in 2001 by faculty at Northwestern University and now at the University of California, the company grew out of collaborations with multiple pharmaceutical and biotech companies involving virtual screening (see for instance, Doman et al., Molecular docking and high-throughput screening for novel inhibitors of protein tyrosine phosphatase-1B. J Med Chem 45 (11), 2213-21 (2002)). Blue Dolphin is located in San Anselmo, CA.

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 this 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.