SOURCE: DOR BioPharma, Inc

November 15, 2006 08:10 ET

DOR BioPharma Reports Advances in Stabilization and Optimization of RiVax™ Vaccine Formulation

MIAMI, FL -- (MARKET WIRE) -- November 15, 2006 -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or "the Company") announced today that the Company has made advancements in the long-term stability and optimization of the formulation of RiVax™, a vaccine that contains a recombinant subunit of the A chain of ricin toxin and has been shown to induce ricin neutralizing antibodies in humans and animals. An article characterizing the conditions for maintaining long-term stability of RiVax™ has been published online in advance of print publication in the Journal of Pharmaceutical Science.

The article, entitled "A rapid, three-step process for the preformulation of a recombinant ricin toxin A-chain vaccine," by Laura J. Peek, Robert N. Brey, and C. Russell Middaugh, can be found on the internet at The article describes optimizing conditions for maintaining the natural structure of the RiVax™ subunit. These conditions were established using high-throughput spectral techniques developed in the laboratory of Professor C. R. Middaugh in the Department of Pharmaceutical Chemistry at the University of Kansas. The ricin A chain is very fragile and difficult to maintain structurally in water solutions that are commonly used for human vaccines. The article further describes the use of compounds that are added to solutions of protein to stabilize the structure. These compounds essentially prevent the unfolding of protein during stress conditions, such as heat, and keep the protein in its natural state. These studies also identified conditions to optimize the interaction of the protein with adjuvants containing aluminum salts, which are immune-enhancing agents with a long history of use in human vaccines licensed by the U.S. Food and Drug Administration ("FDA").

"We have taken a fundamental approach to understanding the structure of the ricin A chain and its relationship to generating effective immune responses in animals and humans," said Robert N. Brey, Ph.D., Chief Scientific Officer of DOR. "Long-term stability is the key factor for the further clinical development of RiVax™ and for potential U.S. government vaccine stockpiling purposes. The successful development of an effective vaccine against ricin toxin may actually reduce the threat of its use as a bioterror weapon. The techniques that Dr. Middaugh and his colleagues have developed are valuable and also generally applicable to other proteins and vaccines."

Dr. Middaugh also commented on the program, stating, "We have used very sensitive probes to detect changes in protein structure. We have employed these techniques in a systematic way to identify optimal conditions for the long-term stability of RiVax™."

DOR has been leading a consortium of academic and industry vaccine investigators under funding from National Institute of Allergy and Infectious Diseases ("NIAID") in the development of RiVax™. The consortium effort began in 2004 with a $6.4 million grant award covering process development and GMP scale manufacturing for RiVax™. Recent grant funding of approximately $5.0 million has broadened the development capabilities of the program in further animal testing and formulation.

About Ricin Toxin

Ricin toxin is a potential bioterror threat due to its high toxicity in small doses, ease of production and ability to be aerosolized. Exposure to small amounts can lead to lung damage if inhaled, and rapid onset of nausea, fever and abdominal pain if ingested. The effects of the toxin are generally irreversible, with death occurring from general organ failure within several days after exposure. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. Currently, there is no FDA-approved vaccine or countermeasure against ricin toxin.

About the Department of Pharmaceutical Chemistry at the University of Kansas

The Department of Pharmaceutical Chemistry, established at The University of Kansas in 1967, is defined by the philosophy: that success in understanding drug action requires a thorough understanding of the basic aspects of analytical, biophysical, organic and physical chemistry. These principles are equally important for the development of traditional small molecule drugs and for emerging biotechnology products such as peptides, proteins and nucleotides. The Department encompasses the areas of research and instruction in pharmaceutics, physical pharmacy, preformulation, formulation, pharmaceutical analysis and bioanalytical chemistry.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of bone marrow transplantation. DOR BioPharma has filed a Marketing Authorization Application (MAA) with the EMEA and a New Drug Application (NDA) with the FDA for orBec® for the treatment of GI GVHD. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. The ricin toxin vaccine, RiVaxTM, has successfully completed a Phase I clinical trial in normal volunteers.

For further information regarding DOR BioPharma, please visit the Company's website located at

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec®. Where possible, DOR 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 cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, 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 the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program, 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. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: because orBec® 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® approvable based upon existing studies, orBec® 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 expects or may never gain approval; DOR 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® may not gain market acceptance; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR 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.

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