DOR Dor Biopharma

DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company") announced today the first successful evaluation in animal tests of a nasal, bivalent combination of its botulinum toxin vaccine, BT-VACC(TM), addressing two of the most prevalent serotypes of botulinum toxin, types A and B. DOR is designing BT-VACC(TM) to be administered by the mucosal route, which offers significant advantages to the end user in terms of increased safety, lack of pain from injections, and ability to induce protective antibodies in the lung and intestines. These types of antibodies are associated with inactivation of botulinum toxins before they enter the body. These results are the first ever report of a combination of botulinum vaccine serotypes given by the mucosal route. In these experiments, the botulinum toxin vaccine serotypes A and B were mixed together and given to mice and rats by vaccinating the nasal passages through inhalation of the vaccine. The animals were given a small quantity of the bivalent combination vaccine containing each of the type A and type B antigens (10 micrograms) three times two weeks apart. All of the animals developed equivalent immune responses to A and B types in the serum. Importantly, they were then protected against exposure to each of the native toxin molecules given at 1000 fold the dose that causes lethality. The immune responses were also comparable to the same vaccines when given by intramuscular injection. Typically, vaccines given by mucosal routes are not immunogenic because they do not attach to immune inductive sites. In the case of the combination BT-VACC(TM), both the A and the B antigens were capable of attaching to cells in the mucosal epithelium and inducing an immune response with similar magnitude to the injected vaccine. "These results are significant because they demonstrate that we can induce an effective immune response to a combination of botulinum toxin serotypes in animals without using injections and, moreover, without using adjuvants that are usually needed with injected vaccines," said Michael T. Sember, President and CEO of DOR BioPharma, Inc. "The next steps will involve the addition of botulinum toxin type E serotype vaccine to the mucosal cocktail. We intend to move the mucosal vaccine as rapidly as possible towards clinical studies. We hope to compete successfully in supplying the government and the Department of Defense needs for mucosally administered botulinum toxin vaccines that are effective, safe and easier to use than traditional injected vaccines." In related work, DOR also reports that its collaborators at Dowpharma(SM) have expressed the cocktail of BT-VACC(TM) antigens through utilization of their Pfenex Expression Technology(TM), a Pseudomonas-based technology. These antigens are expressed in the correct configuration expected for the vaccine and enriched in the surface fraction of the host cells for ease of purification. These bacteria produce high level expression of recombinant proteins and peptides in comparison to other commercially available microbial expression systems such as E. coli. Botulinum toxin, considered the most poisonous natural substance known to mankind, is classified as a Category A biothreat by the Centers for Disease Control (CDC), and has been used in a number of well-documented incidents. It can be aerosolized and is 100,000 times more toxic than sarin gas, and currently there is no FDA-approved vaccine or therapeutic. 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. Once exposed to botulinum toxin, blockage of peripheral nerve function and descending flaccid paralysis ensues, which usually leads to death. About Dowpharma Dowpharma(SM) serves the pharmaceutical and biopharmaceutical industries with innovative technologies, products, and services in drug discovery, development, delivery and manufacturing. Dowpharma has one of the broadest and deepest capabilities in the global outsourcing industry with services that include process development, route selection, methods development, custom solubilization, chiral capabilities, and associated analytical services, as well as manufacturing and scale-up from feasibility, through clinical trials, to commercial manufacturing. Dowpharma manufactures small molecule Active Pharmaceutical Ingredients (APIs) and intermediates, nucleic acid medicines, cGMP polymers, peptides and therapeutic proteins from microbial fermentation and plant-based systems. Dowpharma draws upon over 30 years of excellent cGMP regulatory compliance in the organic synthesis of APIs and pharmaceutical intermediates with the ability to provide client support in filing and validation strategies. Dowpharma operates research, process development, and manufacturing facilities in North America and Europe. More information is available at http://www.dowpharma.com. About Dow Dow is a diversified chemical company that harnesses the power of science and technology to improve living daily. The Company offers a broad range of innovative products and services to customers in more than 175 countries, helping them to provide everything from fresh water, food and pharmaceuticals to paints, packaging and personal care products. Built on a commitment to its principles of sustainability, Dow has annual sales of $46 billion and employs 42,000 people worldwide. References to "Dow" or the "Company" mean The Dow Chemical Company and its consolidated subsidiaries unless otherwise expressly noted. More information about Dow can be found at http://www.dow.com. 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 by second quarter 2006. 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 in normal volunteers. We have also initiated 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, 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 presently is involved in financing 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.