DOR Dor Biopharma

DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company") today announced that it has successfully completed the second development milestone for its ricin vaccine, called RiVax(TM), under the Challenge Grant previously awarded to DOR in September 2004 by the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health. For the second milestone, the Company has completed the development of a process for large-scale manufacture of the key vaccine ingredient consisting of a modified ricin toxin subunit protein. In addition, supplementary characterization and formulation objectives have been achieved. DOR is developing the vaccine under the Challenge Grant in conjunction with the University of Texas Southwestern Medical Center, Stanford Research Institute, University of Kansas, and Cambrex Biosciences in Baltimore. This consortium led by DOR has resulted in development of a robust and reproducible manufacturing process and purification scheme for large-scale production of the ricin A chain subunit protein ingredient in RiVax(TM). This process will be sufficient to supply millions of vaccine doses. The ricin A chain is the catalytic subunit of ricin toxin that accounts for its main ability to inhibit protein synthesis and kill mammalian cells. Modification of the A chain to remove toxicity sites was required to make a vaccine safe enough and effective enough for use in humans. An early formulation of RiVax(TM) using a smaller scale process has been evaluated in a Phase I clinical trial in healthy volunteers, the first time such a vaccine has been tested in humans. The major results of that trial will be announced next week and discussed in publication. Based on the improved production methods and high yields of RiVax(TM), DOR is manufacturing clinical batches which will be evaluated in additional human studies to examine the effect of the formulation and vaccination regimen on the human immune response. Continuing studies in animals are focused on correlating the level of antibodies in serum with protection against ricin exposure to various routes of exposure, including aerosol and oral. The demonstration of the functionality of human antibodies and passive protection in animals is a key step in providing evidence of efficacy under the FDA Animal Efficacy rule. Under this rule, the FDA can permit human licensure of a vaccine by relying on results from animal trials when human trials cannot ethically evaluate efficacy. "We are very pleased with the progress we continue to make with our ricin program," stated Michael T. Sember, DOR's CEO and President. "We now have a well defined and scalable manufacturing process that is suitable for all future commercial needs as we continue development of this important biodefense countermeasure. We will continue to work closely with our partners and NIAID to expeditiously develop a safe and efficacious ricin vaccine." 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, especially by inhalation, can lead to lung damage, nausea, fever, abdominal pain, and 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 are no FDA approved vaccines against ricin toxin. 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 completed the clinical portion of its Phase I clinical trial in normal volunteers. We have also 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, 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.