SOURCE: DOR BioPharma, Inc.

March 13, 2007 07:01 ET

DOR BioPharma Reports Successful Completion of 1 Year Interim Analysis of RiVax™ Stability

MIAMI, FL -- (MARKET WIRE) -- March 13, 2007 -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR," or "The Company") announced today that it has successfully completed a 1 year interim analysis in the long-term stability program of the key ingredient of RiVax™, a recombinant subunit vaccine against ricin toxin intended to protect against exposure to ricin that might result from purposeful release of toxin in an aerosolized form or as a poisonous contaminant in food or water.

The results of interim analysis in the formal stability program demonstrate that the immunogen component of RiVax™, a recombinant derivative of ricin A chain, is stable under storage conditions for at least one year without loss of its natural configuration or the appearance of any detectable degradation products. A vaccine for ricin is considered by many the best way to prospectively protect certain human populations who are at risk of exposure. Since this vaccine would presumably be added to the Strategic National Stockpile and dispensed in the case of a terrorist attack, the activity of the vaccine must be maintained over a period of years under potential stockpile storage conditions.

DOR has studied the stability of the RiVax™ immunogen using a variety of spectral techniques aimed at examining the three-dimensional and two-dimensional structure of the protein as well as other techniques that detect small changes in the nature of the protein during exposure to elevated temperature conditions. These results have shown that certain common materials can be added to solutions of the protein to maintain the stable configuration that is thought to be correlated with optimal immune response in animals. Without stabilization of the protein structure, the ricin A chain subunit component is extremely sensitive to elevated temperatures and forms aggregates and other complexes that negatively affect shelf life.

DOR has been working closely on the characterization of new methods for analysis of protein stability with the laboratory of Professor C. R. Middaugh at the University of Kansas, Department of Pharmaceutical Chemistry as well as with Lonza Baltimore, Inc. (formerly Cambrex Biosciences, Baltimore), who have conducted a portion of the stability studies to date. Lonza has been working with DOR to develop a robust process for manufacture of RiVax™.

"Long-term stability is one of the key factors for the further clinical development of RiVax™ and for potential US government vaccine stockpiling purposes," said Robert N. Brey, Ph.D., Chief Scientific Officer of DOR. "We have successfully completed a Phase 1 clinical trial of RiVax™ in which safety and immunogenicity have been demonstrated and we are now able to produce RiVax™ under GMP conditions and at large scale. With the $4.8 million of continued grant funding we have recently received from NIAID, we are in a good position to make further strides in the generation of a vaccine product that will have sufficient stability for the Strategic National Stockpile of biodefense countermeasures."

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, rapid onset of nausea, fever, and abdominal pain if ingested. General organ failure leading to death can occur within several days. 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. The successful development of an effective vaccine against ricin toxin may act as a deterrent in the actual use of ricin as a biological weapons and can be used in rapid deployment scenarios in the event of a biological attack.

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 nuclecotides. The Department encompasses the areas of research and instruction in pharmaceutics, physical pharmacy, preformulation, formulation, pharmaceutical analysis and bioanalytical chemistry.

About Lonza

Founded in 1897, Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture. Lonza is the global leader in the production and support of pharmaceutical active ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SWX Swiss Exchange. In 2006 Lonza had sales of CHF 2.91 billion. Further information can be found at www.lonza.com.

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 GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA with the FDA for the treatment of GI GVHD, and has received a PDUFA date of July 21, 2007. In addition, the FDA's Oncology Drug Advisory Committee ("ODAC") will review the NDA for orBec® on May 9, 2007. An MAA with the EMEA for orBec® has also been filed and validated. 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. DOR's ricin toxin vaccine, RiVax™, has been shown to be safely tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

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

Contact Information