SOURCE: DOR BioPharma, Inc.

May 09, 2008 07:00 ET

DOR BioPharma Announces Appointment of Christopher J. Schaber, PhD, to Board of Directors of the Alliance for BioSecurity

EWING, NJ--(Marketwire - May 9, 2008) - DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage biopharmaceutical company, announced today that its President and Chief Executive Officer Christopher J. Schaber, PhD, has joined the Board of Directors of the Alliance for Biosecurity, a collaboration among leading biosecurity research organizations and select biopharmaceutical companies committed to developing biodefense countermeasures to address a range of bioterrorism and natural pandemic threats.

The Alliance for Biosecurity works to promote a stronger, more effective partnership between government and the BioPharma industry to better develop critically needed medical countermeasures. The Alliance also seeks to usher in a new era in the prevention and treatment of severe infectious diseases that present global security challenges. This new era will be characterized by the capacity to rapidly develop, produce and stockpile medical countermeasures for the country. The Center for Biosecurity and biopharmaceutical members of the Alliance are striving to create a long-term national security vision for achieving and sustaining defenses against a range of current and future biothreats.

"Dr. Schaber's experience in regulatory affairs and drug development adds a significant asset to an already experienced Board," stated Anita Cicero, Executive Director of the Alliance for Biosecurity. "We look forward to his participation in our meetings within the alliance and on Capitol Hill. Additionally, since the potential use of ricin toxin has been recently highlighted in an FBI Bioterror report, DOR's important work in the area of ricin and its other bioterror vaccine development can help to augment the nation's preparedness efforts."

"Both DOR as a company and I are honored to be a part of the Alliance for Biosecurity," stated Dr. Schaber. "While we believe we have much to contribute, we are also glad to be able to draw upon the wealth of biodefense expertise within this elite group of organizations that has the potential to enhance our ability to participate in this important and growing area of research."

About the Alliance for Biosecurity

The Alliance pursues opportunities to partner with government and other stakeholders to develop new solutions aimed at greatly enhancing our country's ability to defend itself against biothreats. The Alliance's activities include:

--  Educating members of Congress and other government stakeholders about
    biosecurity and drug development issues.
--  Promoting the creation and successful implementation of the Biodefense
    Advanced Research and Development Authority (BARDA) within the Department
    of Health and Human Services.
--  Providing venues for stakeholder dialogue about key biosecurity policy
--  Developing and presenting consensus policy proposals to government.

Other members of the Alliance include: Acambis, Inc., Bavarian Nordic, Center for Biosecurity of University of Pittsburgh Medical Center, Cangene Corporation, DynPort Vaccine Company LLC, a CSC company, Elusys Therapeutics, Inc., Emergent BioSolutions, Hematech, Inc., a subsidiary of Kirin Pharma Company, Ltd., Human Genome Sciences, Inc., Iomai Vaccines, NanoViricides, Inc., Pfizer, Inc., PharmAthene, Siga Technologies, Inc., Battelle Medical Research and Evaluation Facility, and Lovelace Respiratory Research Institute.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a late-stage 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 or BDP), 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 filed a New Drug Application for orBec® with the FDA for the treatment of acute GI GVHD and received a not approvable letter in which the FDA has requested data from a confirmatory Phase 3 clinical trial to demonstrate the safety and efficacy of orBec®. A Marketing Authorization Application with the European Medicines Evaluation Agency has also been validated and is under review. orBec® is currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has initiated a development program with its Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the 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, botulinum toxin and anthrax. DOR's ricin toxin vaccine, RiVaxTM, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, Inc., 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 US Government or other countries, that the US 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: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; 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; orBec® may not gain market acceptance if it is eventually approved by the FDA; 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.