SOURCE: DOR BioPharma, Inc

October 31, 2006 09:09 ET

DOR BioPharma Announces New Collaborations for Ricin Vaccine Development

Company Accelerates RiVax™ Development Through NIH Cooperative Consortium

MIAMI, FL -- (MARKET WIRE) -- October 31, 2006 -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR," or the "Company") announced today that it has formed an alliance with the Wadsworth Center of the New York State Department of Health in Albany, New York and Lovelace Respiratory Research Institute (LRRI) in Albuquerque, NM, to build upon expertise in testing RiVax™, DOR's recombinant vaccine against ricin toxin, to protect against inhalation and oral toxin exposure. The Company has been developing RiVax™, a subunit vaccine against ricin toxin, by leading a consortium of academic and industry vaccine investigators under funding from National Allergy and Infectious Diseases (NIAID). DOR's consortium effort began in 2004 with an initial $6.4 million grant award. Recent grant funding of an additional $4.8 million has broadened the development capabilities of the program.

The additional capability in the development of animal models is essential to validate vaccine safety and efficacy under the FDA "two animal" rule, which dictates that products that cannot be ethically tested in humans must be tested for efficacy in animals where the correlates of human protection are well understood. These additional models will be co-developed in conjunction with LRRI, who have established facilities for handling aerosolized toxins. In addition, animal testing for examining the effects of aerosolized ricin toxin and vaccine-induced protection on mucosal surfaces in the stomach and intestine will be performed using models developed by Dr. Nicholas Mantis at the Wadsworth Center of the New York State Department of Health in Albany.

In the development of RiVax™, DOR has been working closely with the University of Texas Southwestern Medical Center (UTSW) where new research facilities have been constructed for the testing of animals using aerosols of ricin toxin. The company has also collaborated with UTSW in the transition of the product to advanced development. UTSW has also separately been awarded a complementary grant for $2.2 million over 5 years to conduct research in fundamental areas to characterize immune responses in small animals and to develop novel ricin vaccine formulations. The successful outcome of that research will be factored into further options for alternate routes of delivery of RiVax™.

The Company has collaborated closely with academic and industrial partners during the initial stages of development of RiVax™. Under NIAID grant arrangements the Company in turn funds the activities of its development partners, since the unique facilities for animal testing and handling of select agents, such as ricin toxin, are only in place in a few universities and laboratories in the country. The new consortium continues with the contributions of Stanford Research International, in Menlo Park, CA, who has been working also on small animal models and evaluation for vaccine potency. The vaccine that is being developed contains an adjuvant system which is necessary to increase the level of ricin neutralizing antibodies and also to lengthen the period of immunity to ricin exposure. The development of an adjuvant formulation has centered on the need for protein stabilization, which is being pursued with the Pharmaceutical Chemistry Department at the University of Kansas. The Company in conjunction with Cambrex Biosciences has already developed large scale purification processes and has manufactured product under cGMP conditions. This process will be used in the final adjuvant product for continued late-stage clinical development.

"The consortium approach to developing medical countermeasures is critical to the success of this type of project, since the facilities and expertise needed is distributed among a number of premier institutions, both academic and industrial," said Robert N. Brey, Ph.D. "The development work we are performing forms a good working example of how academic institutions and biotech companies can work together with government for the development of countermeasures. The early clinical success in demonstrating seroconversion and induction of ricin neutralizing antibodies underlies the further development of this vaccine."

Newly Formed Alliance for Biosecurity

As part of the effort to enhance the consortium approach to development of vaccine and countermeasures for emerging pathogens and bioweapons, DOR is working closely with the newly formed Alliance for Biosecurity, an industry group of biotechnology and pharmaceutical companies working in collaboration with the non-profit Center for Biosecurity of the University of Pittsburgh Medical Center to promote changes in the way the government approaches the procurement of such products. The Alliance for Biosecurity is actively engaging with key officials in Congress, Department of Health and Human Services (HHS), and FDA to advance effective ways to significantly accelerate research, development, and procurement of countermeasures.

Both the House of Representatives and the Senate are now considering important, bi-partisan bills that will provide for additional advanced development funding that will structurally improve the BioShield program. Outside of the direct countermeasure procurements of the BioShield program, the NIH has funded basic research and development, an effort that has grown from $53 million in 2001 to $1.8 billion in 2006, and broadly includes research in a wide area of emerging diseases, including pandemic influenza. The fundamental work has not yet generated the array of new products that are needed for procurement.

To accelerate development through BioShield and NIH, the HHS has just unveiled a new strategy for the development of medical countermeasures to complement the prioritization of the strategic plan initiated in 2004 under Project BioShield. This new plan calls for the HHS to define specific countermeasure requirements in light of the stage of development and to develop a new integrated research and development portfolio. As a result, HHS has just published an RFI (request for information) to gather input to the HHS implementation plan for its strategy document, with the ultimate goal of acquiring the most appropriate medical countermeasures for mitigating the health effects from the CBRN threats facing the nation.

About Ricin Toxin

Ricin is a potent plant toxin derived from castor beans. It is easily manufactured and purified, heat stable, and is classified by the CDC as a Category B biothreat. Ricin is a potent inhibitor of protein synthesis in mammalian cells. Exposure to ricin leads to irreversible tissue damage, especially if it is inhaled, shock-like symptoms and multi organ failure that can result in death in several days.

About Lovelace Respiratory Research Institute

Lovelace Respiratory Research Institute is a not-for-profit research institution founded in 1947 by Dr. William Randolph Lovelace II. It is one of the nation's largest independent research institutions and the only one focused solely on respiratory health. Scientists at LRRI are committed to eradicating respiratory diseases through research aimed at understanding their causes and biological mechanisms, eliminating exposures to causal agents, and developing more effective treatments.

About the Wadsworth Center of the NYS Department of Health

The Wadsworth Center is the reaserch arm of the New York State Department of Health. As a public health laboratory, Wadsworth conducts programs in comprehensive biomedical and environmental research based on the tenet that in order to fulfill its regulatory and analytical missions most effectively, innovative approaches to investigating diseases and environmental hazards of public health concern must be pursued.

About the Alliance for Biosecurity

The Alliance for Biosecurity was formed in June of 2005 by pharmaceutical companies, biotechnology companies and the Center for Biosecurity of the University of Pittsburgh Medical Center. Alliance members are committed to partnering with government and promoting a new era in the prevention and treatment of severe infectious diseases -- particularly those that present global security challenges -- through innovative and accelerated research, development and production of countermeasures. Company members of the Alliance include: Acambis, Inc., Caprion Pharmaceuticals, Inc., DOR BioPharma, Inc., Dynport Vaccine Company, Elusys Corporation. Emergent BioSolutions, GlaxoSmithKline, Human Genome Sciences, Inc., Novartis Vaccines and Diagnostics, Inc., Pfizer, Inc., PharmAthene, and VaxGen, Inc.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. is a biopharmaceutical company developing products for life-threatening side effects of cancer treatments, serious gastrointestinal diseases, and bioterrorism. Our 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 recently filed a New Drug Application (NDA) with the FDA for orBec® for the treatment of GI GVHD. orBec® may also have applications in treating other gastrointestinal disorders characterized by severe inflammation.

Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. Our biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. Our ricin toxin vaccine, RiVax™, 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 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, 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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