MIAMI, July 26, 2005 (PRIMEZONE) -- DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company") today announced it has entered into a joint development agreement with Dowpharma(sm), a business unit of The Dow Chemical Company (NYSE:DOW), to advance the development of DOR's proprietary oral botulinum vaccine, BT-VACC(tm). BT-VACC(tm) is designed to protect against exposure to botulinum toxin, which is one of five Category A bioterrorism threats identified by the U.S. government.
Under the agreement, Dowpharma will provide process development leading to current Good Manufacturing Practices (cGMP) production services for BT-VACC(tm) using its Pfenex Expression Technology(tm), a Pseudomonas-based technology that accelerates speed to market for vaccines and biotherapeutics by surpassing the quality and yield capabilities of existing microbial systems.
DOR's BT-VACC(tm) is an orally administered vaccine that protects against exposure to botulinum neurotoxins. Oral administration of BT-VACC(tm) produces protective antibodies that afford protection or prolonged survival of treated animals against 30,000 times the lethal dose of botulinum toxin serotype A. The oral route of administration of a vaccine is believed to be preferable to the injectable form due to benefits derived from safer and easier administration, lack of skilled medical personnel needed for administration, and relative ease of distribution to the civilian population. DOR believes that it is the only company developing an orally delivered botulinum toxin vaccine. Recent preclinical studies of BT-VACC(tm) for serotype B resulted in similar immunogenicity and protective efficacy results. Ongoing studies at Thomas Jefferson University are focused on serotype E and multivalent immunization experiments using serotype A, B and E antigens given simultaneously to animals.
"This is an important relationship for us as we continue to develop BT-VACC(tm)," commented Michael T. Sember, president and CEO of DOR BioPharma, Inc. "Results to date indicate that BT-VACC(tm) has the ability to induce protective antibodies in appropriate animal models. With Dowpharma's Pfenex Expression Technology(tm), we intend to expedite the production of multiple botulinum toxin serotype antigens from the laboratory to cGMP production so that we can rapidly advance BT-VACC(tm) into the clinic."
Dowpharma has an unmatched record in developing high-productivity strains for numerous protein products, for both clinical and industrial applications. Dowpharma has developed a Pseudomonas-based technology and know-how directed toward protein expression and downstream processing of expressed proteins and other biologically active compounds known as Pfenex Expression Technology(tm). Pfenex is built around specially modified strains of Pseudomonas fluorescens bacteria that increase cellular expression of recombinant proteins and peptides while maintaining critical solubility and activity characteristics.
"Dowpharma is committed to the development of biodefense products as this is our third program to address bioterrorism threats," said Nick Hyde, Business Director of Dowpharma. "Pfenex is proven to improve protein production and consistently outperforms other commercially available microbial expression systems such as E. coli. We are honored to work with DOR to expedite the development of this important vaccine."
Botulinum toxin is considered the most poisonous natural substance known to mankind and is classified as a Category A biothreat by the Centers for Disease Control (CDC). It is aerosolizable and has previously been used in a number of well-documented incidents. It is 100,000 times more toxic than sarin gas, and currently there are no FDA-approved vaccines or therapeutics. 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 occurs which ultimately leads to death within hours.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of therapeutic products and biomedical countermeasures for areas of unmet medical need. 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 gastrointestinal disorders characterized by severe inflammation. We intend to file a new drug application (NDA) with the FDA for orBec(r) for the treatment of iGVHD later this year.
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 ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(tm), is currently the subject of a Phase I clinical trial in normal volunteers. We have also recently 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 (including that the results of its Phase I clinical trial of RiVax(tm) will demonstrate acceptable safety and immunogenicity/efficacy), 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, 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). 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.