Miami, FL - November 17, 2005
DOR BioPharma, Inc. (AMEX: DOR) ("DOR", or the "Company") today announced it has completed a feasibility study with DowpharmaSM contract manufacturing services, a business unit of The Dow Chemical Company (NYSE: DOW), focused on the expression of three recombinant heavy chain botulinum fragments used in the development of BT-VACC™, DOR's proprietary mucosal botulinum vaccine. BT-VACC™ is designed to protect against botulinum toxin poisoning, one of the top three bioterrorism threats identified by the U.S. government and the most poisonous natural substance known to man. Using its Pfēnex Expression Technology , Dowpharma achieved a ten-fold increase in expression levels over the E. coli method previously used by DOR.
"We are thrilled with the significant amount of protein expression we have seen using Pfēnex. This ten fold increase makes BT-VACCTM more viable, saving us significant time and money, which may ultimately accelerate time to market," said Michael T. Sember, President and Chief Executive Officer of DOR. "Pfēnex will allow us to rapidly advance BT-VACCTM through the stages of product development and ultimately into the clinic. Results to date indicate that BT-VACCTM has the ability to induce protective antibodies in animal models."
As part of the joint development agreement announced last July, Dowpharma focused on the expression of three recombinant heavy chain botulinum toxin fragments known as HC50 derived from clostridium botulinum strains A, B and E. Using the Pfēnex Expression Technology, Dowpharma rapidly identified a high performance proprietary strain. The majority of the protein was present in soluble form, which is expected to greatly aid the product recovery process as scale-up proceeds. Further studies will be aimed at development of a scalable purification process to support continued developmental studies.
"This represents another example of Pfēnex outperforming E. coli by delivering significantly higher yields and a faster route through process development which will ultimately enable a reduced overall cost of goods," said Nick Hyde, global business director, Dowpharma. "We look forward to continuing to develop this important biodefense vaccine with DOR."
Mucosal administration of BT-VACC(tm) for serotype A 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 mucosal 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 a mucosally delivered botulinum toxin vaccine. Recent preclinical studies of BT-VACC(tm) for serotype B resulted in similar immunogenicity and protective efficacy results in animals. 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.
Botulinum toxin, considered the most poisonous natural substance known to mankind, is classified as a Category A biothreat by the Centers for Disease Control (CDC), and has been used in a number of well-documented incidents. Recently, the U.S. government completed a Material Threat Assessment (MTA) on the use of botulinum toxin as a terrorist agent. Botulinum toxin is 100,000 times more toxic than sarin gas, and there is currently no FDA approved vaccine or therapeutic. 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® (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® for the treatment of iGVHD in early 2006.
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, RiVaxTM, 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® for the treatment of iGVHD and the prospects for regulatory filings for orBec®. 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®, 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 prior to a date set by AMEX for a hearing regarding the continued listing on AMEX of Dor BioPharma's common stock, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for iGVHD 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 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® may not gain market acceptance; and others may develop technologies or products superior to orBec®. 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.
For Editorial Information:
Evan Myrianthopoulos
DOR BioPharma, Inc.
(305) 534-3383
Kathy Witz Sweeney
Mentus
(858) 455-5500
