MIAMI--(BUSINESS WIRE)--Feb. 4, 2004--In response to recent events and queries received from the investing public, DOR BioPharma, Inc. (“DOR” or “the Company”) (AMEX:DOR - News) is providing this update on the progress of its ricin vaccine program. Ricin is a plant-derived toxin that because of ease of manufacture and potency, represents an attractive potential bioterrorism weapon for which no vaccine or therapy currently exists.
As announced previously, DOR has licensed the worldwide rights to a recombinant vaccine antigen from the University of Texas Southwestern Medical Center at Dallas (UT Southwestern). The vaccine candidate, which is being developed in collaboration with UT Southwestern, is a modified subunit of the native ricin toxin which has been genetically engineered to eliminate both its enzymatic activity and its ability to induce vascular leak syndrome (VLS). Complete elimination of both types of toxicity is likely to render this vaccine safe at effective doses.
To date, UT Southwestern has completed much of the testing required to support the filing of an Investigational New Drug (IND) application. The University plans to file the IND in the first half of 2004 with the intent of entering human clinical testing later this summer. A portion of the work to date has been funded directly through a sponsored research agreement with DOR. In August of 2003, UT Southwestern received a grant of $2.8 million from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This grant is being used to fund further preclinical studies on the safety and efficacy of the vaccine using a ricin aerosol challenge model. The funds will also be used to compare formulations of the vaccine designed to induce systemic versus mucosal activity, including nasal and oral formulations. In addition to this funding, DOR has recently applied to the NIAID for a grant to fund larger scale manufacturing and continued development.
DOR’s President and Chief Executive Officer, Dr. Ralph Ellison, commented on the program: “We are working diligently to develop a safe and effective vaccine to protect against exposure to this deadly poison. Recent events in the news highlight the need for effective countermeasures against bioterror agents such as ricin.”
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a development-stage biopharmaceutical company specializing in the clinical testing of products that meet unmet medical needs. Through its Biodefense Division, DOR is currently developing vaccines against Ricin Toxin and Botulinum Toxin. DOR’s lead therapeutic product, orBec® (oral beclomethasone dipropionate), is currently in a pivotal phase III clinical trial for the treatment of intestinal graft-versus-host disease. 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’s current expectations about its future results, performance, prospects and opportunities, including its product development and product pipeline. Where possible, DOR BioPharma has tried to identify these forward-looking statements by using words such as “anticipates,” “believes” 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, particularly in light of the significant uncertainty inherent in developing mucosally administered 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 enter into profitable biodefense contracts with the U.S. Department of Defense and 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, or that its business strategy will be successful. 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, changed circumstances or for any other reason.
Contact:
DOR BioPharma, Inc. Company Contact: Ralph M. Ellison, MD, MBA (305)534-3383 rellison@dorbiopharma.com or Redington, Inc. Investor Relations Contact: Thomas Redington (203)222-7399 info@redingtoninc.com www.redingtoninc.com
Source: DOR BioPharma, Inc.
