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DOR's Abstract Describing orBec Phase III Clinical Trial Results Selected for Presentation at the Annual Meeting of the American Association of Cancer Research
Friday, April 15, 2005
MIAMI (Business Wire) -- DOR BioPharma, Inc. (AMEX: DOR) ("DOR" or the "Company"), announced today that data from the recently completed orBec(R) pivotal Phase III clinical trial in intestinal Graft-versus-Host Disease (iGVHD) has been accepted for presentation at the 2005 Annual Meeting of the American Association of Cancer Research (AACR) in Anaheim California from April 16-20.
The poster presentation: "A Phase 3 Randomized, Placebo-Controlled Study of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction with Ten Days of High-Dose Prednisone Therapy for Patients with Gastrointestinal Graft vs. Host Disease" will be presented by the study's lead investigator, Dr. David Hockenbery, Member of the Fred Hutchinson Cancer Research Center. The presentation will take place at 1:00 pm PDT on April 19, 2005.
"We are very pleased that this abstract describing our clinical results with orBec(R) has been selected for presentation at AACR, commented Michael Sember, President and CEO of DOR." It will be the first presentation of data from this promising trial to be presented to the medical community."
About Intestinal Graft-versus-Host Disease
iGVHD is a life threatening condition that is one of the most common causes for the failure of bone marrow transplant procedures. These procedures are being increasingly utilized to treat leukemia and other cancer patients with the prospect of eliminating residual disease and reducing the likelihood of relapse. orBec(R) represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec(R) is intended to reduce the need for systemic immunosuppressives to treat iGVHD. Currently approved systemic immunosuppressives utilized to control iGVHD substantially inhibit the highly desirable graft-versus-leukemia (GVL) effect of bone marrow transplants, leading to high rates of aggressive forms of relapse, as well as substantial rates of mortality due to opportunistic infection.
About DOR BioPharma, Inc
DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of biodefense vaccines and therapeutics for areas of unmet medical needs. Through its BioDefense Division, DOR is developing bioengineered vaccines designed to protect against the deadly effects of ricin and botulinum toxins for potential U.S. Government procurement. DOR has also recently announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design. DOR's lead therapeutic product, orBec(R) (an oral formulation of beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a severe, life-threatening form of gastrointestinal inflammation. DOR recently announced top line results of its pivotal Phase III clinical trial of orBec(R) in iGVHD in which orBec(R) demonstrated a highly statistically significant reduction in mortality during the prospectively defined Day 200 post-transplant period and positive trends on its primary endpoint. DOR will meet with the FDA during this month to determine the appropriate next steps for the development of orBec(R).
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 this 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.
DOR BioPharma, Inc.
Evan Myrianthopoulos, 305-534-3383
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