DOR BioPharma Announces Second orBec Clinical Summary Published in
EWING, NJ - September 15, 2008 - DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today that the second summary of clinical trials of its drug orBec® (oral beclomethasone dipropionate, or oral BDP) for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD) has been published in the September issue of peer-reviewed medical journal Expert Opinion on Investigational Drugs. The publication "Oral Beclomethasone Dipropionate, a Topically Active Corticosteroid for Treatment of Gastrointestinal Graft-vs.-Host-Disease," is authored by María Díez-Campelo, Fermín M Sánchez-Guijo & José A Pérez Simón of the University Hospital of Salamanca, Spain. The Expert Opinion paper concludes that orBec® is an effective therapy for acute GI GVHD. As a single agent, the response rates observed with orBec® of 65 - 77% are comparable to historical experience with systemic corticosteroids. An even stronger case can be made for orBec® as a maintenance therapy after an initial response to corticosteroids. Two randomized, double-blind, placebo-controlled trials indicate that orBec® prevents the recurrence of acute GI GVHD. Thus, in addition to the long list of side effects of systemic corticosteroids expected to be lessened by use of oral BDP among this population, an improved outcome in terms of transplant mortality also has been observed. These results provide a particularly strong rationale for the incorporation of steroid-sparing regimens such as orBec® in acute GVHD treatment. The paper also makes note that, although studies cannot be directly compared due to different patient selection or inclusion criteria, orBec® is the only therapy evaluated in a prospective randomized trial in the last 30 years to effectively improve the survival of patients diagnosed with acute GVHD.
The authors' opinion is that two randomized, double-blind, placebo-controlled trials have demonstrated that orBec®, formulated as gastric-release and enteric-coated pills and dosed at 8 mg/day, is safe and effective in treating acute GI GVHD when used in conjunction with a 10-day induction course of prednisone. Among patients eligible for prednisone taper after 10 days of induction therapy, treatment with oral BDP reduces the risk of GVHD treatment failure at study days 50 and 80 by > 60%.
"This is the fourth publication of our data in a well-regarded peer-reviewed journal," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "We believe that publications such as these clearly highlight the importance of orBec® to the hematopoietic cell transplantation community and help to reinforce the need for approval of this therapy in the treatment of acute GI GVHD. We continue to receive keen interest in orBec® from the international medical transplant community. We believe that orBec® has the potential to provide treating physicians with an effective and much needed tool to improve their patient's outcomes including survival."
Expert Opinion on Investigational Drugs is a monthly peer-reviewed journal, evaluating developments in pharmaceutical research, from animal studies through to the launch of a new medicine. Its Senior Advisory Panel and Section Editorial Board are composed of senior scientists involved in drug research and development. Authors are encouraged to express their expert opinion of the status of the research under review, rather than simply reviewing the available data. Its audience consists of scientists, managers and decision-makers in the pharmaceutical industry, and others closely involved in R&D.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate or BDP), 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 filed a New Drug Application for orBec® with the FDA for the treatment of acute GI GVHD and received a not approvable letter in which the FDA has requested data from a confirmatory Phase 3 clinical trial to demonstrate the safety and efficacy of orBec®. orBec® is currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis. Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin, botulinum toxin and anthrax. DOR's ricin toxin vaccine, RiVax™, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
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 secure partnerships or obtain financing within the next nine months to meet operating expenses and to conduct its upcoming confirmatory Phase 3 trial of orBec®, 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 US Government or other countries, that the US 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: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; 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; orBec® may not gain market acceptance if it is eventually approved by the FDA; 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.
Posted: September 2008