DOR BioPharma Announces Second orBec(R) Clinical Summary Published in "Expert Opinion on Investigational Drugs"
Monday September 15, 7:00 am ET
EWING, NJ--(MARKET WIRE)--Sep 15, 2008 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) ("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 full article is available online at: informapharmascience.com.
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(TM)) 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. |
