DOR BioPharma Inc. announced that the second summary of clinical trials of its drug orBec(R) (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 Expert Opinion paper concludes that orBec(R) is an effective therapy for acute GI GVHD. As a single agent, the response rates observed with orBec(R) of 65-77% are comparable to historical experience with systemic corticosteroids. An even stronger case can be made for orBec(R) as a maintenance therapy after an initial response to corticosteroids. Two randomized, double-blind, placebo-controlled trials indicate that orBec(R) 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(R) 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(R) 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(R), 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%. 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.

DOR BioPharma Inc. announced that it has entered into a collaboration with BurnsAdler Pharmaceutical Inc. under which BurnsAdler will act as DOR's distributor of a Named Patient Access Program (NPAP) for orBec(R) to patients suffering from acute gastrointestinal Graft-versus-Host disease (GI GVHD) in all countries within Central America, South America and the Caribbean ('Latin America'). The NPAP is a compassionate use drug supply program under which medical practitioners can legally supply investigational drugs to their eligible patients. Under this program, investigational drugs can be administered to patients who are suffering from serious illnesses until the drug is approved by the regional regulatory authorities. BurnsAdler and DOR will share revenues generated by sales of orBec(R) through the NPAP. DOR will manufacture and supply orBec(R) to BurnsAdler, while BurnsAdler will be responsible for all distribution costs in the Territory.

DOR BioPharma Inc. announced that it has entered into a collaboration with Pacific Healthcare Thailand Co, under which Pacific will act as Dor's sponsor to administer a Named Patient Access Program for orBec to patients suffering from acute gastrointestinal graft-versus-host disease in Thailand as well as other Association of Southeast Asian Nations member countries including Brunei, Cambodia, Indonesia, Laos, Myanmar, Philippines and Vietnam. The Named Patient Access Program (NPAP) is a compassionate use drug supply program under which medical practitioners can legally supply investigational drugs to their eligible patients. Under this program, investigational drugs can be administered to patients who are suffering from serious illnesses until the drug is approved by the various regional regulatory authorities. Pacific and Dor will share revenues generated by sales of orBec through the NPAP. Dor will manufacture and supply orBec to Pacific, while Pacific will be responsible for all distribution costs in the territory.