Earlier this year, DOR filed the proposed Phase 3 protocol with the FDA.Upon completion of its review, the FDA provided written feedback and DORrequested a meeting to gain further clarification regarding the Agency'scomments. At this meeting, DOR and the FDA agreed to all key study designcomponents including maintenance of the proposed primary endpoint,"treatment failure rate at Day 80." This endpoint was successfullymeasured as a secondary endpoint (p= 0.005) in the prior Phase 3 study as akey measure of durability following a 50-day course of treatment withorBec® (i.e., 30 days following cessation of treatment).

"We are pleased to be able to reach agreement with the FDA on the key studydesign elements for this confirmatory Phase 3 study," stated Christopher J.Schaber, PhD, President and Chief Executive Officer of DOR. "Our goal indesigning a highly powered, confirmatory trial was to replicate what we haddemonstrated in our previous Phase 3 study, most importantly as it relatesto our primary endpoint. With FDA agreement on our proposed primaryendpoint of the 'treatment failure rate at Day 80,' an endpoint that wehave previously demonstrated a positive result with, we are confident inour potential for success moving forward."

Dr. Schaber added, "With essentially all of the critical parameters of theprotocol now agreed to with the FDA, we can proceed with revising theprotocol in accordance with those agreements and expect to gain final FDAclearance and initiate the trial in 1H 2009."

About orBec®

Two prior randomized, double-blinded, placebo-controlled Phase 2 and 3clinical trials demonstrated that orBec® provides clinically meaningfuloutcomes when compared with the current standard of care, including alowered exposure to systemic corticosteroids following allogeneictransplantation. Currently, there are no approved products to treat GIGVHD. The first trial was a 60-patient Phase 2 single-center clinical trialconducted at the Fred Hutchinson Cancer Research Center. The second trialwas a 129-patient pivotal Phase 3 multi-center clinical trial of orBec®conducted at 16 leading bone marrow/stem cell transplantation centers inthe US and France. Although orBec® did not achieve statisticalsignificance in the primary endpoint of its pivotal trial, namely mediantime-to-treatment failure through Day 50 (p-value 0.1177), orBec® didachieve statistical significance in other key secondary endpoints such asthe proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80(p-value 0.005) and the median time to treatment failure through Day 80(p-value 0.0226), as well as a 66% reduction in mortality among patientsrandomized to orBec® at 200 days post-transplant with only 5 patient (8%)deaths in the orBec® group compared to 16 patient (24%) deaths in theplacebo group (p-value 0.0139). At one year post randomization in thepivotal Phase 3 trial, 18 patients (29%) in the orBec® group and 28patients (42%) in the placebo group died within one year of randomization(46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04,stratified log-rank test).

In the Phase 2 study, the primary endpoint was the clinically relevantdetermination of whether GI GVHD patients at Day 30 had a durable GVHDtreatment response as measured by whether or not they were able to consumeat least 70% of their daily caloric intake by mouth. The GVHD treatmentresponse at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec®and placebo groups respectively, achieving a statistically significantp-value of0.02. Additionally, the GVHD treatment response at Day 40 was 16 of 31(52%) vs. 5 of 29 (17%) in the orBec® and placebo groups respectively,achieving a statistically significant p-value of 0.007.

orBec® represents a first-of-its-kind oral, locally acting therapytailored to treat the gastrointestinal manifestation of GVHD, the organsystem where GVHD is most frequently encountered and highly problematic.orBec® is intended to reduce the need for systemic immunosuppressivedrugs to treat GI GVHD. BDP is a highly potent, topically activecorticosteroid that has a local effect on inflamed tissue. BDP has beenmarketed in the US and worldwide since the early 1970s as the activepharmaceutical ingredient in a nasal spray and in a metered-dose inhalerfor the treatment of patients with allergic rhinitis and asthma. orBec®is formulated for oral administration as a single product consisting of twotablets; one tablet is intended to release BDP in the proximal portions ofthe GI tract, and the other tablet is intended to release BDP in the distalportions of the GI tract.

In addition to issued patents and pending worldwide patent applicationsheld by or exclusively licensed to DOR, orBec® also benefits from orphandrug designations in the US and in Europe for the treatment of GI GVHD,which provide for seven and 10 years of post-approval market exclusivity,respectively.

About GI GVHD

GI GVHD is a debilitating and painful disease. It is a common disorderamong immunocompromised cancer patients after receiving allogeneic stemcell or bone marrow transplants. Unlike organ transplants where thepatient's body may reject the organ, in GVHD it is the donor cells thatbegin to attack the patient's body -- most frequently the gastrointestinaltract, liver and skin. Patients with mild-to-moderate GI GVHD typicallydevelop symptoms of anorexia, nausea, vomiting and diarrhea. If leftuntreated, GI GVHD can progress to ulcerations in the lining of the GItract, and in its most severe form, can be fatal.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical companydeveloping products to treat life-threatening side effects of cancertreatments and serious gastrointestinal diseases, and vaccines for certainbioterrorism agents. DOR's lead product, orBec® (oral beclomethasonedipropionate or BDP), is a potent, locally acting corticosteroid beingdeveloped for the treatment of gastrointestinal Graft-versus-Host disease(GI GVHD), a common and potentially life-threatening complication of bonemarrow transplantation. DOR filed a New Drug Application for orBec® withthe FDA for the treatment of acute GI GVHD and received a not approvableletter in which the FDA has requested data from a confirmatory Phase 3clinical 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 gastrointestinaldisorders characterized by severe inflammation. Additionally, DOR has aLipid Polymer Micelle (LPM(TM)) drug delivery technology for the oraldelivery of leuprolide for the treatment of prostate cancer andendometriosis.

Through its Biodefense Division, DOR is developing biomedicalcountermeasures pursuant to the Project BioShield Act of 2004. DOR'sbiodefense products in development are recombinant subunit vaccinesdesigned to protect against the lethal effects of exposure to ricin toxin,botulinum toxin and anthrax. DOR's ricin toxin vaccine, RiVax(TM), has beenshown to be well tolerated and immunogenic in a Phase 1 clinical trial innormal volunteers.

For further information regarding DOR BioPharma, Inc., please visit theCompany's website located at www.dorbiopharma.com.

This press release contains forward-looking statements that reflect DORBioPharma, Inc.'s current expectations about its future results,performance, prospects and opportunities. Statements that are nothistorical facts, such as "anticipates," "believes," "intends," or similarexpressions, are forward-looking statements. These statements are subjectto a number of risks, uncertainties and other factors that could causeactual events or results in future periods to differ materially from whatis expressed in, or implied by, these statements. DOR cannot assure youthat it will be able to successfully develop or commercialize productsbased on its technology, including orBec®, particularly in light of thesignificant uncertainty inherent in developing vaccines against bioterrorthreats, manufacturing and conducting preclinical and clinical trials ofvaccines, and obtaining regulatory approvals, that its cash expenditureswill not exceed projected levels, that it will be able to securepartnerships or obtain financing within the next six months to meetoperating expenses and to conduct its upcoming confirmatory Phase 3 trialof orBec®, that product development and commercialization efforts willnot be reduced or discontinued due to difficulties or delays in clinicaltrials or due to lack of progress or positive results from research anddevelopment efforts, that it will be able to successfully obtain anyfurther grants and awards, maintain its existing grants which are subjectto performance, enter into any biodefense procurement contracts with the USGovernment or other countries, that the US Congress may not pass anylegislation that would provide additional funding for the Project BioShieldprogram, that it will be able to patent, register or protect its technologyfrom challenge and products from competition or maintain or expand itslicense agreements with its current licensors, or that its businessstrategy will be successful. Important factors which may affect the futureuse of orBec® for gastrointestinal GVHD include the risks that: the FDA'srequirement that DOR conduct additional clinical trials to demonstrate thesafety and efficacy of orBec® will take a significant amount of time andmoney to complete and positive results leading to regulatory approvalcannot be assumed; DOR is dependent on the expertise, effort, prioritiesand 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; andothers may develop technologies or products superior to orBec®. These andother factors are described from time to time in filings with theSecurities and Exchange Commission, including, but not limited to, DOR'smost recent reports on Forms 10-Q and 10-KSB. Unless required by law, DORassumes no obligation to update or revise any forward-looking statements asa result of new information, future events.

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Company Contact:Evan MyrianthopoulosChief Financial Officer(609) 538-8200www.dorbiopharma.comDOR BioPharma, Inc.850 Bear Tavern Road, Suite 201Ewing, NJ 08628