Healthcare Industry News: GI GVHD
News Release - June 29, 2009
DOR BioPharma Announces Publication of orBec(R) Clinical Pulmonary Data in Bone Marrow Transplantation
PRINCETON, N.J., June 29 (Healthcare Sales & Marketing Network) -- DOR BioPharma, Inc. (DOR or the Company) (OTC Bulletin Board: DORB ), a late-stage biopharmaceutical company, announced today that investigators at the Fred Hutchinson Cancer Research Center, Seattle, Washington, published a paper this morning in Bone Marrow Transplantation in which they demonstrate that DOR's lead product orBec® (oral beclomethasone dipropionate or BDP) decreases non-infectious inflammation of the lung in acute gastrointestinal Graft-versus-Host disease (GI GVHD) patients who received allogeneic hematopoietic cell transplants (HCT). Non-infectious inflammation of the lung is a common and potentially fatal complication of HCT that decreases the exchange of oxygen and carbon dioxide between the lung and blood and, in its severe form, may present as interstitial pneumonitis. The full article, entitled "Influence of Oral Beclomethasone Dipropionate on Early Non-Infectious Pulmonary Outcomes after Allogeneic Hematopoietic Cell Transplantation: Results from Two Randomized Trials," is available online at: http://www.nature.com/bmt/journal/vaop/ncurrent/abs/bmt2009129a.html.Among the data published:
- A decrease in gas exchange as measured by the diffusion of carbon monoxide from the lung (DLCO) was observed in 33 of 42 (79%) of the placebo-treated patients, from pre-transplant to 80 days after randomization, as compared to 27 of 49 (55%) of the orBec®-treated patients (p = 0.02).
- In the first 200 days after randomization, four of the patients treated with placebo developed non-infectious pulmonary complications, such as idiopathic pneumonia syndrome and cryptogenic organizing pneumonia, as compared to none of the orBec®-treated patients (p = 0.04).
The investigators, led by Dr. Jason Chien, reviewed data from two previous randomized, double-blind, placebo-controlled Phase 2 and 3 clinical trials evaluating orBec®, for the treatment of acute GI GVHD. Data from 120 patients (sixty patients treated with orBec®, sixty placebo) were available for this retrospective analysis. Patients were enrolled in these studies at the Fred Hutchinson Cancer Research Center, where pulmonary function testing is done prospectively and all patients with pulmonary complications are evaluated with a standard protocol. The investigators also evaluated adverse event reports of infectious and non-infectious inflammation of the lung.
These observations by Dr. Chien and colleagues on the preservation of pulmonary function among patients receiving orBec® is consistent with findings from the Phase 3 randomized trial reported by Hockenbery et al. (A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood 109: 4557 - 4563, 2007).
"While these trials were not designed to look at pulmonary endpoints, these observations suggest that a metabolite of oral BDP may be having a beneficial anti-inflammatory effect in the lungs of hematopoietic cell transplant recipients," stated Jason W. Chien, MD, MS, Assistant Member, Clinical Research Division of the Fred Hutchinson Cancer Research Center. "There was convincing evidence of preservation of lung function and an absence of non-infectious pulmonary disease in those who had received oral BDP. The explanation for this benefit appears to be related to the delivery of a small amount of the potent metabolite, 17-beclomethasone monopropionate, from the intestinal mucosa to the pulmonary artery via the portal circulation and the superior vena cava."
Dr. Chien added, "This finding has important implications for an alternative method for treatment of pulmonary inflammatory disease, that is, the delivery of a potent glucocorticoid to the pulmonary circulation after ingestion of an oral pro-drug (BDP). Clinical trials examining this novel pulmonary delivery system in patients with inflammatory lung diseases will be of interest."
"The positive pulmonary effects that were observed were clearly of benefit to the GVHD patients," said Brian L. Hamilton, MD, PhD, Chief Medical Officer of DOR. "The publication of these pulmonary results is exciting as they lead the way to the potential development of new applications of oral BDP in a number of pulmonary inflammatory disorders, such as asthma or interstitial lung diseases, having significant market opportunity beyond the GI area."
About orBec®
orBec® 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® is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec® is formulated for oral administration in GI GVHD patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.
In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec® also benefits from orphan drug 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. DOR is also continuing to actively build intellectual property around oral BDP in other inflammatory conditions.
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 GI GVHD, a common and potentially life-threatening complication of hematopoietic cell transplantation. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec® for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of DOR201 in acute radiation enteritis in the second half of 2009. orBec® is also 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(TM), has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
For further information regarding DOR BioPharma, Inc., please visit the Company's website at www.dorbiopharma.com.
This press release contains forward-looking statements that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. 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 cash expenditures will not exceed projected levels, 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 Forms 10-Q and 10-K. Unless required by law, DOR assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Source: DOR BioPharma
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