Healthcare Industry News: organ transplant
News Release - September 17, 2008
DOR BioPharma Forms orBec(R) European Medical Advisory BoardEWING, NJ--(Healthcare Sales & Marketing Network)--Sep 17, 2008 -- DOR BioPharma, Inc. (DOR or the Company) (OTC BB:DORB.OB ), a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today the formation of a European Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it relates to the ongoing development of orBec® for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD).
The MAB will play a crucial advisory role in the design of future clinical studies and associated interactions with the European Medicines Evaluation Agency (EMEA). The European MAB is made up of physicians with extensive backgrounds in the field of allogeneic hematopoietic cell transplantation (HCT), the clinical setting in which GI GVHD occurs. DOR's new MAB members are from a diverse array of European countries, and will bring a unique European perspective to the strategic development of orBec®. The MAB will be chaired by George B. McDonald, MD, Professor of Medicine at the University of Washington, Member at the Fred Hutchinson Cancer Research Center, inventor of orBec® and a consultant to DOR.
Dr. McDonald stated, "I am pleased with the caliber of the orBec® Medical Advisory Board we have selected from key European countries. This experienced and respected group of leading hematopoietic cell transplant oncologists has been assembled based on their substantial practice and research contributions in the transplant field in their own institutions. Their collective research efforts have had a clinical impact worldwide. We are very much looking forward to their productive involvement with the orBec® program in Europe."
"We are very excited to be able to attract key European opinion leaders to participate in the development of orBec® as members of our Medical Advisory Board," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "The formation of a European Board, in concert with the North American Medical Advisory Board established last year, will provide us with critical medical guidance to continue the development of orBec® so that we may make it available to the patients who so desperately require a therapeutic option. The availability of orBec® in Europe under named patient protocols is an important step forward in the treatment for GI GVHD."
The orBec® European MAB Members
George B. McDonald, MD, is a Professor of Medicine at the University of Washington, School of Medicine, and a Member at the Fred Hutchinson Cancer Research Center, where he is head of the Gastroenterology/Hepatology Section. He also serves as the head of the Program in Complications of Cancer Treatment that has as its goals the reduction of morbidity from cancer treatment, improved survival, and prevention of late sequelae of cancer treatment. Dr. McDonald's research is focused on gastrointestinal and hepatobiliary complications of HCT, specifically problems involving the toxicity of high-dose myeloablative regimens that are used to prepare patients for transplant and acute and chronic GVHD involving the gastrointestinal tract and liver. He has recently developed and validated a new method of assessing the severity of acute GVHD, called the acute GVHD Activity Index, an accurate predictor of transplant-related mortality. He was the lead investigator on the clinical trials that pioneered the use of topical corticosteroid therapy with oral beclomethasone dipropionate for GI GVHD.
Dietger Niederwieser, MD, is the Head of the Department of Hematology and Oncology at the University of Leipzig in Leipzig, Germany. Professor Niederwieser is the current President of the European Group for Blood and Marrow Transplantation (EBMT). He has been active with EBMT for the past 20 years, previously serving as the Chairman of the Chronic Leukemia Working Party. He has published more than 300 papers focusing on topics such as the immunology of stem cell transplantation (SCT), minor histocompatibility antigens, graft-versus-tumour reactions, reduced intensity conditioning SCT, standardization of procedures and donor-transmitted diseases. Prof. Niederwieser was trained in Internal Medicine and Haematology at Innsbruck in Austria, and received specialized training on clinical SCT and pathophysiology of GVHD in Basel, Switzerland and Seattle, Washington, USA. He has received a number of awards including the doctor honoris causa of the University of Thessaloniki and the title of Cavaliere della Repubblica Italiana from the Presidente della Repubblica Italiana Napolitano.
Jane Apperley, MD, is the Chair of the Department of Hematology at the Imperial College and the Chief of Service for Clinical Hematology at the Imperial College Healthcare NHS Trust in London, England. She qualified in Medicine from the University of Birmingham and after initial specialization in internal medicine she completed specialist training in hematology in Birmingham, London, Cambridge and Boston. Her particular interests are the biology and management of chronic myeloid leukemia, which has led naturally to an extensive experience in SCT and more recently to the use of signal transduction inhibitors in this disease. Professor Apperley is the past-President of both the EBMT and the British Society of Blood and Marrow Transplantation and serves on the Advisory Board of the CIBMTR CLINT (Facilitating International Prospective Clinical Trials in Stem Cell Transplantation).
Andrea Bacigalupo, MD, is the Head of the Department of Hematology at Ospedale San Martino in Genoa, Italy, where he has served in various capacities since 1974. Dr. Bacigalupo's BMT work began in 1976 in Genoa on allogeneic BMT. He has worked for many years within the EBMT since 1983, and has served as President. He is a member of the International Society for Experimental Hematology and the Societa' Italiana Ematologia. Dr. Bacigalupo has published more than 300 articles in peer-reviewed journals. His research interests lie in bone marrow transplantation, leukemia, graft versus leukemia, aplastic anemia, in vitro growth of progenitor cells, growth factors, CMV, data management, and patient oriented computer-based monitoring.
José Antonio Pérez Simón, MD, PhD, is an Attending Physician in the Bone Marrow Transplant Unit in the University Hospital in Salamanca, Spain, and leads the Cellular Therapy Laboratory of the Department of Hematology in the area of Immunology of Bone Marrow Transplantation. He completed his clinical training in BMT at the Fred Hutchinson Cancer Research Center and his laboratory training at the Karolinska Institute. He has multiple peer-review publications and his major contributions have been in the field of GVHD both in the clinical setting as well as in the basic research.
Hans Hägglund, MD, PhD, is an Associate Professor of Hematology and Internal Medicine Specialist in the Department of Hematology at the Karolinska University Hospital in Huddinge, Sweden. Dr Hägglund completed a post-doc position at the Fred Hutchinson Cancer Research Center. He has multiple peer-review publications in the field of SCT, lymphoma and acute lymphoblastic leukemia. He is a committee member of the Swedish Hematology Association and the national acute lymphoblastic leukemia group.
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. 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 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.
About GI GVHD
GI GVHD is a debilitating and painful disease. It is a common disorder among immuno-compromised cancer patients after receiving allogeneic stem cell or bone marrow transplants. Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's body -- most frequently the gastrointestinal tract, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.
About Allogeneic Bone Marrow/Stem Stem Cell Transplantation (HSCT)
HSCT is considered a potentially curative option for many leukemias as well as other forms of blood cancer. In an allogeneic HSCT procedure, hematopoietic stem cells are harvested from a closely matched relative or unrelated person, and are transplanted into the patient following either high-dose chemotherapy or intense immunosuppressive conditioning therapy. The curative potential of allogeneic HSCT is now partly attributed to the so-called graft-versus-leukemia or graft-versus-tumor effects of the newly transplanted donor cells to recognize and destroy malignant cells in the recipient patient.
The use of allogeneic HSCT has grown substantially over the last decade due to advances in human immunogenetics, the establishment of unrelated donor programs, the use of cord blood as a source of hematopoietic stem cells and the advent of non-myeloablative conditioning regimens ("mini-transplants") that avoid the side effects of high-dose chemotherapy. Based on the latest statistics available, it is estimated that there are more than 12,000 HSCT procedures annually in the US and a comparable number in Europe. Estimates as to the current annual rate of increase in these procedures are as high as 20%. High rates of morbidity and mortality occur in this patient population. Clinical trials are also underway testing allogeneic HSCT for treatment of some metastatic solid tumors such as breast cancer, renal cell carcinoma, melanoma and ovarian cancer. Allogeneic transplants have also been used as curative therapy for several genetic disorders, including immunodeficiency syndromes, inborn errors of metabolism, thalassemia and sickle cell disease. The primary toxicity of allogeneic HSCT, however, is GVHD. In GVHD, the newly transplanted donor cells damage cells in the recipient's gastrointestinal tract, liver and skin.
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.
For further information regarding DOR BioPharma, Inc., please visit the Company's website located 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 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 Forms 10-Q and 10-KSB. Unless required by law, DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events.
Source: DOR BioPharma
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