Healthcare Industry News: GVHD
News Release - March 20, 2007
DOR BioPharma Forms orBec(R) Medical Advisory BoardMIAMI, FL--(Healthcare Sales & Marketing Network)--Mar 20, 2007 -- DOR BioPharma, Inc. (OTC BB:DORB.OB ) ("DOR" or the "Company") announced today the formation of a North American Medical Advisory Board ("MAB") to provide clinical guidance to the Company in anticipation of the potential US marketing approval for orBecŪ for the treatment of gastrointestinal Graft versus Host disease ("GI GVHD"). The MAB is made up of clinical and research physicians with extensive backgrounds in the field of allogeneic hematopoietic cell transplantation ("HCST"), the clinical setting that GI GVHD occurs within. 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 orBecŪ, and a consultant to DOR.
"We are continuing to position ourselves for potential US approval of our lead product, orBecŪ, as well as focusing on additional clinical testing of orBecŪ in other important therapeutic areas," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "The combined experience of this panel of experts and opinion leaders will provide us with critical support and guidance necessary to achieve these goals. If approved by the FDA, orBecŪ will be the first treatment for GI GVHD to be marketed in the United States."
The orBecŪ 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 hematopoietic cell transplantation, specifically problems involving the toxicity of high-dose myeloablative regimens that are used to prepare patients for transplant and acute and chronic graft-versus-host disease 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.
Joseph Antin, MD heads the Stem Cell Transplant Program of the Department of Medical Oncology at the Dana Farber Cancer Institute and is a founding member and past president of the American Society of Blood and Marrow Transplantation. He is a Professor of Medicine at the Harvard Medical School. His current clinical research interest focuses on pharmacologic control of GVHD using synergistic combinations of immunosuppressive drugs and to understand and harness the graft-versus-leukemia effect through non-myeloablative transplantation as well as selective depletion of T cells.
Joachim Deeg, MD is a Professor of Medical Oncology at the University of Washington and a Member of the Fred Hutchinson Cancer Research Center in Seattle. He has a long track record of investigations in preclinical models of GVHD and clinical trials for the prevention and treatment of GVHD. He has multiple peer-reviewed publications in the field and has co-edited a major Textbook on GVHD, now in its third edition. His current research interests at the Fred Hutchinson Cancer Research Center include the pathophysiology and therapy of the myelodysplastic syndrome, programmed cell death and GVHD.
Donna Przepiorka, MD is Professor of Medicine at the University of Tennessee Health Science Center. She was the Chair of the Oncology Drug Advisory Committee at the FDA from 2002-2004 and President of the International Society for Cellular Therapy from 2004-2006. She is a committee member of the National Comprehensive Cancer Network ("NCCN") for acute myeloid and chronic myelogenous leukemia and chairs the Program Project Review Committee of the NIH National Heart, Lung and Blood Institute ("NHLBI"). Her current interest is regulatory matters in drug development, especially biological agents.
Kirk Schultz, MD is an Associate Professor of Pediatrics and Pathology at the University of British Columbia in Vancouver, Canada, and Director of the Pediatric Oncology Research Group at British Columbia Children's Hospital. He is the recipient of the CIHR/Wyeth Clinical Research Chair in Transplantation. His major contributions have been in the immune therapy of Acute Lymphoblastic Leukemia and the pathology of Chronic Graft-versus-Host Disease. In 2000, he was elected the first Chair of the Canadian Bone Marrow Transplant ("BMT") Clinical Trial Group, a group that includes all adult and pediatric BMT centers in Canada. Since 2004, he is the Pediatric BMT Consortium Chair and developed the first pediatric focused section at the American Society of BMT.
Keith Sullivan, MD is the James B. Wyngaarden Professor of Medicine, Duke University Medical Center where he was Chief, Division of Medical Oncology and Transplantation. He currently is the Director, Long-term Follow-up and Information Research Program, in the Division of Cellular Therapy. He has extensively published in the area of bone marrow transplantation with over 400 peer-reviewed publications and book chapters. He is an electee of the Association of American Physicians and a Fellow of the American Association for the Advancement of Science. He leads the national multi-center transplant study for systemic sclerosis within the Hematopoietic Stem Cell Transplantation Trials for Autoimmune Disease at the NIH. His current research interests include the use of hematopoietic stem cell transplantation for treatment of autoimmune diseases and sickle cell anemia.
Daniel Weisdorf, MD is Professor of Medicine and Director of the University of Minnesota Blood and Marrow Transplant Program. He serves as the Scientific Director of the National Marrow Donor Program and Senior Research Advisor for the Center for International Bone Marrow Transplant Research as well as Scientific Director for its Acute Leukemia Committee. He is the University Principal Investigator on the NIH-sponsored Bone Marrow Transplantation Clinical Trials Network. His clinical and research interests are in application of blood and marrow transplant therapies for hematologic malignancies as well as extensive study of the clinical complications of transplantation including opportunistic infections and GVHD.
orBecŪ Submitted for Regulatory Approval
orBecŪ's New Drug Application ("NDA") was filed with the U.S. Food and Drug Application ("FDA"), and the Marketing Authorization Application ("MAA") was filed with the European Medicines Evaluation Agency ("EMEA"). Both health authorities have accepted the filings for review and the FDA has said it will respond to DOR's NDA by July 21, 2007 under PDUFA guidelines. In addition, the FDA's Oncology Drug Advisory Committee ("ODAC") currently will review the NDA for orBecŪ on May 9, 2007.
orBecŪ 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. orBecŪ, if approved by the EMEA and the FDA, would be the first oral formulation of beclomethasone dipropionate ("BDP") available in the European Union and the United States, respectively. orBecŪ 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 U.S. 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. orBecŪ 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, orBecŪ also benefits from orphan drug designations in the U.S. and in Europe for the treatment of GI GVHD, which provide for 7 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 ("GVL") or graft-versus-tumor ("GVT") 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 U.S. 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. is a 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, orBecŪ (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA with the FDA for the treatment of GI GVHD, and has received a PDUFA date of July 21, 2007. In addition, the FDA's Oncology Drug Advisory Committee ("ODAC") will review the NDA for orBecŪ on May 9, 2007. An MAA with the EMEA for orBecŪ has also been filed and validated. orBecŪ may also have application in treating other gastrointestinal disorders characterized by severe inflammation.
Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted 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 and botulinum toxin. DOR's ricin toxin vaccine, RiVax(TM), has been shown to be safely tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBecŪ for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBecŪ. Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. 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 also cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBecŪ, 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 technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, 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 U.S. Government or other countries, that the U.S. 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 orBecŪ for gastrointestinal GVHD include the risks that: because orBecŪ did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBecŪ approvable based upon existing studies, orBecŪ may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR expects or may never gain approval; 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; or orBecŪ may not gain market acceptance; and others may develop technologies or products superior to orBecŪ. 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 Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.
Source: DOR BioPharma
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