DOR BioPharma, Inc. Announces Formation of Acute Radiation Enteritis Medical Advisory Board

January 26, 2009 |

13 min read

EWING, NJ--(Marketwire - January 26, 2009) -

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DOR BioPharma, Inc. (OTCBB: DORB) (DOR or the Company) announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it relates to the development of DOR201 (oral beclomethasone dipropionate) for the prevention and treatment of acute radiation enteritis.

The MAB will play an important advisory role in the conduct of the planned DOR201 Phase 1/2 clinical study as well as in the design of future clinical studies and associated regulatory interactions with health authorities. The MAB is made up of physicians with extensive backgrounds in the field of radiation oncology and gastroenterology. The MAB will be chaired by George B. McDonald, MD, Professor of Medicine at the University of Washington and Member at the Fred Hutchinson Cancer Research Center.

Dr. McDonald stated, “I am pleased with the caliber of the Medical Advisory Board we have assembled. This experienced and respected group of leading radiation oncologists has been selected based on their substantial practice and research contributions. We are very much looking forward to their productive involvement with the DOR201 program.”

“Acute radiation enteritis is a common complication of external beam radiation used to treat several cancers,” stated William Small, Jr., MD, FACRO, of Northwestern University Medical School in Chicago, Illinois. “At times the only alternative for the physician is to modify the cancer treatment, which could potentially decrease the likelihood of treatment success. It is our hypothesis that the preemptive administration of DOR201 may reduce the inflammatory component of acute radiation enteritis, potentially preventing the development of anorexia, abdominal pain and diarrhea following pelvic and abdominal irradiation while also allowing the cancer treatment to be successfully completed.” Dr. Small added, “I am pleased to see that the FDA has acknowledged this unmet medical need that exists in this highly debilitating condition through the granting of ‘fast-track’ designation to DOR.”

“We are very excited to be able to attract such knowledgeable and experienced individuals to participate as members of our Medical Advisory Board in the development of DOR201,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. “The formation of this MAB will provide us with critical medical guidance necessary to embark upon this important clinical development program. We look forward to working with the MAB and initiating the Phase 1/2 clinical study in the first half of 2009.”

The 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 (HCT), 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 (GVHD) involving the gastrointestinal tract and liver. He was the lead investigator on the clinical trials that pioneered the use of topical corticosteroid therapy with oral beclomethasone dipropionate for gastrointestinal (GI) GVHD.

Lisa Kachnic, MD, is Chairperson of the Department of Radiation Oncology at Boston University Medical Center and serves on the Radiation Oncology faculty at the Massachusetts General Hospital. She also serves as GI Radiation Oncology Chair and Discipline Vice-chair of the Radiation Oncology Committee for the Southwest Oncology Group. As such, she has served as principal or co-principal investigator on several national trials, a Phase 2 trial evaluating dose-painted Intensity Modulated Radiation Therapy (IMRT) in combination with 5-fluorouracil and mitomycin-C for the reduction of acute morbidity in carcinoma of the anal canal. As a tribute to these efforts, Dr. Kachnic has been awarded funding as Principal Investigator, National Cancer Institute, U10 CA37422, “Community Clinical Oncology Program (CCOP) Radiation Therapy Oncology Group,” and is the 2008 recipient of the first Radiation Therapy Oncology Group (RTOG) “Next Generation Investigator” Award. Dr. Kachnic belongs to a number of professional organizations including the American Society for Therapeutic Radiation and Oncology (ASTRO), American Society of Clinical Oncology (ASCO), American Association for Cancer Research (AACR), Radiation Research and the International Society of Gastrointestinal Oncology. She serves on the editorial boards of the Journal of the National Cancer Institute and Gastrointestinal Cancer Research, and contributes her radiation expertise to the National Cancer Institute’s Adult Oncology Treatment Editorial Board and to the U.S. Department of Defense Medical Research Study Sections. She is actively involved in the Radiation Therapy Oncology Group’s GI and Outcome strategic committees and has been the RTOG Chairperson of Symptom Management since 2003. Dr. Kachnic received her undergraduate degree from Boston College and her medical degree from Tufts University. She completed her residency in Radiation Oncology at Harvard University, with her last year as chief resident.

Marvin Rotman, MD, is a Professor and Chairman of the Department of Radiation Oncology at SUNY Downstate Medical Center in Brooklyn, NY and a leader in developing cancer treatments that combine continuous infusion chemotherapy and radiation therapy. Dr. Rotman has held senior offices and board positions at major professional societies in his field and has been active in the RTOG and numerous other medical research projects. He has held high office locally (New York Roentgen Society, Radiotherapy Section Chairman, and President, New York Cancer Society) and nationally (President of The American Radium Society, Executive Committee Member-At-Large of ASTRO, Second Vice President of the Radiological Society of North America, and President of the Society of Chairmen of Academic Radiation Oncology Departments) and has served on the Radiation Oncology Residency Review Committee. He is the co-author of four textbooks and the author or co-author of over 40 medical textbook chapters. He has more than 150 refereed journal publications to his credit. Prior to his appointment to the chair at SUNY Downstate, Dr. Rotman was professor of radiology at New York Medical College. Dr. Rotman received his medical degree from Jefferson Medical College and trained at Albert Einstein Medical Center in Philadelphia and at Montefiore Medical Center in the Bronx. He also did post-graduate training at the M.D. Anderson Hospital and Tumor Institute in Houston.

William Small, Jr. MD, FACRO, is a Professor of Radiation Oncology and Vice-President of the Department of Radiation Oncology at Northwestern University Medical School in Chicago, IL, as well as an Attending Physician at the Northwestern Memorial Hospital. He is a member of various medical societies, including, but not limited to, the American Association of Cancer Researchers, the American College of Radiation Oncology, the American College of Radiology, and the American Medical Association. Dr. Small is a recipient of numerous awards. For the past four years, he has been honored as one of the “Best Doctors in America.” Last year he was included in the “Guide to Top Radiologists 2007,” “Outstanding Physicians - Chicago Consumers’ Checkbook,” and “America’s Top Doctors for Cancer.” Dr. Small has authored or co-authored 60 journal articles, eight book chapters, two books, and over 45 scientific abstracts. He is on the editorial boards of Cancer News and The American Journal of Radiation Oncology, and is a reviewer for over 15 medical journals such as The American Journal of Clinical Oncology, The British Journal of Cancer, and JAMA. Dr. Small earned his medical degree from the Northwestern University Medical School. He held an internship in internal medicine at the Northwestern Memorial Hospital where he also completed a residency in radiation oncology.

About Acute Radiation Enteritis

External radiation therapy is used to treat most types of cancer, including cancer of the bladder, uterine, cervix, rectum, prostate and vagina. During delivery of treatment, some level of radiation will also be delivered to healthy tissue, including the bowel, leading to acute and chronic toxicities. The large and small bowels are very sensitive to radiation. The larger the dose of radiation, the greater the damage to normal bowel tissue. Radiation enteritis is a condition in which the lining of the bowel becomes swollen and inflamed during or after radiation therapy to the abdomen, pelvis or rectum. Most tumors in the abdomen and pelvis need large doses, and almost all patients receiving radiation to the abdomen, pelvis or rectum will show signs of acute enteritis.

Patients with acute enteritis may have nausea, vomiting, abdominal pain and bleeding, among other symptoms. Some patients may develop dehydration and require hospitalization. With diarrhea, the gastrointestinal tract does not function normally, and nutrients such as fat, lactose, bile salts, and vitamin B12 are not well absorbed.

Symptoms will usually resolve within 2-6 weeks after therapy has ceased. Radiation enteritis is often not a self-limited illness, as over 80% of patients who receive abdominal radiation therapy complain of a persistent change in bowel habits. Moreover, acute radiation injury increases the risk of development of chronic radiation enteropathy, and overall 5% to 15% of the patients who receive abdominal or pelvic irradiation will develop chronic radiation enteritis.

There are over 100,000 patients in the United States annually who receive abdominal or pelvic external beam radiation treatment for cancer who are at risk of developing acute and chronic radiation enteritis.

About DOR201

DOR201 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. BDP is also the active ingredient in orBec®, currently in Phase 3 and Phase 2 development by DOR for the treatment and prevention of GI GVHD, respectively. DOR201 is a time-release formulation of BDP specifically designed for oral use. In December 2008, DOR201 was granted Fast Track designation by the US Food and Drug Administration.

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 HCT. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec® for the treatment of GI GVHD in the first 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™) 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 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 or future events.