DOR BioPharma Obtains Fast Track Designation for DOR201 in the Prevention of Acute Radiation Enteritis
Tuesday January 6, 7:00 am ET
EWING, NJ--(MARKET WIRE)--Jan 6, 2009 -- DOR BioPharma, Inc. (DOR or the Company) (OTC BB:DORB.OB - News) today announced that its program for the development of DOR201 (oral beclomethasone dipropionate) for the prevention of acute radiation enteritis has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA).
Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, DOR will be eligible to submit a new drug application (NDA) for DOR201 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which implies an abbreviated review time of six months.
"There are no FDA approved therapies to prevent acute radiation enteritis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "The FDA's action in granting fast track designation is an indication of DOR201's potential to address this serious, unmet medical need with over 100,000 patients at risk annually. As the development program progresses, we look forward to working closely with the FDA to potentially expedite the development and NDA review process. The next step will be the initiation of the FDA cleared Phase 1/2 clinical trial in the first half of 2009."
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 gastrointestinal Graft-versus-Host disease (GI GVHD), respectively. DOR201 is time-release formulation of BDP specifically designed for oral use. |
