EWING, NJ--(Marketwire - January 06, 2009) -
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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.
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 hematopoietic cell transplantation. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec® for the treatment of GI GVHD in 1H 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.
Company Contact:
Evan Myrianthopoulos
Chief Financial Officer
(609) 538-8200
www.dorbiopharma.com
DOR BioPharma, Inc.
850 Bear Tavern Road, Suite 201
Ewing, NJ 08628
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