DOR BioPharma Announces NIH Grant Award to Support Phase 1/2 Clinical Trial of DOR201...

DOR BioPharma Announces NIH Grant Award to Support Phase 1/2 Clinical Trial of
DOR201 in Radiation Enteritis

PRINCETON, N.J., Sept. 8 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (OTC
Bulletin Board: DORB) (DOR or the Company), a late-stage biotechnology
company, announced today that the National Institutes of Health (NIH) has
awarded DOR a Small Business Innovation Research (SBIR) grant to support the
conduct of a Phase 1/2 clinical trial evaluating DOR201, a time-release
formulation of oral beclomethasone dipropionate (oral BDP), for the prevention
of acute radiation enteritis. The award will provide DOR with approximately
$500,000 over a two-year period.

The grant application included the Phase 1/2 protocol BDP-ENT-01, which is
designed as a multicenter, open-label, sequential, dose-escalation study in
approximately 36 patients. Patients with rectal cancer who are scheduled to
undergo concurrent radiation and chemotherapy prior to surgery will be
enrolled in four dose groups. The objectives of the study are to evaluate the
safety and maximal tolerated dose of escalating doses of DOR201, as well as
the preliminary efficacy of DOR201 for prevention of signs and symptoms of
acute radiation enteritis. The study is expected to be initiated in 2009.

Acute radiation enteritis is caused by radiation-induced death of cells in the
lining of the bowel. As bowel cells die and are not replaced, gastrointestinal
toxicity develops over the next few days and weeks due to an inflammatory
response to dead cells and bacteria, with chronic diarrhea, vomiting and pain
being the major symptoms. The addition of chemotherapy often exacerbates the
onset, severity and debilitation related to intestinal symptoms. Radiation
enteritis often results in delay or interruption of the cancer treatment.
There are over 100,000 patients annually in the United States who receive
abdominal or pelvic external beam radiation treatment for cancer, and these
patients are at risk of developing acute and chronic radiation enteritis.

"Radiation enteritis is a serious complication for colorectal cancer patients
receiving radiation therapy that impacts their quality of life and can require
treatment modification," stated William Small, Jr., MD, FACRO, Professor and
Vice Chairman, Department of Radiation Oncology, Associate Medical Director,
Robert H. Lurie Comprehensive Cancer Center of Northwestern University and a
Principal Investigator for the Phase 1/2 clinical study. "Based on oral BDP's
proven pharmacology in treating severe gastrointestinal inflammation, DOR201
represents a potential prophylactic option that would enable
physicians/patients to maintain planned treatment regimens to battle the
underlying malignancy. I look forward to working with DOR on the continued
development of DOR201."

"In addition to the FDA's clearance of our IND and its granting of fast-track
designation, this grant award further validates the merits of our DOR201
clinical program," stated Christopher J. Schaber, PhD, President and CEO of
DOR. "Based on its known pharmacology, we believe that oral administration of
BDP may help to prevent or reduce the severity of acute radiation enteritis
and the deleterious effects it has on the patient's and treating physician's
ability to deal with the underlying malignancy. We look forward to working
with our Medical Advisory Board and investigational sites to initiate this
study."

About Acute Radiation Enteritis

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. External radiation therapy is used to treat most types of cancer,
including cancers of the bladder, uterus, 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 potential damage to normal bowel
tissue. 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.

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((R)), 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
a time-release formulation of BDP specifically designed for oral use. DOR201
has been awarded fast-track designation from the FDA for the treatment of
radiation enteritis.

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((R)) (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 hematopoietic cell transplantation. DOR expects to begin a confirmatory
Phase 3 clinical trial of orBec((R)) for the treatment of acute GI GVHD and a
Phase 1/2 clinical trial of DOR201 in radiation enteritis in the second half
of 2009. orBec((R)) 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(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 and botulinum toxin. DOR's ricin
toxin vaccine, RiVax(TM), 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 DOR201,
orBec(R) and LPM(TM), 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 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(R) 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(R) 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(R) may not gain market acceptance if it is eventually approved
by the FDA; and others may develop technologies or products superior to
orBec(R). Factors affecting the development and use of DOR201 and LPM(TM) are
similar to those affecting orBec(R). 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-K. 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.

SOURCE DOR BioPharma, Inc.

Evan Myrianthopoulos, Chief Financial Officer of DOR BioPharma, Inc.,
+1-609-538-8200