DOR BioPharma Announces Second orBec(R) Clinical Summary Published in "Expert Opinion on Investigational Drugs"

EWING, NJ, Sep 15 (MARKET WIRE) --
DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage
biopharmaceutical company developing products to treat the
life-threatening side effects of cancer treatments and serious
gastrointestinal diseases, and vaccines against certain bioterrorism
agents, announced today that the second summary of clinical trials of its
drug orBec(R) (oral beclomethasone dipropionate, or oral BDP) for the
treatment of gastrointestinal Graft-versus-Host disease (GI GVHD) has been
published in the September issue of peer-reviewed medical journal Expert
Opinion on Investigational Drugs. The publication "Oral Beclomethasone
Dipropionate, a Topically Active Corticosteroid for Treatment of
Gastrointestinal Graft-vs.-Host-Disease," is authored by Maria
Diez-Campelo, Fermin M Sanchez-Guijo & Jose A Perez Simon of the
University Hospital of Salamanca, Spain. The full article is available
online at:
http://www.informapharmascience.com/doi/abs/10.1517/13543784.17.9.1389.

The Expert Opinion paper concludes that orBec(R) is an effective therapy
for acute GI GVHD. As a single agent, the response rates observed with
orBec(R) of 65 - 77% are comparable to historical experience with systemic
corticosteroids. An even stronger case can be made for orBec(R) as a
maintenance therapy after an initial response to corticosteroids. Two
randomized, double-blind, placebo-controlled trials indicate that orBec(R)
prevents the recurrence of acute GI GVHD. Thus, in addition to the long
list of side effects of systemic corticosteroids expected to be lessened
by use of oral BDP among this population, an improved outcome in terms of
transplant mortality also has been observed. These results provide a
particularly strong rationale for the incorporation of steroid-sparing
regimens such as orBec(R) in acute GVHD treatment. The paper also makes
note that, although studies cannot be directly compared due to different
patient selection or inclusion criteria, orBec(R) is the only therapy
evaluated in a prospective randomized trial in the last 30 years to
effectively improve the survival of patients diagnosed with acute GVHD.

The authors' opinion is that two randomized, double-blind,
placebo-controlled trials have demonstrated that orBec(R), formulated as
gastric-release and enteric-coated pills and dosed at 8 mg/day, is safe
and effective in treating acute GI GVHD when used in conjunction with a
10-day induction course of prednisone. Among patients eligible for
prednisone taper after 10 days of induction therapy, treatment with oral
BDP reduces the risk of GVHD treatment failure at study days 50 and 80 by
> 60%.

"This is the fourth publication of our data in a well-regarded
peer-reviewed journal," stated Christopher J. Schaber, PhD, President and
Chief Executive Officer of DOR. "We believe that publications such as
these clearly highlight the importance of orBec(R) to the hematopoietic
cell transplantation community and help to reinforce the need for
approval of this therapy in the treatment of acute GI GVHD. We continue
to receive keen interest in orBec(R) from the international medical
transplant community. We believe that orBec(R) has the potential to
provide treating physicians with an effective and much needed tool to
improve their patient's outcomes including survival."

Expert Opinion on Investigational Drugs is a monthly peer-reviewed
journal, evaluating developments in pharmaceutical research, from animal
studies through to the launch of a new medicine. Its Senior Advisory
Panel and Section Editorial Board are composed of senior scientists
involved in drug research and development. Authors are encouraged to
express their expert opinion of the status of the research under review,
rather than simply reviewing the available data. Its audience consists of
scientists, managers and decision-makers in the pharmaceutical industry,
and others closely involved in R&D.

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 gastrointestinal Graft-versus-Host disease
(GI GVHD), a common and potentially life-threatening complication of bone
marrow transplantation. DOR filed a New Drug Application for orBec(R) with
the FDA for the treatment of acute GI GVHD and received a not approvable
letter in which the FDA has requested data from a confirmatory Phase 3
clinical trial to demonstrate the safety and efficacy of orBec(R).
orBec(R) is 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,
botulinum toxin and anthrax. 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 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 orBec(R) for the treatment of gastrointestinal GVHD
and the prospects for regulatory filings for orBec(R). 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 cannot assure you that it will be able to successfully
develop or commercialize products based on its technology, including
orBec(R), 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 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(R), 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). 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.

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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