DOR BioPharma Reports Positive New Survival Findings from Previously Completed Phase II and III Clinical Trials of orBec(R); Res

DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company")
announced today that as part of its process to submit a New Drug
Application ("NDA") for orBec(R) (oral beclomethasone dipropionate)
for the treatment of patients with gastrointestinal Graft-versus-Host
disease (iGVHD) and in response to a specific FDA request, it has
completed an analysis to compare the statistically significant
survival benefit demonstrated in favor of orBec(R) in its pivotal
Phase III clinical trial to the survival results of the earlier
successful 60 patient, randomized, double-blinded, placebo-controlled,
Phase II clinical trial of oral beclomethasone dipropionate for iGVHD.
   Details of these new findings will be discussed by George B.
McDonald, MD, inventor of orBec(R), at the annual Tandem Bone Marrow
Transplant Meeting of the American Society for Blood and Marrow
Transplantation and the International Bone Marrow Transplant Registry
in Honolulu on February 18, 2006 in a presentation entitled "Oral
beclomethasone dipropionate for gastrointestinal GVHD: a
corticosteroid-sparing treatment with improved survival at day-200."
   The randomized, double-blinded, placebo-controlled Phase II
clinical trial of oral beclomethasone dipropionate in 60 patients with
iGVHD was conducted and completed at the Fred Hutchinson Cancer
Research Center in Seattle. The new follow-up data and analysis from
the earlier Phase II trial suggests that the day-200 post transplant
survival results from the Phase II study are in concordance with the
approximate 70% reduction in mortality at day-200 post-transplant
demonstrated in favor of orBec(R) in DOR's 129 patient, pivotal,
multi-center, placebo-controlled Phase III clinical trial of orBec(R)
for the treatment of iGVHD. In addition, the long term follow-up data
from the Phase II clinical trial are also in concordance with the
long-term survival benefit seen in favor of orBec(R) in the pivotal
Phase III clinical trial. As previously reported, in DOR's pivotal
Phase III study, there were 16 (24%) deaths in the placebo arm as
compared to only 5 (8%) deaths in the orBec(R) arm at the
prospectively defined day-200 post transplant mortality endpoint,
achieving a statistically significant p-value of 0.011. Survival at
day-200 was not, however, a prospectively defined endpoint in the
Phase II trial and until recently so requested by the FDA, had not
been previously analyzed.
   The Phase II clinical trial was similar in design to the pivotal
Phase III trial which was completed in late 2004. In the Phase II
study, 60 patients with iGVHD were randomized to receive an induction
course of conventional prednisone therapy plus either oral
beclomethasone dipropionate or placebo. Initial responders continued
to take oral beclomethasone or placebo for an additional 20 days,
during which time the prednisone therapy was rapidly tapered. The
primary endpoint for this study was the clinically relevant
determination of whether iGVHD patients at Day 30 were or were not
able to consume at least 70% of their daily caloric intake by mouth.
The treatment response at study day 30 was 22 of 31 (71%) vs. 12 of 29
(41%) in the oral beclomethasone and placebo groups respectively,
achieving a statistically significant p-value of 0.02. This data was
previously published by Dr. McDonald in the journal Gastroenterology
(1998).
   DOR is also announcing today that in a recently completed analysis
of the day-200 survival endpoint data from the pivotal Phase III
clinical trial, it found that there were no previously undetected
imbalances between the treatment and placebo groups that could have
favored the orBec(R) group over the placebo group. In fact, there was
a higher proportion of high risk patients in the orBec(R) group which
would be expected to put the orBec(R) arm at a disadvantage. In spite
of this, orBec(R) was still the factor with the strongest statistical
association with survival.
   "These new findings give credence to our belief that orBec(R) has
a positive effect on survival in this patient population," said
Michael T. Sember, President and Chief Executive Officer of DOR.
"Since we missed our primary endpoint in the pivotal trial, the FDA
has told us that a very high emphasis would be placed on our survival
data. While the new preliminary Phase II survival results were not a
prospectively defined endpoint, they are nonetheless supportive and
corroborate the results from our pivotal Phase III clinical trial."
   George B. McDonald, MD, Head of the Gastroenterology/Hepatology
Section at the Fred Hutchinson Cancer Research Center, inventor of
orBec(R) and a consultant to DOR stated, "We believe that orBec(R), a
proprietary oral form of the potent site-active corticosteroid,
beclomethasone dipropionate, may represent the first new therapy for
iGVHD that improves survival. iGVHD is the most significant and life
threatening toxicity associated with allogeneic hematopoietic cell
transplants. orBec(R)'s topical activity in the gastrointestinal tract
maintains control of the signs and symptoms of gastrointestinal GVHD,
allowing prednisone exposure to be greatly reduced, resulting in fewer
infections and better survival."

   About DOR BioPharma, Inc.

   DOR BioPharma, Inc. is a biopharmaceutical company addressing
life-threatening side effects of cancer and cancer treatments, serious
gastrointestinal diseases and disorders, and biomedical
countermeasures. Our lead product, orBec(R) (oral beclomethasone
dipropionate), is a potent, locally-acting corticosteroid being
developed for the treatment of intestinal Graft-versus-Host disease
(iGVHD), a common serious complication of bone marrow transplantation
for cancer, as well as other GI disorders characterized by severe
inflammation. We plan to file a new drug application (NDA) with the
FDA for orBec(R) for the treatment of iGVHD in the first quarter of
2006.
   In November we announced that we entered into a binding letter of
intent to acquire Gastrotech Pharma A/S, a Danish biotech company
developing therapeutics based on peptide hormones to treat cancer and
gastrointestinal diseases and conditions.
   Through our BioDefense Division, we are developing biomedical
countermeasures pursuant to the paradigm established by the recently
enacted Project BioShield Act of 2004. Our biodefense products in
development are bioengineered vaccines designed to protect against the
deadly effects of ricin toxin and botulinum toxin, both of which are
considered serious bioterrorism threats. Our ricin toxin vaccine,
RiVax(TM), has completed the clinical portion of its Phase I clinical
trial in normal volunteers. We have also announced the initiation of a
new botulinum toxin therapeutic development program based on rational
drug design.
   For further information regarding DOR BioPharma, please visit the
Company's website located at http://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's current expectations about its future results,
performance, prospects and opportunities, including statements
regarding the potential use of orBec(R) for the treatment of iGVHD and
the prospects for regulatory filings for orBec(R). Where possible, DOR
BioPharma 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 BioPharma 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
obtain future financing or funds when needed, 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 U.S.
Government or other countries, 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, that it will be able to maintain its listing on the
American Stock Exchange ("AMEX") by completing a transaction which
will provide it with shareholders' equity of at least $6 million, or
that its business strategy will be successful. Important factors which
may affect the future use of orBec(R) for iGVHD include the risks
that: because orBec(R) did not achieve statistical significance in its
primary endpoint in the pivotal Phase III clinical study (i.e. a
p-value of less than or equal to 0.05), the FDA may not consider
orBec(R) approvable based upon existing studies, orBec(R) may not show
therapeutic effect or an acceptable safety profile in future clinical
trials, if required, or could take a significantly longer time to gain
regulatory approval than DOR BioPharma expects or may never gain
approval; DOR BioPharma 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; or orBec(R) may not gain market acceptance; and others
may develop technologies or products superior to orBec(R). DOR
BioPharma's business strategy has been revised to include the issuance
of its securities to acquire companies or assets. DOR BioPharma
presently is involved in negotiations which could result in the
issuance of a significant number of shares of its equity securities,
thereby diluting the equity interests of present stockholders. These
and other factors are described from time to time in filings with the
Securities and Exchange Commission, including, but not limited to, DOR
BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR
BioPharma 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.