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DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company")
today announced results of a Phase I clinical trial of RiVax(TM), a
recombinant vaccine against ricin toxin, that has been completed by
investigators at the University of Texas Southwestern Medical Center
(UT Southwestern) led by Dr. Ellen Vitetta, director of the Cancer
Immunobiology Center at UT Southwestern. The results of the Phase I
safety and immunogenicity dose-escalation study indicate that the
vaccine is well tolerated and induces antibodies in humans that
neutralize ricin toxin. The outcome of the study will be published
this week in the online edition of the Proceedings of the National
Academy of Sciences.
The pilot Phase I dose escalation clinical trial of RiVax(TM)
marks the first time a ricin toxin vaccine has ever been clinically
tested in humans. The trial enrolled 15 volunteers in groups of 5 who
were vaccinated with three successive monthly injections of the same
dose level of RiVax(TM). Three dose levels of RiVax(TM) were
evaluated. The vaccine was prepared without an adjuvant to determine
whether the subunit itself was immunogenic and safe. Even without an
adjuvant, RiVax(TM) induced antibodies in all five of the individuals
who received the highest dose, four out of five who received the
intermediate dose, and one out of five who received the lowest dose
levels. The vaccine was well tolerated in all individuals with only
mild side effects that are typical of reactions to vaccines injected
intramuscularly. These side effects included mild transient headaches
and sore arms.
Despite the absence of an adjuvant, antibodies were present in the
blood of several volunteers for as long as 127 days after their last
vaccination. The functional activity of the antibodies was confirmed
by transferring serum globulins from the vaccinated individuals along
with active ricin toxin to sensitive mice, which then survived the
treatment.
"The fact that the animals survived in the presence of antibodies
from the vaccinees shows that the antibodies were functionally
active," stated Dr. Vitetta. "Based on the levels of antibodies made
by the volunteers, we expect that the human volunteers would be
protected against ricin toxin exposure. We are currently conducting
studies in mice to determine whether the vaccine protects them against
ricin administered by aerosols or orally instead of by injection.
Preliminary results are encouraging."
"We have had an excellent opportunity to work with UT Southwestern
and appreciate the efforts of Dr. Vitetta and her team," stated
Michael T. Sember, President and CEO of DOR. "These data, combined
with steady progress in efficacy testing, process development and
formulation by our collaborators, further demonstrate our leading
position in the development of a vaccine against the deadly threat of
ricin toxin."
During the past decade, the Department of Defense (DOD) has
identified the development of a safe and effective ricin vaccine as
one of its eight top development priorities and is currently exploring
the feasibility of available technologies to address that need. Under
the BioShield I Act, the government can authorize, purchase, and use
these vaccines as early as Phase I clinical testing, before a vaccine
is fully licensed by the Food and Drug Administration (FDA). The next
steps for the development of RiVax(TM) will include extensive
evaluation to correlate protection against ricin exposure in animals
to immune responses in vaccinated humans.
Ricin toxin is a potential bioterror threat due to its highly
lethal toxicity in small doses, ease of manufacture, and ability to be
aerosolized. Exposure to small amounts can lead to rapid lung damage
if inhaled, rapid onset of nausea, fever, and abdominal pain if
ingested, and general organ failure leading to death within several
days. The need for protective countermeasures against ricin has been
emphasized by its recent and continued use as a biological weapon.
There currently is no FDA approved vaccine against ricin toxin.
DOR has licensed the underlying technology and pending patent for
RiVax(TM) for commercial development from UT Southwestern. DOR is in
the process of implementing the transition of the vaccine to large
scale development and is also working with the National Institutes of
Allergy and Infectious Diseases (NIAID), a division of the National
Institutes of Health (NIH), under the auspices of a $6.4 million
Challenge grant to assure a smooth and timely progression.
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 successfully completed a Phase I clinical trial. We
have also announced the initiation of a 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.