Dor (AMEX:DOR)
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DOR BioPharma, Inc. (AMEX: DOR) ("DOR" or the
"Company"), announced today positive interim results from its ongoing
Phase I clinical trial of RiVax(TM), its vaccine against ricin toxin.
The Phase I clinical trial of RiVax(TM) represents the first ricin
toxin vaccine ever to be clinically tested in humans and is being
conducted by DOR's academic partner, a group led by Dr. Ellen Vitetta
at the University of Texas Southwestern Medical Center at Dallas. In
the rising dose, open label trial, three cohorts of 5 normal
volunteers each have been dosed three times with 10, 33 and 100
micrograms. These interim data are from the first two lower dose
cohorts of volunteers. Early results demonstrate that the vaccine is
safe and immunogenic after immunization with three monthly injections
of vaccine, with volunteers developing antibodies. This is the first
indication that a ricin toxin vaccine elicits immune responses and
predicts that humans can be protected against ricin exposure. Antibody
data from all three cohorts is expected in the next several months.
RiVax(TM) is a form of ricin that consists of a fragment of the
toxin that has been proven in pre-clinical studies to be non-toxic but
retains the capacity to elicit protective immunity. Ricin toxin is
relatively easy to produce and exposure to small amounts, especially
by inhalation, can lead to lung damage, nausea, fever, abdominal pain,
and death within several days. "We are very encouraged that we have
demonstrated safety and seen antibody responses in the blood samples
of the volunteers," said Dr. Vitetta. "We are looking forward to a
complete analysis of the data as the trial continues."
"We are very pleased with these promising interim results which so
far corroborate our preclinical evaluation of RiVax(TM)," commented
Michael T. Sember, President and Chief Executive Officer of DOR.
"These data, combined with significant progress by our manufacturing
partner Cambrex, are evidence of our leading position in the
development of a vaccine against the deadly threat of ricin toxin."
In 2003, the National Institute of Allergy and Infectious Diseases
(NIAID), a division of the National Institutes of Health (NIH),
awarded Dr. Vitetta and UT Southwestern $2.6M to develop and test the
vaccine. In September of 2004, NIAID also awarded a $5.2 million grant
to DOR for process development, scale up and cGMP manufacturing of
RiVax(TM). The total amount of this grant has recently been increased
to $6.4 million. This grant supports manufacturing and process
development work being carried out by Cambrex.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company focused on the
development of therapeutic products and biomedical countermeasures for
areas of unmet medical need. 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
gastrointestinal disorders characterized by severe inflammation. We
intend to file a new drug application (NDA) with the FDA for orBec(R)
for the treatment of iGVHD later this year.
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), is currently the subject of a Phase I clinical trial in
normal volunteers. We have also recently 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 (including that
the results of its Phase I clinical trial of RiVax(TM) will
demonstrate acceptable safety and immunogenicity/efficacy), 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, 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). 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.