Dor (AMEX:DOR)
Historical Stock Chart
From Oct 2019 to Oct 2024
DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company")
announced today the first successful evaluation in animal tests of a
nasal, bivalent combination of its botulinum toxin vaccine,
BT-VACC(TM), addressing two of the most prevalent serotypes of
botulinum toxin, types A and B. DOR is designing BT-VACC(TM) to be
administered by the mucosal route, which offers significant advantages
to the end user in terms of increased safety, lack of pain from
injections, and ability to induce protective antibodies in the lung
and intestines. These types of antibodies are associated with
inactivation of botulinum toxins before they enter the body. These
results are the first ever report of a combination of botulinum
vaccine serotypes given by the mucosal route.
In these experiments, the botulinum toxin vaccine serotypes A and
B were mixed together and given to mice and rats by vaccinating the
nasal passages through inhalation of the vaccine. The animals were
given a small quantity of the bivalent combination vaccine containing
each of the type A and type B antigens (10 micrograms) three times two
weeks apart. All of the animals developed equivalent immune responses
to A and B types in the serum. Importantly, they were then protected
against exposure to each of the native toxin molecules given at
1000 fold the dose that causes lethality. The immune responses were
also comparable to the same vaccines when given by intramuscular
injection. Typically, vaccines given by mucosal routes are not
immunogenic because they do not attach to immune inductive sites. In
the case of the combination BT-VACC(TM), both the A and the B
antigens were capable of attaching to cells in the mucosal epithelium
and inducing an immune response with similar magnitude to the
injected vaccine.
"These results are significant because they demonstrate that we
can induce an effective immune response to a combination of botulinum
toxin serotypes in animals without using injections and, moreover,
without using adjuvants that are usually needed with injected
vaccines," said Michael T. Sember, President and CEO of DOR BioPharma,
Inc. "The next steps will involve the addition of botulinum toxin type
E serotype vaccine to the mucosal cocktail. We intend to move the
mucosal vaccine as rapidly as possible towards clinical studies. We
hope to compete successfully in supplying the government and the
Department of Defense needs for mucosally administered botulinum toxin
vaccines that are effective, safe and easier to use than traditional
injected vaccines."
In related work, DOR also reports that its collaborators at
Dowpharma(SM) have expressed the cocktail of BT-VACC(TM) antigens
through utilization of their Pfenex Expression Technology(TM), a
Pseudomonas-based technology. These antigens are expressed in the
correct configuration expected for the vaccine and enriched in the
surface fraction of the host cells for ease of purification. These
bacteria produce high level expression of recombinant proteins and
peptides in comparison to other commercially available microbial
expression systems such as E. coli.
Botulinum toxin, considered the most poisonous natural substance
known to mankind, is classified as a Category A biothreat by the
Centers for Disease Control (CDC), and has been used in a number of
well-documented incidents. It can be aerosolized and is 100,000 times
more toxic than sarin gas, and currently there is no FDA-approved
vaccine or therapeutic. The toxin is known to exist in seven different
serotypes, designated A to G, but only three (A, B and E) account for
almost all human cases of disease. Once exposed to botulinum toxin,
blockage of peripheral nerve function and descending flaccid paralysis
ensues, which usually leads to death.
About Dowpharma
Dowpharma(SM) serves the pharmaceutical and biopharmaceutical
industries with innovative technologies, products, and services in
drug discovery, development, delivery and manufacturing. Dowpharma has
one of the broadest and deepest capabilities in the global outsourcing
industry with services that include process development, route
selection, methods development, custom solubilization, chiral
capabilities, and associated analytical services, as well as
manufacturing and scale-up from feasibility, through clinical trials,
to commercial manufacturing.
Dowpharma manufactures small molecule Active Pharmaceutical
Ingredients (APIs) and intermediates, nucleic acid medicines, cGMP
polymers, peptides and therapeutic proteins from microbial
fermentation and plant-based systems. Dowpharma draws upon over
30 years of excellent cGMP regulatory compliance in the organic
synthesis of APIs and pharmaceutical intermediates with the ability
to provide client support in filing and validation strategies.
Dowpharma operates research, process development, and manufacturing
facilities in North America and Europe. More information is
available at http://www.dowpharma.com.
About Dow
Dow is a diversified chemical company that harnesses the power of
science and technology to improve living daily. The Company offers a
broad range of innovative products and services to customers in more
than 175 countries, helping them to provide everything from fresh
water, food and pharmaceuticals to paints, packaging and personal care
products. Built on a commitment to its principles of sustainability,
Dow has annual sales of $46 billion and employs 42,000 people
worldwide. References to "Dow" or the "Company" mean The Dow Chemical
Company and its consolidated subsidiaries unless otherwise expressly
noted. More information about Dow can be found at http://www.dow.com.
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 by second quarter 2006.
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 in
normal volunteers. We have also initiated 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, 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 presently is involved in
financing 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.