DOR BioPharma Announces Advances in Mucosal Vaccines for Botulinum Toxin; Antigens are Made Using Dowpharma's Pfenex Expression
April 07 2006 - 9:19AM
Business Wire
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.
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