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DOR BioPharma and Dowpharma Enter Into a Joint Development
Agreement for BT-VACC(TM), DOR's Oral Vaccine Against Botulinum Toxin Poisoning
MIAMI, July 26 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (AMEX:DOR)
("DOR", or the "Company") today announced it has entered into a joint
development agreement with Dowpharma(SM), a business unit of The Dow Chemical
Company (NYSE:DOW), to advance the development of DOR's proprietary oral
botulinum vaccine, BT-VACC(TM). BT-VACC(TM) is designed to protect against
exposure to botulinum toxin, which is one of five Category A bioterrorism
threats identified by the U.S. government.
Under the agreement, Dowpharma will provide process development leading to
current Good Manufacturing Practices (cGMP) production services for BT-VACC
using its Pfenex Expression Technology(TM), a Pseudomonas-based technology that
accelerates speed to market for vaccines and biotherapeutics by surpassing the
quality and yield capabilities of existing microbial systems.
DOR's BT-VACC is an orally administered vaccine that protects against exposure
to botulinum neurotoxins. Oral administration of BT-VACC produces protective
antibodies that afford protection or prolonged survival of treated animals
against 30,000 times the lethal dose of botulinum toxin serotype A. The oral
route of administration of a vaccine is believed to be preferable to the
injectable form due to benefits derived from safer and easier administration,
lack of skilled medical personnel needed for administration, and relative ease
of distribution to the civilian population. DOR believes that it is the only
company developing an orally delivered botulinum toxin vaccine. Recent
preclinical studies of BT-VACC for serotype B resulted in similar
immunogenicity and protective efficacy results. Ongoing studies at Thomas
Jefferson University are focused on serotype E and multivalent immunization
experiments using serotype A, B and E antigens given simultaneously to animals.
"This is an important relationship for us as we continue to develop BT-VACC,"
commented Michael T. Sember, president and CEO of DOR BioPharma, Inc. "Results
to date indicate that BT-VACC has the ability to induce protective antibodies in
appropriate animal models. With Dowpharma's Pfenex Expression Technology, we
intend to expedite the production of multiple botulinum toxin serotype antigens
from the laboratory to cGMP production so that we can rapidly advance BT-VACC
into the clinic."
Dowpharma has an unmatched record in developing high-productivity strains for
numerous protein products, for both clinical and industrial applications.
Dowpharma has developed a Pseudomonas-based technology and know-how directed
toward protein expression and downstream processing of expressed proteins and
other biologically active compounds known as Pfenex Expression Technology.
Pfenex is built around specially modified strains of Pseudomonas fluorescens
bacteria that increase cellular expression of recombinant proteins and peptides
while maintaining critical solubility and activity characteristics.
"Dowpharma is committed to the development of biodefense products as this is
our third program to address bioterrorism threats," said Nick Hyde, Business
Director of Dowpharma. "Pfenex is proven to improve protein production and
consistently outperforms other commercially available microbial expression
systems such as E. coli. We are honored to work with DOR to expedite the
development of this important vaccine."
Botulinum toxin is considered the most poisonous natural substance known to
mankind and is classified as a Category A biothreat by the Centers for Disease
Control (CDC). It is aerosolizable and has previously been used in a number of
well-documented incidents. It is 100,000 times more toxic than sarin gas, and
currently there are no FDA approved vaccines or therapeutics. 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 occurs which ultimately leads to death within hours.
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 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.
DATASOURCE: DOR BioPharma, Inc.; The Dow Chemical Company
CONTACT: Evan Myrianthopoulos, Chief Financial Officer of DOR BioPharma,
Inc., +1-305-534-3383; or Kathy Witz Sweeney of Mentus, +1-858-455-5500,
ext. 230, for Dowpharma
Web site: http://www.dorbiopharma.com/