Message #7 From:
NewsBot Date: September 29, 2006 06:08:00 AM
DORB News CORRECTING and REPLACING DOR BioPharma Awarded Two Grants Totaling $5.3 Million to Advance Ricin Toxin and Botulinum Toxin Vaccine Programs
MIAMI--(BUSINESS WIRE)--Reissuing release to correct ticker symbol for searching purposes.
The corrected release reads:
DOR BIOPHARMA AWARDED TWO GRANTS TOTALING $5.3 MILLION TO ADVANCE RICIN
TOXIN AND BOTULINUM TOXIN VACCINE PROGRAMS
DOR BioPharma, Inc. (OTCBB:DORB)
(“DOR”, or the “Company”)
announced today that it has been awarded two additional grants from the
National Institute of Allergy and Infectious Diseases (NIAID) totaling
approximately $5.3 million to support the development of its biodefense
vaccine programs. One grant of approximately $4.8 million was awarded
for the continued development of RiVax™, a
recombinant vaccine against ricin toxin. The second grant of
approximately $0.5 million has been awarded to continue additional
research on the development of BT-VACC™, a
multivalent mucosal vaccine against botulinum toxin.
RiVax™
The RiVax™ grant will provide approximately
$4.8 million over a three year period to fund the development of animal
models which will be used to correlate human immune response to the
vaccine with protective efficacy in animals. This is necessary for
ultimate licensure by the FDA, when human efficacy vaccine trials are
not possible. This new grant also supports the further biophysical
characterization of the vaccine containing a well-characterized adjuvant
that is needed to enhance the immune response to recombinant proteins.
These studies will be required to assure that the vaccine is stable and
potent over a period of years. A prototype version of RiVax™
has been evaluated in a Phase I clinical trial last year and was shown
to be safe and effective, while also inducing ricin neutralizing
antibodies as confirmed in subsequent animal studies.
DOR has been developing RiVax™ in a
consortium effort between academic and industrial partners under a
separate $6.4 million NIAID grant that commenced in 2004. DOR has
closely collaborated with the University of Texas Southwestern Medical
Center (UTSW) and the vaccine’s originator,
Dr. Ellen Vitetta, in the transition from early research to advanced
development. Collaborators also include Stanford Research Institute (SRI
International) and the University of Kansas. In conjunction with Cambrex
Biosciences, DOR has also developed a robust large scale purification
process that will be used in the commercial manufacture of the vaccine.
Dr. Vitetta at UTSW has also separately been awarded a grant for $2.2
million over 5 years to conduct research in fundamental areas to develop
novel vaccine formulations and characterize immune responses in small
animals. That research will help support ongoing development of RiVax™.
“Through uninterrupted funding of this
project, NIAID continues to recognize the importance of RiVax™
as a potential protective countermeasure to ricin exposure and the
progress made in the program so far,” said
Robert N. Brey, Ph.D., Chief Scientific Officer for DOR BioPharma. “We
will continue to work closely with our partners and NIAID to develop
RiVax™. We anticipate that we can continue to
move RiVax™ into additional clinical studies
and satisfying the exigencies of HHS initiatives in the near future.”
BT-VACC™
DOR was also awarded a one year Phase I SBIR grant totaling
approximately $0.5 million to conduct further work to combine antigens
from different serotypes of botulinum toxin for a prototype multivalent
vaccine. The grant funding will support further work in characterizing
antigen formulations that induce protective immunity to the three most
common botulinum toxin types that may be encountered naturally or in the
form of a bioweapon. This work will continue the research conducted by
Dr. Lance Simpson and colleagues at Thomas Jefferson University, who
originally showed that recombinant non-toxic segments of the botulinum
toxin can be given by the oral as well as the intranasal route to induce
a strong protective immune response in animals. This observation forms
the basis for development of an oral or intranasal vaccine for botulinum
toxin that can be used in humans. Currently, the recombinant vaccines
under development are given by intramuscular injections. The alternate
route provides a self administration option, which will bypass the
requirement for needles and personnel to administer the vaccine.
About Ricin Toxin and Botulinum Toxin
Ricin toxin is a potential bioterror threat that is toxic in small
doses, is easy to obtain, and has the ability to be aerosolized.
Exposure to small amounts can lead to lung damage if inhaled, rapid
onset of nausea, fever, and abdominal pain if ingested. General organ
failure leading to death can occur within several days. The need for
protective countermeasures against ricin has been emphasized by its
recent and continued use as a biological weapon. Currently, there is no
FDA approved vaccine or countermeasure against ricin toxin.
Botulinum toxin is the most poisonous natural substance known and is
classified as a Category A biothreat by the Centers for Disease Control
(CDC). Botulinum toxin can be aerosolized and is 100,000 times more
toxic than sarin gas. Currently, there are no FDA-approved vaccines or
therapeutics. Botulinum 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 within hours without medical
treatment at a hospital.
Project BioShield
Both the House of Representatives and the Senate are now considering
bi-partisan bills that will provide for additional advanced development
funding and will structurally improve the Project BioShield program
enacted by Congress in 2004. In parallel, the Department of Health and
Human Services (HHS) has just unveiled a new strategy for the
development of medical countermeasures to complement the prioritization
of the strategic plan initiated in 2004 under Project BioShield. This
new plan calls for the HHS to adopt an enterprise-type model to define
specific countermeasure requirements in light of the stage of
development and to develop a new integrated research and development
portfolio. HHS has also just published a Request for Information (RFI)
to gather input to the HHS implementation plan for its strategy
document, with the ultimate goal of acquiring the most appropriate
medical countermeasures for mitigating the health effects from the
biological threats facing the nation.
DOR BioPharma, Inc. is a biopharmaceutical company developing products
for life-threatening side effects of cancer treatments, serious
gastrointestinal diseases, and bioterrorism. Our lead product, orBec®
(oral beclomethasone dipropionate), is a potent, locally-acting
corticosteroid being developed for the treatment of gastrointestinal
Graft-versus-Host disease (GI GVHD), a common and potentially
life-threatening complication of bone marrow transplantation. DOR
BioPharma has recently filed a New Drug Application (NDA) with the FDA
for orBec® for the
treatment of GI GVHD. orBec®
may also have applications in treating other gastrointestinal disorders
characterized by severe inflammation.
Through our BioDefense Division, we are developing biomedical
countermeasures pursuant to the recently enacted Project BioShield Act
of 2004. Our biodefense products in development are recombinant subunit
vaccines designed to protect against the lethal effects of exposure to
ricin toxin and botulinum toxin. Our ricin toxin vaccine, RiVaxTM,
has successfully completed a Phase I clinical trial in normal volunteers.
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, Inc.’s current
expectations about its future results, performance, prospects and
opportunities, including statements regarding the potential use of orBec®
for the treatment of gastrointestinal GVHD and the prospects for
regulatory filings for orBec®.
Where possible, DOR 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 cannot assure you that it will
be able to successfully develop or commercialize products based on its
technology, including orBec®,
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 the U.S. Congress may
not pass any legislation that would provide additional funding for the
Project BioShield program, 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®
for gastrointestinal GVHD include the risks that: because orBec®
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®
approvable based upon existing studies, orBec®
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 expects or may never
gain approval; DOR 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® may not gain
market acceptance; and others may develop technologies or products
superior to orBec®.
These and other factors are described from time to time in filings with
the Securities and Exchange Commission, including, but not limited to,
DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR 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.
