Dor (AMEX:DOR)
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DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company")
today announced that it has successfully completed the second
development milestone for its ricin vaccine, called RiVax(TM), under
the Challenge Grant previously awarded to DOR in September 2004 by the
National Institute of Allergy and Infectious Diseases (NIAID), a unit
of the National Institutes of Health. For the second milestone, the
Company has completed the development of a process for large-scale
manufacture of the key vaccine ingredient consisting of a modified
ricin toxin subunit protein. In addition, supplementary
characterization and formulation objectives have been achieved.
DOR is developing the vaccine under the Challenge Grant in
conjunction with the University of Texas Southwestern Medical Center,
Stanford Research Institute, University of Kansas, and Cambrex
Biosciences in Baltimore. This consortium led by DOR has resulted in
development of a robust and reproducible manufacturing process and
purification scheme for large-scale production of the ricin A chain
subunit protein ingredient in RiVax(TM). This process will be
sufficient to supply millions of vaccine doses. The ricin A chain is
the catalytic subunit of ricin toxin that accounts for its main
ability to inhibit protein synthesis and kill mammalian cells.
Modification of the A chain to remove toxicity sites was required to
make a vaccine safe enough and effective enough for use in humans. An
early formulation of RiVax(TM) using a smaller scale process has been
evaluated in a Phase I clinical trial in healthy volunteers, the first
time such a vaccine has been tested in humans. The major results of
that trial will be announced next week and discussed in publication.
Based on the improved production methods and high yields of
RiVax(TM), DOR is manufacturing clinical batches which will be
evaluated in additional human studies to examine the effect of the
formulation and vaccination regimen on the human immune response.
Continuing studies in animals are focused on correlating the level of
antibodies in serum with protection against ricin exposure to various
routes of exposure, including aerosol and oral. The demonstration of
the functionality of human antibodies and passive protection in
animals is a key step in providing evidence of efficacy under the FDA
Animal Efficacy rule. Under this rule, the FDA can permit human
licensure of a vaccine by relying on results from animal trials when
human trials cannot ethically evaluate efficacy.
"We are very pleased with the progress we continue to make with
our ricin program," stated Michael T. Sember, DOR's CEO and President.
"We now have a well defined and scalable manufacturing process that is
suitable for all future commercial needs as we continue development of
this important biodefense countermeasure. We will continue to work
closely with our partners and NIAID to expeditiously develop a safe
and efficacious ricin vaccine."
Ricin toxin is a potential bioterror threat due to its highly
lethal toxicity in small doses, ease of manufacture, and ability to be
aerosolized. Exposure to small amounts, especially by inhalation, can
lead to lung damage, nausea, fever, abdominal pain, and death within
several days. The need for protective countermeasures against ricin
has been emphasized by its recent and continued use as a biological
weapon. There currently are no FDA approved vaccines against ricin
toxin.
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 in the first quarter of
2006.
In November we announced that we entered into a binding letter of
intent to acquire Gastrotech Pharma A/S, a Danish biotech company
developing therapeutics based on peptide hormones to treat cancer and
gastrointestinal diseases and conditions.
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 completed the clinical portion of its Phase I clinical
trial in normal volunteers. We have also 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, 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 ("AMEX") by completing a transaction which
will provide it with shareholders' equity of at least $6 million, 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's business strategy has been revised to include the issuance
of its securities to acquire companies or assets. DOR BioPharma
presently is involved in 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.