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DOR BioPharma and Cambrex Enter into a Development and
Manufacturing Process Agreement for RiVax(TM)
MIAMI and EAST RUTHERFORD, N.J., Jan. 7 /PRNewswire-FirstCall/ -- DOR
BioPharma, Inc. (AMEX:DOR) and a subsidiary of Cambrex Corporation (NYSE:CBM)
have entered into an agreement with respect to process development for
potential large scale production of DOR's proprietary ricin vaccine, RiVax(TM).
Under the agreement, Cambrex will provide process development and cGMP
(current Good Manufacturing Processes) production services for RiVax(TM).
(Logo: http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGO )
Ricin toxin is a potential bioterror threat due to its highly lethal toxicity
in small doses, ease of manufacture, and ability to be aerosolized. The need
for protective countermeasures against ricin has been emphasized by its recent
and continued use as a biological weapon.
"We believe RiVax(TM) could be an integral part of the U.S. Government's
biodefense arsenal," stated Gregory J. Davenport, Ph.D., President of DOR's
Biodefense Division. "Cambrex has significant cGMP capacity and a proven track
record of manufacturing other developmental vaccines. We are pleased to be
working with Cambrex as we endeavor to meet all the requirements for potential
procurement by the U.S. Government."
DOR will work with Cambrex pursuant to DOR's recently awarded $5.2 million
National Institutes of Health (NIH) ricin vaccine development grant. The
specific milestones for the RiVax(TM) development program funded under the
grant to be undertaken by Cambrex include development of a robust process for
production and purification of the vaccine. Under the current agreement,
Cambrex will be developing the manufacturing process to enable large scale
production to produce quantities sufficient for additional clinical testing,
fulfillment of all FDA requirements for licensure and, approved, commercial
production.
"If these milestones are successfully achieved, DOR will have sufficient
vaccine available for future clinical trials, and will be capable of
manufacturing RiVax(TM) at scale," commented Alexander P. Haig, Executive
Chairman of DOR. "Our goal is to position ourselves as a qualified supplier of
ricin vaccine to the U.S. Government. We intend to aggressively pursue all
future procurement contracts with the ultimate goal of providing a safe and
effective ricin vaccine to our military and at-risk civilians."
"We are excited to work with DOR on the RiVax(TM) project," commented Gary
Mossman, Chief Operating Officer of Cambrex. "We have extensive experience
developing production capabilities for vaccines of all types, and we feel
privileged to work on this important vaccine that could be a critical component
of our national defense."
In accordance with current FDA guidance, DOR has previously demonstrated the
safety and effectiveness of RiVax(TM) in multiple relevant animal models. The
Company has recently announced the initiation of an investigator-sponsored
Phase I clinical study to be conducted at the University of Texas, to test the
safety and immunogenicity of RiVax(TM) in human volunteers using previously
produced cGMP material from UT Southwestern. Once these conditions are
satisfied, the federal government has the authority under the BioShield Act of
2004 to procure bioterror countermeasures for addition to the Strategic
National Stockpile prior to Food and Drug Administration approval.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company focused on the development
of biodefense vaccines and therapeutics for areas of unmet medical needs.
Through its BioDefense Division, DOR is developing bioengineered vaccines
designed to protect against the deadly effects of ricin toxin and botulinum
toxin. DOR's lead therapeutic product, orBec(R) (an oral formulation of
beclomethasone dipropionate), is a potent, locally-acting corticosteroid being
developed to treat inflammation in the mucosal lining of the intestine and
stomach that can occur following allogeneic bone marrow and stem cell
transplants. DOR plans to meet with FDA as soon as possible to review the data
from its pivotal Phase III clinical trial in intestinal Graft-versus-Host
Disease. For further information regarding DOR BioPharma, please visit the
Company's website located at http://www.dorbiopharma.com/.
About Cambrex
Cambrex is a global, diversified life science company dedicated to providing
products and services to accelerate the discovery and commercialization of
human therapeutics. The Company employs approximately 1900 people worldwide.
For more information, please visit Cambrex's website at
http://www.cambrex.com/.
Forward Looking Statements
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. 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, 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; or that its business strategy will be successful. 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.
http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGODATASOURCE: Cambrex
Corporation
CONTACT: Evan Myrianthopoulos, Chief Financial Officer of DOR BioPharma,
Inc., +1-305-534-3383; or Anne-Marie Hess, Director, IR & Corporate
Communications of Cambrex Corporation, +1-201-804-3062, or
Web site: http://www.cambrex.com/
http://www.dorbiopharma.com/
Company News On-Call: http://www.prnewswire.com/comp/134219.html