DOR BioPharma and Cambrex Enter into a Development and Manufacturing Process Agreement for RiVax(TM)
07 1월 2005 - 10:30PM
PR Newswire (US)
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
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