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Covalent Group Signs $1.0 Million Contract to Study Vaccine
Against Plague
Company's Third Counter-Bioterrorism Contract
WAYNE, Pa., May 5 /PRNewswire-FirstCall/ -- Covalent Group, Inc. today
announced the signing of its third counter-bioterrorism vaccines contract
within the past five months. This $1.0 million contract with DynPort Vaccine
Company LLC (DVC) is for a Phase 1 study for the development of a recombinant
vaccine for protection against Yersinia pestis infection, the bacterium that
causes plague. Covalent will provide study design consultation, project
management, clinical site management and monitoring, data management,
biostatistics and medical safety surveillance. The total duration of the study
is approximately 18 months. Covalent will begin recognizing revenue on the
study in the second half of 2004 with initial subject enrollment beginning in
early 2005. The vaccine being studied is the plague recombinant vaccine
conceived and developed at the U.S. Army Medical Research Institute of
Infectious Diseases. The U.S. Army has a U.S. Patent Application pending for
this vaccine.
Plague is an infection caused by Y. pestis, a gram-negative bacterium. It
results in an acute and often fatal disease. In nature, people usually get
plague as a result of a bite by a rodent flea that is carrying plague bacterium
or by handling an infected animal. During the course of history, plague
pandemics have killed millions of people. Today, human weapons are much more
likely than rodent fleas to cause a plague pandemic. Plague is considered one
of the most dangerous agents of bioterrorism. Over the past 60 years, there
have been numerous examples of malevolent groups trying to weaponize Y. pestis.
The threat would come through pneumonic plague, the most deadly and contagious
form of the disease that results from inhalation of the bacterium. Currently,
there is no licensed plague vaccine available in the United States.
Kenneth M. Borow, M.D., Covalent Group's President and Chief Executive Officer,
commented, "An effective vaccine against plague would have enormous benefit for
military personnel as well as civilian populations in the case of a
bioterrorist attack with Y. pestis. The Working Group on Civilian Biodefense
wrote in their Consensus Statement on Plague as a Biological Weapon, 'The
availability of Y. pestis around the globe, the capacity for its mass
production and aerosol dissemination, and the potential for secondary spread of
infectious cases during an epidemic make the use of plague as a biological
weapon a great concern. (Journal of the American Medical Association
2000;283:2281-2290).'"
Dr. Borow concluded, "Covalent and DVC are currently working together on the
assessment of vaccines for protection against botulinum neurotoxin, Venezuelan
equine encephalitis (VEE), and plague. We look forward to the opportunity to
work closely with DVC on other vaccine development programs in the future. We
believe that the development of successful vaccines against bioterrorist agents
is a very valuable addition to the armamentarium against global terror. As
such, we are proud to be on the cutting-edge of this important effort."
About DynPort Vaccine Company LLC
DynPort Vaccine Company LLC (DVC) is a biopharmaceutical company dedicated to
the development and licensure of safe and efficacious biodefense vaccines for
the Department of Defense and civilian populations. As the prime systems
contractor for the Joint Vaccine Acquisition Program, DVC engages the expertise
of subcontractors, research centers and biologics development industry leaders.
Biodefense biologics in development include vaccinia immune globulin, smallpox
vaccine, next-generation anthrax vaccine, plague vaccine, Venezuelan equine
encephalitis vaccine, tularemia vaccine, botulinum bivalent and multivalent
vaccines and botulinum polyclonal antitoxin. Founded in 1997, DVC employs
nearly 120 professionals at its headquarters in Frederick, Md. For more
information about DVC visit http://www.dynport.com/.
About the U. S. Army Medical Research Institute of Infectious Diseases
USAMRIID, located at Fort Detrick, Maryland, is the lead medical research
laboratory for the U.S. Biological Defense Research Program, and plays a key
role in national defense and in infectious disease research. The Institute's
mission is to conduct basic and applied research on biological threats
resulting in medical solutions (such as vaccines, drugs and diagnostics) to
protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army
Medical Research and Materiel Command.
About Covalent Group
Covalent Group is a clinical research organization that is a leader in the
design and management of complex clinical trials for the pharmaceutical,
biotechnology and medical device industries. The Company's mission is to
provide its clients with high quality, full-service support for their clinical
trials. Covalent offers therapeutic expertise, experienced team management and
advanced technologies. The Company has clinical trial experience across a wide
variety of therapeutic areas such as vaccines, biologics, gene therapy,
immunology, cardiovascular, endocrinology/metabolism, diabetes, neurology,
oncology, infectious diseases, gastroenterology, dermatology, hepatology,
womens' health and respiratory medicine. Covalent believes that its leadership
in the design of complex clinical trials, its application of innovative
technologies, therapeutic expertise and commitment to quality offer its clients
a means to more quickly and cost effectively develop products through the
clinical trial process. In addition, the Company's use of its proprietary
TeleTrial(R) technology to support its drug development services creates
consistency in the way it conducts clinical trials globally. With its
wholly-owned international subsidiary, Covalent Group, Ltd., as well as its
Strategic Partners operating in South America, Eastern Europe, Russia and
Ukraine, and Australia, New Zealand, and the Asia-Pacific region, Covalent is
able to meet the global drug development needs of its clients.
This press release contains forward-looking statements identified by words such
as "estimate," "project," "expect," "intend," "believe," "anticipate" and
similar expressions. Actual results might differ materially from those
projected in, expressed in or implied by the forward-looking statements.
Potential risks and uncertainties that could affect the Company's future
operating results and financial condition include, without limitation: (i) our
success in attracting new business and retaining existing clients and projects;
(ii) the size, duration, and timing of clinical trials; (iii) the termination,
delay or cancellation of clinical trials; (iv) the timing difference between
our receipt of contract milestone or scheduled payments and our incurring costs
to manage these trials; (v) outsourcing trends in the pharmaceutical,
biotechnology and medical device industries; (vi) the ability to maintain
profit margins in a competitive marketplace; (vii) our ability to attract and
retain qualified personnel; (viii) the sensitivity of our business to general
economic conditions; and (ix) other economic, competitive, governmental and
technological factors affecting our operations, markets, products, services and
prices. Additional information concerning factors that could cause actual
results to materially differ from those in forward-looking statements is
contained in Covalent Group's SEC filings, including its Registration Statement
on Form S-3, Annual Report on Form 10-K and other periodic reports under the
Securities Exchange Act of 1934, as amended, copies of which are available upon
request from Covalent Group's investor relations department.
Investor relations contact: John Capodanno, (646) 536-7026
Media contact: Cynthia Isaac, PhD., (646) 536-7028
Contact us on-line: http://www.covalentgroup.com/
DATASOURCE: Covalent Group, Inc.
CONTACT: Investor relations - John Capodanno, +1-646-536-7026, or Media
- Cynthia Isaac, PhD., +1-646-536-7028, both for Covalent Group, Inc.
Web site: http://www.covalentgroup.com/
http://www.dynport.com/