Covalent Group Signs $1 Million Contract to Study Vaccine Against Plague

WAYNE, Pa. -- Covalent Group, Inc. announces 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, MD, Covalent Group's president and CEO, 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).'"

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."

Source: Covalent Group, Inc.