CSC's DynPort Vaccine Company Releases Results for Phase 2 Botulinum Vaccine Clinical Trial

News Release -- January 24, 2012

Vaccine candidate under development as a U.S. Department of Defense biodefense medical countermeasure

FALLS CHURCH, Va., Jan. 24 – CSC (NYSE: CSC) announced today that DynPort Vaccine Company LLC (DVC), a CSC company, has completed a Phase 2 clinical trial for its recombinant botulinum vaccine candidate, rBV A/B. The vaccine was safe and well-tolerated, and elicited a strong immune response.

The rBV A/B is being developed for the protection of adults 18 to 55 years of age from fatal botulism caused by inhalational intoxication with two serotypes of botulinum neurotoxin.

This Phase 2 clinical trial evaluated rBV A/B or placebo in 440 healthy adults, comparing two dosing schedules administered intramuscularly at 0, 28 and 182 days or 0, 56 and 182 days.

The primary safety objective was to assess the safety of rBV A/B compared to placebo. The primary immunogenicity objective was to evaluate the neutralizing antibody rate in volunteers given rBV A/B or placebo.

The rBV A/B was immunogenic in healthy volunteers at the dosage and schedules used in this clinical trial. The maximum immune responses to both BoNT serotypes were observed 28 days after the third dose. More than 94% of the volunteers maintained detectable neutralizing antibody concentrations for at least one year after the third dose, indicating that rBV A/B elicited a strong immune response.

The 0, 28 and 182-day schedule produced the strongest immune response and was selected for evaluation in the next clinical trial.

“We are pleased with these results and are looking forward to Phase 3 clinical trials of this vaccine, to support the needs of the Department of Defense and the U.S. warfighter,” said Dr. Robert V. House, president of DVC.

This Phase 2 clinical trial evaluated safety and immunogenicity for an observation period of 18 months, one year after the last (third) dose. There were no clinically significant differences in the incidence, types and severity of treatment-emergent adverse events between volunteers who received rBV A/B or placebo according to the two schedules. All noted serious adverse events were assessed as not related to vaccination.

Botulinum neurotoxin is a key potential bioterror threat, identified as a Category A biothreat by the U.S. Centers for Disease Control and Prevention.

Clinical trials are managed by DVC at its headquarters in Frederick, Md., and conducted using the services of various clinical research organizations.

In addition to clinical trials, nonclinical testing required to support licensure of rBV A/B under the U.S. Food and Drug Administration (FDA) Animal Rule is ongoing.

Scientists working at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) originally identified and developed the vaccine. DVC further developed and manufactured the vaccine under a U.S. Department of Defense (DoD) Chemical Biological Medical Systems-Joint Vaccine Acquisition Program (CBMS-JVAP) contract. DVC has served as prime systems contractor for CBMS-JVAP since 1997.

The safety and efficacy of this product in humans has not been established. The product is currently under clinical investigation and has not been licensed by the FDA.

This study was funded by CBMS-JVAP, DoD Contract DAMD17-98-C-8024 and does not represent official DoD positions, policies or decisions.

About DVC
DynPort Vaccine Company LLC (DVC) manages product development programs and provides consulting, technical and program management services to U.S. government agencies and companies in the biotechnology and pharmaceutical industries. DVC is part of CSC’s North American Public Sector’s Civil and Health Services Group. CSC integrates extensive government health services expertise and commercial best practices to meet federal, state and local healthcare requirements. Services range from optimizing claims processing, to operating disease surveillance systems, to biopharmaceutical product development and management. CSC is improving the quality of health care with better information for better decisions. For more information, visit www.csc.com/dvc.

About CSC
CSC is a global leader in providing technology-enabled business solutions and services. Headquartered in Falls Church, Va., CSC has approximately 97,000 employees and reported revenue of $16.2 billion for the 12 months ended September 30, 2011. For more information, visit the company’s website at www.csc.com.