Theraclone Sciences, Inc., a therapeutic antibody discovery and
development company, announced today first dosing of subjects in a Phase
1 clinical trial of TCN-202, a broadly protective, fully human
monoclonal antibody in development for the treatment of human
cytomegalovirus (CMV) infection. While a relatively common virus, CMV
transmission during pregnancy can cause permanent disabilities in
children, and CMV infection can be life-threatening in individuals with
weakened immune systems.
"TCN-202 was discovered using Theraclone's I-STAR™ platform, which has
demonstrated a unique ability to identify natural human antibodies with
exceptionally broad biologic activity and therapeutic potential," said
Clifford J. Stocks, CEO, Theraclone Sciences. "Broadly protective
antibodies are important, as viruses like CMV are prone to mutations
and, therefore, drug resistance. TCN-202 is directed against what we
believe is a universal target within CMV variations, and this Phase 1
study is a significant step in bringing an important new treatment to
patients with CMV infection."
"Complications of CMV infection are particularly significant in
immunosuppressed individuals as well as in the setting of congenital
infection, and TCN-202 has received Orphan Drug Designation for the
latter," commented Eleanor Ramos, M.D., Chief Medical Officer,
Theraclone Sciences. "We are excited to initiate the Phase 1 study of
our antibody therapeutic in CMV disease and believe TCN-202 could
fulfill the need for a safer and more effective therapeutic treatment
for this disease."
The randomized, double-blind Phase 1 dose-escalation trial in healthy
adult volunteers will assess the safety profile of intravenous
administration of TCN-202 as compared to placebo. The study will enroll
up to 80 normal healthy volunteers at a single site in the United States
and will provide safety, pharmacokinetic and immunogenicity data. Study
results are expected in the first half of 2013.
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