Theraclone Sciences has started dosing subjects in a Phase 1 trial of TCN-202, an antibody in development for the treatment of human cytomegalovirus (CMV) infection.
The dose-escalation trial is designed to evaluate the safety profile of intravenous administration of TCN-202 compared with a placebo in healthy adult volunteers.
Theraclone Sciences CEO Clifford Stocks said TCN-202 was discovered using Theraclone’s I-STAR platform, which has demonstrated an ability to identify natural human antibodies with broad biologic activity and therapeutic potential.
"Broadly protective antibodies are important, as viruses like CMV are prone to mutations and, therefore, drug resistance," Stocks added.
"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."
The randomised, double-blind study will provide safety, pharmacokinetic and immunogenicity data; it will enrol up to 80 normal healthy volunteers at a single site in the US.
Theraclone anticipates study results in the first half of 2013. The company holds worldwide development and commercialisation rights for TCN-202.
Theraclone Sciences chief medical officer Eleanor Ramos said complications of CMV infection were particularly significant in immunosuppressed individuals, as well as in the setting of congenital infection, and TCN-202 has received an orphan drug designation for the latter.
"We are excited to initiate the Phase 1 study of our antibody therapeutic in CMV disease and believe TCN-202 could fulfil the need for a safer and more effective therapeutic treatment for this disease," Ramos added.
CMV transmission during pregnancy can cause permanent disabilities in children, and CMV infection can be life-threatening in individuals with weakened immune systems.