New antibody discovered for treatment of Human Cytomegalovirus infection
TCN-202 is a fully human monoclonal antibody developed specifically for the treatment of CMV. During the phase 1 trial, the antibody showed no serious adverse effects or dose-limiting chemicals, and the CMV virus did not develop immunity to the drug. Due to the successful trial, renal transplant recipients will be tested, since their lower autoimmune defenses make them susceptible to this infection, in Theraclone's Phase 2 trial.
"CMV is a difficult-to-treat indication due to the virus' propensity to mutate and become resistant to currently marketed drugs which additionally are not fully effective and are associated with significant toxicities," Theraclone's Chief Medical Officer, Eleanor Ramos, M.D., said.
Phase 1 was conducted as a randomized, double-blind experiment with placebo integration. 40 healthy adult volunteers received increasing doses of TCN-202, beginning at 1mg/kg and increasing to 50mg/kg. A second volunteer group of eight people received two doses of 15mg/kg two weeks apart. The experiment showed no antibody development against TCN-202 in any of the participants, essentially making it respond as a natural human antibody.
CMV infection can be life-threatening for victims with autoimmune complications, such as leukemia or HIV, and can increase their risk of graft rejection. CMV in congenital cases of pregnancy is one of the leading causes of permanent hearing impairment and cognitive complications in newborns.