SEATTLE, WA, USA I April 2, 2013 I Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, today announced positive top-line data from its Phase 1 trial of TCN-202, which was discovered using Theraclone’s I-STARTM platform. TCN-202 is a broadly protective, fully human monoclonal antibody, being developed for the treatment of human cytomegalovirus (CMV) infection. TCN-202 was well tolerated throughout the study, with no dose-limiting toxicities or serious adverse events observed, and demonstrated a favorable immunogenicity profile.
“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,” commented Eleanor Ramos, M.D., Chief Medical Officer, Theraclone Sciences. “TCN-202 was identified for its broad biologic activity which we believe is directed against a universal target for CMV and could offer an important new option for addressing CMV infection. Based on the strong safety and pharmacokinetic profile seen in the Phase 1 trial, and the lack of immunogenicity against TCN-202, we are confident moving forward to the next step in development. Our planned Phase 2 trial will evaluate the effect of TCN-202 in the prevention of CMV infection in renal transplant recipients, whose immunosuppression leaves them particularly vulnerable to complications of this infection.”
The randomized, double-blind, placebo-controlled Phase 1 study enrolled 40 healthy adult volunteers in 5 single-dose cohorts of TCN-202, escalating from 1 mg/kg to 50 mg/kg and a multiple dose cohort of 8 volunteers who received 2 doses of TCN-202 at 15 mg/kg, 2 weeks apart. TCN-202 showed pharmacokinetic parameters consistent with a human antibody. No antibodies against TCN-202 were detected. The detailed results from this trial will be presented at an upcoming scientific conference.
About Human Cytomegalovirus
CMV disease remains an unmet medical need. In immune compromised individuals, such as solid organ or stem cell transplant recipients or those with leukemia or HIV infection, CMV can cause serious life-threatening disease and may significantly increase the risk of graft rejection. Additionally, the estimated prevalence of congenital CMV infection in the United States is ~1% of all pregnancies and is one of the leading causes of permanent hearing loss and neurological deficits in children.
About Theraclone Sciences
Theraclone Sciences is a Seattle‐based biotech focused on the development of novel therapeutic antibodies for the treatment of infectious disease and cancer. The Company’s I-STAR™ technology harnesses the power of the human immune system to identify rare, naturally evolved monoclonal antibodies from the blood cells of immunologically relevant human subjects. Theraclone has established discovery partnerships with Pfizer, Zenyaku Kogyo and the International AIDS Vaccine Research Initiative. In addition, the Company has two proprietary antibody programs in clinical development for pandemic and seasonal influenza and human cytomegalovirus (HCMV). www.theraclone-sciences.com.
SOURCE: Theraclone Sciences
Post Views: 225
SEATTLE, WA, USA I April 2, 2013 I Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, today announced positive top-line data from its Phase 1 trial of TCN-202, which was discovered using Theraclone’s I-STARTM platform. TCN-202 is a broadly protective, fully human monoclonal antibody, being developed for the treatment of human cytomegalovirus (CMV) infection. TCN-202 was well tolerated throughout the study, with no dose-limiting toxicities or serious adverse events observed, and demonstrated a favorable immunogenicity profile.
“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,” commented Eleanor Ramos, M.D., Chief Medical Officer, Theraclone Sciences. “TCN-202 was identified for its broad biologic activity which we believe is directed against a universal target for CMV and could offer an important new option for addressing CMV infection. Based on the strong safety and pharmacokinetic profile seen in the Phase 1 trial, and the lack of immunogenicity against TCN-202, we are confident moving forward to the next step in development. Our planned Phase 2 trial will evaluate the effect of TCN-202 in the prevention of CMV infection in renal transplant recipients, whose immunosuppression leaves them particularly vulnerable to complications of this infection.”
The randomized, double-blind, placebo-controlled Phase 1 study enrolled 40 healthy adult volunteers in 5 single-dose cohorts of TCN-202, escalating from 1 mg/kg to 50 mg/kg and a multiple dose cohort of 8 volunteers who received 2 doses of TCN-202 at 15 mg/kg, 2 weeks apart. TCN-202 showed pharmacokinetic parameters consistent with a human antibody. No antibodies against TCN-202 were detected. The detailed results from this trial will be presented at an upcoming scientific conference.
About Human Cytomegalovirus
CMV disease remains an unmet medical need. In immune compromised individuals, such as solid organ or stem cell transplant recipients or those with leukemia or HIV infection, CMV can cause serious life-threatening disease and may significantly increase the risk of graft rejection. Additionally, the estimated prevalence of congenital CMV infection in the United States is ~1% of all pregnancies and is one of the leading causes of permanent hearing loss and neurological deficits in children.
About Theraclone Sciences
Theraclone Sciences is a Seattle‐based biotech focused on the development of novel therapeutic antibodies for the treatment of infectious disease and cancer. The Company’s I-STAR™ technology harnesses the power of the human immune system to identify rare, naturally evolved monoclonal antibodies from the blood cells of immunologically relevant human subjects. Theraclone has established discovery partnerships with Pfizer, Zenyaku Kogyo and the International AIDS Vaccine Research Initiative. In addition, the Company has two proprietary antibody programs in clinical development for pandemic and seasonal influenza and human cytomegalovirus (HCMV). www.theraclone-sciences.com.
SOURCE: Theraclone Sciences
Post Views: 225
