SEATTLE, WA, USA I September 10, 2013 I Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, today announced that it has dosed the first patient in a Phase 2a clinical trial of TCN-202 for the prevention of human cytomegalovirus (CMV) infection in solid organ transplant recipients. TCN-202 is a recombinant, fully human monoclonal antibody discovered using the Company’s proprietary I-STAR™ platform.
“TCN-202 was chosen for its broad activity against CMV infection and has demonstrated a favorable safety and pharmacokinetic profile in the Phase 1 study,” said Eleanor Ramos, M.D., Chief Medical Officer, Theraclone. “We believe that this product candidate may provide a much needed option for patients at risk for CMV infections, who face undesirable toxicities and the possibility of drug resistance with current therapies, in both a preventative and therapeutic capacity.”
The Phase 2a proof-of-concept study is designed to evaluate the safety and efficacy of TCN-202 in solid organ (kidney) transplant recipients. In the study, up to twenty renal transplant recipients will receive TCN-202 during the first ten weeks post-transplant. The primary objective of the study is to evaluate the effect of TCN-202 on prevention of CMV infections during the first three months after transplant. Data from the trial is expected in the second half of 2014.
About TCN-202
TCN-202 is a recombinant fully human monoclonal antibody for the treatment and prevention of CMV infections. In immune compromised individuals, such as solid organ or stem cell transplant recipients, or those with leukemia or HIV infection, CMV infection can cause serious life-threatening disease and may significantly increase the risk of graft rejection. Additionally, each year approximately 30,000 children born in the United States have congenital CMV infection and of these, approximately 150 die and over 5,000 have permanent hearing loss, intellectual disability, psychomotor delay, speech and language disabilities, behavioral disorders or visual impairment.
About Theraclone
Theraclone is a biopharmaceutical company focused on the discovery and development of novel, monoclonal antibody therapeutics for diseases that are devastating for patients and their families and which are a significant threat to human health. Theraclone leverages its proprietary antibody discovery technology, I-STAR (In-Situ Therapeutic Antibody Rescue), to identify rare human antibodies that may be developed into antibody product candidates that are potentially safer and more effective than current therapies. Theraclone has a portfolio of innovative antibodies in clinical and preclinical development targeting serious medical conditions with a significant unmet medical need and a primary focus on infectious disease and cancer, which include:
- TCN-032 – a recombinant fully human monoclonal antibody for the treatment of patients hospitalized with serious influenza
- TCN-202 – a recombinant fully human monoclonal antibody for the treatment and prevention of cytomegalovirus, or CMV infections
For more information about Theraclone, please visit www.theraclone-sciences.com. On August 1, 2013, Theraclone Sciences and PharmAthene (NYSE MKT: PIP) announced a definitive merger agreement.
About PharmAthene
PharmAthene is a leading biodefense company engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene’s current biodefense portfolio includes the following product candidates:
- SparVax® – a next generation recombinant protective antigen (rPA) anthrax vaccine
- rBChE bioscavenger – a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides
- Valortim® – a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, in May 2013, the Delaware Supreme Court issued its ruling on the appeal in our litigation with SIGA Technologies, affirming the Court of Chancery’s finding that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back to the Court of Chancery to reconsider the appropriate remedy and award of attorney’s fees and expert witness costs in light of the Supreme Court’s opinion. For more information about PharmAthene, please visit www.PharmAthene.com.
SOURCE: Theraclone Sciences
Post Views: 209
SEATTLE, WA, USA I September 10, 2013 I Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, today announced that it has dosed the first patient in a Phase 2a clinical trial of TCN-202 for the prevention of human cytomegalovirus (CMV) infection in solid organ transplant recipients. TCN-202 is a recombinant, fully human monoclonal antibody discovered using the Company’s proprietary I-STAR™ platform.
“TCN-202 was chosen for its broad activity against CMV infection and has demonstrated a favorable safety and pharmacokinetic profile in the Phase 1 study,” said Eleanor Ramos, M.D., Chief Medical Officer, Theraclone. “We believe that this product candidate may provide a much needed option for patients at risk for CMV infections, who face undesirable toxicities and the possibility of drug resistance with current therapies, in both a preventative and therapeutic capacity.”
The Phase 2a proof-of-concept study is designed to evaluate the safety and efficacy of TCN-202 in solid organ (kidney) transplant recipients. In the study, up to twenty renal transplant recipients will receive TCN-202 during the first ten weeks post-transplant. The primary objective of the study is to evaluate the effect of TCN-202 on prevention of CMV infections during the first three months after transplant. Data from the trial is expected in the second half of 2014.
About TCN-202
TCN-202 is a recombinant fully human monoclonal antibody for the treatment and prevention of CMV infections. In immune compromised individuals, such as solid organ or stem cell transplant recipients, or those with leukemia or HIV infection, CMV infection can cause serious life-threatening disease and may significantly increase the risk of graft rejection. Additionally, each year approximately 30,000 children born in the United States have congenital CMV infection and of these, approximately 150 die and over 5,000 have permanent hearing loss, intellectual disability, psychomotor delay, speech and language disabilities, behavioral disorders or visual impairment.
About Theraclone
Theraclone is a biopharmaceutical company focused on the discovery and development of novel, monoclonal antibody therapeutics for diseases that are devastating for patients and their families and which are a significant threat to human health. Theraclone leverages its proprietary antibody discovery technology, I-STAR (In-Situ Therapeutic Antibody Rescue), to identify rare human antibodies that may be developed into antibody product candidates that are potentially safer and more effective than current therapies. Theraclone has a portfolio of innovative antibodies in clinical and preclinical development targeting serious medical conditions with a significant unmet medical need and a primary focus on infectious disease and cancer, which include:
- TCN-032 – a recombinant fully human monoclonal antibody for the treatment of patients hospitalized with serious influenza
- TCN-202 – a recombinant fully human monoclonal antibody for the treatment and prevention of cytomegalovirus, or CMV infections
For more information about Theraclone, please visit www.theraclone-sciences.com. On August 1, 2013, Theraclone Sciences and PharmAthene (NYSE MKT: PIP) announced a definitive merger agreement.
About PharmAthene
PharmAthene is a leading biodefense company engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene’s current biodefense portfolio includes the following product candidates:
- SparVax® – a next generation recombinant protective antigen (rPA) anthrax vaccine
- rBChE bioscavenger – a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides
- Valortim® – a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, in May 2013, the Delaware Supreme Court issued its ruling on the appeal in our litigation with SIGA Technologies, affirming the Court of Chancery’s finding that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back to the Court of Chancery to reconsider the appropriate remedy and award of attorney’s fees and expert witness costs in light of the Supreme Court’s opinion. For more information about PharmAthene, please visit www.PharmAthene.com.
SOURCE: Theraclone Sciences
Post Views: 209
