Efficacy and Safety of Treatment with an Anti-M2e Monoclonal Antibody in Experimental Human Influenza

Dale W. Usner, Ph.D. , Co-Author of Article Published in Journal of Infectious Diseases

Eleanor L. Ramos¹, Jennifer L. Mitcham¹, Teri D. Koller¹, Aurelio Bonavia¹, Dale W. Usner², Ganesh Balaratnam³, Paul Fredlund¹, and Kristine M. Swiderek¹

1. Theraclone Sciences, Seattle, Washington, USA
2. Statistics and Data Corporation, Tempe, Arizona, USA
3. Retroscreen Virology Ltd, London, UK

Tempe, AZ, October 20, 2014 – Dr. Dale W. Usner, President of SDC, co-authored the article “Efficacy and Safety of Treatment with an Anti-M2e Monoclonal Antibody in Experimental Human Influenza,” which was published by Oxford Journals in the Journal of Infectious Diseases on Friday, October 3, 2014.

Dr. Usner has approximately 20 years of experience leading and executing clinical trial research. Joining SDC in September 2011, Dale has since served the company in various positions of increasing responsibility, including most recently as Vice President of Biostatistics & Data Management and currently as President. Prior to his position with SDC, he worked at AVI BioPharma and ZymoGenetics as the head of statistics and data management, at Bausch & Lomb, Inc. as the global head of statistics and data management, and at PPD, Inc. He maintains an array of therapeutic area expertise, including anti-viral/anti-infective, oncology, ophthalmic device, ophthalmic pharmaceuticals, and gastrointestinal. Dale also has a breadth of regulatory body meeting experience with the FDA, PMDA, and EMA, including involvement in advisory committee meetings. Dale holds a Ph.D. in Statistics from Oregon State University.

“Efficacy and Safety of Treatment with an Anti-M2e Monoclonal Antibody in Experimental Human Influenza” describes the methods, results and conclusions of the Phase 2a trial of TCN-032, a human mAb targeting a conserved epitope on M2e, in experimental human influenza. The data presented in the publication support that “TCN-032 may provide immediate immunity and therapeutic benefit in influenza A infection, with no apparent emergence of resistant virus. TCN-032 was safe with no evidence of immune exacerbation based on serum cytokine expression.” For access to the abstract and full publication, please visit:

http://jid.oxfordjournals.org/content/early/2014/10/03/

Efficacy and Safety of Treatment with an Anti-M2e Monoclonal Antibody in Experimental Human Influenza
Eleanor L. Ramos; Jennifer L. Mitcham; Teri D. Koller; Aurelio Bonavia; Dale W. Usner; Ganesh Balaratnam; Paul Fredlund; Kristine M. Swiderek
Journal of Infectious Diseases 2014;
doi: 10.1093/infdis/jiu539