SAN DIEGO, Nov. 5 /PRNewswire/ -- Ambrx Inc. today announced the scheduled presentation of data from a Phase I/II clinical trial of ARX201, the company's long-acting human growth hormone (hGH) analogue developed in collaboration with Merck Serono, at the International Congress of Endocrinology meeting in Rio de Janeiro. Andrew R. Hoffman, M.D., Professor of Medicine and Vice President of Academic Affairs at Stanford University, will present the clinical results as part of an oral presentation at 9:30 AM local time (GMT -3 / 7:30 AM EST) on November 12, 2008.
The Phase I/II dose-finding study in adult patients with growth hormone deficiency investigated the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ARX201 following single-dose escalation and repeated dosing. The study analyzed 22 individuals with adult growth hormone deficiency (AGHD). The patients had not received hGH replacement therapy in the six months prior to the study.
ARX201 was administered once weekly by subcutaneous injection. Dosing was titrated based on IGF-I response and/or safety findings. Patients were treated for up to 26 weeks. Clinical measures of body composition were taken at the end of the study period.
ARX201 is a long-acting recombinant human growth hormone drug candidate currently developed by Ambrx and Merck Serono for the treatment of growth hormone deficiencies. ARX201 was generated through a lead optimization process using Ambrx's ReCODE(TM) technology, which effectively enables protein medicinal chemistry. Through this approach, Ambrx was able to generate site specific mono-pegylated hGH molecules that were optimized for potency and time of action. Ambrx believes that ARX201 may have improved pharmacological performance over existing growth hormone products, including the potential for less frequent dosing.
In pre-clinical studies, ARX201 met or exceeded key end points in
assays that are believed to be pred
|SOURCE Ambrx Inc.|
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