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Proceedings of the National Academy of Sciences Report Superiority of Human Growth Hormone Generated with Ambrx Technology
Date:5/25/2011

SAN DIEGO, May 25, 2011 /PRNewswire/ -- Ambrx Inc. today announced that data from a Phase 1/2 study, published online ahead of print on May 16 by Proceedings of the National Academy of Sciences, demonstrate the safety, efficacy and superior dosing frequency of ARX201, a sustained action human growth hormone, compared to therapy with native hormone.

The study evaluated adult GH-deficient (AGHD) patients treated with ARX201, which was generated with Ambrx's ReCODE™ technology. ARX201 was shown to have a half-life in patients of four days and to potentially be suitable for weekly dosing, which is superior to current therapy that requires daily dosing. Insulin-like growth factor 1 (IGF-1) a clinically validated biomarker of growth hormone activity was restored to normal ranges with weekly dosing.  ARX201 was found to be safe and well tolerated with repeat dosing.

"This report provides clinical validation of Ambrx technology, which constitutes site-directed protein medicinal chemistry," said Ho Cho, Ph.D., Chief Technology Officer of Ambrx. "ARX201 represents a best in class growth hormone optimized for efficacy, safety and patient convenience. Additionally, Ambrx has successfully scaled the manufacturing process to support advanced product development and eventual commercialization."

The study enrolled 22 AGHD patients who had not received growth hormone replacement therapy in the past six months.  Patients received weekly injections of ARX201 for up to 26 weeks.  ARX201 dose was determined through measurement of IGF-1, the standard indicator for growth hormone therapy.  Efficacy in patients included decreased truncal fat mass and total body fat, while lean body mass levels increased.

About ARX201

ARX201 is a long-acting rDNA-derived human GH drug candidate being developed by Ambrx for the treatment of growth hormone deficiencies. A Phase 2b clinical trial of ARX201 in adult patients with gr
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SOURCE Ambrx Inc.
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