Clinical Data Show Long-Acting Human Growth Hormone ARX201 is Safe and Well... (lean body mass was 3.6 percent. ARX201 w...)

Clinical Data Show Long-Acting Human Growth Hormone ARX201 is Safe and Well Tolerated

Date:11/13/2008

lean body mass was 3.6 percent. ARX201 was well tolerated with temporary pain at the injection site as the only reported side effect. No neutralizing antibodies to either PEGylated GH or to native GH were detected throughout the study.

About ARX201

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 predictive of human pharmacokinetics and biological response. In February 2007, a Phase I/II clinical trial of ARX201 was initiated to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of this product candidate in adult patients with growth hormone deficiency following single-dose escalation and repeated dosing.

About Ambrx

Ambrx Inc. is a clinical stage biopharmaceutical company with a broad biologics platform that allows it to create best-in-class protein therapeutics, including improved versions of native proteins and therapeutic antibodies. Its most advanced product candidate, ARX201, is a long-acting human growth hormone drug candidate partnered with Merck Serono that has successfully completed initial clinical trials. The company has further validated its biologics platform through substantial partnerships with Eli Lilly and Company and Merck & Co. Ambrx is advancing a robust portfolio of product opportunities spanning multiple therapeutic are
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Clinical Data Show Long-Acting Human Growth Hormone ARX201 is Safe and Well...(lean body mass was 3.6 percent. ARX201 w...)