Ambrx initiates Ph I/II ARX201 trial
Ambrx has initiated a Phase I/II clinical trial of ARX201, a next-generation human growth hormone product candidate. The dose-finding study in adult patients with growth hormone deficiency will investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of the agent following single-escalation and repeated dosing. Ambrx expects to complete the trial by the end of 2007.
The agent is a recombinant form of human growth hormone that has been modified using the company's patented RECODE technology to achieve precise spatial positioning of the poly(ethylene) glycol attachment, by biosynthetic incorporation of a chemically unique amino acid (ahGH). The company believes that ARX201 may have improved pharmacological performance over existing growth hormone products, including requiring less frequent dosing.
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