First-Patient-In in the US achieved for Pirotinib, an internally developed proprietary oncology drug
2015-06-16 08:17:04 Author:admin

     Pirotinib, a proprietary oncology drug developed by XuanZhu Pharma, has achieved a significant milestone - The first patient had been successfully enrolled and dosed on April 8th, 2015 for the Phase I clinical study in the United States.  This milestone marks one step closer to Sihuan Group’s vision of globalization.
      Pirotinib belongs to a family of irreversible EGFR Tyrosine Kinase Inhibitors. It is designed to target many EGFR mutation-driving solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC), and others. Data from pre-clinical studies supports Pirotinib to be potentially best in class with remarkable efficacy, unique tissue distribution and PK profile, and good safety window.
      XuanZhu Pharma has collaborated with Covance, one of the biggest clinical trial contract organizations, for preparation and initiation of the Phase I trial for Pirotinib.
      Pirotinib is dosed orally in phase I trial to patients with advanced solid tumors. Current studies include dose escalation and dose expansion, in order to determine maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) and dose limiting toxicity (DLT). In the meantime, preliminary drug safety and tolerability, PK, and efficacy will also be evaluated. The efficacy of Pirotinib will be further evaluated in patients with EGFR family gene mutations in the NSCLC, GC, and CRC types during the dose expansion study.
      Pirotinib phase I trials are conducted in three hospitals in the United States – MD Anderson Cancer Center (MDACC), Melvin and Bren Simon Cancer Center, and Huntsman Cancer Institute (HCI). The first patient was enrolled at MDACC.
     Working with Covance to initiate Pirotinib clinical trials in the US, XuanZhu Pharma and Sihuan Group have reached a significant milestone towards globalization.

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