May 4 2012
Generon (Shanghai) Corporation Ltd. today announced the initiation of a
Phase II clinical trial for F-627 after US FDA regulatory clearance. The
current study is a Phase II, randomized, multicenter, open-label,
active-controlled trial of F-627 in women with breast cancer receiving
myelotoxic chemotherapy. The clinical trial will enroll approximately
200 patients. The clinical trial will be conducted at approximately 35
clinical centers in North America and Europe. The primary objective of
this study is to evaluate the efficacy and safety of various
once-per-cycle dosing of F-627 as compared with the standard dosing of
Neulasta® (pegfilgrastim) in breast cancer patients undergoing
myelotoxic chemotherapy.
Generon completed a phase I study in healthy volunteers in Australia in
2011. The favorable safety and pharmacokinetics and pharmacodynamics
properties of F-627 were demonstrated in this Phase I study. The company
decided to further test the efficacy and safety of F-627 in cancer
patients after chemotherapy in a global multicenter trial.
In reaction to FDA's green light to F-627 moving into Phase II in the
US, Dr. Yu-Liang Huang, the CEO of Generon (Shanghai) Corporation,
expressed the following thought: "This is the first innovative biologic
drug developed by a Chinese biotech company entering global clinical
development. We are very pleased with FDA's decision allowing us to
conduct the Phase II trial in the US. This is a significant milestone
for our science and business. We remain focused on our mission to
innovate for life and to serve global patients."
Source:
Generon (Shanghai) Corporation Ltd.
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