Jan 7, 2013, Evive Biotech today announced the initiation of Phase I/II clinical trial for F-627 in patients after regulatory clearance by SFDA, China’s State Food and Drug Administration. The phase I study is a single center, open-label, dose escalation, repeat dose trial in breast cancer patients to examine the drug safety and tolerability. The Phase II study is a randomized, multicenter, open-label, active-controlled trial in women with breast cancer receiving myelotoxic chemotherapy. The primary objective of the phase II study is to evaluate the efficacy and safety of various once-per-cycle dosing of F-627 as compared with the standard dosing of filgrastim in breast cancer patients undergoing myelotoxic chemotherapy. Dr. Tang Kai Yang, chief medical officer of Evive, says“ We have made significant progress advancing the F-627 clinical program. Although the China clinical development is behind the US/EU clinical trial, we believe that China trial may reach the finish line earlier due to speed of patent enrollment”.

Evive is conducting a Phase II clinical study in breast cancer patients in US and Europe.

About F-627

F-627 is a new generation long-acting human granulocyte colony-stimulating factor (G-CSF) that helps the cancer patients recover from chemotherapy induced neutropenia, a potentially life threatening form of cancer complication.

About Evive Biotech

Evive Biotech is a biotechnology company based in China with a mission to develop innovative biological therapies for patients in China and around the world. In addition to F-627, its most advanced development candidate, Evive has several other drug candidates in various developmental stages. The most noticeable is F-652, a first-in-class anti-inflammation candidate, is currently in Phase I clinical development in Australia.