Date: 2012-03-22
Type of information:
phase: 1
Announcement: completion of the trial
Company: Synthon (The Netherlands)
Product: trastuzumab (biosimilar product)
Action
mechanism: Trastuzumab is a recombinant humanized monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2). After binding to HER2 on the tumor cell surface, trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.
Disease: breast cancer
gastric cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: Synthon has announced that it has successfully concluded a phase I clinical trial for trastuzumab, a biosimilar to Herceptin© (Roche), for treatment of breast cancer and gastric cancer.
All in vitro and in vivo studies conducted so far showed biosimilar behavior of Synthon’s trastuzumab in comparison with the reference product, Herceptin®. The outcome of the phase I clinical trial confirmed these results, showing bio-equivalence of Synthon’s trastuzumab to Herceptin®. The company will now initiate a phase III clinical trial for trastuzumab.
