Symphogen A/S today announced the initiation of a Phase 2 clinical trial to investigate the safety and efficacy of Sym004 in patients who have failed anti-EGFR monoclonal antibody (mAb)-based therapy, with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). In June 2011 Symphogen completed the enrollment of patients in another study to evaluate the safety, efficacy and PK of Sym004 in patients with advanced metastatic colorectal cancer (mCRC) and wild-type KRAS.
The Phase 2 clinical trial is an open label, single arm, multi-center trial study in patients with SCCHN, who will receive weekly infusions of Sym004. The primary endpoint will be progression free survival at 24 weeks. Secondary endpoints include objective tumor response, time to progression, biomarkers, pharmacokinetic profile, and safety. The trial was initiated at the Antwerp University Hospital, Belgium. Additional sites are expected to be opened in Belgium, Germany, France and the US.
Kirsten Drejer, M.Sc. and Ph.D., Chief Executive Officer of Symphogen commented: "The preclinical data published in Cancer Research and Clinical Cancer Research, as well as the Phase 1 data presented at ASCO 2011, hold great promise for Sym004, and we are very excited about advancing this compound into clinical evaluation for treatment of SCCHN as well as mCRC in patients who have failed anti-EGFR antibody based therapy."
"Patients with advanced SCCHN and progressive disease after treatment with surgery, radiotherapy, chemotherapy and anti-EGFR mAb's have few treatment alternatives today. Based on the pre-clinical results, it's new mechanism of action and preliminary Phase 1 data, I believe that Sym004 has the potential to induce tumor responses and provide this severely ill and poor prognosis population with a treatment option," stated coordinating investigator Professor Jean-Pascal Machiels, Cliniques Universitaires St-Luc, Centre du Cancer, Brussels, Belgium.
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