After various inquiries presumable triggered by information in the EU Clinical Trials Register Biotest AG wants to clarify that the Phase I/IIa study with BT-062 in the indications triple negative metastatic breast cancer and metastatic bladder cancer is still ongoing.
The study is conducted in 14 clinical centers in Germany and Belgium.
The study design (presented at the Analyst Conference on November 12th, 2013) is split in two phases:
"Phase I: Dose escalation from 100 mg/m² up to maximum tolerated dose
Phase IIa: Treatment of additional 18 patients in each indication at selected dose level.
In case of outstanding efficacy, treatment of further 15 patients."
Besides the goal to define the maximum tolerated dose in Phase I, the objectives of the study are:
"To evaluate pharmacokinetic, safety and anti-tumor activity of BT-062 in selected
solid tumor indications"
It was planned to treat 40 to 80 patients depending on safety and efficacy obtained. After the maximum tolerated dose had been identified and 39 patients were enrolled and treated no additional patients were required to evaluate the safety and the anti-tumor activity of BT-062. Therefore the relevant authorities had been notified that the recruitment of patients would not be continued. This information was published by one of the authorities in the EU Clinical Trials Register (www.clinicaltrialsregister.eu).
As soon as the study is finalized and evaluated Biotest will report the results.
October 25th, 2016