Cantargia AB: Cantargia’s CAN04 product candidate show very good safety at high dose levels, paving the way for final GLP toxicity study in autumn 2016

Cantargia AB’s ("Cantargia”) CAN04 product candidate is undergoing the final tests prior to submission of the application for clinical trials. The recently completed study investigated repeated treatment with up to 100 mg/kg and showed a very good safety. All the documentation is thus in place for the final GLP (good laboratory practice) toxicity study, for which the study protocol has been prepared. Cantargia will perform additional process development studies to establish a strong foundation for long-term production. Cantargia has therefore chosen to postpone the start of the GLP toxicity study until autumn 2016, which will push back the start of clinical studies to the end of first quarter of 2017.

Cantargia’s toxicity studies show no toxicity from use of CAN04

Cantargia’s CAN04 product candidate has been studied in a "dose range finding study”, one of the purposes of which is to study the safety of dose levels that are significantly higher than the levels that are intended to be studied in patients. The two dose levels that were studied, 50 mg/kg and 100 mg/kg, both showed a very good safety in repeated dosing.

Further development stages

The next step, which will be the concluding step in the company’s planned toxicological programme for CAN04, is the GLP toxicity study, which will be carried out using material produced by the same method that will be used to produce CAN04 for the first clinical study. A completed GLP toxicity study is a requirement for the initiation of clinical studies. With the results from this recently completed study, the study protocol for the final toxicity study is now in place. Under the guidelines that apply for antibody-based cancer drugs, this study will be designed to document one month of treatment with CAN04.

Cantargia has decided to further optimise the process before the start of production for the GLP tox study and clinical trials. The GLP tox study is expected to begin in autumn 2016, and the planned start of the clinical study is moved from end of 2016 to the end of the first quarter of 2017.

"We are very pleased with the outcome of this study, which shows that CAN04 is safe also at dose levels in the order of ten times higher than those that are normally used in antibody therapy of patients,” Göran Forsberg, CEO of Cantargia, says. "We will now move forward to the concluding GLP study, but have for long-term strategic reasons chosen to further optimise the process in order to facilitating the conduct of studies at high dose levels.”

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