Clevegen showed no toxicologically relevant changes in any subject in dose escalation studies.
The drug was administered as a single dose at 3, 30 and 100 mg/kg in the three-week toxicity study. The highest dose of 100 mg/kg was considered the no-observed-adverse-effect-level (NOAEL).
The preclinical study also showed Clevegen administration blocks Clever-1 on circulating monocytes, precursor cells to tumour associated macrophages.
Clever-1 is an endothelial cell surface molecule involved in cancer growth and spread.
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"We are very encouraged to find out about the good safety profile of our wholly-owned asset Clevegen and the high NOAEL concentration," said chief executive Dr Markku Jalkanen.
"We were also delighted to learn that Clevegen administration blocks Clever-1 on circulating monocytes, which are one group of our target cells in our MATINS Phase I/II clinical trial.
"Our plan is now to file the MATINS clinical trial application (CTA) during Q3 2018 and, as previously announced, initiate this first Clevegen human trial in Q4 2018."