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Faron Pharmaceuticals looks to Clevegen opportunity after Traumakine disappointment

Clevegen has shown no toxicologically relevant changes in any subject in dose escalation studies.
man on a ventilator
The drug was administered as a single dose at 3, 30 and 100 mg/kg in the three-week toxicity study

Faron Pharmaceuticals Ltd (LON:FARN) plans to file a clinical trial application for Clevegen after a study into the safety and efficacy of the cancer treatment.

Clevegen showed no toxicologically relevant changes in any subject in dose escalation studies. 

READ: Faron Pharmaceuticals to file clinical trial application for Clevegen after successful study

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 pre-clinical 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 its spread.

Dr Markku Jalkanen, chief executive of Faron, says the results are an “encouraging” first step.

"We are very encouraged to find out about the good safety profile of our wholly-owned asset Clevegen and the high NOAEL concentration," Jalkanen said, adding: "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."

Traumakine disappointment

The move comes after a difficult first half for the company, which saw its stock take a major hit in May after its flagship Traumakine drug did not meet efficacy requirements following the initial read-out from its phase III INTEREST study.

Traumakine was used to treat acute respiratory distress syndrome (ARDS), a life-threatening ailment caused by an inflammation of the lungs that usually coincides with illnesses such as pneumonia or severe flu. 

The trial found that at 28 days the median number of ventilator-free days for patients on the drug was 10 days, only slightly higher than the 8.5 days for those taking a placebo with no medical benefit.

Meanwhile, the mortality rate after four weeks was 26.4% for those receiving the Faron treatment and 23% for the placebo group.

Faron's team is still trying to understand why Traumakine activity was variable in the INTEREST trial compared to previous studies and why the mortality was so low in the group receiving the dummy placebo drug.

"This analysis will continue and we will keep our shareholders and the market informed with progress in due course," Jalkanen said.

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Faron Pharmaceuticals Ltd Timeline

September 12 2018

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