Switzerland-based Basilea Pharmaceutica has concluded enrolment of patients in a Phase I clinical trial of BAL101553 for the treatment of brain cancer.

A total of 28 participants suffering from high-grade glioma or progressive / recurrent glioblastoma (GBM), the most aggressive form of primary brain cancer, have been recruited.

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BAL101553 is a prodrug of BAL27862, which binds to tubulin’s colchicine site in order to induce the death of tumour cells. The therapeutic is being developed to address different cancer types.

In the Phase I study, participants were given a once-daily, oral dose of BAL101553. Investigators found the maximum tolerated dose (MTD) to be 30mg per day.

Trial data showed a favourable tolerability profile for dose levels up to and including 25mg per day.

“The results from the Phase I study in brain cancer patients indicate a manageable safety and tolerability profile.”

BAL101553’s clinical anti-tumour activity was also demonstrated, including a single long-lasting responder who is still on treatment. This patient’s brain tumour tissue was said to have a strong expression of the end-binding protein 1 (EB1), a potential predictive biomarker of therapy response.

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The company added that five other participants achieved stable disease.

Dose-limiting adverse events observed in the trial included hallucinations, gait disturbances and confusion. Basilea noted that these adverse reactions were reversible.

Basilea Pharmaceutica chief medical officer Dr Marc Engelhardt said: “The results from the Phase I study in brain cancer patients indicate a manageable safety and tolerability profile, which is consistent with the safety profile observed for BAL101553 in the treatment of other advanced solid tumours.

“The observation of an exceptional, durable response in a GBM patient whose tissue was strongly positive for EB1 is encouraging, especially as we had previously identified EB1 as a potential response-predictive biomarker for BAL101553 based on comprehensive preclinical studies in GBM models.”

The company is currently performing a biomarker-driven clinical study involving EB1. This study will assess BAL101553 in various cancers, including glioblastoma.