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Basilea begins Phase 2a expansion with BAL101553 in ovarian cancer and glioblastoma.

M2 EQUITYBITES-June 26, 2018-Basilea begins Phase 2a expansion with BAL101553 in ovarian cancer and glioblastoma

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Basilea Pharmaceutica (SWX: BSLN) has dosed its first patient in the Phase 2a expansion arm of its ongoing Phase 1/2a clinical study investigating its novel tumour checkpoint controller BAL101553, the company announced on Tuesday.

The study is exploring BAL101553, administered as weekly 48-hour intravenous (i.v.) infusion, in patients with recurrent glioblastoma and in patients with platinum-resistant or refractory ovarian cancer. The company aims to further characterise the safety and tolerability and to obtain efficacy data in these selected cancer types.

Glioblastoma is the most common type of primary brain cancer and there is a high medical need in ovarian cancer as recurrence after initial therapy is common. Patients with platinum-resistant cancers have limited treatment options.

The Phase 2a single-agent, open label study will aim to enrol up to 40 patients with platinum-resistant or platinum-refractory ovarian cancer and recurrent glioblastoma. It will be conduced at several hospitals across Switzerland.

A dose-escalation study in advanced solid tumour patients that was completed in January established the maximum tolerated doses. The company is also continuing two additional studies with BAL101553: a dose-escalation in a separate recurrent glioblastoma arm of the Phase 1/2a once-daily oral single-agent study and a Phase 1 study in newly diagnosed glioblastoma patients evaluating once-daily oral BAL101553 in combination with standard radiotherapy, conducted in collaboration with the Adult Brain Tumour Consortium (ABTC) in the US.

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Publication:M2 EquityBites (EQB)
Date:Jun 26, 2018
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