Swiss-based Debiopharm Group has initiated patient treatment in a Phase Ib clinical trial of Debio 0932, a heat shock protein 90 (HSP90) inhibitor.
Debio 0932 has a strong affinity for HSP90a/ß, high oral bioavailability and potent anti-proliferative activity against a broad range of cancer cell lines, including many non-small cell lung cancer (NSCLC) cell lines.
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The Phase Ib expansion study will include around 30 patients to evaluate the safety profile, pharmacokinetics and pharmacodynamics of Debio 0932 at the recommended dose level and regimen.
It will also investigate anti-tumour activity in patients with advanced solid tumours.
During the Phase Ib trial of the ongoing Phase I study the recommended dose, which is established at 1,000mg every day, will be tested in additional patients.
Debiopharm Group president and founder Rolland-Yves Mauvernay said the company believes HSP90 is an important molecular target in cancer therapy.
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By GlobalDataHe added: "We are eager to advance this molecule in the Phase Ib clinical trial, as well in our planned Phase I/II studies."
The company recently completed an open-label multi-centre dose escalation Phase Ia study, designed to demonstrate the safety and tolerability of escalating multiple dose levels of Debio 0932 given daily or every other day as a single agent in patients suffering from advanced solid tumours.
Debiopharm plans to begin a combination Phase I/II study in non-small cell lung cancer patients in Q2 2012.
The findings from the Phase Ia portion of the trial will be presented at a medical conference this year.
