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news.Cortice Biosciences has initiated the first stage of an open-label Phase II trial aimed at evaluating the safety and efficacy of its lead drug candidate, TPI 287, in combination with standard-of-care Avastin (bevacizumab) for treatment of patients with recurrent glioblastoma (GBM) that has progressed after Avastin treatment alone.
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TPI 287 is a new taxoid derivative, called as an abeotaxane, which binds to and stabilizes the assembly of microtubules similarly to commonly used taxanes, including paclitaxel (Taxol and Abraxane) and docetaxel (Taxotere).
It has distinct advantages of being able to readily cross the blood-brain barrier and evade common drug resistance mechanisms.
The first stage of the trial is designed to determine the maximum tolerated dose (MTD) of TPI 287 given every three weeks when used in combination with Avastin administered at 10mg/m2 every two weeks.
According to the company, all patients will have GBM that has progressed while on or following treatment with Avastin.
After the establishment of MTD for TPI 287 in this setting, the company plans to expand to the second stage of the trial to assess additional patients with TPI 287 plus Avastin.
The trial’s primary endpoint is safety, while major secondary endpoints, include overall response rate and progression-free survival, which will be assessed per RANO criteria.