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news.to-BBB, a Dutch drug brain delivery company, is set to start patient recruitment in a Phase I/IIa trial to evaluate its lead compound 2B3-101, which is based on its proprietary brain delivery platform - G-Technology.
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to BBB is applying the G- Technology for the delivery of doxorubicin for the treatment of brain cancer as its internal lead product 2B3 101.
The company expects to recruit around 40 subjects in the trial.
to-BBB’s manufacturing partner TTY Biopharm produced 2B3-101
It has demonstrated reduction of brain tumor growth at the Netherlands Cancer Institute in preclinical studies.
The primary endpoint of the trial is safety, tolerability and determination of the maximum tolerated dose (MTD).
However, the secondary endpoints include determination of the pharmacokinetic profile of 2B3-101 as well as a preliminary assessment of efficacy in women with brain metastases of breast cancer.
to-BBB clinical operations head Werner Gladdines said in the trial with 2B3-101 in patients they aim to confirm the positive efficacy and tolerability profile they observed in preclinical studies.
"Furthermore, this trial supports our efforts to further validate our G-Technology to treat patients with brain diseases," Gladdines said.