to-BBB starts clinical trial in patients with brain metastases
to-BBB announced that it has received approval to start treating patients with brain metastases with its lead product 2B3-101 in a Phase I/II clinical trial.
Based on its proprietary G-Technology®, to-BBB is developing its lead compound 2B3-101, brain-targeted doxorubicin liposomes. These liposomes are coated with the endogenous antioxidant glutathione at the tips of polyethylene glycol (PEG) to safely enhance the delivery of free drug to the brain. 2B3-101 has shown reduction of brain tumor growth in preclinical proof-of-concept studies at the Netherlands Cancer Institute. Clinical batches of 2B3-101 have been produced by to-BBB’s manufacturing partner TTY Biopharm and pivotal preclinical safety studies were completed in 2010.
to-BBB is now ready to start recruitment of a Phase I/IIa trial involving approximately 40 patients. The trial will be conducted at the NKI-AVL (Dr. Brandsma, Amsterdam), VUmc (Prof. Verheul, Amsterdam) and LUMC (Dr. Gelderblom, Leiden), all located in the Netherlands. The trial will be managed by the clinical research organization, SMS-oncology.
The primary endpoint of the trial is safety, tolerability and determination of the maximum tolerated dose (MTD). 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. While new therapies are increasing the success of treating systemically metastasized breast cancer, brain metastases still represent an increasing problem for these patients.
Other news from the department research and development
