to-BBB Gets Positive Opinion For 2B3-101 Orphan Drug Designation

The positive opinion for 2B3-101 by the COMP has specifically been granted for the treatment of glioma.

As a proprietary brain-targeted version of the marketed product Caelyx/Doxil (PEG-liposomal doxorubicin), 2B3-101 uses glutathione (GSH) to safely enhance the delivery of doxorubicin across the blood-brain barrier.

to-BBB said that the therapeutic benefit and predictable safety profile of 2B3-101 has been successfully demonstrated in pre-clinical studies and the product is ready to enter clinical trials end of 2010. The product can be developed for multiple brain cancer indications and to-BBB considers development for brain metastases of breast cancer as well as glioma.

However, when the European Commission decides to grant the orphan drug status following the positive opinion of the COMP, to-BBB would receive additional market exclusivity for a period of 10 years following approval of its drug candidate for this indication in Europe. Thereby the orphan drug designation will increase the likelihood that 2B3-101 will become available for glioma patients.

The commission typically grants orphan drug status following a positive opinion from the COMP to a medicinal product intended for the diagnosis, prevention or treatment of a life-threatening or a chronically debilitating condition when the application for designation is submitted.

Willem van Weperen, CEO of to-BBB, said: “We thank the COMP for their positive opinion. We are excited about the potential of 2B3-101 and, supported by the benefits of the orphan drug designation, we will continue to execute our strategy to develop this therapy for patients with life-threatening brain cancer.”