Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) a biotechnology firm advancing DCVax® personalized immune treatments for solid tumor cancers, reported that its common stock commenced trading on the OTCQB marketplace from December 19, 2016. It will trade under the ticker ‘NWBO.’ The stock has been delisted from the NASDAQ exchange.
Northwest Biotherapeutics released an update about the firm’s Phase III study of DCVax®-L for GBM brain cancer. The firm reported that 331 of the intended 348 subjects have been registered in the study, and that data events have been growing towards the endpoints of the study. As recorded in the profile of the study, the firm had estimated that the “events” count to reach the primary endpoints soon.
The firm asked for updates from the external entities managing the study about the count of “events,” that is, tumor recurrences or deaths. Such updates usually take a couple of weeks, comprising quality control checking. Northwest Biotherapeutics expects to obtain this info and be able to proceed for a further update release in nearly the next two weeks. The firm remains blinded in respect to the Trial data and, will only be getting such updates on a blinded basis.
The trial has been dependent to a fractional clinical hold, only on enlistment. As a result of the fractional hold, the Trial has not registered the last 17 of 348 patients. So far, the regulators have not accepted to eliminate the partial hold, but have permitted all of the subjects in the study to continue being cured as per the protocol.
Northwest Biotherapeutics is pursuing continuous dialog with regulators. Yet, at this point the firm considers that the potential advantages that could be received from enrolling the last 17 subjects would not be worth the time required, as the process of re-training and re-starting the sites for further registration would take months, trailed by further months for the enrolment itself.