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Re: Lykiri post# 167417

Saturday, 04/14/2018 8:00:00 PM

Saturday, April 14, 2018 8:00:00 PM

Post# of 725340
Find this google translation exceptionally well though I cannot verify since I don't speak German: [a side note though lots of translators have lost their jobs because of programs like google translator]

"STUDIES
Manufacture of immunotherapeutic DCVax®-L for brain cancer patients
In recent years, the Fraunhofer IZI has been the manufacturer of a clinical investigational product for test centers in Germany and the United Kingdom, the effectiveness of which is still being reviewed in the context of a phase III clinical trial.
The DCVax®-L immunotherapeutic agent was previously successfully used in smaller clinical trials by US biotechnology company Northwest Biotherapeutics Inc. in the United States. This advanced therapy medicinal product (ATMP) is based on autologous dendritic cells for the treatment of glioblastoma, a particularly aggressive form of brain cancer.

In order to manufacture DCVax®-L individually for each patient, both tumor tissue and a blood product were taken from the patient and then the cell-based therapeutic was produced in a complex, multi-step manufacturing process. The recruitment of the number of patients statistically necessary for the study was completed in 2015, thus successfully completing the manufacturing and testing activities at Fraunhofer IZI.

However, since the therapeutic is administered in multiple doses over a period of 3 years to the patients participating in the study, cryopreserved clinical trials samples were sent in 2017 to the participating clinical trial sites for patient application.
This process will continue in 2018 until the last scheduled dosage is shipped. Thereafter, evaluation of the clinical trial by sponsor Northwest Biotherapeutics Inc. is expected."

The interesting point is when will it be the last dose of the last patient in the trial administered?
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