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Re: flipper44 post# 215330

Thursday, 02/21/2019 8:00:24 PM

Thursday, February 21, 2019 8:00:24 PM

Post# of 700676


Fraunhofer seems to like the thought they optimized manufacturing during the second half of the trial. That might account for the eventual increase in three year survival.



Flipper44,

This comes from the annual report 2014 Fraunhofer IZI publication date April 2015.

Manufacture of the immunotherapeutic DCVax®-L for brain tumor patients.

The US biotechnology company Northwest Biotherapeutics Inc. is conducting a phase III clinical trial in Europe to examine the efficacy of its immunotherapeutic DCVax®-L, whereby the Fraunhofer IZI is responsible for manufacturing the investigational medicinal products. DCVax®-L is an advanced therapy medicinal product (ATMP) based on autologous dendritic cells to treat glioblastomas, a particularly aggressive type of brain tumor.



and...

After the clinical trial was approved in the UK and following capacity increases at the Fraunhofer IZI (concerning clean rooms and staff), patient batches for use in British hospitals have been produced since June 2013. In addition, both the clinical trial and a special permit pursuant to Section 4b AMG (”hospital exemption”) were authorized by the Paul Ehrlich Institute. The authorization pursuant to Section 4b AMG permits the manufacture of advanced therapy medicinal products as an individual preparation for individual patients who are not able to be included in a clinical trial due to their indication or other exclusion criteria. Batches for German patients have been manufactured in the clean rooms and administered to patients as part of the clinical trial since August 2014; patient batches for treatment pursuant to Section 4b AMG have been manufactured and administered to patients since October 2014.


https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2014.pdf

This comes from the annual report 2015 Fraunhofer IZI publication date April 2016.

Manufacture of the immunotherapeutic product DCVax®-L for brain tumor patients.

Fraunhofer IZI is producing and optimizing an investigational medicinal product in Europe, the efficacy of which is currently being investigated as part of a phase III clinical trial. American biotechnology company Northwest Biotherapeutics Inc. has already successfully used the immunotherapeutic product DCVax®-L in clinical trials in the US. This advanced therapy medicinal product (ATMP) is based on autologous dendritic cells for the treatment of glioblastomas, a particularly aggressive type of brain tumor


and...

Furthermore, applications to conduct respective clinical trials were submitted to the responsible authorities in the United Kingdom and Germany and initially authorized in the UK. Consequently, in June 2013, production commenced for the treatment of patients there. Authorization of the trial in Germany the following year then also gave the green light for the production of batches for German patients, which has been ongoing since August 2014


https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2015.pdf

Do you see the difference?

Fraunhofer IZI speaks for the first time of an optimized vaccine about 3 years after the production of the first patient batches for use in British hospitals. (June 2013)
Any idea why only after about 3 years? To be sure that it was optimized?
Perhaps this explains why Prof. Keyoumars Ashkan is so enthusiastic about DCvax-L!

So, was the Fraunhofer vaccine a pure copy of the Memphis vaccine or an optimized one?
And IMO if it was an optimized one, when was a copy of the Fraunhofer vaccine available for the patients in the US and Canada?
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