Monday, April 16, 2018 4:30:02 PM
Your post 167568
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The Germans also manufactured for the Brits back then. See below. Recall there was even European licensing for transport of tissue between countries. I'm not certain the manufacturing for the UK's involvement in the trial was not handled by Germany. King's College may have handled the compassionate program -- or perhaps even part of the UK's involvement in the trial, however, it appears Germany played a significant role.
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The first European patient in the Company's Phase III clinical trial of DCVax-is well known British Shakespearean actor Robert Demeger, who has appeared regularly on the stage and in the popular TV series Doctor Who. This patient was operated on in June, 2013, by Dr. Keyoumars Ashkan, a senior neurosurgeon at Kings College Hospital and the lead investigator for the trial in the U.K., to remove his brain tumor and enable him to enter the DCVax-L trial.
https://www.news-medical.net/news/20131231/BBC-TV-report-profiles-NW-Bios-DCVax-L-Phase-III-trial-for-GBM-brain-cancer.aspx
I suppose he got his first vaccination September 2013.
From the annual report 2015 Fraunhofer IZI : “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.”
I think the production of batches for UK patients came from Germany.
I agree that King's College may have handled the compassionate program.
The following is from King’s College London news and event. Article: Brain Cancer vaccine trial. Posted on 14/05/2012
“Farzin Farzaneh, Professor of Molecular Medicine and head of cGMP cell product manufacturing at King’s College London, said: 'We are excited to be undertaking the manufacture of the vaccine here at King’s. Such immune therapies represent an exciting new class of products, and we are pleased to apply our expertise and facilities for cell therapy to help bring DCVax® immune therapies to the UK and to collaborating centres in Europe.'”
https://www.kcl.ac.uk/newsevents/news/newsrecords/2012/05May/Brain-Cancer-Vaccine.aspx
Note: British actor Robert Demeger passed away in London on 14 September 2014.
Flipper44,
From your post 167582:
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“Basically, what [Fraunhofer] appears to be saying is that 300 enrollment was statistically sufficient for the trial. Perhaps for everyone. Remember what a big deal NWBO made about 300?”…….” Why Fraunhofer did not discuss the apparent 31 still (at that time) to be enrolled somewhere else is a bit mystifying.”
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If I understand you correctly then it means that there were no more German patients enrolled in the trial after the beginning of August 2015.
If that is true,the last German patient had his surgery at the end of April or early May 2015. This means that from that moment no more German patients were recruited for the trial That looks like a self-imposed hold on screening. ( Hey,i read the same words in this K10 page 5 https://www.sec.gov/Archives/edgar/data/1072379/000114420417020754/v464066_10k.htm)
Note: when i read post 167616 LesslsMore it seems that most longs here (I still wonder who he means!) believe that the primary (PFS) endpoint failed. We know for sure there was no IA end April, beginning May 2015. ( see presentation Linda Powers May 2015)
Last note about Cognate Management Buyout.
From the PR.:” BALTIMORE, MD and MEMPHIS, TN – Cognate BioServices, a leading contract development and manufacturing organization (“CDMO”) in the global cellular therapies industry, announced today it has completed a management buyout (“MBO”) and raised capital from a group of global investment firms including Santa Monica, Calif.-based Tennenbaum Capital Partners, LLC (“TCP”), Medivate Partners and affiliates (“Medivate”) based in Seoul, South Korea and a sovereign wealth fund……….”“Our investment was driven by a combination of the tremendous opportunity in personalized cell therapy manufacturing and our confidence in the strong management team at Cognate,” said Medivate’s Managing Partner Roger Kang. “We are very excited to be a part of this syndicate and look forward to being part of their continued growth.” https://www.cognatebioservices.com/cognate-completes-management-buyout-raises-growth-capital-fund-commercial-cellular-therapy-manufacturing-expansion/
South-Korea???????
From the annual report 2013 Fraunhofer IZI
Interview with the director Prof. Frank Emmrich (P.8)
“What other achievements relevant to the institute would you like to highlight here? At the start of 2013, we were able to celebrate the opening of a joint laboratory (JLCI – Joint Laboratory of CNUHH in collaboration with Fraunhofer IZI) together with the Chonnam National University in Gwangju, South Korea, on the campus of Hwasun University Hospital near Gwangju. This strengthened our collaborative work and, above all, staff exchange between the two partners. Our next task is to acquire the South Korean pharma and biotech industry as a new customer.”
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2013.pdf
South -Korea??????
Maybe COINCIDENTALY or maybe they heard about something “very interesting”?
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