Replies to post #26061 on NorthWest Biotherapeutics Inc (NWBO)

[DoGood_DoWell]

Two grams is needed to make DC Vax L, which is about the size of a sugar cube.

[Evaluate]

I am not sure if any of you can help (Evaluate?), but I recall reading through all of the iHub posts that there were several about what the minimum amount of tumor was necessary in-order for Cognate to create DCVax-L. --- gnawkz

Are you perhaps thinking of post 19230 and the link mentioned therein, ie:

Also, the "Specials" arm of the treatment (compassionate use arm) was over-subscribed more than a year ago, as John brought to our notice when he was communicating with Nabil about the treatment options his mother had for brain tumor. I am re-posting the response he received from NWBO (his post was dated 17-Jul-2013 ..... http://www.cancercompass.com/message-board/message/all,72718,0.htm?mid=530754)

Dear Mohamed:

It was a pleasure to speak with you earlier. In answer to your particular questions, I would note:

· we have no means of acquiring tumour (fresh) tissues only paraffin saved ones.

The clinical trial protocol requires fresh tumor tissue. Since your mother is not a candidate for the trial and since, in our conversation, we were considering whether she could possibly be a candidate for a Specials category of patient able to obtain the vaccine through a compassionate use/private pay option in Israel, we are able to manufacture DCVax-L with frozen tumor tissue that has no chemical preservatives. As I mentioned in my earlier email, we typically need 2-3 grams of frozen tumor tissue to produce the tumor lysate which is one of the primary components of the vaccine. Tumor tissue stored in paraffin is NOT usable for the production of the tumor lysate and therefore cannot be used to make the vaccine.

· without any recurrence thats surgically operable we can`t start DCvax-L

Without 2 to 3 grams of untreated, viable, frozen tumor tissue, we will not be able to manufacture DCVax-L. There are exceptions where we have made partial batches of vaccine, occasioned by the availability of lesser amounts of viable tumor tissue but that is not the normal course.

Also see:
http://www.nwbio.com/nw-bio-responds-to-shareholder-inquiries-following-immune-therapy-sectors-recent-market-decline/
includes:

Generally, any GBM patient can be treated with DCVax-L if their immune cells are adequate and just 2-3 grams of their tumor tissue (roughly similar in size to one sugar cube) can be obtained, to provide the antigens for the product.

Also see post 14848:

Heather verifies they only had a 40mg tumor sample.

She said DCVax-L only needs 2-4 gms which sounds about the size of a sugar cube, as you said Flipper. In fact sugar cubes are about 4 grams, so they are at the high end of the range she was told.

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My sister only had a little saved (miscommunication during surgery time) and dcvax wants 2-4g. It's a lot.
I think she had only 40mg saved..
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[flipper44]

Hi Gnawks, it looks like evaluate already gave you the posts demonstrating 2-3 grams of tumor tissue is needed for the trials.

For expanded access, hospital exemption and compassionate use, I suspect the amount might range down to less than a gram.

IMHO, where resection is not feasible, but L may still be helpful, core needle or vacuum assisted biopsy will be used in the future to obtain enough tissue to provide initial treatment.

note: Someone recently raised a concern that the process to obtain a vaccine might take considerably longer than 8 days; however that was years ago. At this time, processing has been reduced to 8 days. The time in trials for standard of care plus Temador plus radiation is the only bottleneck holding up therapy, and I suspect we will hear about various options reducing this time delay as hospital exemption moves forward.

In the United States, the expanded access group may provide a gateway to options not formally using the Stupps protocol, because some patients in that group were only included for treatment after their tumors started to regrow, and yet their first tumor samples were previously preserved and are now used upon progression without the Stupps protocol delay.

In short, as Stupps himself would applaud, treatment protocol should become more patient specific as time goes on.