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Re: Rkmatters post# 37301

Friday, 07/10/2015 11:22:31 AM

Friday, July 10, 2015 11:22:31 AM

Post# of 732145
Heya,

i attached the article posted above. From above: UCLA IRB #03-04-053, FDA IND #11053, clinical trial registration # NCT00068510; n=28. Does the Phase III German Protocol you reference use the same IND as quoted in this clinical trial collaboration study between NCI and UCLA? --RK



The German protocol references both Ph I studies and their IND #s. As well as the Ph III IND.

Is so, freeze-thaw was used. They also used the ATL, which incidentally is included on both theToll-like receptor (TLR) agonists, imiquimod or poly ICLC, and when impiquiod was introduced to the GAA peptitde-pulsed DC vaccination, it did show the negative affect that the attached paper you referenced. However, that was not the case with DCVax-L. It had a positive affect. --RK



Not sure what you mean by "is included on both the TLR agonists." You mean with? If so yes, in one of the two studies NW references for DCVax-L they used them. In the other, smaller one, they did not. The study you quote here compares patients treated with DCVax-L + TLR agonists (not done in Ph III btw) with a group treated with GAA loaded DC alone. This is one of the reasons drawing distinctions between these two groups is confounded. The GAA group did not receive TLR agonists. They also as a group had a lower K score. And the GAA group is very small--just 6 patients. So I can't really take those comparisons seriously. And in fact I'm surprised UCLA tried. Feels almost like they are being promotional, don't you think?

helper.ipam.ucla.edu/publications/cdm2014/cdm2014_11721.pdf
The above UCLA deck is current. It refers to all things related to DCVax-L, including this comparison study above, which concluded findings as of last year (FEB 2014). And, the PDF includes DCVax-L Phase III. Some slides you might want to see:
--TLR-7 agonist, Imiquimod, promotes anti- tumor immunity to CNS tumors
--TLR-7agonist, Imiquimod, enhances dendritic cell survival and migrationII clinical trial of autologous
--Phase II clinical trial of autologous tumor lysate- pulsed DC + immune adjuvants (FDA IND 11053, 2003). --RK



All of that is fun times but irrelevant to the Ph III. No TLR agonists are used in conjunction with DCVax-L. You had a family member in the trial so you know that, right? Recall any odd additional muscle injections with poly-ICLC?

Freeze-thaw is not an issue in the Phase III trial. Looks like use of an immune adjuvants is included in their IND as well. Above highlighted article also shows that only 12.5% of DCVax-L patients were failed screen. According to Wheeler 2009 evaluation of DCVax-L (paid paper), no funny business was found in DCVax-L prior studies. Assuming so, all should end significantly well even if they are using 2003 maturation process. --RK



Freeze thaw is very much an issue in the Ph III. When studies show pointedly that in vitro loading of DC with lysate necrosed via freeze thaw process hinders maturation as well as CD4/CD8 functioning, etc, I wouldn't just dismiss it out of hand. By NW's own admission DCVax-L is inferior. They cite the process causing "confused" DC, and state antigen uptake is only 1/10 as extensive as via the process for Direct.

TLR agonists are supposed to assist in the maturation of DC but according to the study I quoted, freeze thaw lysate loaded DC are resistant to this as well.

Thanks for bringing the freeze-thaw concern to my attention. I truly appreciate feeling more confident about being long NWBO, particularly as it relates to DCVax-L Phase III prospects. --RK



Um you're welcome? ;)

I'd offer you advice, but I just don't care about your money, unless you give me money to care about your money. I might even be tricking you with the above post...

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