Replies to post #17516 on NorthWest Biotherapeutics Inc (NWBO)

[john1045]

Xena....I keep going back to the June 11th PR update on Direct. It really is amazing, tumor cell death, shrinkage considering these solid tumor cancers are the most deadly forms of cancer.

The next Direct update will be significant I believe. It will now include all 36 patients plus the 20 patients from the June 11th PR will be further along. I also believe we will see Direct begin in UK and Germany in near future with possible additional funding from each UK/Germany for this trial.

To date, 20 patients (including the 9 referenced above) have received at least 3 of the 6 total injections, and 13 of these 20 patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of their disease. The Company plans to report more details when the patients are further along in the treatment regimen. The first 3 injections are given in the first 2 weeks of the 32-week treatment regimen (at Day 0, Day 7 and Day 14).

So far, 9 of the patients have received 4 of the 6 planned injections, and all 9 of these 9 patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of the patients’ disease. The 4th injection is administered in week 8 of the 32-week treatment regimen. (The overall treatment regimen includes 6 injections at Days 0, 7 and 14, and Weeks 8, 16 and 32.)

Also, in a new finding, biopsies taken in 3 of these 9 patients now show no live tumor cells in the tumor that was injected. These 3 cases include diverse, advanced and particularly aggressive cancers: 1 metastatic pancreatic cancer case, 1 metastatic colon cancer case and 1 metastatic sarcoma case. These patients’ tumors show some enlargement on imaging scans, but the biopsies show that live tumor cells are no longer detectable and immune cells are now found there. Each of these 3 patients was treated with the lowest dose level (2 million cells per treatment).

In these 3 patients, as well as the other patients in the trial, only one of their tumors has been injected with DCVax-Direct. The Company plans to inject multiple tumors in its further studies of DCVax-Direct.

“These early glimpses are indicating an increasingly encouraging picture – especially the absence of any live tumor cells in 3 of the patients who have received 4 of the 6 planned injections of DCVax-Direct,” commented Linda Powers, CEO of NW Bio. “The 4th injection is still quite early, as it is just 8 weeks into the 32-week treatment regimen. For patients with such advanced, metastatic, inoperable cancers, who have failed other existing treatments, these are exciting findings.”

“We are also quite encouraged to see the patients’ reactions growing as the treatments progress,” noted Ms. Powers. “As of the 3rd injection in week 2 of the treatments, we now have 65% of the patients (13 of 20) showing some positive effects, and as of the 4th injection in week 8 of the treatments, we now have 100% of the patients (9 of 9) showing some positive effects. The patients also report feeling significantly better.”

“Patience will be important as we move through the rest of the treatment regimen for all 36 patients in the Phase I portion of the trial, and proceed with the Phase II portion of the trial. The data may get either better or worse as more data is collected. However, something interesting and encouraging seems to be unfolding so far.”

This growing body of initial early data is a result of both imaging scans and biopsies. The 9 patients who have received 4 injections show a range of tumor reactions, from shrinkage to no growth to some enlargement. However, in all of these patients, the biopsies show substantial tumor cell death, and in the cases of enlargement, the biopsies show major infiltration and accumulation of immune cells in and around the tumors – potential indications of an immune response to the cancer.