Replies to post #11899 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Ou said:

It's going to take years and millions of dollars to get Direct approved. People here weren't predicting that before the PR. Some people here were expecting 80%-100% cures from Direct as was seen in the preclinical. Those that thought that were way off. --Ou

The treatment regimen is not over. Many current non-responders may become responders. Again, immunotherapy of this nature can increase efficacy over time, whereas chemo does the opposite.

Breakthrough therapy and AA may be applied. Tumor response is the fastest way to accelerated approval.

[gnawkz]

Maybe my understanding of DCVax-L is off ... but the longer it takes for events to occur for a cancer like Glibo ... then the more effective the immunotherapy product is right?

So if 60% occured back in December, and the next 80% doesn't hit till this December, that should speak VOLUMES of the efficacy of the product.

I believe, in a way ... every day that passes where the next event has not triggered is just another positive data point. Please correct me if I am wrong ...

[theel72]

Absolutely, nothing is guaranteed, but you have to remain objective and look at all the evidence--German approvals for DC-Vax L, before that the PR release this Feb detailing that over 200 patients had been treated with DC-Vax L with an over 50% response rate (contrasted with the average of only 20% for most new cancer treatments), and most recently the clear and convincing evidence that DC-vax Direct is working wonders in numerous people, not just mice. Contrast all this overwhelming positive news flow with a company with a reasonably close market cap--TGTX. Roth Capital just made that company a Focus List stock and has a price target of $15, whereas the price finished up 4.15% today after this news release on its Phase I update:

"TGR-1202 in ongoing Phase I clinical studies; 100% of CLL patients achieved a peripheral response with 67% achieving a partial response (TGTX) : Co announced clinical results from its ongoing Phase I single agent study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody and from its ongoing first-in-human Phase I single agent study of TGR-1202, the co's oral, once-daily, PI3K delta inhibitor. Data from these Phase I studies are being presented today at poster sessions during the 50th American Society of Clinical Oncology (TATD) Annual Meeting in Chicago, IL, with both posters selected for discussion later in the day during oral Poster Highlight sessions.

Today's poster presentations include data from 35 patients with rituximab relapsed and refractory hematologic malignancies treated with TG-1101 at doses ranging from 450 mg to 1200 mg, and from 40 patients with relapsed and refractory hematologic malignancies treated with TGR-1202 at doses ranging from 50 mg to 1800 mg QD.
The overall response rate (ORR.V) for the Phase 1 dose escalation component and expansion cohort was 43% (30% PR, 13% CR) among the 30 rituximab relapsed/refractory patients evaluable for efficacy. TG-1101 displayed marked clinical activity as a single agent in a variety of lymphoma subtypes, reporting a 67% (4/6) response rate in patients with CLL and 44% (8/18) response rate in iNHL (22% CR, 22% PR).
Among patients with CLL, depletion of circulating lymphocytes was rapid and profound with 100% of patients achieving a peripheral response (defined as either a normalization in absolute lymphocyte count (ALC.TO) or > 50% reduction in ALC from baseline) with a median time to peripheral response of 1 Day and a median reduction in ALC at the first response assessment in excess of 90%.
TG-1101 (ublituximab) was well tolerated at all dose levels tested in 35 patients evaluable for safety, with Day 1 infusion related reactions (IRR) being the most frequently reported adverse event. All IRR's were Grade 1 or 2 in severity, were manageable and occurred more frequently in patients with CLL. Infusion times for the fourth and later infusions of TG-1101 averaged approximately 90 minutes.
Clinical activity was observed in patients with CLL treated at doses = 800 mg with all (9/9) patients exhibiting significant nodal reductions. Seven of nine evaluable patients (78%) exhibited a nodal response ( > 50% reduction in nodal size) of which three of these patients achieved a partial response per the IWCLL 2008 criteria. The remaining two patients exhibited > 40% reductions in nodal size at first efficacy assessment and remain on study awaiting upcoming efficacy assessments."

Will AF be bashing this stock this evening or tomorrow morning in a post read by everyone on the internet because Yahoo Finance posts it, or the The Street.com posts it, or Msn Money posts it??? Of course not, it's not a really significant threat to big Pharma...Neither is CLDX, or CLVS, or dozens of other small or mid-cap biotech stocks...Again, patience is a huge virtue with NWBO...

[john1045]

ou....I respectfully disagree on your point that Direct did not reach 80-100% as in pre-clinical. MD Anderson has not even completed all of the scheduled injections and they are still very early in only 3 dosages levels they are seeing necrosis in tumors as noted below in the PR. We also know that that Direect continues to work as more injections continue. These patients had no treatment options available and even if Direct stabilizes the cancers for months let alone tumor necrosis and systemic response with immune memory it gives these patients quality of life let alone the possibility their cancer is gone.

Among the 19 patients who have received at least half of the 6 treatments, 11 patients have already shown some preliminary positive responses to the treatments, including the following:

8 of the 11 patients have shown signs of tumor necrosis (cell death) and immune cell infiltration, as well as stabilized disease that has stopped progressing, following the injections of DCVax-Direct.

For all of these 8 patients, biopsies indicated substantial to extensive tumor necrosis, as well as substantial accumulations of immune cells infiltrating into and around the patients’ tumors, following the DCVax-Direct injections.
For 6 of these 8 patients, imaging scans also indicated either tumor shrinkage or no disease progression following the DCVax-Direct injections.

For the other 2 of these 8 patients, imaging scans seemed to indicate some enlargement of their tumors. However, the needle biopsies revealed that the tumor was filled with necrosis (dead tumor cells) and infiltrating immune cells, as noted above. In addition, these patients have reported significant improvement in their physical condition and clinical symptoms.

The other 3 of the 11 patients have shown stabilized disease, with no growth in their advanced and aggressive tumors following the DCVax-Direct injections, but have not yet shown definitive necrosis or infiltration of immune cells into their tumors.
Among the remaining 8 of the 19 patients who have received at least half of the 6 injections in the trial:

1 of these 8 patients requires more data before a preliminary assessment can be made;
7 of these patients have shown progression of their disease.