Northwest Biotherapeutics to Host Conference Call This Afternoon, May 27th (NWBO, Buy, $6.25)
Northwest Biotherapeutics announced today that the Company will host a conference call and webcast with CEO Linda Powers today, May 27, 2014, at 4:30 p.m. Eastern time to review the early results of the Phase I/II DCVax®-Direct Trial announced this morning and answer questions.
Participants must register in order to participate in the conference call. There are three ways to register:
- Parties may pre-register in advance through the following linkhttp://dpregister.com/10047169.
- Participants may register at the time of call by phoning an operator at 1-877-270-2148 or 1-412-902-6510 and asking for the Northwest Biotherapeutics call.
- Participants may register at the time of the call to listen through a webcast athttp://services.choruscall.com/links/nwbo140527.html
Participants wishing to submit questions may send their questions to the Company athttp://tinyurl.com/lqxf9ud by 3:30 pm Eastern time.
Tagged as dcvax direct, Northwest Biotherapeutics Inc., NWBO + Categorized as Smith On Stocks Blog
From the release:
“The Phase I portion of the trial includes 36 patients. To date, 19 patients have completed at least half of the 6 treatments with DCVax-Direct, which are spread over 8 months. None have yet completed all 6 treatments.
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.
The Phase I/II DCVax-Direct clinical trial includes a total of 60 patients: 36 in the Phase I portion and 24 in the Phase II portion. The DCVax-Direct trial began treating its first patients in Q3 of last year.
As is often the case with first-in-man studies, the Company’s DCVax-Direct trial was required, as a regulatory matter, to proceed slowly until safety considerations could be assessed. The Company was required to treat just one patient with at least 2 of the 6 treatments in the overall regimen, then wait 2-3 weeks before treating the next single patient in the same way, and so on, treating just one patient at a time.
By March, the Company was permitted to begin enrolling without such pacing limitations. In the period between March and May, most of the remaining slots in the 36-patient Phase I trial have been enrolled or completed screening. (Enrollment occurs after both the screening and the product manufacturing have been completed for that patient.)
The DCVax-Direct treatment regimen in the clinical trial includes a total of 6 injections: initially at Day 0, Day 7 and Day 14, followed by injections at Week 8, Week 16 and Week 32.
“We are excited to already begin seeing some initial positive responses in such a substantial percentage of the DCVax-Direct patients,” commented Linda Powers, CEO of NW Bio. “We had anticipated potentially seeing responses within a couple of months after treatment, but seeing such responses while these patients are still only part way through their treatment is especially encouraging.”
“It is also exciting to see these initial responses in diverse cancer types, and in patients with very advanced, inoperable metastatic cancers – especially with only one tumor being injected with DCVax-Direct in the current trial,” Ms. Powers continued. “Of course, we must emphasize that it is still early in the DCVax-Direct trial, and the results may become greater or lesser as more data is obtained. However, there are no effective treatments for these metastatic cancer patients today, and we hope that DCVax-Direct will be able to offer an important new treatment option for these patients.”
Hi Larry……..Can’t wait to hear your take on the news that Linda, etal put out today…..Sounds like
the best news we could possibly hope for…..Way over the top……MD Anderson should give us a
much clearer picture at ASCO….Need types of cancer, and stuff you would know much better than I…What I can’t wait for is for Germany to approve with a special exemption the use of “D” because it
is superior to “L”…..They are sooooooo far ahead of us……Of course, you have read my 20 questions and someday, maybe I’ll get some answers……Are the folks who are now signing up in Germany for “L” blinded or unblended? Are there more hospitals seeking authorization to begin “L”
treatments? What about the EU? What about the UK? What about the Japanees? the Chinees? So much possibilities……..almost to much for one small company…..I realize they will sell more shares…..so what? raise money, start more tests. get more information….grow, baby, grow….Thanks Larry……Maybe you should go to ASCO…….Cheers, LongNwbo
Good Morning Larry…..What is your opinion on NWBO’s announcement that they are planning to begin a trial in Germany for the treatment using “L”???
I wish they had said “D”!!! How will they get the German patients to sign up for a blinded trial using “L” when the patients can get the real deal and have it paid for by the German health care system??? Sorry, I just don’t get it and I really wish you or someone with more insight than me would comment on this long, money sucking test will prove to be…I do have other questions, but I guess I’ll save them for another time….Thank you if you happen to read this and respond