DCVax-Direct: First Case Study Announced

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lichens
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DCVax-Direct: First Case Study Announced

Postby lichens » Thu May 15, 2014 3:32 pm

http://www.marketwatch.com/story/nw-bio-announces-first-data-from-ongoing-dcvax-direct-trial-2014-05-15

The specific case study announced today involves a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. This patient received the first 3 DCVax-Direct injections through the course of a month, starting in February. He received a fourth injection in early April and then was scanned for results in early May. At that time, this patient's MRI scan showed extensive necrosis and partial collapse of the injected large tumor mass, and a CT scan showed some early indication of shrinkage of one of the non-injected metastasized tumors. These results suggest both local and systemic effects of the DCVax-Direct treatment, as were seen in the pre-clinical studies.


Can't wait to see more data as they become available, specifically of the drug's effect on carcinoma patients!

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Maia
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Re: DCVax-Direct: First Case Study Announced

Postby Maia » Tue May 27, 2014 9:07 am

Update Mat 27th 2014
Results, so far, from the trial at MD Anderson (Texas and Florida) Safety and Efficacy Study of DCVax-Direct in Solid Tumors
It's a press release, so take it with a pinch of salt, but we should trust the numbers are those.

05.27.14
Early Positive Responses Seen In Over 50% Of DCVAX®-DIRECT Patients To Date

Initial Responses Seen Before Patients Have Completed Treatments; Preliminary Signs of Cancer Cell Death, Tumor Shrinkage & Stabilization of Disease

BETHESDA, Md., May 27, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today provided a summary of initial data to date in its ongoing Phase I/II clinical trial of DCVax-Direct for all types of inoperable solid tumors. The Company reported that over 50% of the patients who have completed at least half of the 6 treatments in the trial are already showing preliminary signs of cancer cell death, tumor shrinkage and/or stabilization (i.e., stopping the progression) of their advanced cancer.

Further information will be available at the Company’s exhibit booth at the upcoming ASCO conference. The Company also plans to conduct a conference call to discuss the initial preliminary data.

The Company’s Phase I/II trial of DCVax-Direct is treating patients with advanced, inoperable cancers involving multiple metastases (including metastatic colon cancer, pancreatic cancer, sarcoma, melanoma and others). Although these patients have such advanced metastatic disease, only one tumor is being injected in each patient because the current trial is a first-in-man study. In future studies, the Company plans to inject DCVax-Direct into multiple tumors in each patient.

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.”
Dr. Marnix Bosch, Chief Technical Officer of NW Bio, noted, “As a drug developer and a scientist, it is exciting to see this early DCVax-Direct progress indicating the induction of anti-tumor immune responses. We are eagerly looking forward to seeing the ongoing data.”

DCVax-Direct is a personalized immune therapy for all types of inoperable solid tumor cancers, using dendritic cells (the master cells of the immune system) to mobilize the full immune system to attack the patient’s cancer. DCVax-Direct is administered by direct injection into the patient’s tumors, and can reach tumors in virtually any location in the body (with image guidance for interior locations).

Further information about DCVax-Direct and the Phase I/II clinical trial will be available at the Company’s exhibit booth at the upcoming ASCO conference, and Company personnel will be available to discuss this information. In addition, the Company will be presenting a poster describing the DCVax-Direct clinical trial. The Company encourages anyone attending ASCO to visit the Company’s exhibit booth.
http://nwbio.com/early-positive-respons ... s-to-date/

lichens
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Re: DCVax-Direct: First Case Study Announced

Postby lichens » Tue May 27, 2014 9:17 am

Great find, Maia! Can't wait to hear what MD Anderson will say about this at ASCO later this week!

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Maia
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Re: DCVax-Direct: First Case Study Announced

Postby Maia » Tue May 27, 2014 9:36 am

Can't wait, me too!
And lichens... thank you, but I have zero merit about any finding: just set a Google Alertwith "DCVax-Direct" and it lands in your email. :D

dianne052506
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Re: DCVax-Direct: First Case Study Announced

Postby dianne052506 » Tue May 27, 2014 9:37 am

Is it really possible to inject the vaccine into lung tumors? It feels so dangerous to me.
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
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still recovering; looking at trials again

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Maia
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Re: DCVax-Direct: First Case Study Announced

Postby Maia » Tue May 27, 2014 9:46 am

Dianne... when someone has RFA to ablate lung tumours, they use a needle electrode to get to current to the tumour (http://www.radiologyinfo.org/en/info.cfm?pg=rfalung Ouch), which is way more thick than an injection needle. Or are you thinking about risks not from the procedure but from the injected substance itself?

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Re: DCVax-Direct: First Case Study Announced

Postby dianne052506 » Tue May 27, 2014 2:53 pm

Maia,
I am highly needle-phobic. Can't stand to look at one. I had a needle biopsy on one breast years ago that was just a cyst, but haven't needed anything since then. I'm not sure I could describe the location of the various lung nodules I have, but I would think at least some of them would be difficult to get to. I know one is in the mediastinum, another in the left lingual area, and another near the top of the left lung. Since I have heard of lung nodules in locations too problematic to radiate, I just assumed that the location might cause problems for the vaccine injection. It would be nice to be wrong and have this as another thing to try down the road, although I haven't checked to see if the PD-L1 study excluded me from this also.
I'll worry about that another day.
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

lichens
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Re: DCVax-Direct: First Case Study Announced

Postby lichens » Tue May 27, 2014 4:43 pm

dianne052506 wrote:Maia,
I am highly needle-phobic. Can't stand to look at one. I had a needle biopsy on one breast years ago that was just a cyst, but haven't needed anything since then. I'm not sure I could describe the location of the various lung nodules I have, but I would think at least some of them would be difficult to get to. I know one is in the mediastinum, another in the left lingual area, and another near the top of the left lung. Since I have heard of lung nodules in locations too problematic to radiate, I just assumed that the location might cause problems for the vaccine injection. It would be nice to be wrong and have this as another thing to try down the road, although I haven't checked to see if the PD-L1 study excluded me from this also.
I'll worry about that another day.
Dianne


From what I understand about DCVax-Direct, only the biggest tumors get injected with the vaccine. In theory, the injected dendritic cells will 'record' the scent (antigen on the cell surface) of the cancer cells and then travel to the lymph nodes to 'teach' the B and T cells to recognize and neutralize the cancer cells. The immune response would be systemic, so every cancer cell in the body should be fearful of getting destroyed.

Here is the link to the trial:

http://clinicaltrials.gov/ct2/show/NCT01882946

Unfortunately one of the exclusion criteria does state "Prior active immunotherapy for cancer within the past 2 years."

dianne052506
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Re: DCVax-Direct: First Case Study Announced

Postby dianne052506 » Tue May 27, 2014 6:09 pm

My last treatment with the PD-L1 drug was in Feb of this year. Guess I need to hang on while!
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

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Maia
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Re: DCVax-Direct: First Case Study Announced

Postby Maia » Tue May 27, 2014 6:16 pm

And you'll do, Dianne! And with a pill -no needle involved :wink:
((hugs))

ColOrPan
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Re: DCVax-Direct: First Case Study Announced

Postby ColOrPan » Wed May 28, 2014 8:03 am

My hsband has had several RFA for bone mets and was under general anesthesia each time so no need to worry about the needle! :)
I wonder if they can do the DCVAX in lymph nodes or bone mets tumors since they say they can do it virtually anywhere in the body.
06/2012 DH rare intestinal type Ampullary/duodenal cancer. They extrapolate from colon cancer. FOLFOX 6 been working since Aug 2013. Feb 2014 once a month folfox as maintenance.
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lichens
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Re: DCVax-Direct: First Case Study Announced

Postby lichens » Thu May 29, 2014 12:18 pm

For those interested, Northwest Biotherapeutics, the company behind the DCVax technology, had a conference call discussing their press release on initial trial data for DCVax-Direct earlier this week. The summary of the call and the transcript of the Q&A portion are captured by a bio-tech stock analyst/blogger and are available at:

http://smithonstocks.com/northwest-biotherapeutics-management-discusses-interim-data-on-phase-12-trial-of-dcvax-direct-nwbo-buy-6-00-free-content/

One thing that stood out is the company's response to the question about which types of solid tumors they think will respond the best:

Question: Can you determine which types of solid tumors will respond best?

NWBO: It is too early to tell. So far, we are seeing responses in multiple solid tumor types. We previously reported on a response in a sarcoma patient and we have seen a response in a second sarcoma patient as well. We have also seen Reponses in pancreatic cancer and metastatic colon cancer.

lichens
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Re: DCVax-Direct: First Case Study Announced

Postby lichens » Wed Jun 11, 2014 9:59 am

http://www.prnewswire.com/news-releases/dcvax-direct-trial-update-indicates-further-positive-responses-3-case-studies-show-no-live-tumor-cells-in-injected-tumors-262686921.html

Today the company released additional case studies. You can find some some of the more interesting tidbits below:

in the ongoing Phase I/II clinical trial of DCVax-Direct for all types of inoperable solid tumors, all 9 out of 9 patients who have received 4 of the 6 planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization (i.e., stopping the progression) of their advanced cancer. In addition, in 3 of these 9 patients, biopsies now show no live tumor cells in the injected tumor.


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. ...Each of these 3 patients was treated with the lowest dose level (2 million cells per treatment).


Below is a direct quote from Linda Powers (company's CEO):
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.


Personally my interest in this technology is because of the concept of a dendritic cell vaccine. Ralph Steinman won a Nobel Prize in 2011 for his discovery of the role of dendritic cells in adaptive immunity. If one's own immune system can recognize and memorize the characteristics of cancer cells, then cancer would have a hard time to to take hold in one's body (Dendritic cell functions to teach the immune system to recognize other cells).

Past attempts of dendtritic cells cancer treatment involved the use of immature dendritic cells. What's different about DCVax-Direct is the dendtritic cells used here is partially matured then injected back into the tumor. Supposedly this will allow the DC cells to better pickup tumor antigens.

Since this technology is from a tiny development stage biotech company based in Maryland, it lacks the marketing prowess of a Merck or a Roche, so you won't hear much about it from the mainstream media. But in concept, the vaccine approach to cancer treatment is just as if not more promising than all the immune checkpoint inhibitors (PD-1/PD-L1, CTLA-4) that are all the buzz right now.

janderson
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Re: DCVax-Direct: First Case Study Announced

Postby janderson » Wed Jun 11, 2014 12:34 pm

That is some amazing results. I wonder since it is a small company producing it they would be more or less likely to give the drug to one of us on a compassionate basis.
DX 10-05 stage IV
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lichens
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Re: DCVax-Direct: First Case Study Announced

Postby lichens » Fri Jun 27, 2014 10:51 am

For those interested in DCVax-Direct, there are some encouraging developments. Northwest Biotherapeutics (company behind the technology platform) recently updated their pipeline, they are now planning a new phase I/II trial specifically for colon cancer metastases. What this may suggest is, from the ongoing DCVax-Direct inoperable solid tumor trial, colon cancer patients may have the highest response rate to the treatment approach.

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