Northwest Biotherapeutics: Update On DCVax-Direct Based on ASCO Abstract and Positive, Early Results for First Patient Reported On (NWBO, Buy, and $5.94)
Investment Conclusion
The ASCO abstract on DCVax-Direct was released last night. It contains only a description of the drug and the goals of the phase 1/2 trial. This abstract was submitted some months ago and describes the basic structure and goals of the trial. It does not give any specific patient results.
This trial is being conducted in patients who have inoperable solid tumors. The primary emphasis is on colorectal cancer but it will also enroll melanoma, pancreatic, liver cancer and some miscellaneous cancers. In the treatment of solid tumors, the standard procedure is to surgically remove as much as the primary tumor mass as possible and then try to reduce or eliminate the remaining tumor tissue with drugs and radiation. In cases in which the tumor cannot be resected because the tumor has broadly metastasized or cannot be operated on because of its location, the prognosis is much worsened. This trial is being conducted in very advanced, inoperable solid tumor patients. This means that any signs of biological activity will be received with great interest by the medical and drug development community.
Because this is an open label trial, results on patients can be reported as the trial progresses. This morning, NWBO sent out a press release on results for a specific patient who is suffering from an advanced, inoperable and very difficult to treat sarcoma. I believe that over 20 patients in the first phase of the trial have received three or more injections which compares to the four injections for the sarcoma patient. As the year progresses, we should get significant information on these 20 patients and others that will give investors a pretty good insight into the potential of DCVax-Direct.
Treatment was started in February, 2014 for this sarcoma patient so that the results are very preliminary, but MRI scans, CT scans and a biopsy suggest that DCVax-Direct is killing cancer cells at the site of the primary tumor and importantly at distant metastases. It also appears to be creating an immune response against the tumor which is the goal of cancer vaccines. In this patient, the investigators noted that there was a partial collapse of the primary tumor. I am trying to clarify what this means, but I believe that this indicates that there was around 50% shrinkage in the tumor mass. If so, this qualifies as a partial response and will certainly get the attention of the medical and drug development community as this type of sarcoma has extremely poor outcomes and there is no effective drug therapy.
This is very early data and it will take several more months to begin to assess the ultimate effect of DCVax-Direct on this sarcoma patient. However, these intial results are quite encouraging. Because the 60 patient phase 1/2 study is open label, the Company can report results as they occur. Hence, investors can follow the progress of this sarcoma patient and I would expect there to be numerous other case reports and follow-ups in 2014 and 2015.
The commercial opportunity is huge for a product that is effective in inoperable solid tumors as there are no really effective current therapies. Also, the regulatory pathway will be much shorter if DCVax-Direct produces encouraging results. DCVax-Direct has the potential to be as or more important than DCVax-L in the NWBO investment thesis. However, at this point we have seen preliminary data on just one patient and extremely positive animal data. It is very exciting but very early.
ASCO Abstract
The abstract on the phase 1/2 trial of DCVax Direct was released last night and was as follows:
Background:
Dendritic cells (DC) are antigen presenting cells proficient in inducing de novo immune responses, and the presence of intratumoral DCs confers a survival advantage to patients, likely due to an improved balance between the immune system and the growing tumor lesion. We have initiated a Phase I/II clinical trial to exploit this finding, by using partially activated autologous DCs (aDC; DCVax-Direct) for intratumoral injection in inoperable tumors for which limited treatment options exist. These aDC retain antigen uptake and presentation capability and are conditioned to complete the maturation process following injection, resulting in initiation of a broad anti-tumor immune response. Preclinical animal data have demonstrated that these aDC can mobilize both local and systemic immune responses, and effectively clear both injected (local) and non-injected (distal) inoperable tumor lesions.
Methods:
The Phase I component of the trial aims to enroll 6 patients each in following indications: colorectal cancer, lung cancer, breast cancer with brain metastases, pancreatic cancer, melanoma and ‘other’. Patients must have had at least one recent anti-tumor treatment other than active immune therapy prior to enrollment into the trial. A dose escalation across indications investigates the safety of 3 dose levels. The aDC are injected intratumorally, using imaging guidance, at days 0, 7 and 14, followed by injections at 8 and 16 weeks. Initial DLT assessments are done following the first three injections. Tumor biopsies are taken at the time of injections to assess local effects on the injection of aDC, and tumor response is assessed using both RECIST and Immune Related Response Criteria, starting 8 weeks after the first injection. The first dose cohort of the Phase I component has completed DLT assessments, and the second dose cohort’s enrollment is nearly complete. In addition, the “other” cohort of multiple cancers has been fully enrolled.
Specific Case Report on Sarcoma Patient
While there was no outcomes data in the abstract, NWBO did report on a specific case. Because this is an open label study in which the outcomes of patients is known, we can expect periodic reports on the 60 patients in the trial in 2014 and 2015 providing a flow of meaningful information that could give an insight into the drug’s potential. It is my understanding that there will be other cases reported before ASCO ends on June 3. This should give some insight into the potential biological activity of DCVax Direct.
The specific case reported on in a press release today was on a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. Sarcomas are tumors that affect bone, cartilage, fat, muscle, vascular, or hematopoietic tissues. Those sarcomas that are confined to a particular area such as a leg or arm bone can be treated with surgery and chemotherapy, but in metastasized, inoperable tumors such as this case there is no effective therapy. Advanced sarcoma has been a beacon for drug development because the large unmet need provides a rapid pathway to regulatory approval. However, this has also been a graveyard for drug development efforts.
The sarcoma patient received three DCVax-Direct injections in February, 2014 and a fourth injection in April. In May an MRI scan was performed and this scan was compared to an MRI taken before treatment began in February. The MRI scan showed extensive necrosis and partial collapse of the injected large tumor mass. Also a CT scan showed some early indication of shrinkage of metastases that were not injected; this indicates that there is a systemic effect as well as a local effect on the injected tumor mass. This is consistent with pre-clinical studies. Biopsies taken at the time of the most recent injection showed a high rate of tumor necrosis and appearance of T-cells infiltrating the injected tumor. This is what cancer vaccines are supposed to do; they mount an immune response to attack and destroy the tumor.
This early response is encouraging as immune therapies work more slowly than conventional chemotherapies. If past results with new immunotherapy drugs like Provenge, Yervoy and the anti-PD-1a under development by Merck and Bristol-Myers are indicative, we should expect results to improve over time. With chemotherapy, there is an initial shrinkage of the tumor that is invariably followed by recurrence and regrowth of the tumor. It is important to note that side effects of DCVax-Direct are mild unlike the severe, often life-threatening side effects of chemotherapy.
DC Vax Direct and Phase 1/2 Background Information
DC Vax Direct is a product that is based on injecting a patient’s partially mature dendritic cells directly into a tumor lesion where they pick up tumor antigens in vivo. This differs from DC Vax-L in which antigens are loaded into dendritic cells ex vivo before the product is intra-dermally injected back into the body.
Past experience with products using a similar concept to DC Vax Direct, i.e. introducing dendritic cells not pre-loaded with antigens, have produced disappointing results. Dendritic cells in the body go through a maturation process in which they differentiate from monocyte precursors through various stages of maturation until they become mature dendritic cells. During the maturation process, immature dendritic cells pick up antigens from the tumor (in the case of cancer). They then differentiate into mature dendritic cells that are capable of displaying the antigens to other agents of the immune system.
The Company believes that it understands the reasons for past failures. Northwest believes that the key to efficacy is identifying at what point the immature dendritic cells are most capable of both taking up antigens and displaying them. The cells in DC Vax Direct are partially mature dendritic cells somewhere in the maturation stage between monocytes and mature dendritic cells. The Company believes that prior development efforts used cells that were either too immature or too mature. It believes that it has identified a dendritic cell maturation stage that will work. This requires both precision and control of the manufacturing process in order to consistently replicate this batch after batch.
DC Vax Direct began a multi-center phase I/II trial in 2013. This is an open label trial and efficacy will be measured in terms of tumor regression (shrinkage or elimination) that is expected to occur fairly rapidly (within a month or two following administration) if it is going to occur. Since the trial is not blinded, the Company can release data from this trial in any way that it determines — even on a patient by patient basis. This may mean that there will be some meaningful, if anecdotal, data released in 2014 and 2015 as in the case of the sarcoma patient.
This is a phase I/II trial which will begin with a phase I component that will escalate the dose of DC Vax Direct. For most oncology drugs, phase I is intended to determine the maximum tolerable dose that can be given before unacceptable, dose limiting side effects occur. If DC Vax Direct is comparable to the three other dendritic cell therapies- Dendreon’s (DNDN) Provenge, ImmunoCellular’s ICT-107 and Northwest’s DC Vax-L, it will have very modest side effects so that the evaluation of different dose levels will be mainly focused on determining therapeutic efficacy rather than the maximum tolerated dose.
The primary goal of phase I will be to determine the correct number of cells to administer. Dosing will start at 2 million cells per dose and will subsequently be escalated to 6 million and finally 15 million cells. In conventional drugs, there is usually an increase in efficacy with increased dose, but this may or may not be the case with immune therapies. In the case of DC Vax-L, doses of 1 million, 5 million and 10 million cells were tested. Efficacy resembled half of a bell shaped curve in which the 1 and 5 million doses were about equally effective and efficacy actually decreased at 10 million cells. There are several views about why this may be the case, including that administration of larger numbers of cells all at once creates a crowding effect in the area of the injection site, which interferes with optimal functioning of the cells.
Phase I will enroll patients having a number of different types of inoperable solid tumors and will go through cohorts of about six patients each. Many of these patients will be ones whose cancers have metastasized to the point that surgical excision is not feasible or is thought to be futile. These patients will be given escalating doses of cells going from 2 million to 6 million and then 15 million. The Company believes results in most patients will be seen by week 8 or 16.
The Company has indicated that it is aiming to enroll at least a minimum number of patients for each of four cancers, plus an additional group of patients with miscellaneous diverse cancers. So, the trial will aim to treat six patients with liver cancer, six with melanoma, six with pancreatic cancer, and twelve with colon cancer plus six miscellaneous. There will be two key variables in the trial, the number of cells received by the patients and the type of cancer they have. The dose of dendritic cells given for each cancer will have a degree of randomness.
The phase II stage of the trial will proceed as soon as the Phase I stage is done – the Company does not have to go back to FDA to start phase II. The Phase II stage as now planned will focus on 24 patients with colon cancer who will be given the most effective dose as determined in phase I. The endpoint of the trial will be tumor regression which has been the most frequent basis upon which accelerated product approvals have been given by FDA. The injection of cells is image-guided directly into a lesion of the cancer. Bear in mind that these tumors are inoperable so that they may have widely metastasized throughout the body, including to the brain. The injection can be given at sites of primary tumors or at metastases or both. There will be two valuable observations that can be made at the end of the trial. One will give a glimpse into or perhaps proof of principal as to whether DC Vax Direct works in various solid tumors. The other will be a meaningful amount of data in 36 colon cancer patients that could be the basis for a phase III trial design.
The Company is very excited about results seen in pre-clinical mouse studies. Based on past experience, investors are very cautious or even cynical about extrapolating animal data into humans. As the Company readily acknowledges, curing cancer in mice has been much easier than curing cancer in men. Skeptics and even optimists will ask why the experience with DC Vax Direct could be different.
The pre-clinical studies were done in mice which were injected with tumor cells to cause cancers. When treated with DC Vax Direct, very consistent and impressive performance was seen across multiple tumor types; 80% to 100% of the animals in the various test groups eradicated all of the tumors in their body. These included large tumors relative to body weight. After these mice were successfully treated, 60 days later they were re-injected with tumor cells and interestingly the cancers did not re-establish which suggests that there was immune memory. If human results approach what was seen in pre-clinical, it would be extremely encouraging.
Tagged as dcvax direct, dendrtic cell cancer vaccines, Northwest Biotherapeutics Inc., NWBO + Categorized as Smith On Stocks Blog
Northwest Bio Exploits Cancer Patient To Promote Stock Ahead of ASCO ’14
By: Adam Feuerstein
http://www.thestreet.com/story/12703931/1/northwest-bio-exploits-cancer-patient-to-promote-stock-ahead-of-asco-14.html?puc=yahoo&cm_ven=YAHOO
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As opposed to some others, I don’t mind Feuerstein overly much… he tempers enthusiasm, among other effects, and I used his puncturing of today’s stock price rise to enlarge my position at a more advantageous price than might otherwise be possible.
Of course I hope he’s wrong; this news release sounds very hopeful, although it IS only one patient.
Hello Larry,
You said: “Also, the regulatory pathway will be much shorter if DCVax-Direct produces encouraging results”
Would you please provide the detail on the steps in the shorter pathway (and why it is shorter if not obvious). Extra credit for a theoretical timeline.
Thanks much
In an optimistic case, they could start a phase 3 trial (probably inoperable colorectal cancer) in 2015 with a primary endpoint of objective response rather then overall survival that is the gold standard for almost all cancer trials. There might be topline data in 2H, 2016 or early 2017. Approval could then be gained in late 2017 oe r early 2018. This assumes that we see strong evidence of objective responses in colorectal and other types of solid tumors.
Hi all………..I do have an opinion, just not scientific or informed by education or analysis….I got deleted from Seeking A. because they wanted facts, not opinions and threatened to ban me if I kept
up just giving my hopes and dreams, so I’ve come here in the hope that I can post freely, as long
as I state it just my humble opinion…….I so enjoy reading what other people wish to post and some
have great insight, and some, not so great……With that said, my insight is disappointment with what
(I don’t know who) chose to publish this report as a prelude to the actual report that will be made at the ASCO in May/June……..Yes, it is exciting that they chose to highlight one patient that (seemed) to respond
in such short order and with stunning results……….But, what about all the people who went before that patient??? Phase l, Phase l/ll had many patients and many unblinded statistics that may have been reported and analysed and could have been formulated into somekind of report…….No, they highlight one patient and then the AF machine takes off into high gear saying it is a fraud……Of course, the saving grace for me, is that Linda said this press release is only the first of several, (or maybe many) releases that will be forthcoming as we move closer to the actual conference…….I don’t want to sound like I am whining about their handling of the data or the efficacy of the treatment, so I’ll just wait and see how it all unfolds, but right now, today, after their press release, I feel I am no better off than before……One hand-picked patient out of the many they have treated, does not lend itself to me, IMHO, as scientific……..It sounded like a pure PR event….I truly hope their next press release will add tremendous data to the discussion…..Hope to read more here and on SA, though I will not respond on SA……..Probably for the best, LOL………cheers, long
I feel like these are the big points coming out of the abstract and recent press release from NWBO. Correct me if I am wrong or missing something Larry or anyone reading this.
1. Direct has completed it’s enrollment for the 60 patient trial.
2. The Sarcoma Patient showed partial shrinkage in the primary tumor and one other tumor in the body, which indicates an immune response.
3. The Sarcoma Patient is an example of Direct having an affect in a matter of a few months.
4. The Sarcoma Patient is most likely not the first patient to receive this drug. After all his case started in February. Linda Powers on Feburary 10th in the New York conference said “NWBO finish the first dose level testing for patients and is starting the second dose level for patients.”
My thoughts: My guess is Sarcoma Patient was in the group with second dose level. The first dose level is always the lowest to make sure the protect is safe. It is possible that the patients that came before the Sarcoma Patient did not show much or any drug performance because of the dose level being low, so that is why NWBO choose this patient for the press release. I have a feeling most of the important results will happen from the patients in the second dose level in February and beyond, but this is just my guess.
The shrinkage of the tumor mass is important. I think that the mass may have shrank by as much as 50%. If so, this would qualify as a significant signal in a difficult (impossible) to treat disease. In chemotherapy, the shrinkage of the tumor occurs quickly and then stability followed by inevitable reoccurrence is the norm. With immunotherapy, we have see slow initial shrinkakage followed by more shrinkage, not growth. At least, this occurred with Yervoy and Provenge. Let’s watch for this with DCVax-Direct. The effect on distant metasteses is key. Death usually is the often result of metasteses, not the primary tumor mass. Any measureable effect on the lung metastases of this patient would be huge. Also, the safety of the product is a big positive. NWBO plans to release more results on a patient by patient basis with some probable before ASCO. All very encouraging, but just one patient.
On my last comment I meant to say: “The first dose level is always the lowest to make sure the product is safe.”
The sarcoma patient received three injections in February and one in April. There are around 20 other patients who have received three or more injections. We should hear on some of these in coming days, weeks and months.
My thoughts in figuring out the enrollment numbers on information given in the abstract.
DCVax-Direct
Phase I/II Trial Design
60 patients- Phase I/II Trial for all inoperable solid tumor cancers
Phase I stage: 36 patients
– safety, feasibility, dose-finding
(Colon, breast cancer with brain metastases, lung, pancreas, melanoma & other/misc.)
Phase II stage: 24 additional patients
in one selected cancer – e.g., colon
I want to focus on the enrollment for phase 1 portion of the trial. We know there are 36 patients total in the phase one trial. There are also six cancers in the phase 1 portion of the trial
1. Colon
2. Breast Cancer with brain metastases
3. Lung
4. Pancreatic cancer
5. Melanoma
6. “Other”
So we take the 36 patients and divide them evenly among the 6 cancers. That means there are 6 patients for every cancer in the phase 1 trial. We also know there are “3 dose levels/ cohorts” as Larry Smith has said in this article. Cohort is another term for dose level. We would want to take the 6 patients per cancer and divide it by the 3 dose levels. Giving two patients a low dose level, another two patients medium dose level and another two patients a high dose level per cancer.
Example of the math:
36 patients/ by the 6 cancers in phase 1 =
6 colon patients, 6 lung cancer patients, 6 breast cancer with brain metastases patients, 6 pancreatic cancer patients, 6 melanoma patients and 6 “other” cancer patients
6 colon cancer patients/ 3 dose levels = 2 patients with low dose level, 2 patients with medium dose level, 2 patients with high dose level
6 lung cancer patients/ 3 dose levels = 2 patients with low dose level, 2 patients with medium dose level, 2 patients with high dose level
6 breast cancer patients/ 3 dose levels = 2 patients with low dose level, 2 patients with medium dose level, 2 patients with high dose level
6 pancreatic cancer patients/ 3 dose levels = 2 patients with low dose level, 2 patients with medium dose level, 2 patients with high dose level
6 melanoma cancer patients/ 3 dose levels = 2 patients with low dose level, 2 patients with medium dose level, 2 patients with high dose level
6 “Other” cancer patients/ 3 dose levels = 2 patients with low dose level, 2 patients with medium dose level, 2 patients with high dose level
Which brings us to 12 patients per dose level or 12 patients per cohort. 12 patients gets the low dose level, 12 patients get the medium dose level and 12 patients get the high dose level. Let’s go back to the abstract. The abstract says “The first dose cohort of the Phase I component has completed.” That means all 12 patients in the low dose level is enrolled. The abstract also says: “the second dose cohort’s enrollment is nearly complete.” Let’s say two thirds of the second dose level has completed enrollment. That would mean 8 of the 12 patients in the second dose level are enrolled. The abstract also says: ” In addition, the “other” cohort of multiple cancers has been fully enrolled.” Meaning all 12 patients in the high dose level are enrolled.
Math on enrollment:
12 patients in low dose level = complete enrollment
12 patients in medium dose level = nearly complete enrollment, so we will say roughly 8 patients completed enrollment give or take a few
12 patients in the high dose level = complete enrollment
Total = 32 patients enrolled and 4 patients left to be enrolled give or take a few
While I am not a hundred percent sure that the math is correct. Base on the information given to us by the abstract and the NWBO powerpoint presentation this seems to make the most sense for enrollment numbers. The math is base off the idea that NWBO divided the different cancers and dose levels evenly among patients. If the information from the abstract is up to date than there is a very good chance that all 36 patients will be enrolled by the time we get to ASCO 🙂
What do you make of the BioMed Report by Brian Wilson on Sunday 18 May 2014 which was extremely critical of press release being a “useless piece of news specifically to pump up a retail owned stock” being gullible traders and that they are running out of ways to promote the company. And we should be suspicious that Northwest Bio does not plan to release any efficacy data from the Phase II trial at the ASCO 2014 conference. Thanks.
It is not at all unusual for a company to release data from an open label phase 1 trial. IN phase 1, the primary goal is to determine safety, but companies are also looking for signals of efficacy. Seeing a signal in a difficult to treat sarcoma is an important event for a small company developing a potential paradigm shifting therapy. It is certainly not useless. This is not a controlled trial so there is no attempt to blind the data. You see this type of phase 1 data routinely refreered to on the eveing news. I found this to be important news and I suspect you been to. I think this is a naive comment. I know Mr. Wilson. He is 25 years old and has no background in doing biotechnology research other then writing blogs based on news releases. Like several other bloggers, he is an AF wannabe. AF erects a strawman argument every time NWBO releases important news to deflect investor attention. He is remarkably good at getting investors not to focus on positives.
Larry, are you planning on attending ASCO?? You cover many companies, but I am most interested in NWBO……..If you go, I have many questions about “L”……I think you will ask Linda about “L” & “D”…I posted my questions on another article about NWBO that you wrote on this website….If you can’t find them, I can repeat them for you…..Hope you go and get the insights all us investors have been waiting so patiently for…….Have a fantastic Memorial day weekend…….cheers, long
I am not going to ASCO. I think that NWBO may have a call post ASCO to discuss the DCVax Direct abstract. Bear in mind that this is a poster presentation, not an oral presentation. In an oral presentation, the lead author of the abstract will make a presentation to an audience in a symposium. With a poster presentation, the poster is tacked on a board that is one of several hundred such posters displayed in a large gallery. Physicians and other interested parties walk by the board and read the abstract. The author may or may not be present at the poster to answer questions. The conversations that take place are genrally between the author and one or two people asking questions. This is not a forum that should be expected to give insights into the reaction of physicians to the information in the abstract .Don’t expect news flashes about this abstract. The most imprtamt information will be a press release in which the lead author will offer his key conclusions that will be issued at the same time as the poster is presented.
PS…………..My questions were posted on your March 28th article…..Thanks
Larry
My question is on the pending data for the first interim results. What will I expect to see once the pending is done. Will it be efficacy has been accepted or failed to reach end point or will it be an actual data from the 66 patients? I am still learning on how this DC Vax L trial design works. Also any idea roughly when the second interim analyses is expected to be due by either you or NWBO.
Larry
Also if there is no data coming out in the first interim analysis, which interim analysis will provide us some data on the patients? Thanks
Why haven’t we seen the efficacy analysis? Let me suggest a simple and plausible reason. The first interim efficacy analysis has not yet been done. Ms. Powers indicated that the protocol of the trial allowed the Company to expand the size of the trial. From a statistical basis, this increases the probability of success. From a clinical basis, it allows the Company to enroll more patients in Germany and the UK which is important to get physician involvement and awareness of DCVax-L in those countries. In the event of a successful outcome of the DCVax-L phase 3 trial this could be quite important for commercialization. I think that NWBO after consultation with the FDA received a go-ahead to expand the size of the trial.
I think that the logical conclusion is that NWBO made the decision to enlarge the size of the trial and the first interim analysis criteria has not been reached and therefore no efficacy analysis has been conducted. The original plan was to enroll 312 patients and the first interim analysis was to be conducted, I think, when 110 events had been reached which on the primary endpoint of progression free survival would be the cancer beginning to grow again or death. However, if the trial were enlarged by say 20% then the number of events would also be enlarged by about that amount to roughly 132.
My hypothesis is that it was probably the case that NWBO thought that the 110 events were about to occur in February. However, with the enlargement of the trial size, the DSMB had to wait for another 22 or so patients to progress in order to conduct the first interim statistical analysis on efficacy. So how long would it take for 22 more events to occur? I have no way to judge.
What does all of this mean? In general, the longer the trial takes to hit an interim analysis the better for the possible reason that patients are not progressing as fast as thought. However, these trials are so complex and complicated that there could be other reasons for the delay in hitting the interim event number. One could be that enrollment was slower than expected.
If my hypothesis is correct and the first interim analysis has not been reached, when might we see an announcement that that the safety and efficacy analysis has been completed and the DMB issues a recommendation? I think it could be days, weeks or a month or two. What will the DMB recommend? It is almost certain that the recommendation will be that the safety and efficacy analysis has been completed and the trial should continue. There will be no statement on whether DCVax-L is trending positively or negatively toward the endpoint.
Hi Larry and fellow investors,
I was rewatching Linda’s last presentation on March 27th and some interesting factors came up I wanted to discuss on this thread. Around the 25 minute mark Linda states that the company will have data on 6 patients per cancer indication for DC-Direct which should provide an interesting glimpse into efficacy. I want to make sure I am understanding this correctly that the company intends to intact report on 6 patients per cancer indication whom are using direct? This would be a big window into its efficacy. The second issue I wanted to bring up it the fact that Linda says DCVax L, if approved can be used for all types of operable cancers with a mere label extension. Is this intact as big of a deal as it sounds?
By the way, here is a link to the webcast I am referring too.
http://www.ustream.tv/recorded/45431940
Everyone,
DC Vax L should complete enrollment on June 30th. According to Cancer Reaserch UK 🙂
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-of-a-vaccine-called-dcvax-l-for-glioblastoma-multiforme
You can also get there by google search engine: Type : (Cancer Research UK DC Vax L.)
A trial of a vaccine called DCVax-L for glioblastoma multiforme
This is a trial looking at personalised vaccines to treat a type of brain tumour called glioblastoma multiforme.
If you have a glioblastoma multiforme (GBM), your treatment may include surgery, radiotherapy and chemotherapy. In this trial, doctors want to see if adding a vaccine called DCVax-L helps.
To make DCVax-L, researchers use some of your own white blood cells to make what are called dendritic cells. They mix the dendritic cells with proteins taken from your brain tumour to make a dendritic cell vaccine. It can help your immune system to recognise and kill cancer cells.
The aim of the trial is to see if DCVax-L helps people with glioblastoma multiforme.
Recruitment
Start 01/06/2013
End 30/06/2014
Phase
Phase 3
Everyone,
An important website was found. Say DC Vax L should have complete enrollment by June 30th.
It’s on the Cancer Research UK website for DC Vax L. It also gives side effects of the drug.
Type in the google search engine: “Cancer Research UK DC Vax L.” At the top of the page you will see (A trial of a vaccine called DCVax-L for glioblastoma multiforme). That’s the title of the article and website.
Thanks Larry et. al. Going to UK website, waiting for news flash from NWBO at ASCO, waiting for interim analysis for “L”. Hoping to hear more from Germany. One week to go for ASCO and some promised news from NWBO. Have a fantastic Memorial Day. Cheers. Long
Ok…. went to the website and it does say enrollment ends on June 30, but does not indicate reason for the ending date….
Can it be extended if it is not fully enrolled? What is the size, how many are enrolled? I could not find information that is published at our GovTrials.org…..I do not how to interpret the information that is published on this Cancer UK website……Anyone that knows how to follow-up and bring more color to this important trial in the UK, please chime in ……….Cheers
Thank you for your thoughts Larry. It certainly would make sense. In regards to the number of case studies presented on at or by asco, would you agree that based on what Linda said during her last presentation/webcast that the company should be reporting on 6 per cancer indication with DC Direct?
Everyone,
For people who do not know. According to Jefferies Conference, Linda Powers will be speaking on June 4th in Ballroom V at 2:00 pm. Hopefully we will get some detailed answers in the progress for both Direct and DC Vax L. To check this site. Type in the google search engine: “AGENDA MONDAY, JUNE 2, 2014 Jefferies 2014 Global …”
As for what Larry just said. I think he is mostly likely correct on why DC Vax L interim is still pending because trial expansion has been brought up multiple times by Linda Powers in earlier conferences. In fact, I hope he is right for a number of reasons. I wrote a list on the pros and cons of expanding Phase 3 trial. Any extra thoughts is appreciated by anyone 🙂
Pros for trial expansion
1. Increase chance for FDA approval
2. Stronger Efficacy Conclusion and Power
3. A longer time to use German Exemption to fund both Direct and DC Vax L trial
4. Less likely that PFS is not going to be an acceptable primary end point because of the increase in coloration of OS and PFS.
5. Less chance that DC Vax Direct will be affected by the success or failure of DC Vax L. The more time that goes by, the more data DC Vax Direct gets and the less affect DC Vax L will have over Directs future.
6. Increases physician involvement and awareness in both Germany and UK, which improves commercialization in the future.
Cons for trial expansion
1. Longer time to reach drug approval and if it would have been a successful anyways. Than it will take longer for investors to make some good money from this product.
2. Increase dilution in shares or at least for this year until German Exemption really kicks in. Remember: Linda Powers has the most to loose by dilution, so she has thought long and hard about this. I honestly think dilution will be minimal because of the German Exemption.
Conclusion
I believe the pros out weigh the cons and if I was Linda Powers. I would have done an increase in trial expansion. I really hope Larry is right about his hypothesis because I think this is the best case scenario for the company. Even though I really would like to see DC Vax L get approval sooner and make some serious money off of this investment.
The guy with the picture,
1. From my understanding and many others 6 patients per cancer is right, but I am not 100% sure. I used that idea in trying to figure out enrollment numbers from the abstract, which I post in the comment section in here. Having an equal amount of patients with different types of cancers and different types of dose levels makes the most sense to me in this 36 patient phase 1 trial. Sorry I can not be more helpful.
2. You brought up a very important point that a lot of people ignore. “DCVax L, if approved can be used for all types of operable cancers with a mere label extension. Is this intact as big of a deal as it sounds?”
I personally do not know how to take this news. Small Bio tech is new to me. The label change is true, but my questions would be “How hard is it to get a label change from the FDA? Also would each cancer get it’s own patent for when the drug starts and expires in a country or is it just base off of DC Vax L’s patent time frame?” I am surprise more people have not talked about this because it makes DC Vax L just as important as DC Vax Direct.
Hi Larry,
Here we are almost one year after your article above and the comments it engendered.
No ASCO posters this year, but a dog and pony one hour lecture given by Dr. B.
No new news on any front about L or D….. No news about Germany or England
No news about collaborations….
If you read this, could you please post a comment somewhere where I might read it and give me your opinion on what is really happening with this company and science??
I am becoming so quizzy about the lack of transparency and follow-through on
promises made….always, “stay tuned” and never, here are the facts…..Thank you if you read my questions and can address them………Cheers, long
The reimbursement process has been slower than expected.
DCVax-L is in a phase 3 trial. There is no expectation of data until the trial completes which the Company now says is mid-2016.
The potential for a collaboration with a company with a checkpoint modulator is high.
You sound like AF has gotten inside your head.