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Thanks for the quick responses guys. I found it. It was the BIO CEO Conference presentation in Feb. I was thinking of.
Hello all, I have a family friend who was recently diagnosed with inoperable lung cancer with brain metastasis. I am currently digging up all the DCVax -Direct data I can, and I seem to remember a recent slide deck where Linda gave an update on several patients in the trial. Could somebody please point me to that slidedeck. Thank you very much.
So I'm sure most of you remember how AF gushed about his darling Bluebird Bio after they release extremely early, but promising P1 data on 2 Beta-Thal patient treated with their gene therapy platform several months back. Of course he had no issue with the release of preliminary case studies before the trial is even 1/4 enrolled. Fast forward to yesterday, when BLUE released VERY early data from a third patient that reveals this patient isn't responding nearly as well as the first 2 P1 patients. Of course Adam blogs about this, but makes sure to highlight that this reduction in efficacy is really not that big a deal. Imagine if NWBO released a case study yesterday that said Direct wasn't working as well on 1 patient as it did in the previous case studies...
http://www.thestreet.com/story/12944247/1/new-patient-receiving-bluebird-gene-therapy-responding-more-slowly.html
Hey Flipper Adam has responded to the CLDX 20% drop...
http://www.thestreet.com/story/12942692/1/celldex-therapeutics-shares-fall-on-breast-cancer-study-changes.html?puc=yahoo&cm_ven=YAHOO
He matter of factly states that the drop is because CLDX has modified the P3 breast cancer protocol to expand enrollment criteria so that more are eligible to enroll. He also points out that the primary endpoint is now progression free survival... He makes no negative comments about either of these things. He has railed on NWBO for months and months now for PFS as a primary endpoint and derided them for changing their P3 protocol. No such statements about CLDX when they do the same things... Shocking...
-Olive
Actually Austin you are on to something. NWBO did cherry pick in their PR today. They cherry picked the 55 patients with the most aggressive tumors possible. They cherry picked individuals who don't even qualify for the clinical trial because their prognosis is so poor. They cherry picked these individuals and DCVAX-L has doubled their expected survival time...
I read this as UCLA was given blood serum and monocytes from from patients who have had at least 3 shots in the direct trial at MD Anderson.
The Liau's student then analyzed cytokines in the serum and activation markers on the monocytes. The data indicated that there was an increase in pro-inflammatory serum cytokines (indicative of a immune response) and also an increase in activation marks on the monocytes (also indicative of immune response).
This abstract validates that immune cells are being activated in vitro, and that when they are injected intraturmorly in vivo they are illiciting a whole body cytokine response, and are capable of proliferation in an activated state. This does not address whether or not this is process is leading to actually killing the tumor itself, but still promising nonetheless...
How can MDA Drs. in good faith recommend a patient for the P2 part of the Direct trial when their VP of clinical research has negatively publicly commented on the efficacy of it?
Direct patients have no other treatment options left, so I don't think Buzdar's comments will negatively effect enrollment, but the potential is there. I wish NWBO could drop MDA and leave them out of the rest of the trial...
When it comes to the Buzdar situation I am most disturbed about the public comment on the validity of the science behind a current trial that is ongoing at MDA. Imagine being part of the Direct trial and you read online that the VP of clinical research at MDA is publically doubting if the therapy you are currently on for an inoperable tumor could possibly work. That seems like adding insult to injury. Hope is all some of these people have... Its not right.
Gotcha TOB-
CLDX was "careful" and "correctly" PR'd their preliminary P1 data for their ASCO poster, therefore it is acceptable to divulge early/preliminary p1 data about individual patients before a trial is complete.
NWBO on the other hand "incorrectly" PRd their preliminary data for their ASCO poster, thereby making it unacceptable to divulge early/preliminary P1 data about individual patients before a trial is complete.
Thank you for clearing that up for me...
TOB- What are you thoughts on CLDX's P1 preliminary data release for ASCO that I mentioned in post #13959. That 24 patient open label p1 study is still recruiting yet the PR makes statements about preliminary data that is "promising" and "favorable" like:
"one patient achieved a partial response (PR) at 2.7+ months; confirmatory scans are currently pending."
and
"a heavily pre-treated patient with aggressive Hodgkin lymphoma achieved a complete response (CR) after three cycles of varlilumab (0.3 mg/kg). She currently remains in remission at 12.9+ months."
and
" One of these patients experienced significant tumor shrinkage (36%)."
Would you consider this apples to oranges to NWBOs releases on Direct? Thanks.
Feel free to repost whatever I post here to any other forum you think is appropriate.
Also one more point- On June 2 Celldex, which is AFs sweetheart, released preliminary data for its phase 1 trial of the Varlilumab for the treatment of lymphoid and solid tumor malignancies (http://finance.yahoo.com/news/celldex-therapeutics-varlilumab-continues-demonstrate-181215120.html). Keep in mind this trial is still recruiting, and they gave specific information (or case studies if you will) about individuals, and the "promising signs of clinical activity" of their drug. Sound familiar...
Here is a fun snippet which would probably shock and dismay Buzdar
"In the lymphoid malignancies dose escalation arm (n=24) two patients are currently continuing treatment and have not yet been evaluated for response. As previously reported, a heavily pre-treated patient with aggressive Hodgkin lymphoma achieved a complete response (CR) after three cycles of varlilumab (0.3 mg/kg). She currently remains in remission at 12.9+ months. Six additional patients with Hodgkin lymphoma have been enrolled, the majority to the 10 mg/kg dose level, with one patient awaiting initial response evaluation. Three additional patients with non-Hodgkin lymphoma have experienced stable disease (SD) with a progression-free survival (PFS) range of 4.5 to 14 months. One of these patients experienced significant tumor shrinkage (36%)."
RRR i agree as well. Yesterday I said I thought that Buzdar had no idea of the shit storm he was starting and that he was playing into Adam's hands... After thinking about it, I no longer think this is the case. MD Anderson has now came out an said that Buzdar was only clarifying their position that results should only be released at pre-determined time points, and NWBO releasing data as they did was not sanctioned nor condoned by them as an institution. That is all fine and dandy and well within MDAs rights to take that position. What I find highly suspicious is that after "rebuking" NWBO for the actual release of data, Buzdar went on to opine on the merits (or lack thereof) of direct injection immunotherapy for treatment of solid tumors. This comment was not aimed at the actions of the company or to clarify MDAs position on releasing data while a trial was ongoing. This comment was made purely to sow the seeds of doubt that NWBOs technology could actually be working. It is HIGHLY irregular for at investigator at a clinical trial site to publically negatively comment on the scientific and technical merits of a ongoing trial at their home institution, and this was no accident.
One concern I do have though is that it is very possible that Buzdar has seen the patient records of enrollees, or is talking to MDs that have. These doctors take their repuatation seriously and if Direct is working as well as NWBO claims, Buzdar will have a lot of egg on his face. This is definitely something to consider... I hope that NWBO has carefully analyzed the data from the patient records, and has ran it by an independent, unbaised, outside experts for their opinion...
Imagine if you were a patient or a family member enrolled in this trial and you are seeing some initial positive effects. Then you read these negative comments by Dr. at the very place you are having the treatment. Seems like that would be very disheartening, and exactly what a patient with terminal inoperable cancer does not need to hear...
MD Anderson makes a significant chunk of it money through performing clinical trials. It is really not in their best interest to have their MDs spouting off to reporters about their opinion on PRs released by a trial sponsoring company. Especially for an unblinded trial still in progress. That is bad for business. I bet Dr. Buzdar has no idea how AF would spin this and the shit storm this was going to create...
There is not much else to add that hasn't already been said, but IMO Dr. Budzar has made a serious error in judgement speaking about his personal feelings on the release of the P1 data to a reporter from an a stock market associated website. Especially considering the trial is ongoing, and sponsored by a publically traded company... If he did have reservations about the data release, there are several other avenues available to him to relay those to NWBO and MD Anderson. Additionally, this quote really bothers me..
"A patient or an investor may read these press releases and see a rosy picture"
Why does he mention investors specifically. He is an M.D., so I can understand his concern that patients may be mislead, but why is he concerned with investors? He played right into AF's hands with that quote, and I think he is going to be feeling some major heat because of it.
MACK doubled today on their P3 pancreatic cancer results which were considered a success. Their drug only worked in combination with 2 other drugs, not alone, and exhibited an OS benefit 1.9 months. Approx 50% of patients had at least some type of nasty side effect and 3% exhibited life threatening sepsis. This just goes to show you how low the bar for clinical success is for aggressive cancer therapies.
Austin I see your point and although I think NWBO WILL present some data, I am cautious... I have a sizable position here and I am optimistic about the science. LP intimated that the reason why NWBO hasn't given an update on data from the Direct trial is because of the ASCO submission. If ASCO comes and goes with no data being released, it would leave a really bad taste in my mouth. That coupled with the odd situation of the pending/outstanding interim efficacy decision will probably preclude me from holding this stock after ASCO. If that means I miss out on a big winner, so be it, but I am usually right when I trust my gut...
-Olive
Thanks Hodge,
This is the quote from the prospectus dated Feb 5, 2013 that Hodge posted a link to.
"The primary endpoint of our Phase III trial is progression free survival. Sometimes regulators have accepted this endpoint, and sometimes not. There can be no assurance that the regulatory authorities will find this to be an approvable endpoint for Glioblastoma multiforme cancer."
Adam F acting like this language being added to the newly filed 10K is something new is at best a mistake, and at worst a blatant deception....
I posted this in the comments section of Adam F's article today and I am curious if he will reply, doubt it.
Hi Adam,
What are your thoughts as they relate to Avastin? It was approved for GBM without showing an overall survival benefit , and without a statistically sig. PFS benefit (http://www.mdanderson.org/newsroom/news-releases/2014/diagnosed-glioblastoma.html). I can't imagine a scenario where DCVAX-L hits 6 month statistically significant PFS and the FDA throws out the study or doesn't approve based on lack of OS. Thanks in advance.
MOLBIO, what are you thoughts on this??
UPDATE: The Street didn't accept my comment...
ASCO ACCEPTED!
She is smacking down Adam F calling it compassionate use, referring to "some commentators" misrepresenting Hospital exemption
Presentation is delayed until "shortly after 3pm" as per the ustream website... DELAY!!! Does this mean the presentation is "pending" or "outstanding!" What will Adam F say!!!???
Thanks fox for your absolutism.. My apologies for disagreeing, and being so wrong (in your mind).
If you are so convinced that Linda cannot say an abstract submitted by MD Anderson to ASCO, which will be presented by MD Anderson at ASCO, was accepted, that's your problem. Also, Direct is unblinded, and the company has held onto initial data for months. Releasing initial snippets of data (such as tumor necrosis)would also be wholly acceptable and not require a press release prior to discussing at a conference being broadcast LIVE to the public.
-Olive
I disagree that she cannot disclose anything of import. Linda could announce during the talk that they are presenting at ASCO (aka abstract was accepted). Also, they could give the "gkimpses" of the Direct data that she has mentioned before. They have had some Direct data for months now and they could absolutely show some during the talk today (which also assumes ASCO abstract was rejected).
While I am optamistic that NWBOs Direct abstract will be accepted, there is no gaurantee. If it is rejected it will most likely be because the lack of mature data, not negative results. That being said, it is not a "late-breaking" abstract so NWBO should know sometime this week based on the ASCO timeline of late March notification. If it is rejected, I don't believe NWBO HAS to issue a press release that it has been rejected. Also, they are then free to release initial Direct data at any time. If the abstract is rejected, NWBO must release Direct data shortly after hearing from ASCO, and if they don't, the stock is going to get HAMMERED. Can you imagine the field day Adam F. would have if we are sitting in mid-late April and they haven't given an update on whether the abstract was accepted, AND they haven't released Direct data... Yikes...
Hey all, have a look over at ECYT... It has doubled today on positive P2b results for small cell lung cancer. It is interesting because the study met its primary endpoint which was PFS. I thought (according to Adam F.) PFS cannot be used as a primary endpoint if you want your drug approved... Also it seems that the OS was only trending in the positive direction, and not significant.
http://finance.yahoo.com/news/endocyte-announces-phase-2b-target-120907716.html
A week for translation-
Hi all, long time reader, 1st time poster. Been enjoying the back and forth on this board. I have a biotech/law background. We frequently file patents on behalf of pharmas/biotechs in foreign, non-english speaking countries. To do this we farm out the translation to a firm who has a certified translator in the language we need (usually a firm in the actually country where we are filing), whether in be chinese, german, dutch, whatever. Generally patents can range from 20 to a couple hundred pages and can be very technically complex. The patent translation is then certified by an independent translator before we submit it to the patent office for the country in which we are filing. Depending on the application, I would be surprised if we received the translation back within a week. We could put a "RUSH" on it and pay out of the nose, we could then expect to get it back within 2-4 days. A week to get a certified translation of NWBO PEI approval document is COMPLETELY within a reasonable timeframe, and I would expect nothing less than a certified translation before releasing the information to the public. Just my two cents.