Here's what we know, based on the info divulged in the 11/4/14 press release:
"In the E1512 trial, 125 patients were randomized to one of the three arms: erlotinib, cabozantinib, or the combination. During a pre-planned interim ECOG-ACRIN Data Safety Monitoring Committee analysis for futility, it was found that the trial met its primary endpoint of improving progression-free survival (PFS) with cabozantinib alone and also with the combination of cabozantinib plus erlotinib, as compared to erlotinib alone, and the results were highly statistically significant. Safety data were consistent with those observed in other trials of cabozantinib. At time of analysis, the median follow-up was 5.9 months and overall survival data were immature.
The results of the trial are the subject of ongoing analyses and will be submitted by the investigators for presentation at a future medical conference."
This study - sponsored by the NCI, and chaired by Doc Joel Neal of Stanford - is the P2 Cabo NSCLC trial that reported positive top-line results on 11/4/14. In that EXEL PR, presentation at future venue was suggested. A quick review of revised updates to this study reveals that the study has been updated nearly each day of this month. Color me optimistic, but if we don't get news regarding this study during tomorrow's market, I think we are in for show-stopping news come Saturday. Oughta make for an interesting Monday...hope y'all have taken advantage of this pullback.
FYI - the ELCC 2015 news site updates regularly during the conference. It's an easy Google...GL
Published 1/15/15 Cell Death Dis H Liu et al....
"Collectively, our data suggest that ganetespib, as a new potent treatment option, can be used for the molecularly targeted therapy of GC patients according to their expression profiles of EGFR."
The abstract is also online at PMC... GLTA
Published in Int J Cancer 4/15/15, EK Song, et al...
I think the addition of a predictive biomarker for Cabo response in CRC is noteworthy.
"...we set out to determine the efficacy of cabozantinib in a preclinical CRC patient-derived tumor xenograft model. We demonstrate potent inhibitory effects on tumor growth in 80% of tumors treated. The greatest antitumor effects were observed in tumors that possess a mutation in the PIK3CA gene. The underlying antitumor mechanisms of cabozantinib consisted of inhibition of angiogenesis and Akt activation and significantly decreased expression of genes involved in the PI3K pathway. These findings support further evaluation of cabozantinib in patients with CRC. PIK3CA mutation as a predictive biomarker of sensitivity is intriguing and warrants further elucidation. A clinical trial of cabozantinib in refractory metastatic CRC is being activated."
Watched a cable TV interview with Chris Kyle's brother a few days ago, and was intrigued with the story. Saw the movie tonight. I cried. Do yourself and your country a great service. Support the Wounded Warrior Project. Give a Vet a break.Give a Vet a job. Give a Vet a hug.
No matter how you cut it, those players that bought in the $1.30's have nearly doubled their stake.
You can psychoanalyze MMM all you want, but the institutions are loading up. You guys shoulda covered instead of subscribing to all that endless BK nonsense. The uptrend is pretty apparent...
At least to those playing the stock and not over-analyzing the players. MMM is a novice, and we all know it. The BOD wants him...what're ya gonna do? The stock's on a tear, everyone's making money here...
Except the shorts. C-Ya at the top, boys...
Titled as above: Published as a JCO early release article today 1/26/15, Morris, et al...
Scher, Higano, Logothetis and a respectable list of co-authors...
"Conclusion rPFS was highly consistent and highly associated with OS, providing initial prospective evidence on further developing rPFS as an intermediate end point in mCRPC trials."
Of course, these results are from the Abiraterone COU-AA-302 trial...
But...these results also support the argument for Cabozantinib in an appropriately administered treatment setting (not necessarily late stage) My humble interpretative consideration is that the game in mCRPC is still on...and defining the biometrically-appropriate group for Cabo is now more important than ever.
"In September 2014, the company announced that a Phase 3 trial for metastatic castration-resistant prostate cancer (mCRPC) failed to meet primary endpoints.
In December, the company also announced that a second Phase 3 trial for bone pain in MCRPC also failed to meet primary endpoints.
Now, the company is expecting to release Phase 3 data of cobimetinib in renal cell cancer (RCC) in the second quarter."
Very poor reporting...
Failing to identify the Comets by name...and placing Cobi in a P3 in mRCC.
Is this kid AF in drag??? God save us all...
I'd be very careful in over-interpreting the Ward article...
If you look very closely at the selfie he uses for promotion, you can see just a hint of skull elongation...exactly as described by Giorgio Tsoukalas, the renowned ancient alien hunter. No...really, I saw it on TV. In addition, this is not an adaptation - it is a mutation. Social can explain what that means...
The importance of this observation cannot be underestimated. It means Daniel Ward's ancestors probably had sex with aliens. No kidding...stranger than fiction,eh?
Both active combination trials of Cabo/erlotinib in prior treated, refractory NSCLC posted significant changes in protocol focus on 4/9/15. I suspect these focal changes may indicate that the original protocols were either exhausted...or revamped to accommodate a changing treatment landscape. Either way, both of these P2 trials are nearly mature, and early reporting has been very positive. For my money, NSCLC is a real sleeper here...and next data-reporting could be game-changing for EXEL. GLTA
Published in Clinical GU Cancer 3/5/15... Kutoglu, et al. NIH Cabo PI Andrea Apolo is corresponding author:
"In the present review, we focus on targeted therapies that have yielded the most promising results alone or combined with traditional chemotherapy, including the antiangiogenesis agent bevacizumab, the human epidermal growth factor receptor 2 antibody trastuzumab, and the tyrosine kinase inhibitor cabozantinib."
UC is another sleeper indication that could produce positive results at any time...JMO
"Why is the stock selling so low...?
Lots of potentially toxic debt, lots of evidence of inefficient (and possibly inept) management is the bear case. The bulls see the potential of a viable drug development platform with two late stage drugs in development - one approved in a very small indication...another one likely to be be approved later this year in melanoma in combination with the Roche drug, Vemurafenib. The stock has a history of pops and drops, and is anything but a Wall Street darling. Be cautious in selecting an entry point, there's a good chance you've missed the bottom...but short interest is very high, and EXEL shorts have shown a tenacity you don't often encounter.
Welcome aboard...good luck...do your DD...ask questions. At its best, this MB is one of the best anywhere.
At its worst, it's a nightmare of short drivel, conspiratorial camaraderie, and near-criminal misinformation...
"Sometimes social media can be really cool..."
In addition, with each new clinical site that that comes on line, there will be a contiguous sense of sponsor support for what appears to be a safe and successful post-trauma intervention. As patients 3, 4, and 5 are enrolled, there will be an evolving sense of brethren amongst patients and investigators alike...and that sense of community is an invaluable asset to the introduction of future studies to include growth factors, stem cells, and expanded indications. One of the greatest obstacles to the clinical trial process is often enrollment, and that doesn't seem to be at issue here. GLTA - especially the brave trial participants.
Beyond perhaps a mention of a promising new implant procedure, I wouldn't expect much from Doc Coric. The NSS safety trial is not yet half enrolled, and professional clinical protocol requires presentation before discussion. Don't let MB frenzy blind you to the nature of clinical process. It's early, and it's all looking good... But there are acceptable standards of presentation to which adherence is SOP. Be patient.
Personally, I think we witnessed a simple strategy shift based upon ongoing EDAP dialogue with the FDA. That dialogue has obviously proven productive and fruitful. Exploring approval via premarket approval (PMA) places undue weight upon the FDA to consider technological precedence to HIFU approval and intended intervention(s) application. By pursuing approval via Direct De Novo pathway, EDAP's HIFU technology can be considered for 510k approval based solely upon its own merits. I like this path to approval and think this strategy will work quite well. I expect to see FDA response by Sept, and I expect that response to be positive - positive for patients, for EDAP, and - importantly to me - positive for shareholders. JMO
Shall we add goal_10_1 to your list of aliases?
When you offer relief from your boasts - suggesting that others put you on ignore...
...which of your multiple aliases do you offer for the ongoing ignore list?
BTW - how's offsite? You guys enjoying any reacharround fun these days?
Has the door to the loony bin been left open once again?
How many of you are there today?
My apologies to you, ulingt... In fact my apologies to all that I might offend now, or have in some way offended in the past. However, I will not change the way in which I address a smarmy dooshwaddle non-contributor of Hairy's ilk. Ever... And here's why:
IMO, Hairy is a cubicle tool...and for my money he is the same character that has posted here endlessly under a variety of pseudonyms for many years. If that dooshwaddle possessed any thing short of an institutional agenda, he'd at least keep the same handle so we could all know just who we are addressing. The guy is a freakin paid ghost - hiding behind each new alias...which he changes with regularity. Probably a Shkreli disciple...spouting an endless reel of misinformation, FUD, and unusable, distasteful garbage. The guy is pure junk. If he steps on himself - no worries. A new Yahoo handle...and back to business. If you don't like what I have to say, put me on ignore. You can't hurt my feelings.
"I take issue with the line..."
Tumor escape is poorly understood, even amongst clinicians...
Change, adapt, realign, re-posture, evolve, alter, reassign, re-catalyze, reform...
Re-landscape, re-educate, re-formulate, excommunicate, disassemble, discombobulate...
The essence of the author's message is clear...
Just be glad he's not assigning a level of abject persnicketyness to you...
"HSP90i suppresses Lipopolysaccharide-induced Lung Inflammation" published 1/23/15 PlosOne, Lilja, et al...
"Ganetespib also suppressed B cell and NK cell accumulation, inflammatory cytokine and chemokine induction and MMP9 levels. These data identify non-myelosuppresssive HSP90 inhibitors as potential therapies for inflammatory diseases refractory to conventional therapy."
Sorry. It's my best response to a preposterous thread. Felt the need to highlight that fact.
Keep up the good work, Mike. Dog...Yer way outta bounds...you need a collar, a leash, and perhaps a cattle prod up the ol' Bazoo. A civil approach to communication is key. Beyond that, a Louisville Slugger is my first opt...Ski mask, empty parking lot, a jug of wine, and thou... Kapoww!!!
Yeah. That's the ticket... That's definitely the ticket...