opportunity to be somewhat unimpressed. Because they set higher expectations 20% for PFS at 6 months, big F deal. Get a F life idiot!
Analyst Boris Peaker tells salesforce CLDX initially established an ambitious criteria for success of 20% progression-free survival at six months in the Avastin-refractory patients. Notes only 2 of 25 (8%) achieved this metric. Says while this finding may be viewed as disappointing, there is unfortunately no good comparator to make the assessment. Notes initial results from first 40 of 70 Avastin-naive patients
presented. All major endpoints favored rindopepimut over the control. Rates outperform. B.Brodie
Is this not of the SAME exact caliber but in an early incarnation of the above? Perhaps when it is 150.00 then
we can seriously consider 275+
Yes, agreed. However, one thing is absolutely certain. No secondary the likes of the recent NWBO
Probably something like interesting results, but not enough data, but keep this lit but on the back-burner. This time the lemmings will be burnt on front and back burners. He is such an idiot.
to clarify for newcomers I meant the effectiveness of Rindo with Avastin, so the effectiveness of targeting multiple cancers that over express EFFRvIII (as we saw today with Avastin) will be additional means of expanding applications, other cohorts that oevr express this same marker. Then (just for play) we apply CDX-1127 to the Rindo/Avastin combination and induce even greater effectiveness, let alon 1127 working on its own in synergy with multiple other targets. This can make one quite dizzy! LOL The fact is the like of this emerging commercial biotech (fully targeted antibody immunology) has not been seen to date.
They not only have a deep pipeline, they have multiple levels of combination therapies, for example, with CDX-1127 (in near future, 2+ yrs) that will further boost the overall effectiveness (first gimpse we see today with Avastin, wow) of their now and to be current pipelines and working with other cohorts across pharma, The house of Celldex is quite impressive and moreover, it ain't no linear model, the word synergistic with many (hence changing the field of Immunology) comes to mind.
But wait a minute that is really a euphemism. It means they didn't win Approval! LOLOL The shorts (remaining) are absolute toast! OOps we have CDX-011 coming into phase III next on news,,, F the idiots, wanna be's and lemmings
Sorry for type,meant Avastin has NOW become reincarnated with the new immunology technology catalyst Rindo which eliminates EGFRvIII expression which previously prevented effectiveness in patients and gave ZERO hope to some.
More conclusive? lol What are you talking about? Avastin now FIRMLY appears to work with multiple levels of exponential efficiency with Rindo (Cdx-110). The latter eliminates EGFRvIII expression even more so than a stand alone in frontline Rindo, according to the story 4X as more elimination of the latter expression. Therefore, Avastin has not become REINCARNATED!!!!!!! How many more patients can now be effectively treated. What people are not realizing is that there is a overwhelming strong probability that they will not have to go through a full phaseIII and that breakthrough status approval, in addition, in probable as well. Also the field of immunology where targeting EGFRvIII has now seen its very first glimpse of combination immuntherapy with existing drug in action. This is Big. Very VERY VERY BIG!
I think, partially, even though the clinical data is out because it (1127) is so new and such a huge potential breakthrough in really addressing immunology in entirely new and novel manner that will transform we approach disease and treatment that the "market" doesn't know how quite to price it. By the time it is more fully realized shall we say, phase II, mid way, then priced in it will be and then 150+ will be only half its value.
I don't think many outside a few know what we have here in this soon to be first of a kind commercial immunology.
You are quite the F piece of work, aren't you now?! Lol WHen you in all your divine wisdom say, "Historical controls are not good enough..." you are willfully and transparently distorting. Tell that to the patients that have lived on frontline Rindo 14^ for over 5 years. The versus historical control (which you have infantile removed from context) means here, there is no available historical data anywhere, historical control or any control group receiving any treatment for GBM anywhere that have survived more than a matter of months. You deplorable little imbecile!
How transparent (perhaps needy) to get back in, that you would repost this here with a repeated bs admonition response. Please get lost. Get off this board. lol
Hokie, just a bit curious why you think that NWBO would challenge Rindo. While numbers to date are more impressive the breakdown of the actual clinical data is not broken down into as much detail as you would expect to find in release. Yes, they give numbers on OS and PFS, but no no deatil comparative control data, and moreover they just blanket target with their DC-VAX without specifying specific phenotypes and detailed/associated toxicities. Granted there are no toxicities to date but what are the phenotypes and associated ORR per type. I don't by blanketed approach, 100% of all is HIGHLY dubious. Secondly, they have no staff, they have no scientists, they are not a company. They are a two person operation with Linda F Powers (former VP of Global Finance at Enron). everything is outsourced. They continue to dilute. Cannot fund squat, as you have said. Ispo facto, Extremely suspect! Perhaps they will be bought out for 10+ dollars. God help those holding this. But I would not put a penny into this penny stock
Really new name today idiot! Based on what? Failure of FDA approval? LOL
With Rindo a 66% in OS survival to date and a 55% increase of PFS over control groups. F MORON!
Hey numb nuts can you read moron or would you just acre to attempt to manipulate, LOL
terim ReACT Overall Survival and Progression-free Survival Bevacizumab-Naive Recurrent GBM
Rindo + Bev (n=20) Control + Bev (n=20)
OS 12.0 months 7.9 months HR = .43 (0.13, 1.44) ; p=0.16
PFS 3.7 months 2.0 months HR= .74 (0.34, 1.61); p=0.47
Avastin (first combinatory immunotherapy vaccine/drug). It is a strong buy. It will see approval. I am wondering if it will have some PROFITABLE partnership with Roche tomorrow AM Mind you not a buyout of the company, but some type of deal here that is worth mucho, mucho!
And enter the piesta resistance:
Remarkably robust humoral responses comparable or exceeding those seen in the frontline setting (ACT III) were observed despite advanced disease, use of steroids, prior chemotherapy exposure and the presence of bulky tumor. There was a four-fold increase in anti-EGFRvIII antibody titers in 84% of bevacizumab-naive patients and 79% of bevacizumab-refractory patients. A high-titer response was noted (range of 1:12,800 to 1:6,553,600) in 50% of bevacizumab-naive patients and 67% of bevacizumab-refractory patients and titers increased with time on study. Importantly, the study suggests that early development of anti-EGFRvIII titer may be predictive of improved outcomes in this patient population as improved survival was associated with rapid generation of humoral response. These results also provide further support for the rindopepimut/bevacizumab combination approach, as prior studies have suggested that bevacizumab can enhance immune-mediated anti-tumor effects in tumor model and may, in turn, optimize EGFRvIII specific immune response.
This conclusively PROVES that Avastin works in synergistic magnificence, flying F colors, when CDX-110
which (nothing else on the market) effectively targets EGFRvIII. Improved survival correlated with rapid immunogenic response 84% in naive avastin patients and 70% in last end Avastin refractory patients is FANTASTIC news both for these suffering human beings. The problem was that Avastin did not halt the positive EGFRvIII. Well, Well, Well, CDX-110 (Rindo) not only allows Avastin to work by to maximize fully its effectiveness as it has a four-fold increase of effectively eliminating EGFRvIII, A four-fold increase anti--EGFRvIII elimination of expression while synergistically allowing Avastin to perform, In fact, the increase of anti-EGFRvIII was EVEN BETTER than frontline (phase III) Rindo to date. Bottom line: It works FABULOUSLY!
It is the first combination, in combination with existing drug
Again, results suggest that early development of high anti-EGFRvIII titer may be predictive for improved outcome in this patient population as improved survival was associated with rapid generation of a robust humoral response. For the 13 patients with high titers by day 57, median OS was 6.6 months versus 3.2 months for the 11 patients who did not develop high titers (HR = .33 (0.08, 0.67); p=0.009).
69% of patients with high titers were alive at 6 months
compared to 18% of patients who did not develop high titers.
69% alive who developed high antibody response compared to 18% is Impressive. I wonder why that 18% failed in their opinion to develop high titer response. Would large or longer term results bear out the same percentage of high titer response (69%) ?
*With no comparative data available to define expected outcome for EGFRvIII-positive patients who have failed bevacizumab, an ambitious goal of progression-free survival of 20% at 6 months was established as the primary endpoint for this arm; 2 out of 25 (8%) patients are progression-free at six months.
So 40% of patients out of 20% targeted for PFS at 6 months, basically were given zero hope, no response on Avastin alone. Wow!