Nick, Does it include EGFRv3 Glioblastoma patients? If not, it is not a comparison.
"Ryan has in fact been working on an Obamacare replacement plan for some time, and has reached across the aisle to propose bipartisan Medicare reforms with Oregon Sen. Ron Wyden (D.).
Ryan has also proposed a comprehensive overhaul of federal anti-poverty programs, and was on his way to developing important tax reforms. Each one of these proposals would face resistance from Senate Democrats and President Obama, but Ryan is uniquely capable of striking deals that move the ball down the field."
Okay chart readers, you are up.
Nick, I don't actually disagree with you completely, but remember, mid year to q3, 2016, we start getting results from Varli as well. PPS will likely begin to factor that little gem into the mix as well.
I think we see a slow and steady climb, now that we have this supporting ReAct long term data. I sure hope you actually have those 10500 shares.
Well said Frank. Cujo and SCR have good reason for staying up half the night posting negative diatribe..., they know their collective short positions are in deep _______. Feel free to fill in the blank.
I agree with your valuation, but think no chance M will sell this year or next. Celldex will certainly share ReAct final data with FDA, as they have ongoing discussions with the FDA regarding Rintega, but may not want to upset the p3 trial by making Rintega available on the market. Does this alter the FDA's requirement of wanting to see P3 data for approval? Don't know. I give it a 40% chance of getting approved for compassionate use, while we wait for further P3 data, with possible early halting of the p3 trial.
Complete BS, unless you are referring to Celldex having no interest in selling until they advance this puppy much further along. M will not give this company away; the lesson has been well learned.
scr20022000; And when the same Rintega is given as first line treatment, (healthier group) what then? Then ad a PD1 and Varli. What then? Come on man, read the writhing on the wall. It gets even better from here, and everyone but you know it.
And let us not forget how this treatment provides better quality of life during treatment with less or not steroids, which is a big deal for those with Glioblastoma, and the doctors who treat them.
"“They took a group of patients that are probably the toughest to treat,” Michael Lim, director of brain tumor immunotherapy at Johns Hopkins Medicine, Baltimore, who wasn’t involved in the study. “The fact that they showed any sort of signal is very intriguing.”
Despite the modest median survival gains, researchers were struck by the durable survival in 25% of the vaccine patients. The result is similar to the surprising long-term survival seen in trials of Bristol-Myers Squibb’s Yervoy, where about 21% of melanoma patients survived at least three years, despite many initially not appearing to respond to the treatment.
“Once patients are surviving long term, they don’t die” of the disease, said John Sampson, chief of neurosurgery at Duke University Medical Center and co-principal investigator on the study. “This is the kind of thing we look for with immunotherapy.” It will take larger studies and longer follow up to determine the significance of that result. Dr. Sampson is an inventor of the vaccine with a financial stake in its success.
Based in part on earlier data from the study, the U.S. Food and Drug Administration granted the vaccine breakthrough therapy designation last February, a status that could hasten regulatory review. In addition, a late stage, or phase 3, study involving 745 newly diagnosed glioblastoma patients is fully enrolled, with an interim look at the findings expected early in 2016."
"Celldex Vaccine Rindopepimut Cuts Death Risk From Brain Cancer, Study Shows
Researchers say it is first time an immunotherapy treatment improves survival in randomized trial of glioblastoma patients"
By RON WINSLOW
Nov. 20, 2015 5:25 p.m. ET
"The strategy of enlisting the power of the immune system to attack cancer is showing early promise against another tough-to-treat malignancy: the brain cancer called glioblastoma."
I think the word is getting out...
"Further down the road, the Celldex drug could be combined in interesting ways with other treatments. Some of the immunotherapies known as checkpoint inhibitors from Bristol-Myers Squibb and Merck are designed to “release the brakes” on the immune system, allowing T-cells to attack tumors that would otherwise remain hidden. The Celldex “vaccine” approach could naturally be complementary, because it’s sort of like “pressing on the accelerator,” or showing the immune system specifically what it should be attacking as foreign. Given that both approaches are showing an ability to help extend survival time much longer than would be expected, the possibility of combination therapy will surely be a topic of conversation among researchers today at the Society for Neuro-Oncology. They will surely be thinking of ways to extend the “long tail” of survival time even further, and for more than just one-fourth or one-third of patients."
"SURVIVAL: RINTEGA+BV demonstrated a statistically significant, clinically meaningful overall survival benefit compared to BV alone. Consistent with previous studies of RINTEGA and the published data observed for immune-mediated therapeutics, this survival benefit includes a “tail” on the RINTEGA survival curve with multiple patients exceeding what is customary survival for EGFRvIII-positive glioblastoma. Nine patients on the RINTEGA arm continue to be followed for survival, including five without disease progression per central review. Two patients on the control arm continue to be followed for survival, including one without disease progression per central review. At two years, the survival rate for RINTEGA patients in the ITT population is 25% versus 0% for control patients."
Ed, great new on the Celldex ReAct P2 study, long term survival benefit in recurrent glioblastoma. Just out.
“The results of the ReACT study change the way we think about glioblastoma—offering patients and their families new hope in the face of one of the most difficult to treat cancers and upending the notion that the brain, masked behind the blood brain barrier, is beyond the reach of the promise of immunotherapy,” said David A. Reardon, M.D. “The long-term survival benefit observed in this study is unprecedented as it is exceedingly rare for patients with highly aggressive, EGFRvIII-positive glioblastoma—even in the newly diagnosed setting—to live beyond two years. Most striking perhaps is that not only are patients living considerably longer, they are also living better, with minimal side effects and a reduced need for steroids. The ReACT data also build considerable anticipation for the ACT IV study in newly-diagnosed glioblastoma as these patients typically present with much stronger immune systems and stand to derive an even greater benefit.”