The research into such personalized medicine includes targeted immunotherapy, too -- that is, teaching a patient's own immune system to fight the cancer. "I wanted to find a hospital that deals with glioblastomas, that is doing research and has other options to offer," says Ryan DeGrand of St. Louis, Missouri, who chose to have surgery locally 10 years ago when he was diagnosed with one of the deadliest forms of brain cancer but then looked at his broader options. That search led to a vaccine treatment at Duke Cancer Institute in Durham, North Carolina. "My local hospital was honest," he says. "They said, 'You may live 18 months. You may live two years. We just don't know.'" DeGrand was 32 at the time with two young children, and that prognosis wasn't acceptable.
This is a very important statement which US-FDA might consider as the one of the many clinical results towards accelerated approvals.
" - DeGrand has been going to Duke once a month for a shot of Rindopepimut, a vaccine that stimulates his immune system to produce antibodies that fight the protein. He has been cancer-free since beginning the treatment-"
Do You Need to Ask for Genetic Testing After a Cancer Diagnosis?
Experts say that depends. Some of the more common genetic tests performed today are so-called reflex tests for known diagnostic markers, says Lichtenfeld. These include the HER2 protein for breast cancer; EGFR, a protein, and ALK for lung cancer; the fusion gene BCR-ABL for chronic myeloid leukemia; the KRAS gene for colon cancer and BRAF for melanoma. "If you have one of these cancers, you're going to get that test," he says.
Advanced genetic screening, in which hundreds of genes are tested, may not be currently necessary for common or early-stage tumors, says Richard Haspel, assistant professor of pathology at Beth Israel Deaconess Medical Center in Boston. These tests may be useful if the "tumor is advanced or rare and the oncologist has limited treatment options," Haspel says. The important question for a patient to ask, he says, is "Does my doctor understand what genetic testing is available and when it's appropriate?"
SRPT looks more fraud when CEO makes baseless claims.....He has Ebola vaccine in his pocket and if asked by FDA he can show it. Well will it Works....? Hummm.... CEO says he tried long back and will show it only if FDA ask him....LOL
As per SEC fillings CDX-011 ReACT study in recurrent GBM to produce interim data anticipated by year-end 2014, and a potential Hampton, N.J.-based Celldex could file for faster approval of CDX-011, which the company has developed without a partner, if positive results come to pass in either of the co-primary endpoints of the trial, objective response rate or PFS. In short CLDX catching up with PBYI before their NDA filling in Mid 2015.
CLDX immunotherapy combinations under investigations are - Avastin-Genentech, Yervoy(R) and Opdivo(R) - Bristol-Myers Squibb, Mozobil(R)-Genzyme Corporation; Hiltonol(R) - Oncovir.
But researchers have seen the most eye-catching results when the drugs are used in combination with another very similar immune therapy, which targets part of a completely different T-cell ‘handshake’ – a molecule called CTLA4.
CTLA4 ‘handshakes’ take place in our lymph glands, where T-cells meet up with other immune cells called ‘antigen-presenting cells’, or APCs. Here, APCs alert the T cells to invaders (or tumour cells) and signal to the T cells to gear up for action and start dividing rapidly – into an army of clones, primed to recognise and zap that invader wherever it resides in the body (this is what causes swollen glands when you’re ill).
But CTLA4 ‘handshakes’ switch off this process, preventing the eager army from growing, and hampering their ability to march out and fight the enemy. In a parallel story, researchers have already developed drugs that target CTLA4, and in doing so, have proved that unleashing the immune system, rather than targeting the cancer itself with drugs, is hugely promising.
One of these drugs, ipilimumab (Yervoy) BMS , is already on the market and has shown benefits for patients with advanced melanoma . Another, tremelimumab, PFE is in advanced trials.
Now we’re discovering that when PD-1 blockers and CTLA4 blockers are used together, they have a much greater impact than either alone: knocking out CTLA4 allows the body to create an army of anti-cancer T-cells, and knocking out PD-1 or PD-L1 allows this army to attack.
Preliminary trial results, again, have been extremely promising.
Before PBYI apply for NDA in Early 2015, CLDX will catch up with solid results from more than 100 clinical sites from world over.
this according to Analyst ....
Good thing about CLDX is that they are modest in PR or Earnings call and despite so diverse platform they are not giving out any PR to hype the market. PBYI was the another example of modest and lucky companies for investors without being in limelight.
You may not like this but ....SRPT is dead cat finding all other opportunities to create a hype. EBOLA ...Common !!!!!!!!!CEO stop junking drug market.
CEO Chris Garbedien is a FRAUD and company SRPT itself is a huge fraud......Caveat Emptor !!!!!!!!!!!!!!!!!xxxxxxxxxxxx)))))))))))))))0000000000000000
Investors are falling all over themselves to buy into Puma Biotechnology (PBYI .... patient population, the drug did achieve survival times 30.8 months vs 20.6 months for a placebo in a sub-group but ... Celldex is a multi-product clinical stage biotechnology company, one with two ... related to the strong data from its breast cancer product CDX-011 is compared with Puma Biotechnology's neratinib but CDX011 is simply more effective.
This results are far more better than Puma Bio- PBYI but for CLDX its just only matter of time for everyone to know.
For all patients treated at the maximum dose level, tumor shrinkage was seen in 62% (16/26) and median PFS was 9.1 weeks. A subset of 10 patients had "triple negative disease," a more aggressive breast cancer subtype that carries a high risk of relapse and reduced survival as well as limited therapeutic options due to lack of over-expression of HER2/neu, estrogen and progesterone receptors. In these patients, 78% (7/9) had some tumor shrinkage, 12-week PFS rate was 70% (7/10), and median PFS was 17.9 weeks. Tumor samples from a subset of patients across all dose groups were analyzed for gpNMB expression. The tumor samples from most patients showed evidence of stromal and/or tumor cell expression of gpNMB.
If event 50 Interim results shows any positive indication in QTLY Earnings report then it would take this back into $30 range easily.