GSK's (GSK) Tykerb fails to hit its goal in a Phase III trial that tested its use in women with early stage breast cancer. Tykerb, a rival to Roche's (RHHBY.PK) Herceptin, is approved in 107 countries for treating metastatic breast cancer.
GlaxoSmithKline's drug Tykerb failed to hit its goal in a clinical trial testing its role in women with early breast cancer, dimming hopes for its use in this setting.
Britain's biggest drugmaker said results from a Phase III study of Tykerb given in the delayed adjuvant setting, following initial surgery or chemotherapy, did not reach statistical significance.
The findings from the so-called TEACH study were presented late on Thursday at the San Antonio Breast Cancer Symposium.
The disappointing outcome follows other poor results in previous adjuvant studies and analysts at Deutsche Bank said the data suggested substantial use of Tykerb in the adjuvant breast cancer setting was "very unlikely".
Tykerb, a rival to Roche's Herceptin, is already approved in 107 countries for treating metastatic breast cancer, a later stage of the disease when cancer was spread around the body.
Pfizer lung-cancer drug fails in two Phase III studies
Pfizer's Dacomitinib drug has failed in two Phase III trials of patients with refractory advanced non-small cell lung cancer.In the ARCHER 1009 trial, which included patients previously treated with chemotherapy, Dacomitinib did not significantly improve progression-free survival (PFS) when compared with the Erlotinib (Tarceva) drug.In the second study, Dacomitinib was unable to lengthen survival vs a placebo.A third Phase III trial is assessing Dacomitinib in a different patient population, with the results expected in 2015
How about dummy NeuVax where everyone knows who is Arnh0le and what tricks he has trying to pull from his hat or under pants ?!!!
Sentiment: Strong Sell
I disagree if the wording of the failure news will be as you mention, I think it will be like this:
From an investment perspective, Galena is stereotypical of the companies that have previously
characterized as high risk. Specifically, they initiated a Phase-III study without positive Phase II statistical data and without a global partner, and have issued numerous and redundant press
releases to maintain investor interest. In regards to the latter, the company issued a total N10 press
releases on its clinical trials,
In the absence of POC data, companies will provide justification for investment in a Phase III trial by
comparing the data from their non-randomized Phase II study with historical controls. Such comparisons
have no statistical validity, they are meaningless. The reason for this is that these are apples to oranges
comparisons. The patient populations are usually different and the historical data are usually from a point in
time when the standards-of care-were different.
There are countless examples of where very compelling comparisons with historical controls failed to hold up
in randomized Phase III trials. One of the best examples of this was with the melanoma drug Canvaxin.
CancerVax, the innovator, had conducted ~10 non-randomized Phase II trials and went to great lengths to
convince investors that the Phase II data was prognostic of their pending Phase III results. On October 3,
2005, CancerVax announced the discontinuation of its Phase III trial based on their Data and Safety
Monitoring Board’s (DSMB) assessment that a positive outcome was unlikely.
Other such examples include Melacine, Oncophage, Bec-2, Theratope, PANVAC-VF, etc. Keryx’s perifosine,
an AKT inhibitor in development for colorectal cancer, is a more recent example.
There are many contemporary agents “advancing” on similar tracks: Galena’s Neuvax, Newlink’s
Hyperacute Pancreas vaccine and Vical’s Allovectin vaccine are but a few examples. In regards to the latter,
what a nonsense. GALE had with phase II enough "POC" data, given that phase II patients were clustered in appropriate subsets. And the PII patient subset with statistically significant efficacy data in phase 2 was defined as the ITT population for the phase 3 trial. So, don't we worried about this claim not to have a prove of concept in phase 2 as it is claimed above ....
Sentiment: Strong Buy
This article is over TWO years old (see below).........don't ya' think GALE knows/learned from it.....da..............
Healthcare Stock Recap: St. Jude Medical Hit by FDA, JNJ Collaborates with Pharmacyclics
Tanya Harding | More Articles
December 09, 2011
GSK’s (NYSE:GSK) Tykerb fails to hit its goal in a Phase III trial. The trial tested Tykerb use in women with early stage breast cancer. Tykerb, a rival to Roche’s (RHHBY.PK) Herceptin, is approved in 107 countries for treating metastatic breast cancer.
yes that's very likely. see the path for gsk
phase 1 = positive top line results
phase 2 = positive top line results
fda said proceed to phase 3
phase 3 = negative bottom line results
if a great co like gsk failed then how about gale
I have some interesting herceptin statistics from phase 3
remember herceptin was approved in 1998 while fda was still growing up
for example look at piggy meat by product called acthar gel , approved in 1950 by fda without any clinical efficacy trials and $1 piggy meat by product which could be bought at butcher store now sells for $30k by qcor that too for 19 fda indications from farting balding multiple sclerosis infantile spasms nephrotic syndrome ,,, who knows next will be breast cancer too..
but won't happen anymore
fda has grown up
The article that you have posted states: "The disappointing outcome follows other poor results in previous adjuvant studies". Neuvax on the other hand has shown nothing but "outstanding results" through its clinical trials and that was in spite of not every patient receiving the "optimal dosage". Phase 3 is designed with all patients receiving the "optimal dosage" so results should be even better than "outstanding". Thanks for your pathetic attempt at bashing. It provided a good platform to post just how great the phase 3 results are going to be. The interim results are due out in about 6 months so you may want to cover your short position and load up on shares now. They won't be cheap for long.
Sentiment: Strong Buy