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AMGN's OncoVex
Phase II single-arm study of 50 patients has shown reasonable response rate with impressive durability and good safety. The encouraging part for me was the fact that response was seen with durability also in uninjected lesions including visceral sites. However, I'm only a bit optimistic on this as no details on the visceral metastases were given.
Phase III study has a good chance of success (ie repeat the data seen in phase II) for several reasons: it's quite similar to the phase II, has an SPA and the trial design is appropriate (the nature of the control arm, primary endpoint being durable response rate and not OS, good selection of patients (eg exclusion of certain metastases etc). Commercial success if approved is something else.
Well, it's not like it really matters who manages the Queen patents royalty stream until expiration in 2014...
I do not believe there is an option for retreatment, you can fool the immune system only once.
The advances in virus delivery mentioned in the article continue to be exciting.
Interesting how treatment with the host virus in this case is a one shot deal due to immune response.
Thanks, M! I owe you 4 hours 10 minutes
How slow is enrollment in GALNS? In clinicaltrials.gov I see - Estimated Primary Completion Date: September 2012
By prior agreement with the FDA, the study reported here is the only phase-3 trial GILD needs to support FDA approval of Elviegravir. (Why only one phase-3 study? I’ll make the answer a quiz.)
Baxter's Aralast and Kamada's Glassia are also being studied in the alpha-1 antitrypsin (AAT) treatment in type 1 diabetes area:
http://clinicaltrials.gov/ct2/results?term=aat+type+1+diabetes
Haven't checked the IP state yet, figured it's too early...
Edite: just noticed the AAT in Omni's study is actually Aralast, so one less competitor to worry about.
AUXL
Adrian Adams is now in the driver seat. Not suggesting anything but 3 companies he was previously CEO of were acquired :)
http://finance.yahoo.com/news/Auxilium-Pharmaceuticals-Inc-prnews-64575073.html?x=0
EXEL
Cabozantinib inhibited osteoclast activity as assessed by serum NTx, a marker of bone resorption.
GHDX/Oncotype DX data in DCIS
When rigorous* pathologic assessment is being used to define 'low risk' vs 'high risk' DCIS patients, docs can evaluate the risk of recurrence and decide on treatment accordingly. Since most patients get a surgery anyway (hence parameters like tumor size and surgical margins status are available), and chemotherapy is generally not required, the question is about adjuvant radiation. GHDX will need to convince docs that OncotypeDX score is a better prognosticator than these pathologic criteria.
* As in study E5194 ( http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773217/?tool=pubmed ) mentioned in the PR you've posted.
Most of Israeli Gaucher patients, (accounting for ~10% of the market), get home infusion of Cerezyme by nurses.
PLX goes down 13% here on the delay.
ILMN - rumors about a possible takeover
http://www.bloomberg.com/news/2011-12-05/illumina-climbs-on-speculation-gene-analysis-toolmaker-is-takeover-target.html?cmpid=yhoo
Differences in safety, efficacy, and dosing (in 'real life' setting i.e. when docs have some latitude on how often to schedule injections), do not strike me as significant enough to make docs prefer one drug over the other. Still, there's the (modest) price difference.
SGEN' Adcetris is her best bet (assuming CD30 expression). In the relapsed/refractory Hodgkin's trial, patients had 3.5 prior therapies on average and autologous stem cell transplant. ORR was 74% (of that 34% was CR), and median OS was 22.4 months. Since it was approved in Aug, the only way to get the drug here is via private insurance or out of pocket (prior to approval we had a compassionate program but it was shut down with approval). Unfortunately, there are no clinical trials with the drug in Israel either. They refuse to cover it not really because it's so new, rather because the health committee has to vote on every drug and there are quite a few in line with budget problems.
So there are in vitro antagonistic drug-drug interactions
Meanwhile, AFFX is trying to diversify by acquiring eBioscience (for $330M):
http://finance.yahoo.com/news/Affymetrix-Acquire-bw-1911103919.html?x=0
Another worry would be fibrotic patients that may lack these enzymes in their damaged livers to activate the prodrug.
OT
superiority clam
Given the amount of time 7977 has been in the clinic, no one has tried even a ex-Vivo experiment
the FDA reviewers think Eliquis has something to offer in this indication beyond what Pradaxa and Xarelto can. The data for Eliquis in warfarin-intolerant patients provides such a justification
The same newspaper reported yesterday that Atorvastatin was already shipped to the US by Teva.
The Tofacitinib study was normal, but it is my understanding that MTX non responders with active RA, often get the monotherapy weekly dose of Humira that is more effective (before switched to other anti-TNF or other class).
I just noticed that in this study Humira was dosed once every two weeks in pts with active RA with inadequate response to methotrexate (MTX), while in these pts it is usually dosed every week.
Andromeda/Teva/Clal DiaPep277 in type I diabetes
The first phase III trial met its primary and secondary endpoints, and was found to be effective and safe.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000699926&fid=1725
Eli Hurvitz, former CEO and chairman of the board of Teva, died.
When I posted #msg-68962285 and the following #msg-68969140, I haven't read the paper and I have to admit that even after reading it I didn't pay attention to the 'median of 4.7 days after the acute incident'. I think you're right that it is very unlikely that in this setting Xarelto will impact on Lovenox in ACS. That doesn't change my view on Xarelto results in ACS #msg-68991909.
Xarelto in ACS data
Urche,
On the discordancy in dosing between Afib and ACS: different indications for different populations on different background therapy and I agree that an additional study will be required but IMO only in the overlap population.
On intracerebral hemorrhages: looking at Fig. 2 in the NEJM paper, the subgroup of patients with previous stroke or TIA had the worst data and I'd expect they also had the majority of intracranial hemorrhage events.
On NNT and NNH values, your calculations are correct and like you said, we're looking at mortality benefit vs. increased major bleeding but I believe it will be considered a significant net clinical benefit.
So, my point is that IMO the decision to use riva in ACS is far from clear cut.
VRUS/PSI-7977
so the label will be restricted to:
patients with GT2/3 and
patients with GT 1 who can not tolerate INF?
VRUS/PSI-7977 phase III program
Not only in GT2/3: the NEUTRINO trial will enroll all genotypes who can not take interferon, including (and probably many) GT1 patients. The GT2/3 group is a sweet-spot for VRUS and based on data from ELECTRON trial, there's a very good chance that PSI-7977/RBV can cure these patients in 12 weeks.
But the program also has a third phase III trial - FISSION that will test 12 weeks of PSI-7977/RBV vs. 24 weeks of PEG-IFN/RBV in 500 treatment-naïve GT 2/3 patients. So not restricted to patients that can not tolerate INF.
Edit to my previous post
The reduction of 9.1% in death from CV, MI, or stroke was for the 2.5mg dose not both doses. The combined reduction for both doses was 8.9%.
One more point that was mentioned in theheart.org article is the number-needed-to-treat-to-benefit (NNT) - 56 (one death prevented for every 56 patients treated for two years), which is quite good.
Urche on xarelto ACS data
There is also a problem now with dosing. Faced with data that even this small dose of Xarelto is associated with 4 fold major bleeding risk, how are we going to view the higher doses (I think it was 20 mg) approved for other indications such as A. fib?
The biggest problem I see is that even for the lower 2.5 mg BID dose, the "major bleeding risk" is about 4X that for placebo (2.1% vs 0.6%).
The bleeding risk would be tolerated, of course, if the efficacy were high enough. But, the absolute survival benefit of treatment with riva was only 9.1 vs 10.7 for placebo or 1.8%.
from a clinical viewpoint, that makes little difference
I understand you meant 10% x 10% = 1%. Imo, it will be higher, not sure how high, perhaps 50% x 10% = 5%, just guesstimates.
The New England Journal of Medicine paper:
Rivaroxaban in Patients with a Recent Acute Coronary Syndrome
http://www.nejm.org/doi/full/10.1056/NEJMoa1112277?query=OF#t=articleBackground
And the accompanying editorial:
http://www.nejm.org/doi/full/10.1056/NEJMe1112770?query=OF
I haven't read the New England Journal of Medicine paper but here one can find a few comments from experts:
http://m.theheart.org/article/1309137.do
My own view is that the 2.5mg dose will cause more than 1% loss of overall US Lovenox sales attributable to ACS.
Based on today’s CC, BMY doesn’t think much of the Xarelto results in ACS
Pending presentation of the full dataset from this study
MRK’s Vorapaxar
So it failed on both - lack of efficacy and increased bleeding. That's even worse than I thought.
Sounds like their VIAtab project:
http://www.biodel.com/content/pipeline/viatab.htm
I won't hold my breath for that one.