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Couldn't read the whole piece (not a subscriber), but they got the protease inhibitor part as well.
We can now speculate on how special this PI is :)
BLRX/BL-8020
I've asked and just got an answer: it is indeed an oral NS3/4A protease inhibitor.
About 20 million Bioline shares moved today in TASE. We beat you big time
Yes, it was up over 26% early morning. There was one analyst who wrote that the deal is worth 10-$15M and he gave Bioline a price target of about 70% above the current one.
Looked at the few publications they have. They were studying the molecular mechanism of HCV NS3-4A resistance to PIs. So, my guess is they either used their knowledge to design a PI candidate that can overcome resistance or some new molecule that helps circumvent resistance to PIs or some new unrelated MoA to be used in combo with current approved anti virus treatment. I now tend against the first.
I will most certainly give it a try :)
BLRX
The average daily volume on TASE is ~0.8 million shares. Today it was more than 10 times.
I said if (don't know for sure) it is a PI cause I've looked at the web of Genoscience - the French company from which BLRX licensed the compound:
http://www.3dgenoscience.com/molecular_modeling/drug_discovery_and_viral_drug_resistance.htm
BLRX was up 34% in TASE on this news:
http://www.globes.co.il/serveen/globes/docview.asp?did=1000718479&fid=1725
If this is an oral HCV protease inhibitor that didn't even enter the clinic, I don't understand the market's reaction at all.
End of story for D-Pharm's DP-b99 #msg-71233181
Another stroke drug bites the dust:
D-Pharm/DP-b99 phase III trial was stopped for futility. (sorry no link in English yet).
Suggest that the full Kaplan-Meier PFS curves, show that at most time points separation between regorafenib and placebo is greater and the median PFS is just not representative of the the overall shape of the curves, and the hazard ratio is more indicative of the benefit of the drug.
We're on the same wavelength about regorafenib clinical relevance #msg-71008932
Regorafenib data are clinically relevant imo, because it is used in salvage setting.
Bayer/ONYX regorafenib in mCRC
Correct. Fabry male patients are better subjects to analyze a-gal A activity than females because they have the mutant gene in every cell while females can have two cell populations in the same tissue - mutant and wild type*. That makes the results from the 013 study more accurate.
Some females with Fabry disease can be severely affected like males but the main point in enrolling males only is to have lower noise* to signal ratio in the samples.
* Here we have a fine example of the observation that women are more noisy than men
Did you catch the point of why only males in #msg-70875464?
Interesting. If I tried to be the party-pooper, I would note the small effect size on weight, and more importantly, they claim in the discussion that it was a a "short-term irisin treatment" that induced the beneficial changes, while it was actually a treatment that increased the gene expression (through a viral vector). It would be nice to see a demonstration of an effect for actual hormone delivery. It might be hidden somewhere in the paper; I'm afraid I haven't read every word...
FOLD/amigal+ERT in Fabry
Note that only males were enrolled in the trial (see slide 16 in the link you've posted here #msg-70829476).
FOLD/amigal
They have 17 (out of 26) phase II patients remained on amigal monotherapy (slide 8) and my guess is these are the patients having 'amenable' mutations. If so, I am less bearish on the monotherapy treatment than before because certain mutations were one of the phase III study 011 inclusion criteria. Chaperone monotherapy failed in Gaucher and Pompe but perhaps it has a better chance in Fabry due to better selection of patients (mutations, urine GL-3 levels etc). When used in combo with ERT, chaperone treatment should work for all mutations as it binds to the exogenous enzyme not just the endogenous one and safety should also be better due to less frequent dosing.
Nice fight to LIFE's announcement except ILMN didn't mention pricing, so I guess they cannot yet compete with the $1K tag.
I presume you meant LIFE not ILMN #msg-70703176
One more interesting note from the study is that the Vitamin D treated group had worse clinical characteristics to begin with: viral load (50% vs 42%, P < 0.01), and fibrosis score (> F2: 42% vs 19%, P < 0.001) than the controls.
There was a similar price hike last Jan. And btw, Teva is not alone in the price hiking game. For example Avonex' price has more than doubled since 2007.
I am only aware of trials combining an mTor inhibitor with Avastin in RCC:
http://clinicaltrials.gov/ct2/show/NCT00631371
http://clinicaltrials.gov/ct2/show/NCT01198158