Note the small size of trial needed for Avastin to get accelerated approval for second line use, because of the lack of alternatives.
Avastin failed for first line use in two phase III trials in combination therapy despite improved PFS likely due to quality of life (guess) . OS in trial for Avastin arm and control arm in first line were both averaged 16 months.
On May 5, 2009, the U.S. Food and Drug Administration granted accelerated approval to bevacizumab injection (Avastin®; Genentech, Inc., South San Francisco, CA) as a single agent for patients with glioblastoma multiform (GBM) with progressive disease following prior therapy
(based on 2 trials n=78, n=56)
Found this on Avastin which recently showed almost zero OS improvement, improved PFS with a big disclaimer: "reduced cognitive function and quality of life"
You can google MD Anderson News release:
"Symptoms and quality of life were significantly worse for patients receiving bevacizumab, particularly at weeks 22 and 34. In particular, symptom burden, including treatments, and generalized and affective symptoms were greater, with persistent differences seen in treatment-associated symptoms. Additionally, overall symptom burden, tumor and treatment-related symptoms, as well symptoms that interfered with daily activities, were also worse for those on bevacizumab over the treatment course."
Thinking it was a big surprise ICT-107 got picked for an oral presentation, that is a big deal.
Odds are overall survival will be better than control arm, just not statistical?. This favors a phase III, Strongly favors a phase III trial if the subsets mentioned in the letter to shareholders is what ASCO wants to discuss in the oral presentation. Quality of life will be monitored in OS patients and is something that glioblastoma patients and their support groups will be interested in. Also, will a significant number of longer surviving patients with quality of life show up as an outlier patient subgroup?
Glioblastoma is a horrible disease that is not responding to new therapies. Maybe ASCO is seeing something in the full detail data can communicate to them that couldn't be released to the public due to FDA regulations?
Wild speculation so take this post with a big grain of salt. Anyone else have some negative or positives to add?
Why I'm expecting better results on the late reporting patients.
Importance of HLA
HLA is kind of like blood type. People are born with a certain HLA type (e.g. A1, A2, etc.). About 70% of people in North America have either HLA-type A1 or A2, and ICT-107 is designed to work only in these patients. The vaccine targets six different tumor antigens, but only two (MAGE1 and AIM2) in A1 patients and four (HER2, TRP2, gp100, and IL-13Ra2) in A2 patients. Thus, ICT-107 should only have an effect on A1 patients who have MAGE1 and AIM2 on their cancer cells; it cannot attack the other tumor antigens in A1 patients. For A2 patients, ICT-107 only targets four tumor antigens; A2 patients with tumors only having MAGE1 and AIM2 should see no benefit. ICT-107 is essentially two different products: one for A1 patients and the other for A2 patients.
* Zero benefit for about 30% of patients will show up in early data?
Wall Street has plenty of contacts in the medical press. The Medical Press is fully aware of hundreds of long term therapies than cost well over $100,000/year. Some treatments are in the $500,000 and up range. The articles continue to come out on Gilead's CURE.
Probably a long summer on Gilead price? GLTA, hold tight to your medical stocks with solid cures.
As ImmunoCellular points out:
The OS analysis includes data on ((67)) events (patient deaths) out of a possible 124, whereas the PFS analysis includes data from ((103)) events. ICT-107 was shown to be generally safe and well tolerated, with no imbalance of adverse events between the active and placebo groups.
(PFS was significant as of the December readout)
After the easy money in Buda's shallow wells I'm seeing more written about Pearsall potential at deep depths.
The latest CC has me digging for more news on what may be the potential talked about besides the Buda oil formation
I'm growing more curious if there is more to this area than the buda oil. Looking into it I found an older presentation from an Oct 2011 Momentum presentation showing the Maverick Basin that overlaps USEG's Buda (Oily part of Upper Eagle Ford region). A basin? Lots of interesting maps for those interested in googling.
The Motley Fool article, There's More Underneath South Texas Than Just the Eagle Ford (September 28, 2013)
Dallas Operator Targeting Naturally-Fractured Buda Limestone
Joe Fisher January 9, 2014
Dallas-based Gulf Coast Western LLC has secured 3,500 acres in Wilson County, TX, where it intends to target the "revitalized" Buda Limestone Formation with 10 horizontal wells initially. The naturally fractured Buda is just below the Eagle Ford Shale and is seen as a lower-cost oil opportunity than the Eagle Ford
BlackBrush’s Buda completion stands out in Frio Co.
January 20, 2014
In Frio Co. BlackBrush Oil & Gas recently completed the second best well in the county over the previous year with their Derby Ranch 2H targeting the Buda formation IPing at 962 boepd (75% oil, 29°API) on a 24/64 in. choke. The well was drilled to 9,243 ft MD (7,393 ft TVD). Last year Frio Co. saw 45 completions averaging 430 boepd (82% oil) including a total of 7 Buda wells (6 operated by BlackBrush) averaging 511 boepd (70% oil).BlackBrush has ~33,000 operated (~90% WI)
"Georgetown is below the Buda, separated by a thin shale formation named Del Rio Shale."
The Georgetown also looked promising when it was brought up a couple of times during the last conference call.
After the easy Buda oil has been drilled what's next? from Jaime Kammerzell a year ago:
The Buda-Georgetown lime play has been a solid source of oil since the 1970s. Buda is a naturally fractured oil formation, which lies about 100 ft below the Eagle Ford Shale. Because it does not have to be fracked, it costs significantly less ($4 mil vs $7 mil) to drill and produce compared to the Eagle Ford. Georgetown is below the Buda, separated by a thin shale formation named Del Rio Shale.
You are right, there has been a renewed interest in the area in the last year or so. The Texas Railroad Commission revealed that the Dan Hughes Oil Company found a sweet spot in Northern Dimmit County and Sage Energy found one in a nearby well. Dan Hughes’ first well, which is 5 mi northeast of Big Wells, produced 154,019 bbl in its first year of production, the Railroad Commission announced. Just west of there, the company drilled the Heitz 302 3H well, which produced 200,151 bbl from June 2012 through February 2013. These results, combined with the cost of drilling the well, are better than the best Eagle Ford wells thus far.
In addition, Buda wells are typically drilled underbalanced and horizontally, which allows the oil in the Buda to start producing within two weeks of spudding, as compared to the Eagle Ford, which requires fracking and completion prior to production start, which could take as much as 4 months.
GILD's share price continues to add pain to their short positions as the share price slowly marches higher daily. Is the short club just adding more short positions? Hope so.
Siga has a lot of cash on their books while PharmAthene is bleeding cash. Think Parsons is aware a remedy delay continues to reward the "bad faith" management and seriously penalize ALL shareholders?
From the earnings call transcript, Keith Larsen. One of the more interesting Q&A sessions. He didn't go into the stimulation in any depth. I get the impression the operators of the sites are limiting the info released on the most promising results they are seeing that may be possible in the Buda area.
After another year of full time standard Buda drilling, It's so high margin. I'm guessing the operators will go back to explore the more interesting results seen in the other formations, especially the Georgetown. Austin Chalk, Eagle Ford, Edwards and the Pearsol . Buda cash flow paying for the high payoff Buda formations first. The stimulation and tracking potential in the other levels likely a subject for 2015 or later?
GLTA, on many profitable years in the many formations
'In addition, down spacing and fracture stimulation of the Buda formation and other formation development in each prospect may enhance the oil and gas reserve potential."
I'm guessing the consolidation phase for the share price is coming to an end.
Shorts got lots of Press today on cost factor. Whatabout:
For patients not covered by health insurance, a single hemodialysis treatment typically costs up to $500 or more -- or, about $72,000 or more per year for the typical three treatments per week. Injectable medications and vitamins can add hundreds of dollars to the cost, depending on what is prescribed
72,000/year for at least 5 years. Ask the patients how much they would prefer a cure in a pill that takes only a few months? Hedge funds have a lot of friends in the right places to run attack articles. Max pain for hedgies all through end of quarter