by DrKSSMDPhD | November 30, 2014 9:55 pm
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Source URL: https://www.stockgumshoe.com/2014/11/big-bucks-from-big-prostates/
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Frenchy, God bless from lulu et Canada. i know CEO Allan will forgive. ….Thinking if you and thank you as a neighbor!
New article. The party is moving> http://www.stockgumshoe.com/2014/12/microblog-dawn-of-the-planet-of-the-tloglodytes/?utm_source=12814kss&utm_campaign=DrKSS&utm_medium=email
SPHS down 75%
What I don’t understand is that if the shares have fallen over 80%, should we assume that this 12 week interim look has made the end result of the 52 week study nearly certain to fail? Does the company plan on proceeding with their prostrate cancer study in the first half of 2015? Should the company just throw in the towel and dispense what cash is left on the books….. I have so many questions…. I e-mailed IR at Sopheris and got quick answers….that I really didn’t understand. Any comments?
What, and look for a new job sooner rather than later?
Hi George…thanks for posting. If you will look at the graph in the article above this thread, that shows phase 2 results out to 12 weeks. These were such amazing results that my view was that even if effect size shrank in phase 3 (which it usually does) there was still plenty of room for success as defined by 2 IPSS points better than saline vehicle. They didn’t see this, and so with no success early on, in weeks after agent is place, the chance of success at 52 weeks is almost zero. The aerolysin cell-bursting agent they are injecting doesn’t hang around forever, and should begin to exert its first effect in no more than 3 weeks.
As I understand they will phase 2 the same agent in localized prostate cancer in 1Q15.
For reasons related to statistics and math, for reasons of types of patients, a trial can succeed in phase 2 and fail in phase 3 even though the protocols are the same (except that phase 3 has more patients). It has to do with to whom the study is opened. A phase 3 is about so-called external validity, which is the extent to which findings in phase 2 apply to a broad array of patients. Phase 2 patients are often the very best, choicest patients in a practice…often very good at reporting symptoms and complying to the letter. All trial patients are chosen carefully, but a phase 2 may allow a site to choose 3 while a phase 3 may allow a site to choose 30. The overall average quality of patient in your chosen 30 will not be as high as among your chosen 3.
Thank you very much! Now that made plenty of sense and was far more clear than the answere I got from IR…..Greatly appreciated….
Dr. KSS, should one consider buying SPHS after it was knocked down 80%? Or should one wait and see? Steve Olson
Hi Steve: it’s not clear. in 1Q15 they are starting up a phase 2 in local prostate cancer, which is to say tumors that might have been irradiated. It can work for this….presumably the urologist has more discretion about how much to inject at how many sites. I think assessing response will be trickier however. Superficially it stands to reason that since prostate cancer cells really crank out PSA, which activates Sophiris’s drug, that it should kill prostate cancer cells well.
One thing I was never clear on with SPHS was how they arrived at the plan, as regards treating BPH, of giving 6 injections around the peri-urethral parts of the gland that were each 0.5 cc. Instinctively, to me that just seems like too little. They are burning a candle for that trial to see if things “work” at 52 weeks, and I view this as utterly pointless. The agent has diffused away with a day or two of placement, and if there is no benefit at 12 weeks (the first endpoint) there cannot reasonably be benefit at 48 weeks.
According to trial databases, SPHS hasn’t posted the study protocol for the prostate cancer study. If that gets posted and looks appealing (I have no idea how much agent they will let be used), it might not be foolhardy to play here. But I would NOT do that til one has seen the protocol. Do not invest on the promise of a study…..they could yet choose to abandon those plans and close shop.
I am not sure that the protocol specifies only 6 injections of 0.5cc? From what I understand and my calls to the company, the protocol is to inject 20% of the volume of the prostate, which, per inclusion criteria, and as determined by TRUS, has to be 30mL-100mL (if memory serves), so between 6 and 20mLs of PRX-containing solution (or vehicle)
The other sad side that cancer patients have to face after being diagnosed with it.
http://www.fool.com/investing/general/2014/12/27/the-unfortunate-concern-that-nearly-half-of-all-ca.aspx
Cheers,Glenn
Glen, watched a news program last evening that told the story of how cancer patients west of Ontario (Canada) have access to higher priced cancer medications when eastern provinces medicare won’t cover them. ( its provincial). However in the west, the diagnosis is free and the drug free but the required side effect meds are bankrupting. Then adding to the saga, the insurance company upping the fees of the company that said patient is employed by, so the business changes insurance companies to save money and then that same person is no longer covered. Survived 18 months vigorously, happy until meds denied, gone is 6 months. It was so very sad. TIC That Is Canada. Hopefully Obamacare isn’t following.
Very sad indeed Lulu.I hope Obamacare is not following also but I get the feeling it will eventually.I really do not know the answer to this but there has to be a better way.
Cheers,Glenn
RBC’s top 5 Biotech stock buys for 2015.
http://247wallst.com/healthcare-business/2014/12/23/rbcs-5-top-biotech-stocks-to-buy-for-2015/
Cheers,Glenn
Mmmm, RBC, Merrill nor Credit S have consensus on any Bio for 2015, other than 2 for CELG, Glen. Long KSS
$SPHS is getting close to final (primary endpoint) results for the phase 3 trial, due in Q4, 2015. Just wondering if you had any updated thoughts on the matter? I have followed the stock all year (under gambly1 on stocktwits) and spent probably 100’s of hours doing DD on just SPHS alone. I’d love to ask your thoughts on the name and/or lay out my theories why I think the primary endpoint will be met (other than the CEO saying, in Dec 2014, after the interim did not meet the 2.0 point IPSS delta, that he was “quite confident” that they still could achieve the primary endpoint.
For full disclosure, I started my $SPHS position after the fall in Dec 2014, and have added to what I consider a sizable position currently, so I might be a biased long.
GLTA
Let me get a loading dose of coffee on board, and will post some thoughts on Sophiris,
Any updates on SPHS or, more importantly, BPH and its best treatment? tx!
(BTW, what happened to SPHS and at under 3 cents, is it a viable long-shot speculation?)
Writing this in Feb 2021……
$SPHS-gambly1 please join us on the current biotech thread at: http://www.stockgumshoe.com/2015/10/is-zafgen-kaput/
I took the liberty of posting your last post to the current thread. Best2U-Ben
Any updates on SPHS or, more importantly, BPH and its best treatment? tx!
(BTW, what happened to SPHS and at under 3 cents, is it a viable long-shot speculation?)
Writing this in Feb 2021……