The eyes and ears team for bio trialsThis discussion came about as the result of the GS thread ”This Tiny, Unknown Biotech is About to Unleash Its ‘Holy Grail’ Drug”
It is hoped that all/any that can throw light, can brainstorm here and feedback consensus to the thread. Good work Guys. my best Alan Harris.
This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.
Whoah guys!…..Its important that we debate, not bicker. Only by that means to we move our collective understanding onwards. There are many here who do not have the scientific/investment knowledge to judge the informed from the scurrilous. Please be kind and respectful to all.
May I ask (as I have before) that any new (ish) contributors identify their credentials so that we may all better judge the validity/reliability of their comments. Simply slinging mud and unfounded/unsubstantiated opinion is not welcome here. Reasoned argument is always welcome from whoever. Rampers/derampers, pump and dumps are very definitely just unwelcome noise that simply serves to irritate and confuse.
As is true of any specialist subject, there will always be differing opinions, often heated… especially regarding as yet unproven paths. If we knew already knew the answers as fact, there would be no point in tests/studies; now would there? Its CONSTRUCTIVE debate, brainstorming, analysis, and review that moves science forward. Not not not YA BOO!
If you wish to debate, state your credentials (not personal identification info) rather than cause mischief while hiding behind a username veil of anonymity. Only then will others take your comments seriously. You do want to be taken seriously don’t you?
Well said, Alan. Totally agree.
“The next generation cancer treatment”
Does anyone have an opinion about BIND, Bind therapeutics, with it’s nanoparticles.
http://www.fiercedrugdelivery.com/story/bind-biosciences-strives-revolutionary-nanomedicine/2013-02-19
Looks quite promising.
Thomas if you want to go to the original thread on post 63 Dr.KSS discussed ISR.There are others who liked the company as well that posted.Just hit CTRL and F then enter ISR and this will bring up past posts on company.Hope this helps.Cheers,Glenn
Thanks for that tip Glenn: CTRL F, I still only see ISRG come up (INsurgent) not ISR(IsoRay)
It is a radiation treament that gets closer to the target without damaging other organs. Using in Prostrate early detection.
Hi Thomas;
When scanning, try 3 different ways;
Company name -> isoray (caps not needed)
symbol with trailing ) -> isr)
symbol with trailing space -> isr (to eliminate partial matches isrg)
Found on #51 and #63
Hi Thomas, there maybe more info on ISR on the huge thread that this thread evolved from. Here is the link.
http://www.stockgumshoe.com/reviews/biotech-supertrader/this-tiny-unknown-biotech-is-about-to-unleash-its-holy-grail-drug/
subramania why did you sell RNN profit or other reason? Thanks
Thank you Tanglewood and Bradley.
Isoray may not be a bad company. It is a play on a cesium radioisotope for brachytherapy. Brachytherapy is treating tumors by implanting pellets or seeds near them that emit radiation, and has been used with success for lung and prostate tumors. The former element of choice for this was palladium. The cesium isotope has better characteristics in terms of path length and half life. My key questions about it, which based on what literature is out there seem not easy to answer are:
(1) why now? Cesium and its isotopes are not new. They are not recent discoveries. Why is this being advanced only now and not 20 years ago?
(2) what is exceptional about THIS company vis a vis cesium? Do they have some lock-up on the supply chain? What keeps a competitor from doing the same thing?
(3) and perhaps a restatement, but I got the feeling from what I read that data are being awaited, that this is up and coming. Why? Why has it not been advanced before? Is the supply better? Has there been some tech innovation to make cesium brachytherapy more workable (I couldn’t find any)?
I am concerned the company is marketing this as some big brand new idea. Brachytherapy is old.
Any help to answering these questions would be appreciated. I am sure the answers are there to be found, but I spent about 4 hours a couple of weekends ago digging through what is out there about cesium brachytherapy and found no answers to these specific concerns. I think there may be some resistance among MD’s to really invoking cesium brachytherapy because of former regimens with palladium seeds. I think people were pretty underwhelmed by their efficacy. They were in vogue for about 5 years and really just vanished. For prostate cancer, some people who had these implanted got considerable radiation proctitis, always a risk when irradiating this region.
Certainly seem investor enthusiasm for Venaxis (APPY) waned today. I would reiterate that there is no reason to be in the stock. When they try to market their new and improved test for diagnosing appendicitis, I feel there will be much resistance. It will add to costs, and will never take the place of a surgical consult and CT scan. The company’s test is based on a CRP (already done) plus a second protein that rises in GI tract inflammation. Which really just means that ANYONE, LabCorp, Quest, Mayo Diagnostics, can come along, put out a cheap assay for that same protein, and trounce APPY. The protein is not a new or arcane one at all. No lab test will ever supplant clinical judgement, and hot appendices scare people. The prevailing thought is that it is better to take out normal ones that to leave, or risk leaving, bad ones behind (if it ruptures, morbidity is very high). An old hospital quality measure is that if a surgeon is not taking out appendices of which 20 per cent are by pathologist review normal, he probably is not aggressive enough. APPY’s test will change nothing. Keep in mind I am not advising what people should invest in. I am saying this is not a compelling company. So what if it made a little money last week? That doesn’t make it a good investment, especially for buy and hold types like me. Plus I think it is better to regard a company with skepticism and sit on the sidelines if it makes money than to regard a company with optimism and see it plunge in value. I sincerely do not see APPY’s test panel ever catching on. Doctors have been dealing with hot appendices for decades, and frankly their algorithms work well. APPY’s test is a trivial refinement based on non-new technology that will make a difference in perhaps 1-2 per cent of cases. Surgeons will operate or not based on “clinical assessment,” a vague entity that is part exam, part intuition, part CT, and frankly not so much based on labs. When the test, if it is used at all, confirms their suspicion, they will operate, but not based on the test. If it does not jive with what they suspect, they will ignore it. I think surgeons do a good job with clinical assessments based on non-quantitative things. This company despite good data is well away from all time highs and I am just not sure it will ever see those again.
I agree with Dr KSS on APPY. I have followed the original post and subsequent comments, and it is going to be hard to rely on a negative test when it is not the standard of care. It is a nice thought to get investors money, but I would not be in long term for Dr KSS points above. I’m an ER physician in a referral hospital.
CTIX’s IND application for Prurisol should have an FDA decision by this week. (The FDA has up to 30 days to let Cellceutix know which is this Thursday). I know we have discussed this here but today’s drop looks like a great buying opportunity.
Thanks for the update Brian! How’s Miami?
CTIX’s enrollment in phase IIb for brliacidin is moving alone nicely. It is comparing brief oral dosing of brilacidin with 7 days of iv daptomycin. Briliacidin is so potent that one dose can be highly efficacious. It literally blows holes in bacteria cell membranes but does not affect host cells at all. There is no known resistance to it among bacteria.
Phase I for Kevetrin, the p53 potentiator is moving along also. Being done at Dana Farber, which is quite choosy about which studies it will do. I feel this drug has amazing potential for overcoming cancer drug resistance. No p53 agent has ever come so close in cell culture and animal studies. It makes tumors much more susceptible to any chemo drug.
40 per cent of this company’s shares are owned by two insiders. The CEO’s stake is worth $55 million, and he has quite a history of successful drug development. No institutions own shares yet, but my feeling is that they are going to start buying as brilacidin just looks so shockingly promising. I have rarely seen an antibiotic look this good in development. Novel mechanism, oral dosing, no resistance, no toxicity, and huge spectrum of activity.
The company recently announced it has new gram-negative antibiotics in development. It also has perhaps 10 other compounds in pre-clinical studies.
It is a good company to be in, and still mostly ignored by the market.
Dr KSS,
‘Mr John Davis’ posts were undoubtedly opaque – he did not state his qualifications or interest in the stock under discussion, which is not credible.
You clearly contribute a lot to this site for no reward and that is very admirable. However in this instance I feel you have overstepped the mark.
In your own words on March 16, 2014 at 5:17 pm:
“We are polite and gentle people here John Davis, and for you to come on here and open your comments with ad hominem insults and lashing out is unacceptable.”
I wholeheartedly agree with these sentiments; however you then followed this statement with your own ad hominem attacks not 3 hours later:
March 16, 2014 at 8:06 pm
“John Davis… and Bibio are… sniggering amongst themselves like adolescent wankers… it is all hoi polloi sociopathy. The people at the other site are the sorts of craven bogans earnestly burlesqued in Martin Amis’s novels.”
You do your own good name here a disservice by sinking to the level of your detractors. The comment about ‘craven bogans’ in particular is indicative of an unpleasant sort of class snobbery.
Please do try and rise above it!
My disclosure: long-time lurker and first time poster here at GS, with no specific Biotech knowledge or current positions in any stock under discussion.
I suspect there is more than just a disagreement over the mechanism of action that Davis proposed. Dr KSS seems very well connected in the Biotech world, and some things particularly about clinical trials didn’t jive. Some of it sounded legit, but now I have to buy an immunology text book to ferret out if Davis might have valid points. I think Dr. KSS gets upset when someone may be throwing too much chaos our way.
There was discussion on the canonical thread about BMSN, a nanocap San Diego company developing a product for aplastic anemia. My concern then was the same as concern I voiced here during the weekend about a certain British company: both companies are means of providing capital so that people with academic posts can advance their careers (in lieu of grant funding).
For all shareholders of record as of tomorrow, BMSN plans to divvy up 20 million new shares in its subsidiary company Regen BioPharma, also in San Diego. It plans to give one Regen share for every 147 shares in BMSN. Ordinarily I would totally dismiss this (when you see the price of BMSN …). But in August 2013, Regen licensed from Benitec the ddRNAi method. It plans to use this to generate shRNA against indoleamine-2,3-dioxygenase, an amino acid degrading enzyme that is associated with blunted immune responses to cancer. They plan to use this in dendritic cells, probably obtained by leukapheresis.
Pre-clinical data on this enzyme as well as data from human tumor tissues is compelling, I feel, and this is a newish area. Regen has no outstanding shares at present, but will likely pursue an IPO. Their lead science advisor is David Suhy of Benitec.
A very high risk play, of course. I am not convinced of its merit. But I do think recent steps suggest the company wants to go from being indolent and idle to active. And they are in the world’s most vigorous biotech start-up city. They seem to have decided to stop cutting bait and to fish instead.
Incyte has a chemical inhibitor of the same enzyme in phase II for melanoma and ovary cancer. No data yet.
Doc: Speaking of Ovarian cancer my friends wife was diagnosed last year and recently concluded 2 rounds of Chemo and a massive round of radiation in between. Everything seems fine for now but she said she will not go for chemo again. Would Gradalis “Fang” therapy be a good choice? Or could you point me in the right direction.Thanks
Sorry to hear about that Randy. Gradalis’s FANG trial is looking for stage III/IV patients who have had at least 6 cycles of platinum (cisplatin or carboplatin) based therapy. Depending on where they are, what places are accessible to them, I would look into clinical trials available at the nearest tertiary/academic cancer center. I am aware of a couple of studies looking at maintenance dosing with oral inhibitors of oncoproteins specific to ovarian cancer, but a lot of deciding what to go with there depends on how close people are to what center.
I know you are asking Dr KSS….and he can verify if this approach is wise, but I try to wait for the 10-year results to come out before I begin personal use. I’ve made the exception for oral immunotherapy for our own kids’ peanut allergies. We have a place in Medical City, in Dallas, that has been doing it for about 5 years, with a couple of hundred kids successfully treated by them. But, we are just starting the process, so we are excited and scared at the same time! It’s the only thing I can think of that I haven’t waited for the 10-year results, only because of the life-and-death situation, so I mention it for the perspective.
I too looked at buying BMSN, but held off due to not being able to get comfortable with the management or the finances. For those of us who already own Benitec, I see no reason to jump into BMSN or Regen. From a financial risk/reward standpoint, you already have exposure to Regen through the Benitec licensing agreement. If Regen is commercially successful, Benitec would see increasing revenue which should be reflected in Benitec’s LT share price. If you own all three, and either Regen or BMSN fails, you would likely take a hit to all 3 share prices. (BMSN will still own approximately 50% of Regen after the dividend spin-off.) If you just own Benitec, the impact on your investment portfolio if one of these companies fails will be less. It may be wiser to spread your investment risks out by diversifying with other recommended stocks besides BNSM/Regen.
Thank You Professor Z. Seems like sound advice to me!
Yes, wise counsel I feel. One unspoken thing about Regen I don’t like is that basically their strategy is not to do research on their own, but rather to have legions of patent attorneys scouring patents for licensing opportunities, paring the list down to the 1-2 per cent of those opportunities that are cheapest, and then pursuing those. And they thus….groan….chose Benitec. Benitec famously is not charging people much to license ddRNAi. Each deal they make is structured company by company, and has contingencies for more revenue if the company makes revenue from the licensing, but Benitec is not aggressive about pricing its method to a level it is worth. Because the worth of ddRNAi has not been proven yet in an evidence-based way. That may all be about to change, however.
Dr KSS,
Thanks for asking! Miami is great (was warm today and not a cloud in the sky). I am finishing up reorganizing my portfolio because I will be studying my life away for boards, which is in June. Hope everything with you is well too! Have a great rest of the week.
-Brian
Susan Graham and others wishing to discuss ScanCell are welcome to join us over on the NASH/ICPT thread.
Thanks very much. I’ll try, but the link I just tried was to an irregulars-only thread.
log
A new study showing that perceived side effects from statins are quite high in people on placebo. http://cpr.sagepub.com/content/early/2014/03/06/2047487314525531.abstract
This is the nocebo effect. The placebo effect is benefit from an inert pill. The nocebo effect is harm from an inert pill. Whether one experiences a placebo or nocebo outcome depends on what one expects. People expecting statin side effects get them just as often as when they are dosed with an inert pill as when they are dosed with a statin.
This is an important lesson in how flawed the arguments are of the vitamin/natural/alternative crowd. It is data, not belief. If you expect a prescription to harm you, you perceive it as doing so.
I take a low dose of simvistatin with great results and no side effects–don’t even take CoQ10 although it might not be a bad idea.
I now hold SVA Dr. KSS and love it’s prospects for growth especially with its promising new HFM vaccine. Still thinking about getting in on TRGT soon as it’s at a very attractive valuation given it’s promising science.
I got in TRGT the other day. It seems to have technically broken out of an ascending triangle on the chart. I like the valuation as well!
Dr KSS; It seems relatively easy to implant false memories.One study involved people who had been to Disneyland &when queried about rides & etc. & if they had seen characters Mickey, Donald Duck, Bugs Bunny, or Yosemite Sam a surprising number had seen Bugs Bunny. Perhaps you should apply for a grant to study “nocebo” effect because it certainly seems to be increasing in the modern ‘infotainment’ world. I have already used nocebo as my new word of the day,Thanks to you DR.
Doc your generosity with time and knowledge is truly appreciated.
Please do NOT cause my comments below to jack the thread just felt I should share them with respect and for a laugh.
I must unlurk with a pranamasana and particular namaste to Dr. KSS for his patience with, and insights for, all of us on this and other thread(s). Bolstered by your depth and clarity of writing I did my own DD on BNIKF and bought a bit. We’ll see what we see, but I do know that for me a chunk of “payment” for such investments is the return on feeling one can do good for those in need while simultaneously – hopefully – doing well.
I popped up now as I was unaware of the nocebo effect – although its existence should have been easy to deduce. (Or is it induce? Never mind) It does, however, beautifully explain in one logical word the results experienced by some that validate preconceived notions in those predisposed to choose alternative medicine.
Although of course the nonsensical positive effects of some ridiculous suggestions simultaneously beggar belief AND cause even the hardest-core scientists among us to pull hair in frustration. I have a bar of soap in my bed. Why? Because this stupidity was discussed on multiple fora with regard to curing leg cramps – from which I have suffered virulently all my life. There is and was no explanation as to why a fershlugginah bar of soap – no brand, no ingredients – just the d@mn bar should work, just a lot of agreement it did. I mean does it give off fumes …?
How stupid. So I put the damn bar in my bed 6 months ago … AND HAVE NOT HAD A CRAMP IN BED SINCE. NOT ONE D@MN CRAMP. And I have never gone more than a few weeks without them before. One could look to a new-ish drug I take or … but IT DRIVES ME CRAZY. I’d love to say “eh, power of suggestion” but except for the fact I’m sure the bar lives in the mind palace of my subconscious, I forget it until the linens are changed …. and then forget again an hour later.
*Sigh* But please keep up the great science and discussion on here and elsewhere. I was – before disability – a lawyer [d@mmit Jim] not a scientist, and while I can spend 12 hours a day dissecting all available material on a company, the science can ABSOLUTELY bamboozle me. So as with technicals, my gift is not to “get” them, but to just be able to cull them to follow the lead from those who appear to know their microscop-y stuff and try to hitch my cart to their winners.
Here’s an interesting article on how the placebo effect is thought to work.
http://www.jneurosci.org/content/25/45/10390.full
The article says there is not one physiological mechanism, but many. Some are blocked by naloxone, an opioid antagonist. If you take naloxone and your leg cramps come back, I guess you know that it’s the placebo effect! But who knows, maybe it’s the soap fumes. Taking naloxone sounds like a bad idea, in any case.
Alan
Exact Sciences Up Pre-Mkt; Analysts See Data Positive W/ Caveats
2014-03-19 12:38:28.169 GMT
By Cristin Flanagan
March 19 (Bloomberg) — Exact Sciences climbs as much as
17.8% from yday’s close, to $16.99 high in pre-mkt trading after
Mayo Clinic press release yday indicated that EXAS’ Cologuard
about as powerful as colonoscopy at detecting colon cancer.
* EXAS data “solid and encouraging” ahead of March 27
panel, bodes well for CMS reimbursement, writes Mizuho
analyst Peter Lawson (buy); cautions on more false
positives, higher rate of technical failure vs fecal
immunochemical testing (FIT)
* EXAS data looks to be “incrementally positive,” writes
William Blair’s Brian Weinstein (reiterated outperform),
sees FDA panel recommending for approval, yday’s news
doesn’t dimish importance of panel, reimbursement,
commercialization aspects
* Expects EXAS to host conf. call tonight or Thurs.
* EXAS up 23% YTD vs 12% gain for RGUSHS (as of yday close)
* EXAS now up 7.4% from prior close to $15.49 in pre-mkt
trading
* EXAS has 10 buys, 1 hold, 3 sells w/ avg PT of $16.90 (7.0%
upside from pre-mkt price): Bloomberg data
It seems that even Adam F likes it. This is from Adam yesterday. But note his comments in last section regarding false positives and cost factor:
“The pivotal study of Exact Sciences’ (EXAS_) Cologuard stool-based DNA screening test for colon cancer were published in the New England Journal of Medicine tonight, one day earlier than expected due to an embargo break by the Mayo Clinic.
There are a lot of numbers to go over so let’s get to it.
The sensitivity of Cologuard to detect colon cancer was 92.3% compared to 73.8% for fecal immunochemical testing (FIT), the comparator used in the study.
The sensitivity to detect advanced pre-cancer was 42.4% for Cologuard compared 23.8% for FIT. For polyps with high-grade dysplasia, the comparative sensitivities were 69.2% for Cologuard and 46.2% for FIT.
Exact Sciences’ previously disclosed Cologuard’s superiority to detect colon cancer and pre-cancerous lesions compared to FIT. The data in the NEJM study bear out this finding, with statistically significant results. The study authors note that Cologuard’s superior sensitivity was due to the screening test’s DNA marker and algorithm. The performance of Cologuard’s hemoglobin component was similar to FIT.
There were more false positives with Cologuard than FIT in the study. Cologuard specificity was 86.6% compared to 94.9% for FIT.
The number of people required to be screened to detect 1 cancer would be 154 with colonoscopy, 166 with Cologuard and 208 with FIT, the study concludes.
To detect a single precancerous polyp would require screening of 13 people by colonoscopy, 31 by Cologuard and 55 by FIT.
Cologuard was associated with a higher rate of technical failure. Of the 11,016 people evaluable in the study, 689, or 6%, had Cologuard results excluded due to stool samples that could not be evaluated or technical failure. By comparison, only 0.3% of FIT results were excluded.
The study authors conclude Cologuard was associated with a 27% relative increase in the rate of detection of stage I to stage III colon cancer and a 78% relative increase in the detection of advanced precancerous lesions compared to FIT.
An accompanying editorial in the NEJM concurs with the author’s conclusions about the superior sensitivity of Cologuard over FIT but includes cautious remarks about the former’s specificity and the higher technical failure rate, which raises the risk that cancers might be missed.
The higher false positive rate for Cologuard is an “important consideration when determining the appropriate interval for screening,” the editorial states.
Cologuard is expected to cost more than FIT, so any recommendation of more frequent testing interval could cause reimbursement headaches and lower adoption.
The FDA is convening an advisory panel to review Cologuard on March 27. “
A little while back we had a discussion about IsoRay (ISR) which has taken off today. It is largely due to the attached article. https://invest.ameritrade.com/grid/p/site#r=jPage/https://research.ameritrade.com/grid/wwws/stocks/news/story.asp?docKey=100-078u3169-1&c_name=invest_VENDOR
I was a patient of the Dattoli Cancer center 14 years ago and received 95 Palladium seeds in the prostate bed. For me it has been very successful and almost a non-event. Due to the extensive research I went through, I became very knowledgeable about brachythreapy and recognized many benefits with ISR (half-life mostly) plus that they are the sole source of Cesium-131. I was also intrigued by their diverse methods of delivery which are very adaptable to special situations. As an aside, Dr. Dattoli in Sarasota is a leading pioneer of brachytherapy and a delightful caring doctor.