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“This Tiny, Unknown Biotech is About to Unleash Its ‘Holy Grail’ Drug”

Biotech Supertrader teases that "This May be the Most Radical Advance in Medicine in the Last 100 Years"

By Travis Johnson, Stock Gumshoe, January 8, 2014

Robert Morris is helming a biotech-focused stock newsletter that’s called Biotech Supertrader (modesty has no place in the world of newsletter promotions, of course), and I’ve never covered this letter before so I thought I ought to have a look at the latest teaser we’ve been asked about.

Morris, incidentally, has been featured in our pages before — but that was back when he was editor of China Stock Insider at the same publisher. That letter, like almost all China-focused investment newsletters, seems to have disappeared quietly into that good night … which probably tells you that it’s time to invest in China again, since the newsletter publishers are ignoring the Middle Kingdom and rushing out their pitches about biotech and tech stocks. At the time, Morris was teasing NQ Mobile (NQ), which has turned out to be pretty good if you bought it down there in the $6-8 neighborhood (though it’s been a wild ride).

So now what’s he pitching for his Biotech Supertrader?

Well, the destruction of “Man’s deadliest disease”, of course. Here’s how the teaser gets our attention:

“This Tiny, Unknown Biotech is About to Unleash Its ‘Holy Grail’ Drug on Man’s Deadliest Disease

“Their ‘Guided Missile Approach’ Could Save Thousands of Lives Each Year

“It’s about to become the most talked about advancement in cancer treatment in our lifetimes and you can lock in a life-transforming fortune if you act quickly….

“I’m urging my subscribers to load up on this stock NOW….

“I’ve just uncovered a tiny, unknown biotechnology company with a new cancer drug in phase 3 clinical trials which is showing remarkable success at treating several types of cancer.

“Their scientists have found an innovative approach to cancer care which involves a breakthrough in treatment. It goes deep inside the inner workings of our cells.

“Plus, this medicine looks to be many times more effective and with fewer side effects than the chemo, radiation, and drug therapies currently available.”

If there’s one thing that investors know can make them rich and make them feel good about themselves and the world, it’s a cure for cancer — we’ve seen that effective cancer treatments can and do (occasionally) turn little biotech stocks into gigantic successes, so the dream lives on that you’re going to catch one of these lottery tickets and own the next Genentech. Will we be so lucky? Well, let’s see which one he’s pitching:

“When this drug wins FDA approval – which I believe it will – this small company’s $4.16 stock price will go straight to the moon.

“And the market for this drug is absolutely huge!

“You see, this small biotech is targeting its new drug, let’s call it ‘drug S’, at cancers of the blood and bone marrow. And it is already in very promising phase 3 trials for these two types of cancer.

“But here’s where it gets really interesting. It looks like the drug this company is developing will also work on other types of cancer!

“There are positive signs it works on Non-Small Cell Lung Cancer (NSCLC) too. There are 1.1 million people with this type of malignancy. Just in the United States alone there are over 300,000 patients with this disease according to The American Cancer Society. Each desperate for a cure.

“Plus it looks like ‘drug S’ may turn out to be an effective treatment for ovarian Cancer. There are more than 204,000 new cases of ovarian cancer diagnosed worldwide each year with 22,280 of these in the United States according to the National Cancer Institute estimates.”

So … who is it? Thinkolator sez this is Cyclacel Pharmaceuticals (CYCC)

Cyclacel is indeed a little biotech around $4 (it closed at $4.35 yesterday), with a market capitalization of only about $80 million — so be careful, we’re a big enough group here that if just a small percentage of Stock Gumshoe readers got enthused about this stock it could drive the shares up, less than a million dollars worth of shares trade each day (Biotech Supertrader says they limited their readership to 750 people — I don’t know if that’s still their cap or if they’ve hit it, but we’ll have more folks than that reading this free article).

And like many biotech stocks, it’s got some impressive scientists and it’s been losing money for a long time as they’ve been searching for a viable drug (their current lead drug also was a big focus of theirs back when it was in Phase 1 trials five or more years ago, so that’s a good reminder of the time these things take, it’s just starting Phase 3 trials now). It looks like they must have gone public in 2004, when they were about eight years old, and a quick scan of ten years of their financials over at Morningstar indicates that they’ve never generated more than a token amount of revenue (meaning, they’ve probably had some research collaboration payments or partnership funding, but never got a product to market), and have accumulated more than $250 million in losses to date. And had two reverse splits to keep the price from sinking far into penny territory.

So that’s not unusual, but it means that — as with all developmental-stage biotechs — it’s not about the financials or the fundamentals, it’s about what’s going to happen in their clinical trials and whether things are going well enough that they can continue to finance the trials … which get much more expensive as you progress through Phase 2 and Phase 3.

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All I know about them so far is that they say they’ve got enough cash to get through enrollment in their key Phase 3 study for “drug S” (which is sapacitabine) as of September when they last updated their investor presentation, but I know nothing about the science or the competing cancer drugs that are out there or how fabulous this particular one might be, so I asked our favorite medical writer, Doc Gumshoe (who, yes, is not a doctor) to check them out quickly and chime in. Here’s what he could share after looking into them for a few minutes (he’s just looking at the medical stuff, not so much the “investor presentations”):

    Cyclacel’s Prospects

    Cyclacel has three drugs in development at this time, and is involved in eight clinical trials with these drugs, not including two clinical trials that have been terminated. Their top contender is sapacitabine which targets the division of cancer cells. If you can prevent cancer cells from dividing and reproducing, you have the cancer whipped, so targeting cancer cell division (or mitosis, which is the technical term) is a highly promising avenue for treating cancer. However, we need to take note of the fact that sapacitabine is one of a large number of drugs that propose to fight cancer by this method.

    At present, all eight of Cyclacel’s clinical trials involve sapacitabine. Of these, at least one has been completed – a Phase 1 study of the safety and pharmacology of the drug. Four others are current, with no information about results. These are likely Phase 1 or small Phase 2 studies, to assess safety, determine what a correct dose might be, and evaluate whether the drug does what it’s supposed to do in human subjects with the target diseases, which in this case include acute myeloid leukemia (AML), cutaneous T-cell lymphoma, and some advanced solid tumors. Prior to the clinical trials, sapacitabine has demonstrated impressive results in delaying the spread of metastatic liver cancers in mice.

    From what I can gather from public sources (i.e., the NIH Clinical Trials Registry), there is one Phase 3 trial, which started recruiting patients in February of 2013 and is expected to be completed in late 2015. The trial is in elderly patients with AML, and compares alternating cycles of sapacitabine and decitabine with decitabine alone. Decitabine (Dacogen) is FDA-approved for treating AML and also targets cancer cells’ replication by attacking their DNA.

    It is possible that the Phase 3 trial by itself could lead to FDA approval for sapacitabine, depending on the strength of the results. However, that trial would not get the drug approved for use as monotherapy, since it is not being investigated as monotherapy. My guess is that Cyclacel is planning more trials of sapacitabine as monotherapy, perhaps in younger patients. And my further guess is that FDA approval is still quite a long way off.

    Sapacitabine is also in a Phase 3 trial with cyclophosphamide and rituximab for the treatment of relapsed chronic lymphocytic leukemia. Cyclophosphamide (marketed under several trade names) is a well-established chemotherapy agent used in a number of cancers, and has led to remission in many cases; however, it is associated with truly harrowing adverse effects. Rituximab (Rituxan, Genentech) is used not only in cancers but in some autoimmune diseases. And sapacitabine is also being studied in patients with previously-treated non-small-cell lung cancers.

    Although the piece from Biotech Supertrader said that the drug – identified as “drug S” –is also a promising treatment for ovarian cancer, I find no clue that it is being studied in such patients. [ed note: that’s because that “promise” is in the lab still, not in people — they had a press release about this in the Fall, “75% of Ovarian Cancer Patient Samples Highly Sensitive to Sapacitabine”, not studied in patients but on patient samples]

    Cyclacel has two other drugs in development: selicilib and a drug designated as CYC116. One selicilib study has been terminated, and in a second Phase 1 study, selicilib is used with sapacitabine in patients with advanced solid tumors. Remember, however, that Phase 1 studies are many rungs of the ladder below what’s needed to gain FDA approval.

    CYC116 is an aurora kinase inhibitor, meaning that it blocks the action of an intracellular enzyme that facilitates cancer cell mitosis. This is a promising avenue of cancer treatment, however, the traffic on this avenue is fairly heavy, and includes several other classes of drugs including tyrosine kinase inhibitors, and taxol based agents such as paclitaxel (Taxol, Bristol Myers Squibb); docetaxel (Taxotere, Sanofi-Aventis), Abraxane (a newer formulation of paclitaxel from Celgene) and others.

    CYC116 supposedly also inhibits vascular endothelial growth factor (VEGF), which induces the growth of blood vessels that nourish cancer cells. Inhibiting VEGF is a well-established means of combating cancer, and CYC116 could hardly be characterized as a radically new departure in cancer treatment.

    The one trial involving this agent has been terminated. That, of course, does not mean that development of CYC116 stops dead in its tracks – there are many reasons why a trial can be terminated, and ours is not to speculate without more information.

    Beyond those three drugs, it’s hard to guess what Cyclacel may have up its corporate sleeve. It is certainly true that a successful cancer drug – even if only moderately successful– can be transformational for the biotech that develops the drug. But the drugs that Cyclacel has under development do not appear to this skeptical observer to be radically new departures in cancer treatment.

    It’s important to remember, when trying to estimate the likelihood of a single drug demonstrating sufficient efficacy and safety to gain FDA approval and market share, that the competitive field is vast. As I mentioned earlier, Cyclacel has a total of 8 clinical trials in process at this time.

    For the sake of perspective, it’s worth knowing that at present there are 41,445 cancer trials being conducted. So those are the odds.

So there you have it — it’s almost impossible to find a development-stage biotech whose financials look great or that makes your heart go pit-a-pat over their valuation, especially in a biotech bull market like we’ve seen over the past year or so, and Cyclacel doesn’t jump out as spectacular on that front either, not unless you’re a big believer in the promise of their specific drug. They’re a small stock and they don’t get much attention, other than from the analysts who probably helped them sell shares in secondary offerings in recent years, and there aren’t any major “skin in the game” insiders as far as I can tell (the CEO owns $1 million worth of shares, but he gets paid more than that every year), and there’s only one really focused owner on the institutional side that seems to have any kind of biotech focus (Eastern Capital owns about 7% of the shares, roughly $5 million worth … don’t know much about them).

So I don’t see a lot to make them stand out other than Robert Morris’ apparent enthusiasm for the shares (which certainly goes over the top, he calls his special report “The End of Cancer Worries Forever“), and I don’t know enough about the science to be a believer (though, to be fair, I almost never speculate on developmental biotechs because they’re so hit-driven and I’m not smart enough to be a hit-picker in the sector). It is at least encouraging that they are enrolling patients for Phase 3, and that they probably won’t have to raise more money before they have some indication of how the trial is going, but sometime in the next year or two they’re probably going to have to either get good results from this trial that let them raise cash at a good price, or have promising enough results that some big pharma company wants to jump in and help fund development of “drug S” (or just buy up the whole company, as happens with some regularity when a little biotech gets promising results).

Oh, and they are presenting at an investor conference next week, so maybe they’ll have something interesting to share then. As you can tell, this one doesn’t jump into my cup of tea … but these kinds of stocks almost never do. Sound interesting to you? Interested in the science or the lottery-ticket possibilities of $80-million developmental biotechs? Have any experience with Robert Morris or know whether or not we should consider him a biotech savant? Let us know with a comment below.

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karmaswimswami
February 4, 2014 1:33 pm

To James Fernow: Furiex is up on news of great phase III data for its investigational new drug, eluxadoline, for irritable bowel syndrome. The drug acts on mu-opioid receptors at the gut level. Basically it “chills” the bowel the way a narcotic does, but does not cause the systemic euphoria of a narcotic. Furiex is a company that emerged from the CRO company PPD, and is near RTP North Carolina. They are likely, I feel, to be acquired.

IBS is an entity that makes most gastroenterologists groan a bit. It is an illness but not a disease. Patients often have waxing waning abdomen pain and variable bowel habits, tending either toward constipation or diarrhea. It has a strong overlay with the psyche, and is often highly ameliorated by exercise. People suffer with it, though by definition it does not kill or harm anyone. Drugs for it come and go. The GI tract is a very dumb organ, not well regulated by the brain, and at the whims of local neuromuscular and neurohormonal regulatory mechanisms. It often misbehaves and is unpredictable.

Eulaxadoline will almost certainly big FDA approved and be a huge seller, at least for a time. My prediction is that its beneficial effect on patients will fade with duration that they take it. Patients tend to buy into new treatments, only to come back a few months later complaining that the new therapy no longer works.

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jamespaul108
jamespaul108
February 4, 2014 2:52 pm
Reply to  karmaswimswami

I see. Thanks for those insights. I have known people with IBS; one finally resorted to surgical removal of a portion of his colon, which gave him relief. I don’t know if the duration was permanent.

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karmaswimswami
February 4, 2014 2:04 pm

Oh, i definitely mean no disrespect to William Tweedie at all. He is a very nice guy, and his point about Thomas Kuhn’s books is correct. Arthur Danto wrote on this as well. But my main point is that I do not regard what is going on as a revolution. Any of us here could cobble together $10,000, pick any of a dozen other supravital dyes (eosin, for example) that are equally cheap, put melanoma implants on mice, inject those with that dye, and watch them slough. We could call ourselves a start-up biotech. All supravital dyes like Rose Bengal are all drunk up by cells, but then mostly prove to be toxic and cause cell death. The bystander effect is not new, and the cell lysis liberates tumor antigens. Anti-melanoma oncolytic viruses do the same thing. We discussed them here recently. When PVCT’s PV-10 finally gets into a phase III trial, if it does, it will face comparison with other standards of care, like Yervoy, and I predict them that what the agent is doing will prove to be eyewash. Again, the company is just outright concealing long-term follow-up data on patients with metastatic melanoma given PV-10. My guess is that they are all dead, as this is how melanoma goes. If they were alive, PVCT would be exclaiming that. They are lost to follow-up.

Alan Harris
Guest
Alan Harris
February 4, 2014 3:31 pm
Reply to  karmaswimswami

I think this post demonstrates an important point. Dr KSS has said that he’s an investor and is clearly interested in the advancement of the science. Doubtless others (eg me) are interested in making a quick buck. WT appears to be saying ‘Ya Boo, you missed a trick coz my shares are a double’. KSS is saying ‘Fine, but I suspect its a short term gain’. Possibly both are right.
What would be fab is if someone could say ‘ Heres a list of short term winners, but this will be THE long term winner’, then Id know which to buy, sell at x% and which to hold……. (perhaps I should I be saying that to myself? I wish I had the knowledge) Trouble is that KSS’s put downs (sorry) only speaks about THE one winner, which means I miss out on the ten short term wins. As said, its all about identifying someone to trust. Swammi, could you please condition your replies to ID which are buy and %-gain sells, and which are buy and holds?

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arch1
February 4, 2014 3:55 pm
Reply to  Alan Harris

Alan I agree. I manage to lose $$ with best companies. I think you once ask for what I buy so you can short? I recently close last bio-tech holdings due to my extreme
“Obamacarephobia” & my tendency to “just don’t do something—stand there. Adage: pig
get fat, hogs get slaughtered always finds this little piggy in privy @ feeding time. That said I sold nnvc & bxt tho thinking long-term look good. That said ‘great oaks from little acorns grow’ also great aches from little corns = pain in foot. cheers.

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arch1
February 4, 2014 4:05 pm
Reply to  arch1

correction I think bio-time BTX and to Dr.KSS I imply no criticism of you .

Dr KSS from you I learn more in minutes than in some cases years of
others.

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professorredbag
February 7, 2014 4:13 am
Reply to  karmaswimswami

One of the most widely recognized and acclaimed aspects of all the work done to date with PV-10 is it’s superior safety profile. The FDA would not have approved a Breakthrough Drug Therapy application for PV-10 if Compassionate Care program recipients and P2 subjects were all dead; that’s common sense, not inflammatory guesswork.
(Phase 2 Trial) “data show that if a tumor is accessible to PV-10 injection, the drug is likely to DESTROY that tumor. If approved, PV-10 would be the first tissue-sparing local therapy for recurrent melanoma.” …”Furthermore, we believe our clinical and immunologic mechanism data show that it may be possible to delay or prevent melanoma metastasis to distant sites.”
“While the rapid ablative effect immediately evident in patients treated with PV-10 highlights our path to initial approval, the bystander effect continues to be of scientific interest and studies to quantify systemic tumor-specific immune response in cancer patients are ongoing. This emerging understanding of the secondary effect of tumor ablation with PV-10 is an important foundation for future studies to assess the long-term impact of PV-10 on distant metastasis and possible combination strategies for use of PV-10 in the treatment of cancer patients with more advanced disease.” Chief Executive Officer Craig Dees, Ph.D.

BREAKTHROUGH STATUS. That is: Section 902 of the FDASIA articulates two general criteria according to which the FDA may designate an investigational drug as a breakthrough therapy. First, this designation can be applied only within the context of a “serious or life-threatening disease or condition.” Second, it must be predicated on “preliminary clinical evidence indicat[ing] that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints.” The FDA has interpreted the second criterion to mean that data from studies in animals or conducted in vitro showing that a drug has promise are NOT sufficient to justify this designation; data from clinical trials in humans are needed.” (1) Footnotes: (1) Expediting Drug Development – The FDA’s New “Breakthrough Therapy” Designation Rachel E. Sherman, M.D., M.P.H., Jun Li, J.D., Ph.D., Stephanie Shapley, M.B.A., Melissa Robb, R.N., and Janet Woodcock, M.D. N Engl J Med 2013; 369:1877-1880 November 14, 2013DOI: 10.1056/NEJM p1311439.
(My caps in the above quotes)
Please contact the company or to have your conjectures founded in fact. No disrespect intended either.

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newby3867
newby3867
February 4, 2014 2:58 pm

Doctor KSS do you have any thoughts on Synthetic Biologics(SYN)?Randal Kirk a big buyer in December of 2013.Trimesta for multiple sclerosis and SYN-04 for clostridium difficile infection prevention look interesting.Both are in phase 2.Thanks,Glenn

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karmaswimswami
February 4, 2014 3:06 pm

This 2011 NEJM paper should truly lay to rest any concerns that AAV8, as Benitec is using in the TT-034, can succesfully transfect and transduce normal human liver cells.
http://www.nejm.org/doi/full/10.1056/NEJMoa1108046
In this study, 6 patients with hemophilia B (factor IX deficiency) were given an AAV8 packaged with a gene for factor IX. Factor IX is produced exclusively in liver. The AAV8 was given by peripheral iv. All patients showed new production of factor IX, and four of the six were able to stop receiving factor IX concentrates. That is, they stopped having a bleeding tendency. None died. Evidence of liver injury was minimal and not worrisome. All patients began with essentially undetectible levels of factor IX, and ended up with 2-11 per cent of normal factor IX levels, which is enough in most cases to prevent spontaneous bleeding.

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Subramania Kaushik
Subramania Kaushik
February 6, 2014 10:06 am
Reply to  karmaswimswami

Dr. KSS as of this morning i am bag holder of Benitec. Thanks for your in depth analysis on Benitec. Also planning to buying Xencor, Evoke when they dip further!

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ockrazor
ockrazor
February 4, 2014 3:23 pm

Earnings after the close * Gilead Sciences (GILD) 4:05pm, $0.51

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karmaswimswami
February 4, 2014 4:14 pm

Frank, no, none taken. Not to worry. You and Alan are right though. I am tending to think of things in buy, hold or sell terms, and we need to have a term and way of thinking as regards stocks that will attract public attention and surge, only to come to ground later. EVOK is such a company. I think I mention that years ago, I bought shares of Inkine on this basis. 1000 per cent appreciation is 6 months, whereupon I sold, and a dead company soon after. Some companies are buy-for-short-term-hold. Despite the fact that I dabble in this, I am still surprised by how many companies I just haven’t heard of. I know I heard of Furiex several years ago, as regards their IBS drug, but had lost track of them. It’s why we need a Gumshoe database. Every biotech that is of even remote interest. Truly had I known about Furiex and about Intercept, I would honestly really have declared of both, I predict this will work and that shares will pop. So I welcome names of new companies, though I am finite and the day has but so many hours.

Alan Harris
Guest
Alan Harris
February 4, 2014 4:38 pm
Reply to  karmaswimswami

Fab, and accepted that there are only 24/7…..thats why I earlier wondered about your ability to field ‘personal’ medic probs. More than full marks for having done so, and if I had a prob, KSS would be precisely the guy I’d be asking.
GS clearly and understandably, doesnt intend doing this. So, Siva, you have said (I think) KSS should start a tip sheet and offered to excell ish the watchlist (via another site). KSS doesnt have 25/8, so perhaps you could manage the software charts based on what comes across here from ALL contributors. If you can chart this stuff, Im certain there will be subscribers to pay for your time. All you need is a deal with the swammi and your off and running. I’m happy to be the founder subscriber.

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arch1
February 4, 2014 5:37 pm
Reply to  Alan Harris

Alan I agree what you suggest very desirable,implementation difficult
Overwhelming amount of new info coming online. For example:
In Wilsonville Oregon is tiny startup ( essentially one-man) who as former
battlefield experience (Afghan) found way to deal with direct-pressure to
stop bleeding in penetrating wounds using shrimp-shell component chitosan.
Probably tremendous use in civilian world for outdoor activity,accidents
gunshots etc.in EMT field as well as self treat till surgical repair. Method slows blood loss
by starting clotting cascade. Many hurdles to pass regulatory, Both FDA & stock exchange & problems normal in bringing to market any product. May be years before
could be pink-sheet.What do you do with this?
&

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sivapann
Member
sivapann
February 4, 2014 6:41 pm
Reply to  Alan Harris

Alan: Dr and I have just started working on a potential platform where we can facilitate this conversation and manage such data. Stay tuned.

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Alan Harris
Guest
Alan Harris
February 5, 2014 6:14 am
Reply to  karmaswimswami

If only this post had been 24hrs earlier. Furiex up 130% on 4/2/13. ‘If only’ …….the two saddest words in the English language.

arch1
February 5, 2014 7:48 am
Reply to  Alan Harris

Alan I think FURX $40 Monday is $105 now I also not share in. I awoke
@ 4A.M. local smoke alarm imitation of cricket ( 6month age device with
10 year life battery) & decide to check if poverty/prosperity is thriving.
Evil Omniscient Machine before me inform of death of celebrity from low-cost
heroin. Seems glut on market from half-million acres of poppies in Afghanistan.
Seems U.N. agriculture instruction leads to decision more profit in not growing
wheat. If Mr. Al Quidda decide to import banned substance would he hide it
in heroin shipment? Open borders are boon to many. I muse,when was last war won?
War on poverty & drugs not great success. If absolute power corrupt what is
effect of absolute huge money pile. Lenny Bruce 1950era comic used to say
“there’s a lot of money in poverty”, seems he was correct also seems holds true
in any dependency endeavor. two saddest words rivaled by 3 ” I meant well”

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KindergardenInvestor
February 6, 2014 1:08 am
Reply to  karmaswimswami

Hmm, Dr. KSS “is finite and the day has but so many hours”. Too bad we can’t clone you… 🙂

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lskulow
lskulow
February 4, 2014 4:42 pm

And I would gladly subscribe!

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karmaswimswami
February 4, 2014 4:45 pm

To James Fernow: Are you sure the friend you are speaking of didn’t have inflammatory bowel disease (IBD) rather than IBS? Removing the colon, or part of one, for IBS, would be extraordinary really. It would be extraordinarly difficult to find a surgeon anywhere willing to do that because IBS is a syndrome with no definable pathology….normal biopsies, normal imaging, normal motility studies. There are occasional patients out there who have taken so much in the wat of laxatives for so long that colonic atony sets in, and in rare cases a colon may be taken out to prevent a recurring need for hospital admissions for fecal impactions. But a surgeon who would do a colectomy for just plain IBS is not a surgeon I would want. IBS is often spoken of as a syndrome of heightened visceral nociception. The colon is normal, but the patient is excessively aware of every gas bubble and wave of peristalsis. Subjecting a patient to general anesthesia, doing an open laparotomy for colectomy, and getting a third party payer to cover it, for irritable bowel syndrome would trigger a major quality assurance investigation in any hospital.

karmaswimswami
February 4, 2014 4:47 pm

To Glenn Newberry: I poked around SYN. I am trying to figure out what Randal Kirk knows. I must say that

karmaswimswami
February 4, 2014 5:16 pm
Reply to  karmaswimswami

To Glenn Newberry: I poked around SYN. I am trying to figure out what Randal Kirk knows. I must say that (sorry I hit the wrong key on the entry above) that the estriol work isn’t so exciting really. It’s an old idea, that estrogen may have temporizing benefits in women with multiple sclerosis. If estriol works, I would expect a boat load of other hormone manufacturers to be talking up their products to physicians treating MS. It would be off-label, sure, but sales reps do this frequently. I am not sure anything is unique about estriol.

They are studying a beta-lactamase oral preparation for Clostridium difficile enterocolitis. A few point about that. C. diff. is present in most colons. but suppressed by other flora. 30 per cent of the dry weight of feces is bacteria, millions of species. C. diff can occasionally overgrow in normal people. More often, it overgrows after antibiotic therapy. Such therapy harms other populations in the colon fecal biome, and their disappearance causes absence of a repressive effect on C. diff. It elaborates a toxin that causes fluid secretion and profound diarrhea. ANY antibiotic can cause it. Clindamycin is the worst offender. It is now such a hospital problem that it has become de rigeur to give patients on iv antibiotics doses of oral probiotics.

SYN’s agent would have no role in treating C diff. It might have a place in preventing it, but only in the setting of beta-lactam administration. That would be ampicillin, ceftriaxone, cephalexin, ceftazidime….any penicillin class or cephalosporin class of drug. They are heavily used, but are by no means the only classes of agents.

Many gut bacteria make beta-lactamase. Meanwhile, penicillin family agents are generally given with tazobactam or sulbactam, beta lactamase inhibitors, and increasingly there is a move toward adding these to cephalosporin therapy. So I am saying it is already made in the gut, and patients are often redeiving inhibitors of it that make their way into the gut.

I do liver and GI, and deal with C, diff literally every day. Mostly we treat it oral vancomycin, iv metronidazole, rifaximin or fidaxomicin. I have a hard time seeing an oral beta-lactamase making huge inroads into the C. diff. armamentarium. Again, it would be preventive, not therapeutic. I think it would be quite hard for that to catch on with doctors.

They are devising agents for Acinetobacter and pertussis. I am sure that is not why Kirk bought. He must have bought because the two year phase II estriol trial in MS is wrapping up. A report on that should be coming soon. There surely has been an interim analysis by now. He must have seen data. But how would he have? He is not on the board, not an exec, not an advisor. Estriol is not a novel estrogen. Something does not add up.

Do you know anything else about the company or about Kirk?

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newby3867
newby3867
February 4, 2014 10:22 pm
Reply to  karmaswimswami

Wow, Doctor thanks for the breakdown of this company.All i know with Mr.Kirk it seems when he is in a company it usually does well and he likes to be majority holder.Sold Clinical Data(CLDA)for over 1 Billion dollars and Forest Laboratories(FRX) for 1.2 Billion dollars.Lately he is a big buyer in synthetic biology stocks such as Intrexon and (SYN).Kind of like how the Baker Brothers jump into these biotech stocks and it turns to gold alot.If you ever get any kind of investment letter going for biotechs please count me in.You have been so kind and great with your time and advice to people on this thread.Much thanks,Glenn

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jim t
jim t
February 4, 2014 5:36 pm

Again, apologies for my personal question that came out as a reply to #328. Oops.
Moving forward – are there any opinions on Antares Pharma (ATRS). I held from $1.40 up to $5 but then when OTREXUP, a product for the delivery of methotrexate using Medi-Jet technology for the treatment of rheumatoid arthritis was FDA approved, the stock dropped back to the $3.60 range (sold at $4). It now seems to be on the rise again as sales have begun. Their big deal seems to be their delivery system (Medi-Jet), but I just don’t see the value in it. Am I missing something?

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karmaswimswami
February 4, 2014 6:05 pm

Frank: there are lots of good ideas out there. The chitosan idea has been patented and is in use formally by the military:

http://www.hemcon.com/Products/ChitoGauzeHemostaticGauzeOverview.aspx
US patent 5836970, Abhay S. Pandit, “Hemostatic Wound Dressing”, issued 1998-11-17
US patent 8106030, Craig Hardy, Lee Johnson & Paul Luksch, “Hemostatic Material”, issued 2012-01-31
US application 2011052665, Craig Hardy, Andrew Darby & Guy Eason, “Hemostatic Material”

Chitosan seems to be more an agent that is a potent inducer of platelet aggregation where it is applied. The platelets come in and provide ample membrane with exposed tissue factor. This binds to factor VII, which cleaves f X to Xa. Xa and Va activate prothrombin to thrombin.

David B.
Member
February 4, 2014 6:35 pm

Another nano to add to the stem cell list for consideration is SCTPF, currently listed on the Candidan Venture Exchange.
I am also a believer in immunology as I feel it’s future is quite bright. Why not treat disease by boosting one’s natural defenses rather than introducing mild poisons that weaken the immune system (traditional chemo, antibiotics etc…). I currently hold Stellar Biotech SBOTF and Xencor. Are there other companies that look very promising to others with a focus on immunology?

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arch1
February 4, 2014 8:06 pm
Reply to  David B.

Donald did you mean Canadian Venture exchange? “Candidan” sounds like yeasty bunch?
Sorry,blame senior/senile moment….I have many such

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arch1
February 4, 2014 6:38 pm

I am amazed at your knowledge & you are completely correct in all points. Startup
mentioned has DOD contract.

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arch1
February 4, 2014 6:46 pm
Reply to  arch1

I apparently did not make clear that I was mainly referring to “direct pressure”
problem.

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Leslie
Leslie
February 4, 2014 8:16 pm

Extraordinary really that Dr. KSS is willing to share his vast knowledge with us all. I’ve become an avid reader of this thread although much of the science is a stretch, and I’m excited to hear that Siva and the Dr. are working on a more efficient platform. I’ve taken a position in Benitec and hope beyond hope for the sake of someone dear to me that TT-034 is what it appears. I’d like to ask if Dr.KSS or others have an opinion of Exelixis (EXEL), which has had a nice run-up (until lat week, anyway) and is due to report two significant P3 trials this year. There are a few very knowledgeable and informative medical folks on their Yahoo MB who are worth a read, unusual for such a board.

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jamespaul108
jamespaul108
February 4, 2014 9:19 pm

To Dr. KSS regarding post 348. Yes, I’m sure I was mistaken about IBS vs. IBD. My friend’s doctor was recommending that he have surgery for years, and he resisted. I recall that there was some visible pathology of the colon. So it must’ve been IBD. Thanks for the explanation/information.

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analog68
analog68
February 4, 2014 9:23 pm

GWPH at a lower price? What a sector it is in for potential growth….or has the growth already been priced in?

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sivapann
Member
sivapann
February 4, 2014 10:44 pm

TT-034 Works !!!! A new abstract released today, Feb 4:

TT-034–encoded shRNA are processed into an unexpectedly diverse panel of putative siRNA strand products.
TT-034–encoded shRNAs induce an increased number of specific cleavages on the HCV replicon RNA genome consistent with an RNAi mechanism of action.
Synthetic analogues of the TT-034–encoded shRNA exhibit comparable activity consistent with an RNAi mechanism of action.
Not all of the putative siRNA guide strands processed out of TT-034 can induce cleavage of the HCV replicon RNA.
RACE-seq reveals siRNA-directed cleavage events can occur beyond position 10–11.
HTML: http://www.nature.com/mtna/journal/v3/n2/full/mtna201373a.html
PDF: http://www.nature.com/mtna/journal/v3/n2/pdf/mtna201373a.pdf

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George
Member
George
February 5, 2014 1:20 am
Reply to  sivapann

Not to be a naysayer, but this provides little new information about how it will work in vivo (in people). These are cell line results to determine more specifically how it works (how it chops up the RNA). In simple terms, it states that some work as expected and some work in ways that don’t cut the HCV RNA. A big question here is how many shRNAs are produced in a real liver cell compared to how many HCV genomes there are in that same cell. In a replicon cell line, the number of genomes can vary and so this activity may not be representative of what will happen in man. If anything, it means the number of shRNAs needed in each cell might be higher than previously estimated. Disclosure: I am long this stock and also trained some of the authors in how to do some of this work years back so dont take my comments as being negative about TT-034.

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jamespaul108
jamespaul108
February 4, 2014 10:58 pm

In case someone is interested, I did a quick web search and put together a list of companies that are or may be doing stem cell work. (I lack knowledge in the field and cannot ascertain from their company profiles whether some of them are really doing stem cell work or not. Their names are preceded by a question mark.)
Aastrom Biosciences Inc. (ASTM)
Advanced Cell Technology Inc. (ACTC)
Athersys Inc. (ATHX)
? Avita Medical Ltd. (AVMXY)
Bioheart (BHRT)
BioTime Inc. (BTX)
Brainstorm Cell Therapeutics Inc. (BCLI)
Cytomedix Inc. (CMXI)
Cytori Therapeutics (CYTX)
Intellicell Biosciences Inc. (SVFC)
International Stem Cell Corporation (ISCO)
? Life Stem Genetics Inc. (LIFS)
Life Technologies Corp. (LIFE)
Mesoblast (MBLTY)
NeoStem Inc. (NBS)
Neuralstem (CUR)
Osiris Therapeutics Inc (OSIR)
? PharmAthene Inc (PIP)
Pluristem (PSTI)
? Protalix Biotherapeutics Inc. (PLX)
Stem Cell Therapeutics Corp. (SCTPF)
Stem Cells Inc. (STEM)

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dolari
dolari
February 5, 2014 5:02 am

I came across Gumshoe only a couple of weeks ago, a few days ago I became a “regular” and after today reading this whole thread I am sure to become an “Irregular”. Dr KSS you are a legend and I hope to continue reading your insights into biotech as well as health related issues. Travis, keep up the great work with Gumshoe, any chance KSS might join your team? I must admit when first reading this thread, I thought he was part of Gumshoe.

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Alan Harris
Guest
Alan Harris
February 5, 2014 11:24 am

Generous and sensible Travis. While a separate site might be have its uses, it could never attract as much fresh blood contributors as GS brings in. This thread has benefitted greatly from GS’s ‘passing trade’. Only today we saw a new (?) contributor, George, who clearly has his finger on the pulse of the topic. I doubt KSS will have the time for his own regular column a la Doc and Myron. Perhaps though there could be a GS brain storming thread with a separately subscribed spreadsheet/whatever. Or perhaps just adapt the GS teaser tracker software. Best of both worlds?

arch1
February 5, 2014 9:11 am

Anon Yes French is the language of diplomacy because it takes many words to
arrive at a non-conclusion. For similar reason English is the language of business
because it allows to say; what you heard is not what I meant. That is why I type
German syntax often as shortcut /shortspeech to express fleeting thoughts.

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arch1
February 5, 2014 9:51 am
Reply to  arch1

I apologize for what was meant as Email return. Once again Evil Omniscient
Machine which refuses to obey & protect me and before which I now bow
has undermined my feeble efforts. My day is increasingly taken up by tending
labor/time saving devices.

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karmaswimswami
February 5, 2014 11:19 am
Reply to  arch1

Frank: Alfonso Decimo <>, a ruler of Spain, said one should use French with friends, German with enemies, Italian with woman, and Spanish with God.

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