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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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cat_bastet
February 12, 2014 1:32 am

Re post #515 and opioid dependence, does anyone have an opinion about BioDelivery Sciences (BDSI)? They just raised $60M for, primarily:
– Execution of the sales, marketing and other commercialization and product supply chain activities to support the anticipated second half 2014 launch of BUNAVAIL™, BDSI’s treatment for opioid dependence which is currently under review by the FDA with a June 7, 2014 PDUFA date, and that BDSI is actively preparing to commercialize on its own;
– for the initiation this quarter of the Phase III clinical program for Clonidine Topical Gel for the treatment of painful diabetic neuropathy, along with the overall clinical and regulatory advancement of this product;
there were a few other things in there, the article is at FierceBiotech http://www.fiercebiotech.com/press-releases/biodelivery-sciences-raise-60-million-registered-direct-offering-institutio#ixzz2t5Qi28Vz
Also thanks, Dr. KSS for a post a while ago mentioning FierceBiotech, I’m finding it a very interesting site. Hopefully I won’t start overwhelming you all with my questions 🙂

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jacklec
Member
jacklec
February 12, 2014 5:30 am

Now Doc KSS must feel a bit like Figaro in Il Barbiere di Siviglia…!

karmaswimswami
February 12, 2014 6:59 am

To Glenn Newberry: I do think the CTIX selloff makes for a good entry point. I am not sure what caused it however. I didn’t see anything new on Seeking Alpha or on a couple of message boards about it.

Ventrus 307 is a diltiazem cream for anal fissures. I would be shocked if it did not sail through phase III, as diltiazem creams made by compounding pharmacists are already in wide use for this indication. Anal fissures are anal tears, usually at the 6 oo’clock or 12 o’clock position, nad are usually caused by a patient really straining to defecate and passing large, hard stool. In the late 90’s a good study showed that intra-anal application of nitroglycerin gel would relax the internal anal sphincter muscles enough to let these heal, after 6 weeks or so. The problem with that is that it must be applied 4x/day and causes typical nitro headaches. Dilt does not cause HA and works well to relax the muscles. They will get a product out of this, I feel, but I do not view it as having as large a market as they claim. On their website, for example, they assert that as many as 4.3 million Americans have anal fissures. Don’t know the source of that, but it is way way off, a gross overestimate. I think a tenth to a fifth of that is more accurate.

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Lou L
Irregular
Lou L
February 12, 2014 9:29 am
Reply to  karmaswimswami

I think it’s related to the same SA article –
“Amazingly we found even more examples of conflicts in what Menon has publicly said. In his NNVC management biography he claims “a PhD in Pharmacology in 1984 from Harvard University2” and yet in the CTIX management biography (where he is President) he claims “a PhD in Pharmacology from Kerala University3”. We don’t see how Menon can be telling the truth in both statements.

It seems Menon claimed in 2005 (when NNVC came public) to be “the holder of 7 US patents4″, yet when we searched the US patent database we could find no patents of Menon’s before he made these claims? Did Menon lie about this or did NNVC fail to do even the most basic of background checks?”

rodj1201
rodj1201
February 12, 2014 8:19 am

Inovio’s CEO Dr. Joseph Kim to ring the Opening Bell at the NYSE this morning. Isn’t this unusual for a small biotech company?

jacklec
Member
jacklec
February 12, 2014 11:10 am

Wow Ventrus crashed today -60% after failing its phase 3b trial on a drug that seemed easy to understand/predict… It is here to remind us what kind of losses one must be ready to face when investing in biotechs!

karmaswimswami
February 12, 2014 12:24 pm

To Jack LeComte: I am truly stunned by that outcome with Ventrus! This one would have seemed a chipshot. The phase IIIb majorly undermines what physicians are doing as regards compounded topical diltiazem for anal fissures. When I first heard the news of this, I thought the trial had failed because they were comparing it with nitropaste. But it was a placebo comparison. Definitely not what anyone was expecting, but facts are facts. We all must stop using dilt cream. Ventrus may have a hard time remaining a going concern because its two other agents, iferanserin for hemorrhoids and phenyleprine gel just have no real cachet, in my view.

arch1
February 12, 2014 2:03 pm

DR KSS I well may have missed comments if you have already covered but is something going on at Gilead GILD. I bought in 2010 for$20 got out after 2years sidewise in 2012 for$20 just before it began to rise,poor timing. Would you buy now?

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karmaswimswami
February 12, 2014 2:34 pm

Frank: I myself am confused now about what to do with Gilead. People following this thread longterm have heard me say different things about it. In January, I felt everything good was priced in and that it could only disappoint. Now I am not so sure. There have been several surprises.
(1) their recent study that for NON-cirrhotic HCV’ers, 8 weeks, not 12, of sofosbuvir/ledipasvir causes sustained virologic response in 95 per cent of patients. This will ciut 50 grand off the cost of treatment and will INCREASE Gilead market share even if it trims per patient revenue.
(2) GILD has submitted NDA for fixed-dose combo of once daily sofosbuvir/ledipasvir, earlier than expected.
(3) its lead competitor for HCV ABBV is fumbling by promulgating a 4 drug regimen. We doctors are all going to thumb our noses at ABBV.
(4) pther competitors like B-I, BMS, Achillion have either scrapped drugs or are behind in development or do not have in an inhouse full regimen for HCV.
(5) GILD has shown clearly that proteinase inhibitors are not needed. We need to come up with a great Gumshoe Gang name for this phenomenon: making your company succeed by devising a strategy that makes others fail! GILD has not squandered a penny on proteinase inhibitors, while others have spent literally hundreds of billions! They will not recoup.
So, with there being so little downside now for GILD I am inclined to buy some shares. I probably won’t take a massive position, but this really should be a $120 stock by this time next year. I think that is realistic.

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arch1
February 13, 2014 2:06 am
Reply to  karmaswimswami

DRKSS I just noticed my post did not ‘take’ Deus ex machina’ Thank you for rapid response & really enjoyed “gumshoe Gang” + strategy comment in (5).. I am greatly conflicted because of ‘Obamacarephobia’ uncertainty & my past timing problems.
Perhaps I should make known what I do so You can do opposite? Dr. do you think there is any benefit in Hyaluronic acid in diet via additive/supplement? I despise the word nutri-ceutical. Also dmso as topical transdermal agent.

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arch1
February 13, 2014 2:11 am
Reply to  arch1

I mistyped,I wanted your thoughts on safety & benefit of dmso.

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KennyG
Guest
KennyG
February 12, 2014 3:10 pm

Per Dr. KSS on Jan 18th: “People may make money in GALE, but I will not touch it. People who have made money in it need to think about taking some profits and getting out.” Well, I was one of those that didn’t listen. And today it is down 17% and falling. It has been reported that it was involved in a stock promoting scheme facilitated by an author on SA (again) that posted two bullish articles on the company using two different names. The story is on The Street by Adam Feurstein.

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David B.
Member
February 12, 2014 3:12 pm

Aradigm is a company that is specializing in inhalable treatments for respitory conditions. They have a pretty robust pipeline and great partnerships and institutional interest. My favorite SA author just wrote a very thorough article on this one. KSS he or she is very respectful and thorough in responses so you wont have to fear being railed at if you have questions or concerns re. this company from TBE. This author doesn’t usually get too excited about a company but thik that he or she is quite high on this one. I don’t think we’ve examined Aradigm yet here.

karmaswimswami
February 12, 2014 6:35 pm

The issue of hyaluronic acid came up on this or another thread. People might want to note that the company Trader VIc mentioned here recently, Dara BioSciences (DARA) has a topical hyaluronic acid gel in trials to be used in instances of burns owing to irradiation. Despite the name “acid” this is a soothing, anti-inflammatory glycosaminoglycan that helps build up the subdermal matrix. My guess is that this agent will be approved (what’s not to like about it?) and that it may easily find its way into the hands of dermatologists as an antiwrinkle cream. I am aware of some physicians having compounded HA preps for that purpose and they work well on canthal lines. Trader VIc considered this one a trade, not a long term hold. The company is so cheaply valued that any product approval will cause shares to surge.

jamespaul108
jamespaul108
February 12, 2014 11:02 pm
Reply to  karmaswimswami

Dr. KSS, are you certain that it’s a hyaluronic acid gel that’s in clinical trials? According to their February 2014 investor presentation (http://content.stockpr.com/darabiosciences/media/c976ca328111dbd3413b3d863250eb19.pdf), the only product that they publicly mention that’s in trials is KRN5500, a product for chronic chemotherapy-induced peripheral neuropathy. Their presentation doesn’t mention that their hyaluronic acid gel product is in any additional trials.
They do mention “active licensing efforts” for “additional supportive care products” with no elaboration.

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Subramania Kaushik
Subramania Kaushik
February 12, 2014 10:53 pm

DR. KSS, I plan to buy CTIX tomorrow. Also thinking should i buy DARA or QRXPY?
Waiting for a pullback on Innate Pharma.
Holding long positions currently on RNN, RXII, Benitec & Xencor currently. Benitec and RXII are my huge positions as of now!
Thanks to all for your inputs. I am coming to know of so many new names worthy of investment.

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biocqr
biocqr
February 13, 2014 10:09 am

Dr. KSS, take a look at Protalix (PLX) … oral ERT for Gaucher disease. Presented P1 data at WORLD symposium…data looks good and serves as POC for oral anti-TNF/Enbrel for a RA/autoimmune….
http://www.protalix.com/resources/WORLD-2014-Presentation-Oral-Zimran.pdf

ProCellEx® is a next-generation recombinant protein expression system that uses advanced genetic engineering and plant (carrot and tobacco) cell culture technology instead of the traditional mammalian- or yeast-based systems, enabling the production of a wide range of complex, proprietary and biologically equivalent human proteins to address a variety of diseases. Protalix’s novel bioreactor system, based on disposable plastic bags, is the first of its kind. The closed system provides stable, optimized conditions, with manufacturing capabilities for the entire range of proteins, including antibodies, complex enzymes, and plant-derived pharmaceuticals.

ProCellEx is the engine behind Protalix’s broad pipeline of biotherapeutic candidates, which is led by ELELYSO™ (taliglucerase alfa), which was approved by the FDA on May 1, 2012 and is the first FDA-approved plant cell-based recombinant therapeutic protein. Additionally, on Sept. 12, 2012, Protalix announced it received marketing authorization from the Israeli Ministry of Health, and on March 18, 2013, it was approved by the Brazilian National Health Surveillance Agency (ANVISA). It also has been approved in Uruguay. In Latin America, ELEYSO is known as UPLYSO™ (alphataliglucerase). Protalix’s plant cell-based approach enables the potential penetration of certain patent-protected markets, thus expanding the product opportunities based on ProCellEx to include the rapidly growing biosimilar and biobetter markets.

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karmaswimswami
February 13, 2014 10:16 am

biocqr: I will. I am snowed in today and so will try to do some catching up here as long as the electricity holds out.

Ron Richardson: Thanks for your comments and thanks for posting. I would be cautious here about AMEUF. I worry the action could be over. I heard during the weekend, via a thirdhand mechanism, about the Cardiocell approval, and posted here about it as soon as I heard. The next day the stock had something like 150x usual trading volume. But it may have returned to oblivion and inertness. The product will catch on, but Admedus may not have a good followthrough reason to buy. The product is a niche one certainly.

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bupsbups
bupsbups
February 13, 2014 10:21 am

Does the Nature paper from Calimunne http://www.nature.com/articles/mtm201311#affiliations have any bearing on Benitec?

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Subramania Kaushik
Subramania Kaushik
February 13, 2014 10:38 am
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Subramania Kaushik
Subramania Kaushik
February 13, 2014 10:43 am

also Benitec licencee, Calimmune, has produced pre-clinical data for its HIV Pl/ll trial
http://www.nature.com/articles/mtm201311#affiliations

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karmaswimswami
February 13, 2014 10:54 am

To Eric Libovitz; Thanks for posting and for providing the link to that paper. It is lovely! Benitec’s shRNA methodology has been licensed to Calimmune. This paper certainly does not hurt their cause at all. Others here, such as JJ, may be more familiar with Calimmune’s intricacies. Their initial approach to an HIV “cure” was silencing expression of CCR5, the lymphocyte protein that HIV uses to enter. People without CCR5 get HIV but clear it, never convert to AIDS and do not need ART. There are certainly not enough such people out there to stem cell transplant the HIV world, and anyway SC transplantation is a big deal. Calimmune did not get quite what they wanted from CCR5 silencing and so have added a gene for the fusion inhibitor. This approach is becoming more and more like wholesale gene therapy…..DNA to make shRNA to shut down CCR5 expression, and also to make (to produce rather than stop production of ) a protein. I like it. Great paper. Preclinical, but things look good for Calimmune. I so hope that they will go public.

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Terje
Terje
February 13, 2014 12:22 pm

Pre-FDA announcement jitters for Chelsea Therapeutics (CHTP)? Down 6-7% so far on solid volume.
I was tempted to go for a quick ‘in-and-out’ this week for what seems to be a ‘sure’ short term winner. However, after reading a few comments here, I decided to watch from the sidelines. Will be interesting to see what happens tomorrow.

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karmaswimswami
February 13, 2014 1:46 pm
Reply to  Terje

Terje: I think you are wise to stay out of it. I do not have the nerves to invest in something like that. One would be forever wondering when to pull the sell trigger. The basic problem is that droxidope is a flawed idea for treating orthostatic hypotension. It works by raising blood pressure all the time. What these patients need is something that causes the blood vessels to squeeze, to clamp down a bit, upon standing. The nervous system usually makes them do this. In the early 90s. there was an idea that somehow this problem owed to overactive beta-receptors. Adrenergic receptors come in alpha and beta. When the alpha’s are stimulated, they cause things to clamp down, blood vessels, sphincters. This is why alpha blockers work for blood pressure and for BPH. These blockers relax things. But beta receptors also cause vessels to relax (beta agonism speeds up the heart and its contractility however). So for years, the treatment for orthostatic hypotension was actually beta blockers. Which didn’t work too well. What no one is coming right out and saying is that droxidopa just works for about 7-10 days, and then tachyphylaxis sets in. This is because it leads to norepinephrine synthesis, and that feeds back negatively on the adrenal gland. I actually went into a bit of frenzy last night and decided to put all of these notions into a piece for Seeking Alpha to warn people. The stock has huge downside and such little upside. I woke up early and they had politely declined to run the piece because they had just accepted one that was to run this am, which makes basically the same points. I really think that for afflicted patients, a good approach may be droxidopa for a week, then midodrine for a week, alternating. The cure for this problem will lie in a central nervous system approach, not a peripheral one. These people have a ganglionic problem.

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Steve
Steve
February 13, 2014 7:46 pm
Reply to  karmaswimswami

Dr. KSS, regarding CHTP, I don’t know if you saw – “Public Citizen”, i.e., Ralph Nader’s 300K member Non-Profit Consumer Advocacy Group’s 2/5/14 scientific Letter to FDA STRONGLY OPPOSING approval of Droxidopa.
http://www.citizen.org/documents/2182.pdf
http://en.wikipedia.org/wiki/Public_Citizen

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biocqr
biocqr
February 13, 2014 3:08 pm
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newby3867
newby3867
February 13, 2014 3:34 pm

Doctor KSS any thoughts on a company called OncoGenex(OGXI)?3 drugs in phase 3 and its flagship drug OGX-11 may release data before May of this year.Thanks,Glenn

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