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.
Kimosabe: Thanks and thanks for asking. DNRA is Dicerna, and this of course is a wordplay on DICER, which is an enzyme that fragments target RNA when that RNA anneals with silencing/inhibiting RNA. That the IPO was so well subscribed to with such a runup today suggests to me how much buying power remains in this market for good companies with good biotech. In actual fact, by now, the RNAi space is getting crowded, and they may be a little late to the game. I don’t see much to suggest that their methodology for drug discovery or targeting is novel. They are going after two oncogenes, k-ras, and myc. I think most of today’s fervor was based on the latter, because the claim is that will be leading to targeted therapies for hepatocellular carcinoma (HCC). HCC is a huge problem of course. For those with HCV who go onto cirrhosis, 5 per cent of them per year get HCC. And the only hope now is transplant. And what often happens in such cases is Lou Reed scenario. Surely there must be some Reed fans here. The media was totally mum about why he died for the simple reason that if the cause came up it would subject Reed’s transplant doctor at Cleveland Clinic to more scrutiny, and he has already gotten plenty. Personally, I think the guy is a good doctor, But at a prior institution, he did a living donor transplant (removal of the right liver lobe of a live person to place in a cirrhotic patient), and the donor died. Very bad. In fact the donor died of bacterial enteritis because of contaminated shellfish someone brought him. It was not the surgeon’s fault, But he got blamed. And ostracized.
In Reed’s case, NY transplant centers turned him down. Reed had HCC. They felt the tumor was too big. The transplant rules for these cases are iffy. If the tumor is big enough, or multifocal, micromets spread around. When the patient gets placed on immunosuppressives post transplant, each micromet blossoms like sunflower seeds given fresh manure. Cleveland bent the rules, Post transplant, Reed sprouted new tumors and absolutely nothing could be done. Stopping immunosuppressives will lead to rejection within hours, and without an immune system to fight the neoplasms, they will grow insanely regardless of chemotherapy.
Just now, I would not precisely hold my breath thinking that DRNA’s method is going to work for HCC. HCC lesions are a plethora of oncogene expression. The therapy for HCC for now will remain transplant. Keep in mind that for the 300+ million people in the world with chronic HBV, they can pop up with HCC at any time, whether or not they are cirrhotic. One thing can be said of all HCC right now: it laughs, just laughs, at whatever drugs you throw at it. Anti-myc siRNA will not fix it. At some point, siRNA against that and several other oncogenes simultaneously may stymie it. (Here again, a way for Benitec to shine. Its vector can be loaded up with multiple DNA sequences encoding multiple RNAis. With the methods of Alnylam and Arrowhead, also Tekmira I believe, one can receive only two strands at a time. I picture a future in which tumor biopsies will be obtained, a mRNA expression library run on the tumor, and then Benitec custom-makes a ddRNAi vector ammo-loaded with an RNAi cocktail specific to your tumor’s oncogene hologram.) HCC is a horrible horrible outcome, and when I have patients with it who are not transplant candidates, I endoscope them to close varices so that they will not die by vomiting blood and drowning in it. I am frank with them that death is coming, and provide medications liberally to placate fear and anxiety and also to kill pain. They often experience right upper quadrant agony. Their mode of exit is that usually the tumor causes a giant clot in the hepatic vein, which flies off through the heart and into lungs, causing cardiac arrest.
I would not buy DRNA here. Its shares will cool way off. Let’s let them get something concrete into firm clinical development and then see. As far as their k-ras program, believe it when you see it. A noble endeavor, but also a path fraught with prior failures. This is now a $765 million company with naught in clinical stage development and it will not hold onto such lofty valuations. But if there is still that kind of latent biotech exuberance in this current market, it bodes well for 2014 when some of our other speculative plays have good news.
Time for an RNAi ETF, I say. Siva, it would be nice if we could devise a separate way to just track the RNAi plays, including naked RNAi, oligonucleotides, exogenous encapsulated RNAi, and ddRNAi.
Dr. K,
Do you see potential for EXEL’s cabo in treating HCC?
Dr KSS. I have sent you a note on Seeking Alpha on RNAi ETF. Please check and let me know.
Re Dicerna, DRNA, the company ranks second only to Baidu, which traded up 354% in its 2005 market debut, in first-day returns since 2000.
http://www.nasdaq.com/article/dicerna-gains-207-in-market-debut-best-biotech-firstday-pop-since-2000-cm322385#ixzz2rw6qapZEhttp://www.nasdaq.com/article/dicerna-gains-207-in-market-debut-best-biotech-firstday-pop-since-2000-cm322385
George Koss re msg #279; That link is only available to subscribers. I found this one.
http://www.boston.com/news/science/blogs/science-in-mind/2014/01/29/scientists-discover-new-simpler-way-make-stem-cells/WfOqon5jKzMeVpgYdkdBQK/blog.html
I mentioned this company and their technology in an earlier post. I do have a small position and have noticed positive activity since their recent attendance at a Dermatologist conference in Hawaii. May be worth investigating and of course doing DD.
“This is the wave of the future for dermatology.”
MAUI, Hawaii & IRVINGTON, N.Y.–(BUSINESS WIRE)– MELA Sciences, Inc. (NASDAQ: MELA), developer of MelaFind®, an FDA approved optical diagnostic device that assists dermatologists in the diagnosis of melanoma, hosted a MelaFind® workshop during the 10th Annual Maui Derm Conference in Hawaii. The conference seeks to increase physicians’ knowledge of developments in medical and cosmetic dermatology.
Dr. Monica Scheel, a Board Certified Dermatologist based in Hawaii, hosted the MelaFind® workshop which reviewed the clinical use and benefits of the device as well as future technology development opportunities for the device and its underlying optical imaging and data analysis technology. Dr. Scheel had also presented clinical data at MELA Sciences’ Clinical Advisory meeting at the Winter Clinical Dermatology Conference held a week earlier.
“Adding MelaFind to my practice has helped mobilize patients and drive disease awareness; I’m thrilled with this new technology,” commented Dr. Scheel. “This is the wave of the future for dermatology, a new way to visualize and analyze atypical pigmented skin lesions below the skin surface. MelaFind has helped increase the sensitivity of my biopsies, as well as helped me prioritize lesions that can be monitored.”
MELA Sciences also displayed four clinical posters at the well-attended and highly successful Maui Derm conference. The posters reviewed clinical data from practice and clinical settings that highlighted how MelaFind has helped dermatologists in the assessment of clinically ambiguous pigmented skin lesions (moles) in a variety of patient types including young adults, an area of growing concern, and those with atypical mole syndrome. The posters and abstracts are available here.
I am curious about your opinions on statins, karmaswimswammi, not as they pertain to investing, but just from a medical opinion. I know a great orthopedic surgeon who told me that as a hobby he likes to read medical studies outside of his field. He believes that at the very least CoQ10 should be required with any prescription as it is in Canada. Beyond that he says they are actually detrimental and that cholesterol comes in many forms and that some are obviously beneficial, and statins don’t allow for creation of good things from natural cholesterol…proteins and testosterone for men etc.
I am curious because I am going to talk to my Physician and tell him I want to stop taking them for now (he is not the original prescriber). My worst number pre Lipitor was 220 or so which was low 40 years ago…now I have the bad number down to 170 or so and good boosted up through Gemfibrizol ….I may keep taking Gemfibrizol as it is a different class of drug, I think. I ask you this today because today was the third time I have had a doctor tell me they are poison in a casual conversation.
Perhaps you could shed some light on the subject, and thank you in advance if you do.
Several years ago I developed severe calf pains and weakness while using Zocor statin drug; after I stopped using it the problems diminished rapidly and in a few months my legs recovered completely. A similar sequence developed when I tried red yeast rice, a supplement readily available in health food stores, from which, I believe, the statin drugs are derived. I would not ever consider using them again, at any dose or any formulation.
The depth and brilliance of this answer astounds me ( re post #274). Thank you for
sharing your amazing erudition with us! I’m long BNIKF becasue of the elegance of
their solution to HCV disease. Benitec uses a nucleotide wand to eliminate the cause
of HCV at its source, while Gilead’s drug batters the HCV with sledge hammers, addressing the effects of HCV and not its cause. I look forward to learning more
about this cool biotech science stuff regardless of the performance of the stock. Though
I have my fingers crossed. I’ll end this missive with a song:
Rexahn,
Don’t you put out the red light
Don’t you walk the streets of the city
Don’t you sell your body to the night.
My compliments to The Police and also Eddie Murphy in 48 Hours!
Looks like Dr. McHutchinson (mentioned by KSS in comment #273) just got a promotion: …”John McHutchison, MD, formerly Senior Vice President, Liver Disease Therapeutics, has been promoted to Executive Vice President and will assume additional responsibility for clinical development programs in the areas of oncology, respiratory diseases and inflammation.” Quoted from http://www.marketnewscall.com/stocks-in-focus-gilead-sciences-inc-nasdaqgild-cell-therapeutics-inc-nasdaqctic-rexahn-pharmaceuticals-inc-nysemktrnn/1217505/#
Don’t say I didn’t warn you, and say you heard it here first. Intermune (ITMN) is crumping today in very heavy volume. The CEO has been dumping 100,000 shares per week during January. This clunker of a company has a lot farther down to go. Be smart and get out.
Benitec is presenting at Bio CEO conference:
New Yorkers – See if you can attend:
February 10-11, 2014
The Waldorf Astoria New York
http://www.bio.org/sites/default/files/email/CEO2014/CEO2014_EBrochure_FIN.pdf
I posted yesterday about HCV regimens and how that space is heating up. It really looks now as if AbbVie is about to fumble the ball. AbbVie is trying to depict its regimen as the great alternative to Gilead’s two agents. With AbbVie, HCV patients will have to take 4 drugs, likely to cost even more. First, AbbVie bought an developed a pan-genotypic proteinase inhibitor developed by Larry Blatt, PhD, before he left Intermune, long ago when Intermune was interesting. This drug has such lousy pharmacokinetics that it must be taken with ritonavir (another AbbVie drug! for HIV) so as to poison the catabolism of the PI. Next they will have patients taking their NS5a replication complex inhibitor and their NON-nucleoside NS5b nuc polymerase inhibitor. I don’t like the non-nuc’s: they work allosterically rather than directly. None of these drugs have names yet. While I still think AbbVie is an attractive company, it is definitely not shaping up to be the great white hope for HCV that people think. I received word today that they are probably going to push the 4-drug combo and that just does not please me.
Karmaswimswami!
I look forward to every time I log into this thread.
You are amazing!! Thank you so much!
Randyman: Thanks for your post about MELA. Personally, I would encourage you to put your money elsewhere. I see little likelihood that what is a re-launch of MelaFind is going to win over dermatologists at all. It seems high-tech, but is quite low-tech. Competing systems have been around for decades. MelaFind flopped when it first came out. I doubt it will be different this time. Dermatologists just aren’t going to plonk down $10,000 for a device that has already been accused of missing lesions. The device is supposed to be helpful in situations where people have numerous moles. If a mole is on the change from a prior visit this can pick that up. But human skin is a finite surface. Dermatologists are going to always be most comfortable with having a disrobed patient that they look over carefully. Good dermatologists can pick up the worrying moles from a huge field of moles quite easily. There are attributes of color change, symmetry, and size that matter. When in doubt, they will excise or do biopsy. Questions linger about whether third party payers are going to cover use of the device, but dermatologists I know say they see no reason to have it at all. Derm is a low-tech, look-see specialty and always has been and I sincerely doubt MELA’s device will change that at all. My feeling is that you would just be so much better off putting that money to real work elsewhere in something likely to succeed. MELA halted trading today to announce it is procuring $12.5 million in private placement to fund itself and this device, and I am stunned that they found this money: proof that there is money with pressure to flow into biotech, but proof also that certain people are easily deceived. Based on the stock’s one-year chart, that it will be NASDAQ delisted seems inescapable. I would jump ship.
Benitec Biopharma Ltd (BNIKF: OTC Pink Current) | Venue Change Wed, Jan 29, 2014 12:00 –
– The symbol, BNIKF, no longer trades on Grey Market. As of Wed, Jan 29, 2014, BNIKF trades on OTC Link. You may find a complete list of venue changes at otcmarkets.com .
To DBMD: I really appreciate your posting and your praise. Coming from you that means a lot.
I had wrangled with myself over whether to go into finasteride, dutasteride and prostate cancer, but you are quite correct. Use of them may decrease the incidence of low-grade, unaggressive prostate cancer, but also predispose to more aggressive forms. And based on what is seen,it is consistent with the estrogen hypothesis. See this:
http://www.cancer.gov/clinicaltrials/results/summary/2013/PCPT-finasteride
A similar debate has gone on for years as regards soy intake, such as with tofu, and prostate cancer. On this issue, no randomized controlled study has been done, but tofu is a great source of quasi-estrogenic compounds such is genistein and the isoflavones. It has been posited that these lead to a reduced incidence of low-grade prostate cancer overall, but also lead to high-grade very anaplastic aggressive prostate neoplasms. The definitive study on this has never been done, and may not be doable.
Estrogen really must be playing a role because obesity is clearly an independent risk factor for prostate cancer. Adipose tissue is associated with two things: insulin resistance and aromatase expression. Insulin resistance does not appear to raise prostate cancer risk, so it must be the aromatase, converting testosterone to estrogen. What orchiectomy is thus doing may not be ridding of a testosterone effect on the prostate, but arresting any production of estrogen by nixing the source of testosterone that becomes estrogen. A strong molecular oncology argument can be made for why estrogen may lead to high-grade prostate tumors; there is a mutation that estrogen can cause in prostate cells
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3073404/?report=reader.
This review discusses aromatase inhibition as a chemopreventive measure for prostate and breast cancers. http://cebp.aacrjournals.org/content/7/1/65.full.pdf+html. Right now, a definitive study of anastrozole for primary prevention of prostate cancer and also as an adjunct therapeutic in men with prostate cancer is crying out to be done.
An inverse relationship between prostate cancer and green tea consumption is credible:
http://www.sciencedirect.com/science/article/pii/030438359503948V
Thanks for pointing that out about metoclopramide. When I was in training, I moonlighted in ER’s a lot, and metoclopramide iv really snuffs a migraine like nothing else does. If a spray form of metoclopramide is approved, physicians will certainly prescribe it off label for migraine treatment. There are occasional neurologists out there who assert “males don’t get migraines,” but on infrequent occasions I do get headaches that certainly have migrainous attributes, and I have never found triptan agents like Zomig to be of much good. My n=1 case series means nothing, but the triptans are rather expensive, and if a metoclopramide spray is reasonably priced that is a market it could control. (Here we are alluding to Evoke (EVOK)). For patients I have who get migraines with nausea, I have rx’d metoclopramide for that for years, and most say it fixes the pain.
I’m not invested in IMUC, but was taken back at maxim’s report that gives a target price of 12$.
http://www.maximgrp.com/research/MaximUniverse.pdf
I have followed the stock a couple of years back with promising dendritic cell based cancer immunotherpary. Their stock fell from 4$ to the current level of 1$. I know I’m missing something but not able to find why it had a fall. But Maxim’s Target Price seems interesting.
http://www.imuc.com/technology
http://www.imuc.com/pipeline
“ImmunoCellular Therapeutics is developing immune-based therapies for the treatment of brain cancer and other tumors. Our lead product candidate, ICT-107, is a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma multiforme (GBM), the most common and lethal type of brain cancer. Our pipeline also includes ICT-121, a dendritic cell (DC) vaccine targeting CD133, and ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens and cancer stem cells.”
I do not know about the promise their pipeline holds, any expert comments on this will be much appreciated.
Siva: I don’t mean to sound like the Herb Greenberg of Gumshoe, but I just cannot see a case for IMUC at all. It issued press releases claiming that its dendritic cell immunotherapy increased progression-free survival in patients with glioblastoma multiforme, a common and incurable brain tumor. But that is pure spin. Just look at the awful p values. The PFS fell way short of statistical significance, and how they will fandango that it justification for a phase III trial baffles me.
I still think the jury is out on cancer immunotherapy, at least as regards tumor “vaccines.” What IMUC and so many others are doing is leukapherizing monocytes, incubating them ex vivo with GM-CSF plus antigens, and then reinfusing them with a pat on the rump and a cheer: “Go dendritic cells, go!” Is it reasonably to presume this will work? I do not think it is. Tumors are about ebullient growth and aggressive expression of antigens. The immune system has been thoroughly introduced to those antigens and knows all about them and for reasons we do not understand is ignoring them. Taking cells outside the body for a lecture on how to fight the antigens doesn’t seem likely to me to work. Also, the ever present specter of the Provenge pseudopositive data phenomenon lurks over our heads. Remember, in the Provenge pivotal trial, there was NO evidence at all that Provenge patients were living longer. Placebo patients, subjected to leukapheresis without GMSCF/antigen incubation were just dying 4.1 months sooner because of immunodepletion. Since we do not know the precise procedure the IMUC GBM patients were subjected to for the palcebo arm, for all we know this same thing is going on. Two months of improved survival is quite minimal, and that is all they saw, and it did not rise to statistical significance.
I feel IMUC has made a mistake in pursuing GBM as their lead strategy. An old notion exists that the brain is “immunologically privileged,” ie, that certain things it expresses do not evoke the same immune response as would happen peripherally. While that theory has been discredited, there is relative, though not absolute, truth, in it. The blood brain barrier is formidable, and given that we do not know if tumor immunotherapy works, the last way I would suggest it be studied is by first going after the brain. Immunotherapy may work outside the central nervous system, but I just see reason to doubt that prepared dendritic cells are going to succeed in getting in and doing anything in the CNS. The brain very much has its own immune system, and I think a wiser way of pursuing this would be to invoke glial cells, entrain them and implant them. And I doubt that is feasible now with what we know and can do, but with stem cells may become possible down the line.
I cannot see IMUC ever making it to $12. Tumors exist because tumors find a way to dodge the immune system. Using the same nonsophisticated ways to activate the immune system, such as GMCSF, are just not likely to succeed in my view. There will be a way to overcome the immune evasion of tumors in the future, I am sure, but I do not think dendritic cells and GMCSF is the answer. The answer will reside in a much deeper understanding of how tumors camouflage themselves, and I don’t see evidence the answer is known yet. If GMCSF methods worked, then giving GMCSF to cancer patients should turn on the system to go and mop up their tumors and this has been tried and does nothing.
Thank you, Dr. KSS. Your above opinion on IMUC is an eye opener for me. I always thought IMUC is a great company though I have never invested in it.
Doctor K was wondering how you fill about Australian Biotech Viralytics(VRACY) and their science?There data
looks really good so far on their drug pipeline. And also if you were still studying CTSO?Thanks,Glenn
To Glenn Newberry: Thanks for asking about Viralytics, an Australian company that trades in the US as an ADR. Shares shot up last year in sympathy, it seems, to overall biotech exuberance. It is examining oncolytic viruses, particularly a modified, tweaked Coxsackie virus as an intralesional therapy for melanoma. (Vague reminders there of Provectus, a stock now on life support.) Two concerns: their phase II study is complete and yet the data still aren’t out. Maybe I am too impatient. But also, they would have their shareholders not be aware, it seems, that Amgen has beaten them to the punch: http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1877950
Amgen is still finishing analysis of phase III data, and has not signaled whether it plans to pursue FDA approval or not. But there are intellectual theoretical reasons why talimogene laherparepvec (Amgen’s method) may be superior to an engineered Coxsackie virus (the Viralytics approach). Viralytics has a meager pipeline. If you are in this one, I might consider taking profits.
As regards CTSO, I remain puzzled. The stock isn’t doing much, even with news of EU approval for its system to be used in ICU patients with sepsis, multi-organ failure. I did read further about the tech, and it isn’t really a high tech method of extracting or binding cytokines. It sounds like a nonspecific hemoperfusion adsorption method. CTSO in theory is quite vulnerable if a major pharm player decides to put one of the four developed monoclonals against interleukin-6 into clinical trials for sepsis In animal models of sepsis, anti-IL-6 mAbs are quite effective). Also, despite a recent presentation of the method to critical care physicians at a conference, shares haven’t moved. If you are long, I would hold. Advocating buying is more difficult. CTSO shares have not participated in the broader (and seemingly ongoing) biotech rally and enthusiasm. The method may yet catch on, but despite every reason to, just hasn’t yet.
DR KSS thank you very much for your response in CTSO and Vyralytics.I do not own either and you helped me understand each much better.This is a great thread and you are amazing.Doctor I have something for you to look at concerning Benitec’s RNAi technology licence to Calimmunes trial going on now for HIV.There is a amazing thread going on right now at POZ.com forums.There is actually two posters posting in this forum whom are in the trials.One of the members posting is JazJohn and the other is SFGMOMO.If you Google search Calimmune Safety Study of a Dual Anti-Hiv Gene Transfer Construct to Treat Hiv you will find it with PDZ.com forums.Really good stuff.I read the foum thread top to bottom. I am sold on Benitec.If this Calimmune trial goes well which I think it will with Benitec science behind it the stock will rock.Thanks for posting about them and their science.Much appreciated.Glenn
To Nick Msg #285 There was a raging debate, and I do mean raging, at Doc Gumshoe’s thread about statins and supplements with active participation by Dr. karmaswimswami. Thank God he decided to stay with us and particiipate in this more civilized thread.
http://www.stockgumshoe.com/2013/12/the-statin-guidelines-looking-at-the-whole-cardiovascular-spectrum/
Hi Glenn,
if you are still interested in CTSO there is also a Microblog : ‘Blood Purification companies discussion’ happening on Gumshoe. Robert V. started it back in September and when CTSO was at 10 cents. I did not pay it any mind until they had moved up to 20 cents that was 2 weeks or less and now they are at 28 cents. Pretty impressive if you are me.
Herbalix thanks I will check it out.