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.
There’s an interesting article on bacteriophages in the March issue of Discover magazine. A few excerpts from the article: “Bacteriophages, about 100 times smaller than bacteria, are the most abundant life forms on Earth…They do their dirty work by infiltrating bacteria…and destroying them from within…But the phages can be finicky and unpredictable…in the 1920s and ’30s, doctors didn’t know about this specificity, so sometimes the preparations worked, and sometimes they didn’t…Western physicians discarded them once the more reliable antibiotics became widely available.” The article mentions Intralytix, which is a privately owned company, whose products include phages for food safety (some go after Listeria or E. coli) and other applications. I looked on http://www.clinicaltrials.gov and didn’t see any commercial companies doing clinical trials on phages.
The article says “numerous stumbling blocks remain before phages could become part of our infectious disease arsenal”.
I have some rather serious concerns about Advaxis. This company is basing its immunotherapy around rejiggering and attenuating live Listeria monocytogenes that can be administered so that the bacteria secrete a fusion protein that is a combination of listeriolysin L and a tumor antigen. I cannot easily convey how scary this is.
Have you ever known anyone who got Listeriosis? There is a good chance the person died. This is a virulent, lethal organism that, at its worst, can cause infections of the central nervous system. It is a gram-postive rod found in soil that contaminates food frequently. In the body, it gets phagocytosed and releases listeriolysin O, a porin that bursts a hole in whatever cell has phagocytosed the Listeria, releasing the germ into the system to infect further.
Yes, this will definitely provoke an immune response alright, a deadly one. In the phase I study of its ADXS HPV therapeutic vaccine, 15 women were given iv infusions of live Listeria organisms modified to be less virulent but also to secrete listeriolysin O as a protein fused with papillomavirus proteins. These were woman with invasive cervical cancer. Of the 15, 6 of them had grade 3 (of 4) toxicity with severe fever and hypotension! This was a very short study, but only 1 patient had a tumor shrinkage, and it was not considered anything other than a partial response.
This approach will never be usable in frail, elderly or really ill patients because they will not be able to tolerate the risk of fever and hypotension. For anybody with a low white blood cell count, as from chemotherapy or just systemic illness, this approach will also be off limits. Under no circumstances would I want anyone I know to participate as a patient in one of these trials. This is a profoundly deadly organism, and attenuated, “tamed,” or not, I regard this as extremely risky. This is going to really extraordinary, hubristic lengths to provoke an immune response. I also have real conceptual doubts that it can work. An “epitope” is a three-dimensional conformation of amino acid sidechains on a protein that an antibody can recognize. It generally consists of somewhere between 5 and 15 amino acids. This will provoke much immunity to the listeriolysin, but it does NOT follow conceptually, at least not to me, that this will lead to more immune response against tumor antigens fused to the listeriolysin. In a best case scenario, one might get antibody or cell-mediated immunity against an epitope at one end of the listeriolysin where it fuses with tumor antigen…..perhaps 7-8 listeriolysin amino acids and 7-8 tumor amino acids. I don’t feel that will help, and the poor antitumor effect seen in the phase I hints at that.
Thanks KSS–I will stay away from this one–don’t need Listeriosis of the stock portfolio.
An additional word of thanks to Travis et al. for the site and thoughtful, discussions. I too felt that this gratis forum needed rewards and have become an irregular on the strength and value of this format and forum. As a surgeon of many years I have waited first for the field of radiology, and then chemistry, and now molecular biology to put me out of the cancer business. The discussions here excite me and raise great hope that this will happen in my lifetime. What a great time and field to follow and invest in.
To James Fernow and others interested in Tapimmune:
This is a 15-year-old company that is no closer to having a product than it was in the late 1980’s. Its tech has not led to a publication in over 7 years, there is obvious inaction on the phase I study at Mayo, and all the methodology, of transfection with TAP, seems to do is result in a decrease in Th2 lymphocytes in tumors. Th1 is tumor killing, Th2 is tolerant. A reduction in Th2 means a relative, but not absolute, Th1 increase, and what is needed is a dramatic, profound, and absolute Th1 increase.
I cannot envision this company going anywhere and would not be an investor in it. It is just sitting there, indolent, biding its time, burning through cash to pay its executives, with nothing on the dance card.
I see. Thanks very much for that information and insight!
James; as to phages my opinion is that raw food irradiation using modern “focused” methods would be much more effective by killing pathogens before we were exposed. Same issue of Discover, had bit that caught my eye ‘abscopal effect’ on metastatic cancer “spontaneous” [my addition] remission. Also cancer ‘seed’ in donor organ that had been immune system suppressed, waking under immuno-suppression of patient. Also a separate bit about choosing not to accept 1st available organ leading to many deaths due to patient not realizing how serious own situation was. Probably none worthy of investment notice but illustrative o f data flood” to deal with. Thus my admiration of Karma grows.
Thanks, haven’t read much of the issue yet, I will look for those.
I got an email about an 80+-year-old male with lung cancer who took artemisinin for a month and had a remission. Couldn’t find that on the web but did find this:
http://www.ncbi.nlm.nih.gov/pubmed/22935909
Frank, is raw food irradiation practical in food prep areas in nursing homes, etc? Use of phages sounds convenient. From the Discover article, which you likely already saw but other SG readers may not have: “In 2006, Intralytix secured FDA approval for ListShield, a cocktail of six phages that is sprayed onto ready-to-eat meat and poultry (like you’d find at the deli counter) to control Listeria, which…has a 20 percent fatality rate.”
To all I am much concerned about increasing listeria outbreaks involved with food harvested by good people doing work Americans won’t. We need better protection of our food chain in any case. Think what terrorist could do. Prevention? ” aun asi trabaja”
Hi James Fernow, TPIV was one of my early micrbio investments and I save my losers as reminders. The press release says the $400 mil Roch, Innovio is an example of the TYPE of deal…an example, not something they are involved with.
Ah, the devils in the detail
I see. I have been cautioned not to invest by Dr. KSS, but appreciate your warning also.
CHTP Chelsea Therapeutics: looks like they have a very good chance of getting a drug approval on Feb. 14 so this might be a good short term trade. I’m not in love with the company but most think the stock will go to $7 or $8 with an approval on Valentine’s Day. It will either shoot up or it will go way down on 2/14/14 any thoughts from others? This could be my Valentine’s Day present to Gumshoe readers. If the drug isn’t approved, it will be a Valentine’s Day Massacre. The odds look firmly in favor of approval from what I can tell, but it’s certainly not a done deal.
Good of you to share. There are no guarantees in investing so we must all take responsibility for our own decisions. Still a considered 51% heads up is most welcome.
CVN Cel-Sci is a company with an intriguing immunological compound targeted against HPV, genital warts and HIV. It has a big recent Navy study going on with this compound against HPV. The company is also targeting neck cancers it appears. There was a recent SA article and from the comments it looks as if this company has been around 30 yrs. with no successful drugs coming to the market. On the one hand they have somehow survived for quite a while. On the other hand, show me the money! The most important question is how promising is their science and current compounds? KSS, you are the go to guy here on that so your thoughts are welcome. I do trust the SA author who is touting the stock as she does good research and writes well. She also is long RNN and Pluristem.
CVM is the Cel-Sci symbol
David B: Chelsea (CHTP) has been a hard race to handicap. The drug in question is droxidopa, which boosts levels of norephinephrine for people who have orthsostatic hypotension (OSH). People with OSH are rare, but what happens is they topple to the ground after rising from a sitting or lying position because of failure to have a rise in blood pressure in response to the posture change. OSH is rare enough that dorxidopa got orphan drug designation.
The stock momentarily cratered in January 2014 because of advance speculation that the FDA advisory committee planning to review droxidopa for the second time would likely recommend rejection. But they voted 16-1 to approve. The final decision is due on or before 14 February.
These adv. comm. recommendations are like the US electoral college system: the FDA will probably follow the advice but is not obligated to. My concern is that Chelsea’s pipeline is quite dry. It had a folate antimetabolite, basically a drug that could replace methotrexate, in development for autoimmune diseases, but put development of that on hold in 2012 following bad phase II data. So my concern would be that if droxidopa is approved, all the mutual funds holding CHTP may use that as a basis for finally liquidating positions in it.
They have a new portfolio of immune modulating drugs, but all that work is still preclinical.
Yes, I agree–not in love with the company but it could be a good short term play. My best guess is that there is an 80% chance of approval on 2/14/14 so it’s a decent short term risk reward situation but only for those who want to gamble a bit. I think your odds are much better here than at any casino here but it’s still risky. Most think the downside is down to about $2 or maybe even $1 from the current price which is something like $4.50. I am not in yet but thinking about it.
David B. If you just want play & if you think will be large move up or down you could buy put $1 or$2 below & buy call ditto above current price a month past possible determination. I think street corner shell gain may be better. Best advice I give is don’t take financial advice that there is “sure thing” n.b.— fa NOT financial adviser
If you expect to lose likely not be disappointed.
Also don’t forget to take profit,if any, soon after initial run up or down.
Thanks Frank and that is my plan. I’m more of an investor than a trader but this looks like a good short term opportunity for a quick profit IMO. I agree with KSS that the company isn’t a great long term play, but why not profit a bit in the short term when the odds look very favorable?
Dr. KSS, as a short term buy on Monday, I was wondering if you believed that CHTP has corrected/satisfied the FDA’s stated reasons for its March 2012 rejection of droxidopa/Northera in its 306B study, and whether 2/14/14 approval makes sense. Links below. Thank you.
FDA’s March 2012 rejection and request for more studies:
http://www.drugs.com/nda/northera_120328.html
FDA’s 3/13 Guidance for resubmission:
http://www.drugs.com/nda/northera_130220.html
2/14 FDA (16 to 1) Panel’s comments:
http://www.healio.com/cardiology/vascular-medicine/news/online/%7Bc97fc6e8-d27c-4f5c-8486-a75b3083e02d%7D/fda-panel-recommends-approval-of-northera-for-hypotension-treatment
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM381154.pdf
Dr. KSS Last year around the same time i was looking at the price of following RNAi stocks.
ARWR: Feb 2013: $1.85 Feb 2014: $17
ALNY: Feb 2013: $24 Feb 2014: $79
TKMR: Feb 2013: $4 Feb 2014: $15
ISIS: Feb 2013: $14 Feb 2014: $49
If Benitec(BNIKF) does well in Phase 1 trial i expect the stock to reach dizzy heights this year! Thanks for all your expertise on this subject!
I just got this thead, site link below, from my 130 twitter biotech obsessives (why would I be cruising all day on Sat…I’m one). Note the text on RNA. I’m on this band wagon. But first,
And the nominees are: ISIS (I own @ 12), ALNY which uses ISIS technology, RGLS( joint venture of ALNY and ISIS.. Dr. KSS says “late to the party”) OGXI, TKMR(I own @5), ARWR( I own @8), MRNA(I own @1), IDRA ( BUYING MONDAY 5+/-) They are into synthetic RNA, there’s a twist.
http://rnaitherapeutics.blogspot.de/2014/02/next-stop-isis-smnrx-for-spinal.html
“In case you were wondering why RNA Therapeutics stocks have been going up and up regardless of the overall markets, it is because it is happening right now: RNA Therapeutics are claiming the role of the 3rd major drug discovery engine, the most vibrant at that, following small molecules (withering) and recombinant proteins/monoclonal antibodies (running out of target space). It therefore becomes important to anticipate the next major event on that road which are the results from two separate multi-dose phase II studies of ISIS-SMNRx to be reported sometime over the coming 6 weeks.”
Posted by Dirk Haussecker at Saturday, February 08, 2014
Rob–which two would you buy right now if you had to pick at today’s price?
David B: I would not put a cent into CVM. Not at all. This company has been logrolling for decades, pretending to do something, while accomplishing nothing. It has been through two reverse splits to stay listed. Its “Multikine” is so opaque, so bizarre, with the literature and discourse on it so controlled by CVM that I literally cannot find out exactly what it is. What is its sequence, size, and with what is it homologous? How is it made? What gene encodes it? What is its mode of action? To what does it bind? Are those even known? Or is it just a potion? This from the company’s website: Multikine is a cytokine mixture.
“The cytokine mixture includes interleukins, interferons, chemokines, and colony stimulating factors; all are molecules which stimulate the body’s healthy immune response.” This is craven wheedling and garbagemongering.
This company’s phase II trial of Multikine in head/neck squamous cell cancer was years ago, and was appallingly run, with no control arm. Patients got cyclophosphamide +/- surgery. +/- radiation, and Multikine injections into the tumor were just bunged into the mix. We have no idea whatsoever whether it does anything or not, and the way its CEO has discussed this trial is just plain deceptive.
If you look at a list of the trial sites for the phase III, it is deplorable. The main US site is a tiny clinic in north Mississippi no one has heard of. It has sites in the Balkans, in Russia, in Ukraine. Sorry, but these are NOT places from which I would trust data at all. I notice its main trial site is Taiwan. I lived in Taiwan, I am quite concerned that head/neck cancer there may be a different entity with different behavior from what it is in Caucasians.
The Navy phase I trial of Multkine is a sort of so-what for me. It will not have toxicity, as tox has already been excluded by other studies. I predict it will do nothing for cervical and anal HPV.
I guess it sounds as if I am a world-class grouch on a screed, but so many of these companies are just junk, spinning yarns that unwary mutual fund managers and hedge fund operators are not canny enough to see through. I would hold CVM between thumb and forefinger, and at arm’s length. Even if the product is approved, physicians will never ever use it. It reeks of voodoo.
Good advice KSS, I’m surprised that Sharon at SA covered this and thinks it is a good play. I definitely wont touch it as I was already suspicious after reading some of the comments after her article.
“Even if the product is approved, physicians will never ever use it. ”
Are you serious??? If it improves survivability by a minimum of 10% you think doctors won’t use it? Wow. You must think physicians are in the business of letting their patients die.
Their Phase III enrollment has been slow but it is speeding up significantly. See http://seekingalpha.com/article/2122483-cel-sci-sees-rapid-enrollment-for-phase-iii-head-and-neck-cancer-trial
Cel-Sci seems to be onto something big and accelerating enrollment and having a CRO put in $10M of their own money in suggests Multikine just might work.
Re: post 423. Dr. Karma, With so many new issues flooding the market, the chance of a Joe average like me to spot a diamond in the rough is nil. I am long on RVNC and KIN through IPO. RVNC’s lead candidate is a topical form of botox vs Allergan’s injection type. Kindred Bio is developing therapeutics for man’s best friend. Your thoughts on them would be greatly appreciated.
Sorry no stock tip, but an interesting article on vitamin C and cancer from the BBC website: http://www.bbc.co.uk/news/health-26038460
Palatin Technologies(PTN) – Is anybody invested in PTN?
Palatin’s focus is on developing peptide based therapeutics. Palatin has particular
expertise in melanocortin receptor (MCR) biology. MCRs, are G-protein coupled receptors
present in the hypothalamus, that regulate many physiological functions including sexual
response (MCR4), energy homeostasis/food intake (MCR4), and inflammation (MCR1).
PTN successfully completed Phase 2b clinical studies with bremelanotide (BMT), a
proprietary MCR4 agonist for female sexual dysfunction (FSD), plans for Phase 3 initiated.
PTN is partnered with Astra Zeneca (AZN) for development of MCR4 partial agonists for
obesity and diabetes, currently in pre-clinical studies. In addition, the pipeline also includes
the MCR1 receptor pathways for inflammatory conditions, currently in pre-clinical studies.
PTN entered into an option agreement for an exclusive license of bremelanotide (BMT)
for FSD in the EU Union and other select EU countries; the option agreement is with an
EU Specialty Pharma with sales & marketing, R&D and manufacturing capabilities
As part of the option agreement, PTN received a $1M non-refundable fee; PTN and the
EU Specialty Pharma will seek regulatory and clinical input from the EMA for Phase 3
FSD endpoints/data for approval of BMT; the option agreement expires by 1Q14
Partnering activities continue in the US; a few potential partners are under CDA – these
include Big Pharma & Specialty Pharma; for reasons relevant to regulatory issues, we
believe that partners may be attracted to BMT over flibanserine for FSD
Astra Zeneca (AZN) continues to develop an improved MCR4 partial agonist for obesity &
diabetes in pre-clinical studies; also in pre-clinical studies are MCR1 pathway agonists as
immune-modulators for inflammatory indications, enter clinic in 2014
As of Sept 30th, PTN had $22.3M in cash; enough resources to continue operations
through 2014 including Phase 3 FSD study preparations/protocols, but not patient
enrollment; patient enrollment will begin once additional funds are committed
Palatin is followed by Roth and Noble.
Noble financials has a Price target of $2.5.
Here is their complete pipeline
http://www.palatin.com/products/overview.asp
Here is their recent fiscal year highlights:
Bremelanotide development for Female Sexual Dysfunction (FSD):
‒ Completed a successful Phase 2B clinical trial and productive end-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA)
‒ Pivotal Phase 3 clinical trials anticipated to initiate patient dosing in the first quarter of calendar year 2014
Obesity Collaboration with AstraZeneca:
‒ AstraZeneca is evaluating the program and next steps following discontinuation of further development of AZD2820
‒ A number of collaboration compounds are in various stages of preclinical testing
Intellectual property developments:
‒ Two United States patents issued in the melanocortin field in the fiscal year ended June 30, 2013
‒ Palatin has advanced its bremelanotide, PL-3994, and new melanocortin peptide patent applications in countries outside the United States
Equity financing:
‒ On July 3, 2012, Palatin closed on a $35.0 million private placement. The offering consisted of the sale of 3,873,000 shares of common stock, Series A 2012 warrants to purchase 31,988,151 shares of common stock, and Series B 2012 warrants to purchase 35,488,380 shares of common stock
‒ Net proceeds to Palatin after deducting offering expenses were $34.4 million
There is no approved drug for FSD. The only drug that is pending approval is Flibanserine from Boehringer Ingelheim.
The potential FDA approval of Flibanserine would help PTN’s cause. Flibanserine is a 5-HT1A agonist/5-HT2A antagonist administered chronically and was
previously tested in Phase 3 studies by Boehringer Ingelheim – the NDA was withdrawn by Boehringer given a
negative FDA advisory panel review. A possible issue could have been the daily diary used as part of the
endpoint. Sprout Pharmaceutical (Pvt) licensed Flibanserine from Boehringer and resubmitted the approval
package after addressing the concerns raised by the FDA during its previous review. If approved, Flibanserine
would be the first drug approved by the FDA for FSD. Approval of Flibanserine would expand the market and
increase awareness and help BMT. A significant difference is that Flibanserine is taken daily, while BMT is on
demand – advantage PTN.
Successfully completed ‘End of Phase 2’ meeting for bremelanotide (BMT) in FSD: Earlier this year, the
FDA and PTN had agreed on a Phase 3 trial design plans. The Phase 3 design is similar to the Phase 2b
design.
I wanted to open up a position with PTN for quite a while when the PPS was 70-80 cents. There was a technical breakout at that region and the price jumped to 1.34 in one day registering its 52 week high. It has now settled down quite nicely. Here’s why PTN looks attractive at these levels atleast in short term for the next couple of months.
– European partner finalized yet to be announced.
– They have shortlisted a couple of USA partner, term sheets in negotiations
– Will start P3 for FSD in Q1.
– OS is 39.19M.
The probability of PTN doubling up or even higher in the next two months is higher when compared to RNN or INO if any of the above events occur.
I like companies that have <100m in OS and has immediate catalysts that can double from the current position and PTN seems to be ideally placed. I do not see any down side at these levels. I can't evaluate the science but regardless this seems to be a good short term play.
I can provide more details on anything if anyone is interested.
The institutional interest is about 33%, the float is 33m only.
You can download the Lifesci report here – http://www.lifesciadvisors.com/clients/palatin/
Bremelanotide is set to enter Phase III trials in 2014 for female sexual dysfunction (FSD). Bremelanotide is an on-demand melanocortin receptor agonist that acts in the central nervous system to positively impact sexual response. The treatment is being developed for the large FSD indication that includes up to 20% of women in the US, but for which there is no FDA-approved drug treatment.
Bremelanotide was most recently tested in a Phase IIb randomized, double-blind trial that examined three doses of drug versus placebo. The trial enrolled approximately 400 women experiencing hypoactive sexual desire disorder or female sexual arousal disorder. After establishing a baseline over a 4-week period of at-home self-dosing of placebo, patients were randomized to bremelanotide (0.75 mg, 1.25 mg, or 1.75 mg) or placebo. Administration was performed at home using a prefilled syringe prior to anticipated sexual activity. The trial met the primary endpoint of increase from baseline to end of study in satisfying sexual events (SSEs), with the 1.75 mg dose achieving statistical significance (p=0.022). The data set the stage for an upcoming Phase III registration trial planned to begin in the first half of 2014.
Thank you Diva for that great desertation on PTN. And WOW , sex surely sells LOL. But seriously I will wait for KSS’s remarks. Not to denigrate your obvious knowledge of the market but the more heavy lifters we can get to pursue these opportunities the better. Thanks again.
My spelling is atrocious. Sorry Siva. Also anyone can weigh in on how to spell desertation . Spell check, and even Webster, did not like it.
OK. Dissertation.
1610s, “discussion, debate,” from Latin dissertationem (nominative dissertatio) “discourse,” noun of action from past participle stem of dissertare “debate, argue, examine, harangue,” frequentative of disserere “discuss, examine,” from dis- “apart” (see dis-) + serere “to arrange words” (see series). Sense of “formal, written treatise” is 1650s.
From http://www.etymonline.com/
Couldn’t stop myself from doing this as an English Prof. 😛
How can I arrange for my partner to GET this condition?
Hi Dr.KSS,
What are your thoughts on SSH, CPRX, ZGNX, PPHM, IPCI, DVAX, DRXX, NVAX, CYTR, PBYI, BLRX, NSPH, NPSP, ONTY, ETRM, EXAS, CBMX, NURO, BAXS, CBLI, SGYP, SNTA, ACRX, CLVS, EXEL, NAVB, BGMD, CUR, REGN, CRTX, VTUS, ADHD, ANIK, ANTH, DRTX, DSCO, FCSC, GEVA, KERX, LGND, MACK, MNOV, NBY, NSPR, OMER, VICL, ORMP, PACB, POZN, RGEN, RGLS, STEM, VASC, ZIOP? Thanks
Brian: aren’t we expecting just a little too much from Dr. K with this request?
Did you just randomly cut and paste from the Nasdaq list?
Youre having a laugh arnt you :)……..arent you? 🙁
LOL exhaustive list! Dr. KSS will faint 🙂
I agree with Kenny on this!
NAME IT: ALPHABETOSIS!!!!!!!
Brian deduce= glad only 1 F in list ? bad joke
Brian, I agree with Kenny ….
Surely you don’t expect our treasured swami to take a question like that seriously.
Asking for an opinion on over 50 stocks is just not appropriate imo.
My guess is that it was a joke. If not, Brian–throw dart at stock list and buy the one nearest to your dart.
Siva: PTN had a presentation on bremelanotide for FSD presented at a 31 Jan 2014 conference in Istanbul. It was a phase II with placebo controls. FSD is definitely an issue where one might predict high placebo effect. However, I cannot find what that study showed or what the presenter said. Do you know? That would be a huge help in predicting what will happen with PTN. The data you provided were quite helpful. Thanks. I am interested.
Another big issue to me is that bremelanotide is a very very short peptide that can be easily manufactured. There may be patent protection issues if it is a copy of a natural product. What is its patent protection, if any?