by DrKSSMDPhD | January 27, 2015 4:15 pm
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In that same issue: human embryonic stem cells for AMD therapy:
http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(14)61376-3.pdf
All well and good…..til you see who the senior author is.
How does Lanzas presence effect the study? He has quite a bio on Wikipedia.
In my opinion, Lanza is a vapid turbo-narcissist just like Tony Robbins. Questions about data reproducibility, about quality of controls in expts, about why he is even listed as an author. A bajillion “preliminary” studies just like this one and they never lead anywhere.
It’s been said that a good plumber is better than a bad philosopher, and you know you are dealing with a deluded narcissist when they “invent” a philosophical system, as Lanza has with his nonsense “Biocentrism” theories. Just wants to sell a book. His disquisitions on this are pure pneumocephalic gobbledygook. I think Wake Forest rues the day he decided to come there. The James Franco of bioscience.
DR KSS Perhaps they confused with Mario Lanza ,,,Tony winner,,,Some Enchanted Evening:>)
Danza, Lanza…..Enrico Ferrari at Monza….garbanza beans….brain in full klang mode today.
maybe a bad plumber is better than a good philosopher?
Danza, Lanza, Enrico at Monza, Garbanza beans…….
Another one to add to the KSS list of Great Philosophical sayings!
Re: Bicyclolides
Dr. KSS, if I may impose on you I’d like your opinion on bicyclolides. I have searched the previous posts and could find no reference to these antibiotics.
In that same vein, your opinion on $ENTA would be appreciated. I have also failed to find any reference in your previous posts to this company. Though the company’s present main source of revenue is its royalty agreement with ABBVIE, its pipeline includes a 5-yr $43MM contract with NIAID, a division of NIH, to fund the development of “bridged bicyclic antibiotic” against Category A and B bacteria. Hence, my question.
ENTA has a market cap of $642MM. 50% of the float (9.11MM out of 18.6MM shares) is owned by institutions and the other 50% by insiders. 15% shorts though. It missed 1Q estimates, reporting revenues of $77.5MM (vs. estimates of $82.2MM), net profits of $42MM (vs. reporting a loss in the same period last year) and EPS of $2.18 (vs. estimates of $3.53). Shares have gone done by some 20% since the beginning of the year.
Because of ABBVIE’s deal, their revenue exploded from $893K in 2013 to $77.5MM last year.
http://www.enanta.com/research/enanta-pipeline/
file:///C:/Users/EcoStar%20Health/Downloads/EnantaPharmaceuticalsInc_10Q_20150206.pdf
Thanks for your help.
Hi JP: A great post from you. At first I thought you were referring to the (five-syllable) Greek dramaturgist of antiquity, but then realize you meant the four-syllable drug (I am joking). I am glad you bring it up, as I had not heard from this class in a long time, not since I have been writing here.
The bicyclolides are much improved macrolides. What does that mean? Macrolides are drugs that I often trust as one-stop shopping for respiratory infection. I know that not only will they get pneumococcus (Gram-positive), BUT will also cover Mycoplasma, things like Legionella (Gram negative intracllular) and weird scary things like Mycobacterium avium. The bicyclolides appear to have stronger activity and may require less frequent dosing.
Now, looking on Enanta’s pipeline I don’t see this addressed. Modithromycin is the main bicyclolide out there—if you have some time, see if you can figure out who owns American and EU rights to it. We covered $ENTA briefly in one of last year’s two column on HCV, and let’s be honest: no one should be in this stock for its HCV pipeline, so betrothed to $ABBV. Since we know that Gilead is offering 45% discounts everywhere, $ABBV’s market share in HCV is going to zero, right??
If you can find evidence that $ENTA has a specific candidate bicyclolide in mind, they may be worth a re-look, but if they are just acting on Obama largesse to start from scratch on bicyclolides, now is not the time to enter.
Thank you Dr. KSS. I’ll do my best to see if I can dig out both what specific bocyclolide ENTA has in mind, and who own US and EU rights to modithromycin.
Re: Modithromycin
In my effort to answer your query, I’ve contacted several people and entities. This person wrote a paper on modithromycin.
Was ENANTA in US, don’t know if they are still advancing the cmpd..
David P. Nicolau PharmD, FCCP, FIDSA
Center for Anti-Infective Research & Development
Hartford Hospital
80 Seymour Street
Hartford, CT 06102
Phone: 860-972-3941
Fax: 860-972-3992
E-mail: david.nicolau@hhchealth.org
Re: Modithromycin
NIH referred me to FDA, which I had already contacted.
JP Modithromycin is variant /derivative of Erythromycin one of the Natural antibiotics.
Here is link to a paper that may interest you ,,pages 18-19
http://www.wiley-vch.de/books/sample/3527332189_c01.pdf
Thanks Frank. I’ll read carefully tonight.
JP Shionogi has Asian rights to Modithromycin,,I do not know where to start looking for Eur/Usa.
Thanks Kenny. Love your photo.
CTIX files an application with NASDAQ. Well happened earlier than I was expecting.
http://cellceutix.com/best-yet-to-come/#sthash.Xv9Mzk6I.qxj0jDQP.dpbs
re $CTIX: I don’t know how significant that filing is insomuch as they don’t currently meet all of the qualifications for up-listing. Does the application merely sit with the SEC until they do meet the qualifications? If so, this may merely be another attempt to mislead investors.
Achillion HCV-1 regimen achieves 100% SVR12 at six weeks
http://seekingalpha.com/news/2282376-achillion-hcvminus-1-regimen-achieves-100-percent-svr12-at-six-weeks?auth_param=l48ch:1adhabj:e6c17538d1bdf9eefa5c4c7a7e772ac4&uprof=51
$ACHN two-agent combination achieves SVR12 in ALL patients with six weeks of therapy. News out this am, a little sooner than guessed. Will be an interesting day for $GILD, $ABBV, $RGLS, $MRK and of course $ACHN.
Long all but $ABBV and $RGLS, and glad I loaded up the truck with more $ACHN last week.
OOps: it was ACH3102 (ACHN NS5a) plus sofosbuvir. But implication is quite strong that their in-house 2-drug regimen will thus cure all gt1 in 6 weeks, regardless of virus burden or severity of liver disease.
Re: ACHN. Ok, so when does an acquisition war start – now, after phase 3 for NS5a + sofosbuvir, or after their in-house 2 drug studies? Amazing times for Hep C patients. Two or three years ago, no hope, and now multiple avenues for a cure.
No man knoweth. I think it will be after in-house 2-drug regimen, which frankly probably is good enough for a 4-week cure. But increasingly the writing is on the wall in a good way here.
I would be totally unsurprised if Roche $RHHBY came roaring out of stage left and picked up $ACHN later. Roche loves HCV, has huge expertise in it, and once led in it. There have to be company insiders who want to see its HCV Reich rise again.
Doc. with this data known, isn’t ACHN moving from HR/HR category to MR/HR category? Or we need to wait for Phase3 to conclude that?
Yes, incrementally less risky than before.
ATNM-Actinium’s Chief Medical Officer to Participate in the Next Gen Immunotherapeutics Panel at the 3rd Annual Sachs Cancer Bio Partnering & Investment Forum on February 23rd
7:00a ET February 9, 2015 (Market Wire) Print
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced that Dr. Dragan Cicic, Chief Medical Officer of Actinium will participate in the Next Gen Immunotherapeutics panel discussion on Monday, February 23, 2015 at 9:45 a.m. as part of the 3rd Annual Sachs Cancer Bio Partnering and Investment Forum in New York, NY.
Dr. Cicic will join leading cancer experts from industry to discuss the increasing role of next generation immunotherapeutics including combination and targeted therapies in Oncology. As part of the panel discussion, Dr. Cicic will provide insight into the potential clinical and therapeutic utility of Actimab-A and Iomab(TM)-B.
News out of $RGLS: in exploratory PoC trials of RG-101, a GalNAc-conjugated siRNA therapeutic that knocks down liver expression of MiR-122, studies clearly demonstrate NO chance of a single dose cure for HCV. Still, impressive virological knockdown, paving the way for further studies and possible shorter duration of therapy. Still, $ACHN is the better story this am, and I remain neutral on $RGLS and glad I did not own shares.
ARTH-10-Q and prospectus out 2/9/15 for 12/31/14
Sogiam,
ATNM, ARTH. Thanks for the updates on ATNM and ARTH. You are all over it this morning. I sold my position in ARTH this morning for a small loss. Just nothing at all positive I can see in the near future for ARTH.
V/R
Tom
JUNO-8:00a Juno Therapeutics Establishes Manufacturing Presence in Washington State (Dow Jones) 8:00a Juno Therapeutics to Manufacture Cell-Therapy Products in Bothell, Washington (Dow Jones)
http://globenewswire.com/news-release/2015/02/09/704376/10119182/en/Juno-Therapeutics-Establishes-Manufacturing-Presence-in-Washington-State.html
AUPH-Aurinia Pharmaceuticals to Initiate an Open Label Clinical Study to Investigate the Impact of Voclosporin on Lupus Nephritis Biomarkers
8:00a ET February 9, 2015 (Business Wire) Print
Aurinia Pharmaceuticals Inc. (the “Company”) (NASDAQ:AUPH) (TSX:AUP) today announced that it will initiate an open label, exploratory study to assess the short term predictors of response using voclosporin in combination with mycophenolate mofetil in patients with active lupus nephritis. AURION (Aurinia early Urinary protein Reduction Predicts Response) will examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48 weeks. The Company expects to complete patient enrolment of this small pilot study by the 3rd quarter of this year.
The Company expects that this study will act in support of its ongoing lupus nephritis clinical program. This study should provide the lupus community with a more clear understanding of voclosporin’s time to onset of action and clinical outcomes.
In the Aspreva Lupus Management Study (ALMS), one of the largest registration quality studies ever completed that investigated the treatment of lupus nephritis, certain biomarkers after 8 weeks were extremely predictive of 24 week response rates. “We believe the AURION study has the potential to provide validation for these early biomarkers and provide valuable tools to clinicians who are managing patients with this debilitating disease,” said Dr. Neil Solomons, MD, Chief Medical Officer of Aurinia Pharmaceuticals Inc. and co-author of ALMS.
TRVN-http://www.businesswire.com/news/home/20150209005138/en/Trevena-Announces-Positive-Results-Phase-1-Multiple#.VNi6A-bF8Qc
Move on to new thread, Jack!
As a “Crohn” I had particular interest in RCPT and the MEIP story – having been given the dreaded lactulose for comstipation(!).
I have purchased a number of shares of each. They are my only biotech holdings and account for ten per cent or so of my portfolio. I should probably diversify slightly, and I have also been intrigued by the TMO and ESPR information. Would I be accurate I thinking that TMO is the comparative giant, with ESPR slightly more established and the other two, upstarts?
The good doctor suggests we all contribute information as and when we see it. Where would we do that? In new discussion threads, back here, in whatever biotech story is latest? What’s the protocol?
Hi Simon….glad you are here. Sorry you have Crohn’s disease. I personally never use lactulose as a mere laxative in any setting because of how caustic and flatulogenic it is, and have even seen its use in Crohn’s cause formal exacerbations. Miralax, now over the counter in the US, is the preferred be-all end-all laxative…not abusable, doesn’t make the gut lazy and dependent.
TMO is a non-traditional biotech play because they help the research happen. ALL labs use TMO stuff. They control this turf utterly. ESPR is, yes, on firmer ground than RCPT and MEIP, though those are catching on. As I see it, it’s not a question of ESPR’s drug being approved—-it’s merely how the FDA will label. I would not be surprised if ESPR shares ran on to $100 from here, and I recently topped up my position because it is now behaving like a mo-mo name.
Long on all stocks you mentioned, with buy sentiments on all.
As far as what to contribute and where/how, just leap in and flail. We are friendly. Choose a stock you like and ongoingly bird-dog the news on that one, and post on it when there is something we need to know.
Thanks for the info, can’t complain about the Crohn’s – I get off very lightly touch wood.
As for the information, I know you will Dr, but do we all know about Google Alerts? If not google “Google Alerts” and then enter “MEIP” or whatever and choose to be updated by email any time Google’s all seeing eye notices something. I will attempt to jump on with any early in the day stuff being in the UK.
The UK where incidentally I seem to to be able to buy Miralax but only for cat constipation!
$RCPT
Oral presentations (2015)
OP024 A randomized, double-blind, placebo-controlled induction trial of an oral S1P receptor modulator (RPC1063) in moderate to severe Ulcerative Colitis: Results of the TOUCHSTONE study
W. Sandborn*1, B. Feagan2, D. Wolf3, G. D’Haens4, S. Vermeire5, S. Hanauer6, S. Ghosh7, H. Smith8, M. Cravets8, P. Frohna8, S. Gujrathi8, A. Olson8
1University of California San Diego, Division of Gastroenterology, La Jolla, United States, 2University of Western Ontario, Department of Gastroenterology, London, Canada, 3Atlanta Gastroenterology Associates, Emory Saint Joseph’s, Atlanta, United States, 4Academic Medical Centre, Inflammatory Bowel Disease Centre, Amsterdam, Netherlands, 5University Hospital Leuven, Department of Gastroenterology, Leuven, Belgium, 6Northwestern University Feinberg School of Medicine, Digestive Health Center, Chicago, United States, 7University of Calgary, Department of Gastroenterology, Alberta, Canada, 8Receptos, Inc., Clinical Development, San Diego, United States
Background
RPC1063 is an oral, selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in clinical development for the treatment of ulcerative colitis (UC) and relapsing multiple sclerosis. The objective of this study was to evaluate the efficacy of 0.5 mg (low dose, LD) and 1.0 mg (high dose, HD) RPC1063 in comparison to placebo (PBO), and characterize the safety of RPC1063 in patients with moderate to severe UC.
Methods
This was an international, 8-week induction trial in UC, with a continuing maintenance period for responders. 197 patients were randomized (1:1:1) and treated once daily with PBO (n=65), LD (n=65) or HD (n=67). The primary endpoint was the proportion of subjects in remission (Mayo score ≤ 2, no subscore >1) at Wk 8. Secondary endpoints were the proportion of patients in response (reduction in Mayo score of ≥ 3 and ≥ 30 % with a decrease in the rectal bleeding score of ≥1 or a rectal bleeding score ≤1), proportion of patients with mucosal improvement (endoscopy score ≤1), and the change in Mayo score. Safety assessments included ECG, Holter monitoring, pulmonary function testing, optical coherence tomography and adverse events (AEs).
Results
95% of patients completed the induction portion of the study. The proportion of patients achieving clinical remission was 16.4% for HD (p=0.0482 vs. PBO), 13.8% for LD (p=0.1422), and 6.2% for PBO. The proportion of patients with clinical response was 58.2% for HD (p=0.0140), 53.8% for LD (p=0.0648), and 36.9% for PBO. The proportion of patients with mucosal improvement was 34.3% for HD (p=0.0023), 27.7% for LD (p=0.0348), and 12.3% for PBO. The improvement in Mayo score from baseline was 3.3 points for HD (p=0.0035), 2.6 points for LD (p=0.0986), and 1.9 for PBO.
The AE profiles were comparable between groups, with approximately 31% of patients experiencing a treatment emergent AE (TEAE) across all groups. The most common TEAEs in the study were worsening of ulcerative colitis (HD 1 [1.5%], LD 2 [3.1%], PBO 3 [4.6%]) and anemia/decreased Hgb (HD 0, LD 3 [4.6%], PBO 3 [4.6%]). Only modest effects on heart rate were seen with no notable cardiac, pulmonary, ophthalmologic or malignancy AEs observed. Transient ALT ≥3x ULN occurred in 3 patients (HD 1 [1.5%], LD 2 [3.1%]) and decreased with continued treatment.
Conclusion
Modulation of S1P receptors in patients with moderate to severe UC with RPC1063 1 mg induced clinical remission, clinical response, and mucosal improvement, validating a novel therapeutic approach for the treatment of UC. The positive efficacy and the safety/tolerability results from this study suggest a favorable risk-benefit profile of RPC1063 that supports a Phase 3 UC program.
Posted in: Oral presentations (2015)
test
Loud & Clear Ben, out!