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I posted something almost exactly along that vein about a minute after I finished reading the article. We'll see if the editors at Seeking Alpha publish it.
I think Leo mentioned using Kevetrin as a mono-therapy in KarinCA's February interview with him...
http://seekingalpha.com/article/2898526-an-interview-with-cellceutix-ceo-leo-ehrlich
Always a good read. I hope Karin is planning a follow up after ASCO to dig into info about some of the other components in development in the pipeline!
Is there any research showing how many index funds cover the Russell 2000 index? And also how much of an initial position they would have to take based on total investment size when a company is first added into the Russell 2000? That could be quite a kicker...
http://www.medicalnewstoday.com/articles/289978.php
Anybody else think of combining a potential cancer stem cell replication blocking mechanism like the graphene flakes appear to offer with Kevetrin's enhancement of the body's own ability to fight off the tumors that have already begun developing? It seems to be an interesting thought...
From article:
Cancer stem cells are precursor cells that can self-renew and differentiate into cancer cells and form tumors. Conventional treatments like chemotherapy and radiotherapy that wipe out the bulk of cancer cells don't always kill cancer stem cells - a residue can survive and grow.
Residual cancer stem cells drive tumor recurrence and metastasis - where cancer spreads to other parts of the body. Metastasis is responsible for 90% of cancer deaths, so any treatment that prevents it will make a huge difference to patient survival.
Cancer stem cells are also thought to drive drug resistance, causing a significant problem for the effective treatment of cancer.
Now, a new study suggests that graphene - a nanomaterial made of extremely thin flakes of carbon that are only one atom thick - may prove to be effective in eliminating cancer stem cells.
Reporting in the journal Oncotarget, a team from the University of Manchester in the UK led by Michael Lisanti, a professor in Manchester's Institute of Cancer Sciences - describes how graphene oxide - a modified version of graphene - selectively targeted cancer stem cells in a range of cancers.
The researchers suggest their findings open the possibility of using graphene with existing treatments not only to shrink tumors but also to prevent recurrence and metastasis.
The team became interested in graphene - in the form of graphene oxide - because it has shown potential as a carrier for drug delivery. The material is stable in water, and readily attaches itself to cell surfaces.
But co-author Dr. Aravind Vijayaraghavan, of Manchester's School of Materials and National Graphene Institute, says they were surprised to find that it is the graphene oxide itself that appears to be an effective anticancer drug. He explains:
"Cancer stem cells differentiate to form a small mass of cells known as a tumor-sphere. We saw that the graphene oxide flakes prevented CSCs [cancer stem cells] from forming these, and instead forced them to differentiate into noncancer stem cells."
However, while he and his colleagues hope these early results will lead to new cancer treatments, they also caution that there is a lot of work to do before graphene is ready for clinical trials with cancer patients.
For the study, the team tested a range of graphene oxide formulations of different flake sizes on cancer stem cells from six types of cancer: breast, pancreatic, lung, brain, ovarian and prostate.
They used a method that is commonly used to test cancer stem cells, called the tumor-sphere assay or test. In the test, a tumor-sphere - a solid spherical, fused mass of cells - develops from a single cancer stem cell. Tumor spheres arising from cancer stem cells are easy to differentiate from clumps of other types of cell.
The researchers found the graphene oxide flakes prevented cancer stem cells from forming tumor-spheres across all six types of cancer, suggesting the method could work for a large range of cancers.
Further investigation revealed that graphene oxide prevents cancer stem cells from forming tumor-spheres by inhibiting several important signal pathways on the cells' surfaces.
The team suggests the results show graphene has potential use in combination therapy, helping to boost results of conventional treatments. Co-author Dr. Federica Sotgia, also of Manchester's Institute of Cancer Sciences, concludes:
"These findings show that graphene oxide could possibly be applied as a lavage or rinse during surgery to clear CSCs or as a drug targeted at CSCs."
The study builds on the pioneering work of two Manchester University physicists - Andre Geim and Kostya Novoselov - who won the Nobel Prize in Physics after successfully isolating graphene from graphite in 2004.
Meanwhile, Medical News Today recently learned of another study where a team showed that camel antibodies can ferry anticancer viruses directly to tumor cells. The findings raise the hope of developing effective gene therapies that target specific cell types.
Written by Catharine Paddock PhD
Yes. Glad I could contribute positively. I posted under my middle name. Please feel free to use the text however you see fit. It was the best I could do in the amount of space allowed.
-Ro
Thanks for the specifics, F1ash! I remembered the numbness and tingling and remembered 1 person discontinuing, but did not remember the dr taking people off treatment well into the treatment due to blood pressure issues. Thankfully the leadership of CTIX has seen fit to revisit the dosing regimen and come up with sufficient quantities that accomplish the task well below the levels that previously caused side effects!
This has been a fun stock to be invested in for the last 2 1/4 years. It's fun seeing the 1000%+ return on the original few thousand shares purchased sub .40!
Good luck to all invested here. Love the pipeline, love the leadership of the company, love the communication, and love the mutual support, calling out, and very powerful DD engine that this board has turned into!
Looking forward to next week's updates. Hoping to hear something on K and P, which are what first brought me here!
I did not want to post "none" as we only know there were no signicant adverse events associated with the drug. at higher dosages and with longer treatments, we know that there were some. i took a liberty by hedging my bet and being willing to err on the side of overly-cautious without having more information at hand. limited to 2000 characters in the comment, and that's how it came out. hopefully it's understandable...
Thanks, Cabel. It's just starting to bother me seeing all these articles saying that T is the first antibiotic discovered since 1987 when this is a patently false statement... I'm even seeing friends of mine reposting the NYT article on Facebook... I guess there's some jealousy involved after following this company and all it's hard work and good decisions, and not having it recognized for what it is...
Just had this published on the NYT article in the comments a few minutes ago. A little more laymen than Astavakra's...
Interesting article, but this compound is at least 3-4 years behind another similar antibiotic that I haven't seen get the attention it deserves. The one I'm talking about just finished Phase 2B trials, was granted QIDP status under the GAIN act, and has had results that match or surpass Daptomycin's 7 day treatment either as a 3 day or as a 1 day course of treatment! Even better, testing indicates that bacterial resistance is extremely unlikely to develop. The company is Cellceutix, and one of their leading drugs in development, Brilacidin, also attacks the bacteria cell walls. Right now, it's going into Phase 3 for severe skin infections, such as MRSA and other resistant superbugs. What to know about it: attacks bacterial cell walls, single dose treatment has proven very effective with minimal drug-related side effects, works just like host defense proteins. It's part of a new class of antibiotics called Defensin Mimetics. Bacteria would need to evolve an entire new cell wall structure to develop immunity, similarly to Teixobactin, only this drug is a lot further along in the approval process! Also, Cellceutix has developed a room-temperature stable compound and are going to start a Phase 2 trial on Diabetic Foot Ulcers shortly! You can Google it and check out some of the company's press releases, including published results! This research is the tip of the iceberg!
When I saw this, I was hoping it'd be about Brilacidin. No luck, and I didn't see a means by which to comment and say that CTIX was already ahead of the game with the an antibiotic that kills bugs without developing resistance. Any of the more educated/literate/knowledgeable on the board wanting to reach out to the author on this, or to Reuters in general, looks like they're keen on the topic right now!!!
Has Teixobactin been discussed on this board? I try to read every post, but at a couple of hundred per day, it's getting a little hard to keep up, let alone remember all the details while also trying to stay gainfully employed... :)
http://in.reuters.com/article/2015/01/07/health-antibiotic-discovery-idINL6N0UM20620150107
-ro
This is one of the lists I was thinking of. only about 15,000 posts ago... alexwv was very enthusiastic early on trying to spread the joy. i think this got itemized more thoroughly at some point into a list of about 15 different items, either by time-frame, or with timeframes that had been indicated in various PRs, presentations, and SEC filings.
Either way, it's a good starting point, and took forever to find thanks to all the great posts between then and now. (side note: when you flip through the comments screensful at a time, you get a very thorough sense of what the stock price was doing... finding the shinier nuggets buried in between is still worth slogging through all the enthusiastic/frantic/annoyed price and volume updates.)
Several months back, somebody was posting a list of about 12-15 catalysts that we had in the hopper with general timeframes. The were a little redundant when posted almost every day, but if they were posted every other Monday or so, I think it'd be a great reminder of why the longs are excited.
We've also had a lot of new eyes on the board recently, so it may be educational for them as well.
My first few thousand shares were bought back in the mid-.30s, but I've been adding periodically due to the science and potential here. For all those concerned with a little pullback here, realize that over the last 3 years, we've enjoyed a 10 bagger here. It's not like this is our first pullback in all that time, either...
Making up future prices is an exercise in creative writing. And making up reasons for pullbacks when we don't really have concrete information is the same. Microcaps can and will be manipulated. Small and Mid-cap will be, as well. And large caps can over-react to rumors and news as well. Systems develop because of patterns and trends. Enough people believing in something make it truth, at least until a new truth comes along. So many computers and algorithms moving so many more shares than ever before can skew volatility. Markets are not rational because the ultimate decision making is still made by people.
Good companies, with good science/technology/models, good leadership, and flexibility have always done better in the long term. With a whole antibiotic/anti-inflammatory platform to develop, a cancer treatment that works alone on at least a couple of forms of cancer and could be beneficial in combination with current main-stream treatments (i.e. it's not the sort of threat that big-pharma is likely to shut down b/c it could make a great sidekick), and a targeted psoriasis drug, and a whole slew of compounds yet to be fully explored, this little biotech has a lot more going for it than most of us can fully appreciate.
Can you really blame our CEO for sounding a little excited at times? Or for being slightly inconsistent in his language or phrasing? IND prep to oversee, CROs to manage, FDA meetings, travel to visit suppliers and potential investors, financials to review and submit, drug development to keep track of, exchange registration and uplisting to worry about, a board of directors to develop, shelf registrations to secure potential future financing, intelligently managing the Aspire deal that's let us get this far, the Aruda issues, conferences and presentations, interviews to prepare for, PRs to develop, and probably a lot more that we don't realize. (Not to mention, he still has a family and theoretically a life outside of CTIX.) He has a lot going on. CTIX has a lot going on.
Much thanks to Big Kahuna, KarinCA, BioHedge, EtradeEdge, Ovidius, the Monolith, INH, Wild, Addict, Gov, the Dane, ShinSekai, Apparition, Dr. J/George, all the TA guys, Smitty, the Toms, the traders, the longs, the excited, and the worried for making this the best board and a good daily read. My apologies to any I forgot. It's a nice community here. Very knowledgeable, willing to share, and diverse. But all here for the same reason.
Cheers to all!
GO CTIX!
-ro
Are you sure you're posting on the right board? That makes absolutely no sense... This stock is near all time high...
Per my understanding, Brilacidin has long half life. That means it stays effective longer. The side effect issues with the Poly trials appear to be from a long term build up, or too high a dosing due to the long half life. This is why cellceutix is running the trials with smaller dosing and shorter dosing period. This is also why it's thought that it might be effective in eye and ear treatments as a topical, as it would stay on the surface and be effective longer.
Kevetrin has a very short half life. This means that it goes in, does its thing, and then doesn't seem to have time to stay in the system to cause adverse reactions.
If my understanding is incorrect, and someone with a more technical background wants to approach this, that'd be appreciated. Thanks!
Any longs out there with a strong opinion on the sustainability/growth of the new revenue stream they're putting together? Looks like they've been getting some lucrative deals, and if they can grow this model a little further as they re-develop a longer term, growing revenue stream... Thanks!
http://ir.achillion.com/eventdetail.cfm?EventID=146699
JMP Securities Presentation going on today. Started a few minutes ago. Slides are up and available. For DD purposes, worth the read through...
In that case, very good timing. enjoy the weekend.
Spades, very impressive timing, unloading at 8.62 when the high of the day is 8.61 so far...
It's almost entertainingly consistent to see the Seeking Alpha hit pieces come out about 48 hours after significant gains in a biotech... Especially the ones that had a lot of shorts get hammered. I've not looked into the background on this author as I did not feel it was worth the time, so maybe it's legit? Most of the articles along the same vein that I've seen have about the same tenor and tone, though...
http://seekingalpha.com/article/2265543-why-big-pharma-has-no-interest-in-achillions-me-too-hepatitis-c-drug?uprof=22
There's a clear standard set for Type 1B with Sovaldi. 12 weeks and minimal side effects. Especially compared to the additional suffering caused by PEG Interferon included treatments that came before it. The next target for competitiveness involves several key areas:
8 week course of treatment
90+% efficacy and no breakthrough
multi-genotype efficacy.
In the US, about 70% of HCV is Genotype 1, per this resource:
http://www.ncbi.nlm.nih.gov/pubmed/22997077
There are between 7 and 11 different identified genotypes recognized worldwide. Certain genotypes are identified in certain regions of the world. In the US alone, an estimated 3.2M people have HCV and statistically 75-80 will develop chronic symptoms and potentially seek treatment.
We're talking a very large potential pie, world-wide...
But trials are going to be particularly expensive in the US b/c blinded trials using Sovaldi arms are going to have to pay $84k per patient for the drug alone, before you factor in additional costs for physicians and trial management operations...
Enjoy the day, all. Even with this big run-up, ACHN has only just barely recovered back to where it was before before the FDA hold threw the stock price down a steep cliff. I firmly believe that there's a good pipeline here. Otherwise they wouldn't be sitting on the amount of cash they have, and they wouldn't have a world class team with significant direct HCV trial experience running their trials.
My poor phrasing. Yes if hold removal request documentation resulted in FDA approving the request to remove the hold. Multitasking while posting. My bad. Still a long slog thru approval of p2 and p1 of various trials.
I do not mind being wrong on the up-side... looks like people positioning themselves in case there's more big news overnight? surprising lack of selloff here toward the end of the day... can they make it 3 days in a row?
If we haven't popped it by lunch, I don't think so. But when something starts running like this a few days in a row, you never know. There should be some healthy profit taking (for those who bought in over the last few days/weeks) but there are a lot of longs who bought in for the pipeline and potential revenue prior to last year's drop who are still waiting to get whole.
The next pop would likely need either huge progress announcements or anticipation/announcement of an acquisition.
as for this being way overvalued based on revenue flow, anybody who has been involved in clinical trials knows just how expensive these sorts of things are. achn does not have anything on the market so are still going off the $200M infusino they got last year. they expect it to get them to significant milestones in development of their current drugs. they're not desperate for funding at the moment, but they're only a couple of years away from that point. either someone picks them up, or they have no problem getting additional funding by issuing another $5M shares at $10 each for another $50M in capital with minimal dilution... they're not in a bad position if you look at the potential revenue based on what Gilead has done and what similar pipelines are being acquired for.
Biotech is rarely rational when it moves big up or down. But it is fun!
3 major catalysts:
1: Yesterday, Idenix got bought for a 250% premium, roughly. others wanted to buy it as well but missed out. They want into HCV market. Achillion is next in line, assuming they get Sovaprevir off hold, and other combo therapies go well.
2: Today, Sovaprevir hold got lifted by the FDA, as the CEO hoped when he gave presentations in March and May.
3: Soon, there may be an acquirer of ACHN either by a JNJ type company who has a massive distribution network worldwide and needs drugs in its pipeline, or by Abbvie or Gilead type companies who want to keep additional kids out of the sandbox.
Those are my thoughts at least... I posted some due diligence links yesterday if you want to read more about the company.
If there's a buyout, i'd expect it to be in the $1.2-$1.5B range, unless bidding escalates it higher. With 96.5M shares outstanding, that'd be a share price of $12-15.
Otherwise, if no buyout, ACHN could be in line for multi-billion dollar revenues in about 2-3 years depending how the pipeline development plays out. Depending on how they structure Phase 3 financing and revenue sharing, could end up being worth about $8-10/share per billion in revenue. A $3B revenue might put them around $25-30 share, if they have good growth potential and anything else in the pipeline for development...
Or if they do not get bought out, and trials do not prove out, could crash and burn... Hard to take that option off the table completely in biotech...
Would love to see some more chatter out here, if possible from those following. Pooling due diligence often makes for best resources. Any other longs or shorts out there wanting to play along and help bring this board back? Any technical analysts been following along?
Hopefully shorts were at least covered on a day like today, else may create some extra downward pressure to leverage back some gains. Could be a little chaotic for the next week as we work to fill either gap: today's big jump or September's big drop...
If FDA approval is received, the company is about 3 quarters behind on one of its studies but probably a couple quarters ahead of where they would have been on other lines of research based on the priority shift...
The largest concern might be the burn rate. CEO says there is enough to get thru to key points in the research to prove the products. $140M is still over $1.40 per share in valuation... But burn rate has been over $50m per year... Well over...
Abbvie makes less sense than jnj unless something in their pipeline isn't panning out... I have not followed them much in the last year and change though... Anybody here familiar with any others with Hcv aspirations and cash flow needs three years out? Pfe might have deep enough pockets and sufficient needs. Eli Lilly too?
Any articles or pr's on non-disclosure agreements? Deals like Pharmasset's can happen quick though...
Not sure on the severity of the enzymes that were elevated. Would have to revisit the articles that discussed it to determine how significant an adverse event it was deemed to be. was serious enough to get the FDA's attention though.
A little suspicious that the CEO change happened not long before the trial was put on hold. I wonder if he was pushing something against popular demand within the company's research division...
The new CEO was touting that they have their own 3 part combo to rival the Pharmasset/Gilead product... Here's a good release discussing their pipeline.
http://ir.achillion.com/releasedetail.cfm?releaseid=831214
This summarizes the response timeframes anticipated late last year. Hopefully there will be resolution shortly. Though it does sound like there is a discrepancy of opinion between what the company things should remove the hold and what the FDA thinks...
http://www.biotechnologyevents.com/node/7251
They also picked up Kevin Kucharski, who ran Pharmasset's clinical operations. That tends to mean he'll eventually reassemble the substantive portion of the team that did the trial management for Pharmasset, and prior...
http://www.thestreet.com/story/11923750/2/achillion-appoints-dr-david-apelian-as-chief-medical-officer-and-expands-clinical-operations-team.html
Disclosure: I bought in last summer, and tripled down after the steep decline and a couple of dead cat bounces. I plan on being long until either a deal is announced or they get going on their own, which will be a much longer, slower ride.
Regulatory hold Sovaprevir during a combination trial. fda didn't like an elevation of liver levels. i think it was in combo with an HIV drug. the good thing is they have additional compounds and drugs in their pipeline that they feel will still outperform Gilead's with regards to a shorter treatment time (8 weeks vs 12 of Gilead), with better than 90% cure rate across all types of HCV, not just the type that Gilead's product gets 100% results against. I think Deshpande was indicating a $50k treatment course in comparison to Gilead's $84k.
curious now with Idenix's acquisition by Merck how the other "me too" hcv pharmas will do... With about 100M shares outstanding, a $1.2B acquisition price would result in a $12 price tag. $2B would be $20.
Gilead acquired Pharmasset for hits HCV drug for over $10B... And may make that back this year alone... Shows you what being first to market is worth...
About 1/2 of the companies on BK's list are big around here: Novartis, GSK, Merck/Shering Plough, JNJ, and Pfizer employ/ed most of our friends. My wife prefers small pharma, having worked in several places with the same "team" of people she worked with when managing Pharmasset's 7977 Phase 3 study before Gilead bought them out. Big pharma may have the deeper pockets, but the bureaucracy makes it almost impossible to get anything done. I'm on the investing side of things, and have immensely enjoyed the chatter from all the contributors here: longs, shorts, flip-floppers, cheerleaders, scientists, analysts, realists, educators, resources, jesters, TAs, doctors, and traders since first taking up a position here in late 2011...
Thoughts and prayers with kelt and teedle, and all others we're hoping CTIX is able to make a difference for both directly and indirectly...
And, of course, GO CTIX!
Interesting, re: JNJ and ABSSI... And potentially CTIX?
http://www.furiex.com/pipeline/discoverydevelopment-pipeline/fluoroquinolone/
JNJ is big in Jersey, as is its Janssen Pharma research facility. (my underline below)
JNJ-Q2
JNJ-Q2 is a Phase III ready novel broad-spectrum fluoroquinolone antibiotic being developed for the treatment of acute bacterial skin and skin-structure infections and community-acquired pneumonia. JNJ-Q2 is effective in treating methicillin-resistant staphylococcus aureus (MRSA) infections. We are developing both oral and intravenous, or IV, formulations of this compound to allow physicians to select the most appropriate method of delivery. Furiex has completed Phase II clinical trials using the oral formulation for acute bacterial skin and skin-structure infections.
Furiex has a license agreement with Janssen Pharmaceutica N.V., under which Furiex has global rights for development and commercialization of the product.
JNJ-Q2 is a novel fluorinated 4-quinolone. In addition to MRSA, it exhibits a range of antibacterial activities in vitro that support its potential as a new agent for the treatment of skin and respiratory tract infections. In recent laboratory studies, JNJ-Q2 was evaluated for its antibacterial potency against bacterial strains known to be skin and respiratory tract pathogens, including strains exhibiting fluoroquinolone resistance phenotypes. Against a set of 118 recent clinical isolates of streptococcus pneumoniae, including fluoroquinolone-resistant variants, JNJ-Q2 was 32-fold more potent than the popular marketed antibiotic moxifloxacin. Against a collection of 511 recently collected MRSA isolates, including 409 ciprofloxacin-resistant strains, JNJ-Q2 was at least 16-fold more potent than moxifloxacin.
In further studies, JNJ-Q2 exhibited bacteria killing activities at lower doses against clinical isolates of streptococcus pneumoniae and MRSA compared to moxifloxacin. JNJ-Q2 also demonstrated a lower potential for resistance development than that for currently marketed fluoroquinolones ciprofloxacin, levofloxacin and moxifloxacin.
The mechanism of action of fluoroquinolones is against specific bacterial enzymes called topoisomerases, typically topoisomerase II (or DNA gyrase) and topoisomerase IV. Some marketed fluoroquinolones target a single topoisomerase more potently than they do the other. The improved activity of JNJ-Q2 is due to its equipotent activity against both of these topoisomerases instead of just one. Furthermore, this dual activity against both target enzymes is consistent with a lower propensity for resistance selection.
Another reason we believe this fluoroquinolone will have a lower propensity for resistance selection is because preclinical studies have shown that JNJ-Q2 is not transported out of the bacterial cell by efflux pumps. Efflux pumps (such as Nor A) are typically implicated in bacterial resistance.
JNJ-Q2 was tested in a Phase II clinical trial comparing the efficacy, safety and tolerability of JNJ-Q2 with linezolid (Zyvox®). The study used a non-inferiority design to test the efficacy of JNJ-Q2 relative to linezolid. One hundred sixty-one patients with ABSSSI received oral treatment with either JNJ-Q2 (250 mg twice daily) or linezolid (600 mg twice daily) for 7 to 14 days. JNJ-Q2 was statistically non-inferior to linezolid for all clinical test-of-cure and short-term follow-up endpoints in the ITT population. At seven days of therapy, 44.6 percent (37/83) of patients receiving JNJ-Q2 were assessed as cured, compared with 37.2 percent (29/78) of patients receiving linezolid; at 10 to 14 days of therapy, 66.3 percent (55/83) of patients receiving JNJ-Q2 were assessed as cured, compared with 61.5 percent (48/78) of patients receiving linezolid; and at the traditional test-of-cure endpoint (short-term follow-up done 2 to 14 days after treatment was completed) 83.1 percent (69/83) of patients receiving JNJ-Q2 were assessed as cured, compared with 82.1 percent (64/78) of patients receiving linezolid. JNJ-Q2 had a favorable safety profile and was well tolerated. Serious adverse events were infrequent in both treatment groups. Nausea and vomiting were more frequent with JNJ-Q2 than linezolid, however, symptoms were mild for both treatment groups. Nausea rates were 22.9 percent for JNJ-Q2 and 11.4 percent for linezolid; vomiting rates were 12.0 percent JNJ-Q2 and 6.3 percent for linezolid. The vast majority of these events occurred on day one to two of treatment and were self-limiting.
JNJ-Q2 was tested in a Phase I pharmacokinetic study in eight healthy volunteers designed to measure the lung penetration of JNJ-Q2, an accepted predictor of efficacy for the treatment of community-acquired pneumonia. Volunteers were dosed orally with JNJ-Q2 and then underwent a bronchoscopic procedure to measure pulmonary drug levels. Levels of JNJ-Q2 in epithelial lining fluid of the lung were, on average, about 50-fold higher than levels in plasma, and levels in alveolar macrophages (which are inflammatory cells in the air sacs of the lung) were 150-fold higher, on average, then levels of JNJ-Q2 in plasma.
We also have results from a double-blind randomized trial where patients with severe community acquired bacterial pneumonia (CABP) received intravenous treatment with JNJ-Q2 (twice daily) versus moxifloxacin (once daily), and were switched from IV to oral therapy as their conditions improved. Although we enrolled only 32 patients, the data from this small study gives us valuable qualitative information about the drug's efficacy and tolerability in this very ill patient population. The results were encouraging, with a clinical cure rate (primary endpoint) of 87.5% for patients receiving JNJ-Q2 versus 81.3% of patients receiving moxifloxacin. For the secondary endpoint of clinical stability at day 4 (determined by patients' vital signs and respiratory status) 50.0% of patients receiving JNJ-Q2 met the endpoint compared with 43.8% of patients receiving moxifloxacin.. Both the IV and oral formulations of JNJ-Q2 had excellent tolerability and safety profiles, with no nausea, vomiting or serious adverse events reported in this treatment arm. These Phase II clinical trial data for CABP, taken together with the excellent lung penetration data, support phase III-readiness for a CABP indication.
View a list of Janssen and Furiex publications.
Fluoroquinolone clinical trials can be accessed at www.clinicaltrials.gov.
Furiex is seeking a development partner for JNJ-Q2. For more information, please view the JNJ-Q2 partnering opportunity selling sheet or contact us.
Fluoroquinolone
The worldwide antibiotics market generated sales of $42 billion in 2009 representing 5 percent of the global pharmaceutical market. The fluoroquinolone class generated $7 billion in global sales. Despite availability of a broad range of treatment options, the growth in antibiotic resistance among potentially life-threating pathogens is creating an increased need for novel products and new classes of antibiotics. Hospital stays for MRSA infections have more than tripled after 2000 and increased nearly ten-fold after 1995, with a 30 percent increase occurring from 2004 to 2005 . Although MRSA had previously been a hospital-acquired pathogen, its incidence has been rising in the community, and it has become the most frequent cause of skin and soft tissue infections presenting to emergency departments in the United States [1]. There are a limited number of antibiotics approved to treat MRSA, and their frequent usage has led to emergence of multi-drug resistant bacteria. Thus, there is significant unmet medical need for new antibiotics such as JNJ-Q2 that provide flexible (hospital and outpatient) treatment options for MRSA.
For those interested in what young Mssrs. Ehrlich and Menon are doing at NanoAntibiotics, an email came out today...
NanoAntibiotics Provides Update on its Novel Efflux Pump Inhibitor
Surfside, FL—March 27, 2014 -NanoAntibiotics (OTC: NNAB) (the “Company”), a development stage nano-biotechnology company focused on the discovery, development, and commercialization of new anti-infective drugs to meet the growing clinical need created by multi-drug resistant bacterial pathogens, is pleased to report successful preliminary in vitro results on its novel efflux pump inhibitor.
The current study involved testing for efflux pump inhibition in Staphylococcus epidermis, a common gram-positive bacterium. In the study, the bacteria were incubated with a tracer dye to observe real time monitoring of its membrane transport systems. The results showed that the bacteria treated with our efflux pump inhibitor demonstrated retention of the tracer dye (showing they were not able to expel the dye), whereas no dye retention was observed in the untreated bacteria. Further studies are ongoing.
The company is excited about these results and its continuing progress to identify and optimize key nano efflux pump inhibitors to “target” and “block” some of the most deadly gram-positive and gram-negative bacteria.
Bacterial Efflux Pumps:
Bacteria efflux pumps are intrinsic defense mechanisms that expel antibiotics before they reach their target and kill the bacteria. These pumps reside in bacterial cell walls and are a leading cause of multi-drug resistance. There are currently no anti-microbial drugs in use to inhibit the activity of these efflux pumps. There is a need for an effective pump inhibitor which would restore the potency of once effective antibiotics which have been rendered insensitive.
About NanoAntibiotics, Inc.
NanoAntibiotics is a developmental stage nano-biotechnology company focused on the development and commercialization of novel therapeutics for multi-drug resistant gram-positive and gram-negative bacteria (also known as Superbugs).
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause NanoAntibiotics’ actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. NanoAntiobiotics has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are NanoAntibiotics’ need for, and the availability of, substantial capital in the future to fund its operations and research and development. The fact that NanoAntibiotics’ compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in NanoAntibiotics’ filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. NanoAntibiotics undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
If lower dose B administered, one of the goals was to reduce the amount of side effects. So that would not be an available tool for determining which patient is receiving which drug.
Also, not every patient experiences side effects. For those with no side effects, no way to determine which antibiotic administered. And it makes sense that "dosing" would continue for the exact same amount of time for each patient that way they would b receiving identical looking dose each of the 7 days, whether Dapto, B, or saline/placebo...
Just looking at the link you referenced, looks like loss on settling on a debt, and loss on conversion of preferred stock. and a gain on forgiveness of debt. looks like a lot of accounting to clean up the books. should lead to cleaner books going forward. i am only here a few weeks, and like the idea behind the tech they acquired (though think the name is kitchy.) Any longs willing to chime in on their perspectives? this is an extremely quiet board compared to what i'm used to with my other main ihub board... thanks!