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  • Cempra: Reviving The Antibiotic Market [View article]
    Some links

    http://bit.ly/1y3aq0t

    http://bit.ly/178uQhK

    Comparative Mechanistic Studies of Brilacidin, Daptomycin and the Antimicrobial Peptide LL1
    http://bit.ly/1y3aq0x
    Mar 24, 2015. 07:13 PM | Likes Like |Link to Comment
  • Cempra: Reviving The Antibiotic Market [View article]
    Good overview. Cempra is on right path. Another biotech company that is doing innovative work on the ABX development front is Cellceutix. Its lead compound, Brilacidin, and other Host Defense Protein-Mimics (HDP-M), stands a strong chance of becoming an effective Super Bug-Killer. The early clinical work was done at U Penn (PolyMedix) under chem/quant visionaries (William DeGrado, Michael Klein, Richard Scott, Gregory Tew). Cellceutix acquired rights to Polymedix IP and other assets in 2013. The therapeutic approach mimics the immune system's natural response with the drug perforating bacterial walls quickly. As a result of this mechanism (lysis), resistance is much less likely to develop. The FDA already has granted Brilacidin QIDP status and, unlike other ABXs that have shown potential still in pre-clinical stages (e.g., Teixobactin), it's in human trials. Its Ph 2b results were comparable to Daptomycin for ABSSSI but as a single dose (not 7 days, like Cubicin). It also is active against MRSA infections. Work being done by Cellceutix at Fox Chase Medical Center on other gram negative bugs--the hardest to kill--is also very promising. HDP-Mimics, in general, have anti-inflammatory and anti-biofilm properties, with some compounds effective against malaria and drug-resistant strains of tuberculosis ... The company will be providing an update on aspects of its ABX pipeline at ECCMID 2015, to be held in Copenhagen, at the end of April. Here's hoping companies like CEMP and CTIX both can get their ABX to market.
    Mar 24, 2015. 04:03 PM | Likes Like |Link to Comment
  • An Interview With Cellceutix CEO Leo Ehrlich [View article]
    Bolo... other CTIX (developed originally by Polymedix) defensin-mimetic compounds show efficacy as to TB. I'm sure we'll hear more when the company presents at the end of April in Copenhagen at the ECCMID http://www.eccmid.org

    xx

    PolyMedix’s lead defensin-mimetic antibiotic compound, PMX-30063, is currently in Phase I human clinical testing. On December 10, 2008, PolyMedix announced the results and successful outcome of the first Phase I human clinical study with PMX-30063. PolyMedix plans to develop PMX-30063 as a pan-Staph agent, for the broad treatment of many forms of Staphylococcus infections. The compounds described in the poster represent new molecules for possible development as potential treatments for tuberculosis, which share the same mechanism of action as PMX-30063.

    The poster describes studies with several molecules spanning several chemical structural series and screening by the Tuberculosis Antimicrobial Acquisition and Coordinating Facility (TAACF). The studies used in vitro assays to measure susceptibility against H37Rv strain of M. tuberculosis and cytotoxicity to monkey VERO cells. Three of the tested antimicrobial compounds exhibited high antimicrobial activity (IC90 < 5 µg/ml) against the H37Rv strain of M. tuberculosis, with selectivity greater than 30-120 fold for TB versus mammalian cells. The synthetic small molecules rapidly killed the M. tuberculosis cells in vitro. These compounds are stable and not immunogenic, and the results indicate they may be successful treatment for MDR and XDR strains of M. tuberculosis.

    http://bit.ly/1z1NVJw
    Feb 9, 2015. 03:40 PM | 4 Likes Like |Link to Comment
  • Cellceutix: Why An Uplisting Is Not Possible Right Now [View article]
    Science first last and always -- that's what's driving this company onward and upward. The rest is but commentary... And yours is highly selective and obviously agenda-driven. Watch and wait. CTIX is going higher....... Perhaps it'll be the Dana Farber update on Kevetrin, or maybe the push forward with Brilacidin. Or perhaps another surprise. Good luck shorting this stock. Imo you'll need it.
    Feb 6, 2015. 02:57 PM | 8 Likes Like |Link to Comment
  • Cellceutix Undervalued By 90+%; Expect A Short Squeeze Soon [View article]
    valid points and i happen to agree... i think all three will be addressed by end of year if not months sooner... while CTIX has benefited from being small and nimble (the PolyMedix acquisition a perf example/a larger company would have had too many hoops to jump thru before pulling the trigger), the time is coming for them up their profile by uplisting, getting a board (oversight). funding i don't think will be a problem. they'll partner on Brilacidin at least for ABSSSI. the antibiotic space is hot w deals, tons of public/governmental pressure -- worldwide -- to get new drugs to market to improve/save lives. Brilacidin gets First in Class and Fast Track designation imo from FDA.
    Jan 30, 2015. 03:38 PM | 1 Like Like |Link to Comment
  • Cellceutix Undervalued By 90+%; Expect A Short Squeeze Soon [View article]
    here here karin - the Polymedix deal (steal) is game-changing for the company. they were ahead of the times, the PYMX researchers, "supercomputing" their way to tackle bad bugs. circa 2016, patients and CTIX Shareholders will reap the rewards. below is some commentary of mine on Brilacidin's approval odds for ABSSSI.

    1) Success rates by stage of clinical trial
    2) FDA anti-infectives advisory committee's unanimous votes on ABSSSI drugs

    recent funding/legislative pushes (allocating more $ to NIH; putting more pressure on FDA to expedite drug development, esp antibiotics) also should be factored in, increasing chances for approval. but of course it's the clinical results to date that speak loudest... the solid science behind Brilacidin----efficacy comparable/slightly better to Daptomycin, current best in class; a better safety profile than single-dose Orativancin.

    1) CLINICAL TRIAL DATA (SUCCESS RATES)

    a) Article: Can Clinical Trial Changes Increase Drug Approvals (Jan 2014)
    http://bit.ly/1yfyJbt

    EXCERPT
    They [citing this January 2014 study in Nature Biotechnology: "Clinical Development Success Rates for Investigational Drugs"... full access behind a pay wall] found the likelihood of approval (LOA) from Phase 1 to be about 10% for all indications, and 15% for lead indications. From Phase 1 to Phase 2 success rates are about 65%; from Phase 3 to new drug applications success rates fall again between 60% and 68%. The biggest drop off comes moving from Phase 2 to Phase 3, with only 32% of all indications advancing.

    The numbers are somewhat less encouraging than previous studies. DiMasi et al. and Kola et al. found higher LOA rates from Phase 1 (19% over 50 years and 11% over 10 years respectively), but both studies looked at far fewer companies, and the current study purposefully considered the success of all indications, rather than just a lead indication.
    [...]
    They [study authors] believe that changing trial design—especially communication with regulators at the end of Phase 2— could help improve rates. The authors point out that heterogeneous trials are far more likely to fail than trials built on specific biomarkers. “The adoption of adaptive trial design may facilitate the identification of targeted subsets of patient populations before study completion,” [e.g., M-ITT] they suggest. “Greater flexibility with alternative surrogate endpoints,… and improved methodologies for assessing patient benefit-to-risk are some areas where improvements can be made.” [SEEMS LIKE CTIX IS DOING IT RIGHT]

    b) Article: A Way To Increase Drug R&D Success Rates (Feb 2014)
    http://onforb.es/1yfyJbu

    EXCERPT
    They [the Jan 2014 Nature Biotechnology article authors] have analyzed 2003 – 2011 data from 835 companies including large pharma/biotech, small to mid-sized pharma/biotech, and emerging biotech. Their data set includes 4,451 drugs with 7,372 independent clinical development paths (the larger number of the latter is due to companies exploring a single compound for multiple indications such as for different types of cancer). They have analyzed the data in many ways, including survival rates by therapeutic area, by molecule type (small versus biologicals) and by lead or non-lead indication. For a drug R&D aficionado, the data are fascinating.

    What was especially interesting to me was the breakdown of survival rates by clinical stage. The stage of greatest compound attrition was in phase 2 – the place where compounds are first tested in people with the disease you’re trying to treat. The data show that only 32% of compounds entering phase 2 make it into phase 3. This is not surprising. While a compound might have been tested in animal models of disease, phase 2 is the first real test of the original concept of the research program. For me, phase 2 was the most important step in the development of a potential new drug, and positive results from these clinical proof-of-concept (POC) studies were always the most memorable.
    [...]
    Survival gets better once a compound makes it to phase 3, where 60% advance to regulatory filing.
    [...]
    However, the main surprise to me in reading this paper was the high rate of attrition in phase 1. Only 64% of compounds are making it through this stage.
    [...]
    Why then don’t more compounds clear phase 1? At times, the in vitro and in vivo preclinical models don’t predict what will happen in humans. But this shouldn’t happen 36% of this time. This should be a relatively rare occurrence if the candidate selection criteria are vigorous and enforced. I can only speculate as to why these number are not higher. As this survey includes a wide variety of R&D organizations, it could be that there are major differences in the rigor of the preclinical studies conducted by different organizations. [AND THIS IS WHERE CTIX BENEFITS FROM ALL THE EARLIER HIGHQUALLITY PYMX WORK ON ITS DEFENSIN MIMETICS PLATFORM, THE NIH AND DEF DEPT GRANTS ETC]. For example, small companies and start-ups might not have the resources, expertise or time to conduct a lot of upfront studies. I do recall that in my time in big pharma, some early development compounds that we reviewed as potential licensing candidates were missing studies that we would have routinely done at that point.

    2) 2014 FDA ABSSSI VOTES (UNANIMOUS)

    Another good sign for Brilacidin once up for approval (again, odds look good) is that, in 2014, the FDA's Anti-Infective Drug Advisory Cmte vote -- which is not binding but typically tips the approval in one direction or the other (thumb up/thumb down) -- was unanimous in their approval for Dalbavancin/Tedizolid… same, the advisors were unanimous, in their support of Astella’s anti-fungal (Cresemba for aspergillosis). [RECALL FOX CHASE RESEARCHERS ARE WORKING WITH CTIX COMPOUNDS SHOWING ANTI-FUNGAL AND GRAM-NEGATIVE PROPERTIES; SEE LINKS BELOW] The cmte voted 8-2 with one abstention on whether to recommend it for mucormycosis, a second indication. (Note both indications had earlier been granted QIDP status.)

    Article on PYMX (without mentioning the company) anti-fungal research
    Defensin Mimetics Show Antifungal Activity (January 2012)
    http://bit.ly/1yfyJbw

    http://bit.ly/1yfyJbB

    Article: Which of FDA's Drug Advisory Committees Were Most Active in 2014
    http://bit.ly/1yfyLQz

    Anti-Infective Drugs Advisory Committee (AIDAC)
    Total Meetings in 2014: 3
    Breakdown of Votes:
    3 Yes votes:
    • 12-0 for Durata Therapeutics’ dalbavancin for acute bacterial skin and skin structure infections (half-day meeting)
    • 14-0 for Trius Therapeutics’ tedizolid for acute bacterial skin and skin structure infections (half-day meeting)
    Jan 30, 2015. 03:18 PM | 5 Likes Like |Link to Comment
  • Cellceutix Undervalued By 90+%; Expect A Short Squeeze Soon [View article]
    some of the science behind Brilacidin -- just a taste
    also recall that the two anti-infectives for ABSSSI in 2014 were approved, with earlier unanimous votes by the advisory cmte... then there's obama's push to double antibiotic funding, other pending legislation that would further fast-truck drug development. the need for new SuperBug killers is great and CTIX with Brilacidin looks as close to a sure thing as possible--admittedly pending phase three.
    some more approval data for you -- note infectious diseases category
    http://bit.ly/1yeaGtx
    http://bit.ly/1yeaGtB
    http://bit.ly/1yeaIBB

    so your thoughts?

    ON BRILACIDIN (and related defensin-mimetics compounds)

    Chemical Mimetics of Host Defense Proteins (Sept 2012)
    http://bit.ly/178uQhK

    A Phase 2 Randomized, Double-Blinded, Dose-Ranging, Active Controlled Efficacy and Safety Evaluation of Brilacidin (PMX-30063) for the Treatment of ABSSSI Caused by Staphylococcus Aureus (SA)
    http://bit.ly/1zE7qgm

    Activity of Brilacidin (PMX-30063) Against Drug Resistance Staphylcocci
    http://bit.ly/1zE7o87

    Metabolism and Excretion of Brilacidin (PMX-30063): A Novel Class of Antibiotics
    http://bit.ly/1zE7o8d

    Small, Nonpeptidic Mimics of Host Defense Proteins Exhibit Potent Killing Activity Against Gram-Positive and Gram-negative biofilm cultures
    http://bit.ly/1zE7qgt

    Nonpeptidic Mimics of Host Defense Proteins as Antimicrobial Agents for E Coli, Campylobacter and Other Foodborne Pathogens
    http://bit.ly/1zE7qwJ

    Nonpepditic Mimics of Host Defense Proteins as Antimicrobial
    Agents for Category A and B Biowarfare Pathogens
    http://bit.ly/1zE7o8n
    Jan 30, 2015. 08:40 AM | 6 Likes Like |Link to Comment
  • Cellceutix Undervalued By 90+%; Expect A Short Squeeze Soon [View article]
    i think you missed the snark in Karin's excellent article. it wasnt to defend shorts (hazard the thought) but to defend a very promising company with a robust pipeline. the last two Seeking Alpha pieces cited were incredibly one-sided and absent any real Due Diligence. karin is just getting the facts out there. that's all. and as the facts become more widely known, CTIX will no longer be the hidden giant-in-the-making many of us shareholders believe. the science is simply strong with this one. wait and see.
    Jan 29, 2015. 05:37 PM | 5 Likes Like |Link to Comment
  • Cellceutix: A December To Remember May Turn Into A 2015 To Forget For CTIX [View article]
    Dear Mr/s Bleecker
    Care to comment on any of the following links below? Some of the actual science behind Brilacidin (QIDP designation by FDA for ABSSSI) via CELLCEUTIX's asset purchase of Polymedix. It might take some time, putting on the thinking cap, but after performing additional DD, I think (hope) you'll see the company has legs -- even if the depreciating value of some of the office furniture seems to have caused you considerable concern. Thought also worth posting another take on Kevetrin, since a healthy exchange is always advisable when it comes to investing----knowing what you own----no?
    Regards, and look forward to your take on the merits of the science.

    ON KEVETRIN (another take)

    Cellceutix Surged As Much As 17% After Lesion Clearance In Metastatic Cancer
    http://bit.ly/1zE7nRP

    ON BRILACIDIN (and related defensin-mimetics compounds)

    Chemical Mimetics of Host Defense Proteins (Sept 2012)
    http://bit.ly/178uQhK

    A Phase 2 Randomized, Double-Blinded, Dose-Ranging, Active Controlled Efficacy and Safety Evaluation of Brilacidin (PMX-30063) for the Treatment of ABSSSI Caused by Staphylococcus Aureus (SA)
    http://bit.ly/1zE7qgm

    Activity of Brilacidin (PMX-30063) Against Drug Resistance Staphylcocci
    http://bit.ly/1zE7o87

    Metabolism and Excretion of Brilacidin (PMX-30063): A Novel Class of Antibiotics
    http://bit.ly/1zE7o8d

    Small, Nonpeptidic Mimics of Host Defense Proteins Exhibit Potent Killing Activity Against Gram-Positive and Gram-negative biofilm cultures
    http://bit.ly/1zE7qgt

    Nonpeptidic Mimics of Host Defense Proteins as Antimicrobial Agents for E Coli, Campylobacter and Other Foodborne Pathogens
    http://bit.ly/1zE7qwJ

    Nonpepditic Mimics of Host Defense Proteins as Antimicrobial
    Agents for Category A and B Biowarfare Pathogens
    http://bit.ly/1zE7o8n
    Jan 23, 2015. 04:06 PM | 12 Likes Like |Link to Comment
  • Cellceutix up on report of positive results in clinical trial [View news story]
    read more about why all the Kevetrin excitement is justified

    Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived (May 2013)
    http://seekingalpha.co...
    Kevetrin: A Novel Genetic Cancer Treatment (April 2013)
    http://1drv.ms/1Aqs6Gk
    Drugs Aim to Make Several Types of Cancer Self-Destruct (Dec 2012)
    http://nyti.ms/1ukDIWJ
    Targeted Cancer Therapies: Awakening the "Guardian of the Genome" (OncLive, Dec 2011)
    http://bit.ly/1ukDGxT
    The Green Baron says Cellceutix' Guardian Angel will make you rich! (June 2011)
    http://bit.ly/1ukDGxU
    Jan 20, 2015. 01:58 PM | 2 Likes Like |Link to Comment
  • Cellceutix Reports Spleen Lesion 'Disappears' in Patient With Metastatic Stage 4 Ovarian Cancer in Clinical Trial of Anti-Cancer Drug Kevetrin [View article]
    read more about kevetrin, why all the excitment is justifiable

    Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived (May 2013)
    http://bit.ly/1ukDI9c

    Kevetrin: A Novel Genetic Cancer Treatment (April 2013)
    http://1drv.ms/1Aqs6Gk

    Drugs Aim to Make Several Types of Cancer Self-Destruct (Dec 2012)
    http://nyti.ms/1ukDIWJ

    Targeted Cancer Therapies: Awakening the "Guardian of the Genome" (OncLive, Dec 2011)
    http://bit.ly/1ukDGxT

    The Green Baron says Cellceutix' Guardian Angel will make you rich! (June 2011)
    http://bit.ly/1ukDGxU
    Jan 20, 2015. 01:53 PM | Likes Like |Link to Comment
  • Cellceutix Overvalued By 90-99% [View article]
    read up Mr Sharvey... again, CTIX has already granted QIDP for B-ABSSSI and likely will for B-OM... with additional expedited designations likely.
    See pg 7 of link below... a QIDP classified drug already meets criteria for Fast Track and Expedited Approval.
    FDA Industry Guidance
    http://1.usa.gov/1yMWN6g

    Brilacidin is what exactly the data shows it to be, a novel anti-infective therapeutic agent that the world is hungering for. And it has been years in the making (under the guidance of National Academy Science member, William DeGrado, at UPENN / PYMX initially).

    The just-released confidence interval data show it's *better* than Daptomycin at **1-day dosage**, the Cubist product, which again, Merck just spent a cool $8.4bn for.

    Some more relevant links for those who actually like to perform DD.

    FDA on need for New Antibiotics
    http://1.usa.gov/1rXxsbr

    FDA on need for speeding Novel Drug Approvals
    http://1.usa.gov/1rXxsbv

    Hatch/Bennet Bill for Expedited Antiobiotic Drug Approval
    http://bit.ly/1rXxsbA

    And that's just a taste of the perfect storm brewing for a CTIX and its Brilacidin platform... if you really want to envision the future, look into CTIX polycides ---- their industrial applications (per the Tufts study below). It potentially could replace Triclosan, which is pretty much everywhere, in everything, but increasingly coming under scrutiny as to efficacy/safety.

    Hope you realize that Brilacidin is here to stay, first/best in class. Patients and investors (well, at least those who don't short) will benefit greatly.

    Triclosan
    http://bit.ly/1rXxsbC

    PYMX (now CTIX) compound better at killing bugs (as to surgical sutures) than Triclosan
    http://bit.ly/1rXxsrS

    PYMX IP Portfolio which is now all CTIX's
    http://1.usa.gov/1rXyrZa
    Jan 5, 2015. 10:18 AM | 6 Likes Like |Link to Comment
  • Cellceutix Overvalued By 90-99% [View article]
    Cellceutix Releases Confidence Interval Statistics Showing Clinical Success Rates for Brilacidin in Treatment of ABSSSI

    BEVERLY, MA–(Marketwired – Jan 5, 2015) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to release additional statistics from the Company’s recent, successfully completed Phase 2b trial of Brilacidin, Cellceutix’s lead drug in a new class of antibiotics called defensin-mimetics, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

    On October 23rd 2014, Cellceutix announced positive top-line results for the randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of ABSSSI. The FDA-defined primary endpoint of at least 20% reduction in area of the ABSSSI lesion, relative to baseline, was achieved in all study populations at 48-72 hours, for each of the three Brilacidin dosing regimens and the active comparator, daptomycin.

    In treated patients assessed at 48-72 hours, 47/51 (92.2%), 46/48 (95.8%), 51/52 (98.1%), and 45/48 (93.8%) achieved clinical success in the Brilacidin 0.6 mg/kg single-dose group, Brilacidin 0.8 mg/kg single-dose group, Brilacidin 1.2 mg/kg 3-day group, and daptomycin 7-day group, respectively.

    The corresponding 95% confidence intervals around the clinical success rates were 85-100%, 90-100%, 94-100%, and 87-100%, respectively. It is important to note that this Phase 2b study was not powered for statistical comparisons. Nevertheless, because the 95% confidence intervals overlap, these clinical success rates are considered similar. Regulators prefer the use of 95% confidence intervals, rather than p-values, when comparing efficacy rates in clinical trials, as they can provide more information than p-values. A much larger study — such as the kind done in phase 3 — would have the power to make statistical comparisons.

    On December 22nd 2014, Cellceutix also reported positive results in the Microbiological Intent-to-Treat (MITT) population. This is an important population that includes patients with baseline cultures positive for common ABSSSI pathogens, such as Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA). In this population, Clinical Success rates at 48-72 hours were again very high (above 90% across all treatment groups) and again very similar (with overlapping 95% confidence intervals).

    “These results are outstanding across all dosing regimens,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. ”The Phase 2 data showing a one-time dose of Brilacidin achieving statistically comparable results to a seven-day dosing regimen for the current gold standard treatment for ABSSSI is fantastic and reason for great optimism going forward.”

    Additional updates on Brilacidin and other drugs in the Cellceutix pipeline will be given at the Biotech Showcase 2015 conference being held at Parc 55 Wyndham San Francisco (Union Square) in San Francisco, CA on January 12-14, 2015. Cellceutix will be presenting at the conference on Monday, January 12 at 2:00 PM PT in Room Powell.

    - See more at: http://bit.ly/1F9AfUQ
    Jan 5, 2015. 07:24 AM | 10 Likes Like |Link to Comment
  • Cellceutix Overvalued By 90-99% [View article]
    Is this all you have to say? Come on. It's okay to debate merits of a company like CTIX, but please cast a wider net in your analysis-commentary. Are you saying none of the above feedback is worth a response from you as author? In past comments you made about CTIX, in relation to uplisting, you poopooed those who were shallow as to research... What's your take on this?

    http://bit.ly/178uPKK

    And the potential of this platform? (Antiinfectives)

    http://bit.ly/178uPKM

    http://bit.ly/178uQhK
    Jan 2, 2015. 09:23 PM | 6 Likes Like |Link to Comment
  • Cellceutix Overvalued By 90-99% [View article]
    Weak. So incredibly weak. Lots of free association and grape to watermelon comparisons... And a .70c price target??? GTFOOH. Have you even looked at the pipeline? Anyone who follows your take, like lemmings to the edge of cliff, deserves what they get.
    For starters, given the complete absence of real content, you might want to research what CTIX picked up in a brilliant acquisition of PYMX. Its defensin-memetics platform is going to deliver, and soon. The FDA just granted QIDP status for Brilacidin ABSSSI and its like Brilacidin for Oral Mucositis will get similar special treatment. Then there is Kevetrin for solid tumors, with an update set for Jan 12th. It's shown safe dosing escalation (10th cohort) and P53 activation -- but then again you probably don't know what that means. Seriously. It's okay to be skeptical, even short (TG for disclosure rules on S Alpha), but not in the way you just did. Zilch as to real due diligence. Mainly innuendo as to management motivations and character. I look fwd to your updated article in a few weeks. By then maybe you'll have done some homework after having really taken it in the, ahem, shorts.
    Jan 2, 2015. 05:56 PM | 17 Likes Like |Link to Comment
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