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  • Detection Of Preclinical Cancer; Imagine What Kevetrin Will Do? [View instapost]
    Very interesting ellaruth.
    Jun 1, 2015. 03:12 PM | Likes Like |Link to Comment
  • Cellceutix up on report of positive results in clinical trial [View news story]
    Good article Allan Harris published here, as usual. I remember his CTIX Stock of The Year Buy rating at about $1.50. Those who listened feel pretty good with the $4.34 today. Those who listened to Sharvy or the other shorts are deeply underwater if they shorted, or missed the boat if they didn't go long.

    http://seekingalpha.co...

    CTIX had a good day today after the dip, up 35.62% to $4.34 on today's news. BTW, the news is not the one case study, it is the heads up that "Research conducted by the hospital [Dana Farber] evaluating p21 expression in earlier cohorts, for which the level of exposure to Kevetrin was substantially lower, showed that about 50 percent of the patients demonstrated at least a 10% increase in p21. The data supported the hypothesis that enhanced p21 is dose related, meaning that as the amount of Kevetrin increased, so did the p21 expression. Hospital scientists are now running samples examining the effect of Kevetrin on p21 at higher dosing levels in more recent cohorts and Cellceutix hopes to disclose the results shortly."

    P21 being the biomarker signifying P53, the Holy Grail of Cancer Research:

    "With the completion of the ninth cohort, and commencement of tenth cohort at 450 mg/m2, the hospital has continued research to determine the effect of Kevetrin on p21, the key biomarker tightly controlled by the tumor suppressor protein p53. p53 is often referred to as the "Guardian Angel Gene" because of its crucial role in controlling cell mutations. In nearly all cancers, p53 is deficient or mutated, thus failing to perform its role as a master cell regulator, which exacerbates tumor progression and metastasis. As such, a drug to reactivate p53 to its normal state is a prime target for a next generation cancer therapy. Because p21 is a recognized downstream target of activated p53, increased levels of p21 in peripheral blood cells suggest that Kevetrin is having an impact on returning p53 to its effectiveness as a tumor suppressor. "

    Read the full PR if interested in getting in ahead of the coming data release. Today was just a teaser.

    CTIX RSI still low and the third largest volume ever on today's big rally, so we could be looking at a break-out to blue sky. But if not now, nearly inevitable later with so many trials progressing.

    Best part of this bio-tech with at least two revolutionary drugs is the very high potential reward with currently reduced risk.

    The potential blockbuster antibiotic Brilacidin is a sure thing to enter a Phase 3 Clinical Trial, with an easy partnership should the deal be "spectacular" as the CEO has set as his requirement.

    The potential blockbuster cancer drug Kevetrin is a near certain Phase 1 Positive Primary Outcome Measure, with a Phase 2 combination trial ready to start. As we're hearing about Positive Secondary Outcome Measures, a Phase 2 for solid tumours is near certain as well. There is also talk of expanding and modifying the current trial for more frequent dosing, and to zero in on tumour types. Or to speed up a move to Phase 2.

    Plus a Phase 1b/2 combination clinical trial of Kevetrin with Sunitinib for drug resistant Renal Cancer is still on the table at Beth Israel Deaconess (Harvard Cancer Centers) the largest recipient of SPORE grants who previously announced that their pre-clinical work with Kevetrin and Sunitinib resulted in the first time shrinkage was observed in a drug resistant line of Renal Cancer.

    The Brilacidin-OM Oral Mucositis Clinical Trial at MD Anderson is active, and should start enrolling soon.

    So lot's of things coming to potentially boost the CTIX share price, with each a safety net for the others, and no real binary catalysts in the meantime. So reduced risk despite very high potential gains. As Allan Harris said, no one trick pony here.
    Jan 20, 2015. 09:49 PM | 2 Likes Like |Link to Comment
  • Cellceutix Overvalued By 90-99% [View article]
    Good article published here by Allan Harris, as usual.

    http://bit.ly/1KZk9xy

    I remember his CTIX Stock of The Year Buy rating at about $1.50. Those who listened feel pretty good with the $4.34 today. Those who listened to Sharvy are deeply underwater if they shorted, or missed the boat if they didn't go long.

    CTIX had a good day today after the dip, up ! 35.62% to $4.34 on today's news.

    RSI still low and the third largest volume ever on today's big rally, so we could be looking at a break-out to blue sky.

    Best part of this bio-tech with at least two revolutionary drugs is the very high potential reward with currently reduced risk.

    The potential blockbuster antibiotic Brilacidin is a sure thing to enter a Phase 3 Clinical Trial, with an easy partnership should the deal be "spectacular" as the CEO has set as his requirement.

    The potential blockbuster cancer drug Kevetrin is a near certain Phase 1 Positive Primary Outcome Measure, with a Phase 2 combination trial ready to start. As we're hearing about Positive Secondary Outcome Measures, a Phase 2 for solid tumours is near certain as well. There is also talk of expanding and modifying the current trial for more frequent dosing, and to zero in on tumour types. Or to speed up a move to Phase 2.

    Plus a Phase 1b/2 combination clinical trial of Kevetrin with Sunitinib for drug resistant Renal Cancer is still on the table at Beth Israel Deaconess (Harvard Cancer Centers) the largest recipient of SPORE grants who previously announced that their pre-clinical work with Kevetrin and Sunitinib resulted in the first time shrinkage was observed in a drug resistant line of Renal Cancer.

    The Brilacidin-OM Oral Mucositis Clinical Trial at MD Anderson is active, and should start enrolling soon.

    So lot's of things coming to potentially boost the CTIX share price, with each a safety net for the others, and no real binary catalysts in the meantime. So reduced risk despite very high potential gains. As Alan correctly points out, no one trick pony here.
    Jan 20, 2015. 09:33 PM | 1 Like Like |Link to Comment
  • CTIX Update - Major Phase 1 Breakthrough [View instapost]
    Good article Allan, as usual. I remember your CTIX Stock of The Year Buy rating at about $1.50. Those who listened feel pretty good with the $4.34 today.

    RSI still low and the third largest volume ever on today's big rally, so we could be looking at a break-out to blue sky. Or is that too bullish to print :-)

    Best part of this bio-tech with at least two revolutionary drugs is the very high potential reward with currently reduced risk.

    The potential blockbuster antibiotic Brilacidin is a sure thing to enter a Phase 3 Clinical Trial, with an easy partnership should the deal be "spectacular" as the CEO has set as his requirement.

    The potential blockbuster cancer drug Kevetrin is a near certain Phase 1 Positive Primary Outcome Measure, with a Phase 2 combination trial ready to start. As we're hearing about Positive Secondary Outcome Measures, a Phase 2 for solid tumours is near certain as well. There is also talk of expanding and modifying the current trial for more frequent dosing, and to zero in on tumour types. Or to speed up a move to Phase 2.

    Plus a Phase 1b/2 combination clinical trial of Kevetrin with Sunitinib for drug resistant Renal Cancer is still on the table at Beth Israel Deaconess (Harvard Cancer Centers) the largest recipient of SPORE grants who previously announced that their pre-clinical work with Kevetrin and Sunitinib resulted in the first time shrinkage was observed in a drug resistant line of Renal Cancer.

    The Brilacidin-OM Oral Mucositis Clinical Trial at MD Anderson is active, and should start enrolling soon.

    So lot's of things coming to potentially boost the CTIX share price, with each a safety net for the others, and no real binary catalysts in the meantime. So reduced risk despite very high potential gains. As you say, no one trick pony here.
    Jan 20, 2015. 09:28 PM | 2 Likes Like |Link to Comment
  • Cellceutix Overvalued By 90-99% [View article]
    "Of course, no serious investor takes company PR as a sole source of information about company potential." Ben Sharvy

    You speak for the "serious investor" class now?

    Your profile reads: "I have no professional background as an investor." -Ben Sharvy

    As a High School teacher Ben, how do you presume to speak for "serious" investors? Show some humility.

    Hint: no "serious investor" makes a random comparison of market caps as an investment 'thesis'.

    No "serious investor" ignores the investigational drug pipe-line of a biotech.

    "Serious" investors also deal with reality, not fantasy, cutting their losses short. Since your last article claiming Cellceutix was undervalued, its shares are up huge, over 100%. From a close of $2.42 that day to recent high of $4.93.

    I expect to be able to make a similar comment about your latest call when CTIX doubles yet again.

    As a contrarian indicator Ben Sharvy, you've proven your worth! Investors just need to do the opposite of what you suggest.
    Jan 5, 2015. 01:38 PM | 7 Likes Like |Link to Comment
  • Cellceutix Overvalued By 90-99% [View article]
    Today, Cellceutix released Outstanding Top-Line P2b Brilacidin Results!

    A positive Brilacidin Phase 3 Clinical Trial looks like a near lock. Certainly an excellent chance at success.

    Antibiotics are not like drugs with a large subjective or placebo effect. The efficacy is measured on very objective terms. It either works, or it doesn't. And we're not talking about 20% - 30% efficacy here, we're in the 90th percentile!

    Brilacidin actually matched/beat Daptomycin in absolute terms for the primary outcome measure in one 1 day arm and in the 3 day arm.

    We're not comparing Brilacidin with Vancomycin here, like other recently approved antibiotics for ABSSSI, we're comparing with the more effective Daptomycin.

    "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 [Daptomycin] is fantastic and reason for great optimism going forward.”

    "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"

    Following comment by someone who actually understands biotech:

    "This is "just a bit" better than I expected. The 2 point positive difference vs. Dapto on the .8 B dose means that B has a 90% chance of at least matching the absolute effectiveness of D in a 500 patient phase 3. Further, B at .8 dose has an overwhelming (I'll get the exact number but I think it is close to 98%) chance of at least parity with D in P3, and a decent (over 50%) chance of a significantly better result than D. The chances of of the 3 day dose beating D in P3 are of course even better. CTIX may want to include the 3-day dose in P3 if possible so that it's effectiveness in a large scale trial can be well established. The 3-day dose could be a back-up for any infections that do not respond to a single dose.

    The other recently approved ABSSSI drugs did not do that good...

    I'm sure everyone remembers my forecast of a 60% chance of matching the absolute effectiveness of D in at least one cell. Well, the chances of a successful P3 are much better now that we have direct data from the 2b.

    Risk has been removed from the equation (again!) here folks. - noretreat"

    Key added data: Proven efficacy against superbug MRSA with similar high response.

    "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)."

    Looks like Brilacidin for ABSSSI has an excellent chance at replacing Daptomycin as the new industry leader.

    With the QIDP designation from the FDA, Brilacidin has access to faster approval routes and an extra 5 years patent protection. Cubist, the maker of Daptomycin was just bought out by Merck for $9.5 Billion. Daptomycin, their main revenue source, goes generic in 2016. What does this suggest about the potential value of Brilacidin?

    CTIX is looking golden here.
    Jan 5, 2015. 01:23 PM | 14 Likes Like |Link to Comment
  • Did The Medicines Company Trump Cellceutix And Others In A $1B-Plus Skin Infection Market? [View article]
    Jim Bowie, the current CTIX started the day after this article was published and anyone who read it and bought CTIX is now up ~280%.

    You were ahead of the curve in predicting market interest in Brilacidin. Thanks again for this informative article.

    The bottom line results are expected in the coming days or weeks. This is another potential catalyst for CTIX (among others). Also, the P2 Clinical Trial for Briladidin for Oral Mucositis is set to begin this month.

    Briladidin has also received the QIDP designation from the FDA giving it the advantage of 5 additional years patent protection and an accelerated approval process. Imagine what this would have been worth to Cubist whose leading antibiotic Daptomycin is going generic in 2016? It was just bought out for $9.5 Billion by Merck.

    Looks like Cellceutix may have the better mouse trap, and patent protection +5.
    Dec 14, 2014. 12:51 PM | 2 Likes Like |Link to Comment
  • Did The Medicines Company Trump Cellceutix And Others In A $1B-Plus Skin Infection Market? [View article]
    Fantastic update Jim. Look forward to your next article.

    CTIX had a blast off day with this news. Yet there is much more to come in the coming days and weeks.
    Dec 8, 2014. 09:45 PM | Likes Like |Link to Comment
  • Cellceutix jumps on QIDP tag [View news story]
    petery,

    Fair to say Prurisol is CTIX's dark horse. Not really reflected in the share price, and yet discussions this month with the FDA to advance Prurisol to a phase 2/3 clinical trial. The Phase I cross over study was successful.

    The MOA appears similar and superior to Methotrexate based upon pre-clincal work.

    Methotrexate:

    48% reduction in serum PRINS
    46% reduction in serum IL-20

    Prurisol:

    96% reduction in serum PRINS
    87% reduction in serum IL-20

    See Here: http://1.usa.gov/1A9vhRb "The anti-apoptotic protein G1P3 is overexpressed in psoriasis and regulated by the non-coding RNA, PRINS."

    Here is a bit of dot connecting I did on Prurisol and Psoriasis: http://bit.ly/1vy3GoD

    Here is more on the mechanism: http://1.usa.gov/1A9vkfV

    Prurisol is a potential blockbuster, yet almost not discussed there is so much going on with Brilacidin and Kevetrin.
    Dec 8, 2014. 09:02 PM | 1 Like Like |Link to Comment
  • Cynapsus Offers Potential Big Returns [View article]
    Cynapsus up-listing to TSX senior exchange effective Friday morning 11/28/14.

    Nice rise in CTH & CYNAF today. Highest close of this post-results rally.

    One would think a re-test of the CYNAF February rally high of 1.385 is in play, as that rally was after a healthy human crossover, and the current P2 Proof of Concept demonstrated efficacy.

    CYNAF $2+ sounds a reasonable target pre-buyout.
    Nov 26, 2014. 09:47 PM | Likes Like |Link to Comment
  • Cynapsus Offers Potential Big Returns [View article]
    Doug, for those without access to CTH on the TSX exchange, Cynapsus also trades on the OTC:QX under the symbol CYNAF.

    Which is available may vary by broker. Interactive Brokers offers both CTH and CYNAF.
    Nov 26, 2014. 09:42 PM | Likes Like |Link to Comment
  • Cynapsus Or Acorda - Whose Market Is It For Parkinson's Disease? [View article]
    Cynapsus up-listing to TSX senior exchange effective Friday morning 11/28/14.

    Nice rise in CTH & CYNAF today. Highest close of this post-results rally.

    One would think a re-test of the CYNAF February rally high of 1.385 is in play, as that rally was after a healthy human crossover, and the current P2 Proof of Concept demonstrated efficacy.

    CYNAF $2 at some point in the coming year sounds a reasonable target, being conservative.

    Good article on competing product, but there appears room for both in this market.
    Nov 26, 2014. 09:30 PM | Likes Like |Link to Comment
  • Update: Cellceutix Calls Out To President Obama About Brilacidin [View article]
    Good trading rookie1981.

    So far CTIX has been good in providing the potential for profits to both swing traders and those who have held. Last year was especially good for swing trading.

    Risk management is very individual, I don't make suggestions to others, but I appreciate others sharing their opinions on what works for them.

    I also like asclepius8's approach. Size a speculative bet appropriately and let it roll. To each his own.

    Myself I favour taking my cost basis off on a good run, then either let my profits run, or buy more on dips.

    IMO CTIX has a good potential to run much further in the coming months with several catalysts coming up. I like the fact that they are spread among three drugs and numerous trials. That way there is some fall-back if any one trial disappoints. Time will tell.
    Oct 6, 2014. 04:08 PM | 2 Likes Like |Link to Comment
  • Update: Cellceutix Calls Out To President Obama About Brilacidin [View article]
    What you seem to fail to understand Hope4Future is that the science is done in the laboratory during pre-clinical research, and in research hospitals during clinical trials.

    There has been quite a bit of pre-clinical research done on Kevetrin, with some of it having been presented in poster sessions at ASCO and other conferences.

    The Kevetrin Phase 1 Clinical Trial in progress at Dana Farber was presented at ASCO.

    University of Bologna has done pre-clinical research on Kevetrin as a combination drug, which they intend to publish. Both Beth Israel Deaconess and MD Anderson are doing pre-clinical research on Kevetrin in combination for various cancer types.

    Brilacidin has been the subject or pre-clinical and clinical research. Those results are science. The Current P2b clinical trial is completed and we are awaiting the un-blinding and top-line results. Later we get the full clinical report, the bottom-line results. That is science.

    These above are examples of science, until complete and published, we have what's available to date to express opinions on. That is what this media is all about, it's not a peer reviewed journal.

    You seem to imagine that people like Ellaruth and KarinCA who are writing about Cellceutix and its drug candidates on blogs and message boards are doing 'science'.

    I'd suggest google the definition of 'commentary' and then google 'science' and compare. You may get a clue.

    Hint: When I, TOB, write a comment on CTIX, its price action, and its drug candidates, what I'm doing is expressing an opinion, not science.

    Here's a fact for you: the day before this update CTIX closed at $2.29, as I type it is at $3.10. It looks like those speculating on CTIX are doing quite well. If they were somewhat encouraged by the opinions and analysis that KarinCA has posted and are placing bets ahead of the actual results of the science, they're doing quite well.
    Oct 6, 2014. 03:45 PM | 2 Likes Like |Link to Comment
  • Update: Cellceutix Calls Out To President Obama About Brilacidin [View article]
    Hope4Future, now you should write something about the details of the science, instead of just making disparaging comments about Ellaruth, KarinCA, and even other commentators such as myself.

    The more detailed the better, but I doubt that is possible since your more suited to personal attacks.

    Oct 6, 2014. 03:25 PM | 2 Likes Like |Link to Comment
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