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KarinCA

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  • Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived [View article]
    Hope4Future… The ASCO meeting is taking place quite early in this phase I trial at Dana Farber. I don’t expect efficacy to be shown at this time. However, I also don’t see the company presenting a poster at ASCO unless they have something of interest to discuss during questions and answers. Companies don’t go to events like this to highlight bad news. I’m waiting for what comes out just like everyone else.

    If Kevetrin works in humans I expect efficacy to be shown by the end of this trial. The test subjects are terminal patients and the primary objectives of the trial are both safety and efficacy.

    See the FDA trial site: http://1.usa.gov/RCqTcC

    Again, good luck in your trading. ;)
    May 16 09:07 AM | Likes Like |Link to Comment
  • Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived [View article]
    Hope4Future… As a contributor that only has articles published on ctix thus far I’d like to explain why that is since it appears to be of concern to you. My focus is in ferreting out high profit potential, albeit high risk companies that stand a better chance than most to make it. Most of these companies are under $1 in share price and Seeking Alpha has a policy against publishing articles below that price range.

    I post here using the same name I post with on iHub since I have a fair amount of followers on iHub. Some seem to have followed me here and read anything I write about. They are sincere traders just looking for information and they are excited about ctix. Many of them are very experienced in biotech stocks and understand the inherent risks.

    I’m truly independent and intend to write about other companies as time frees itself up in the near future. However, the ones I currently like the most are all under $1 at the moment and that has prevented me from writing about them. Before coming to the conclusion that most posting here are insincere you may want to check out iHub. You’ll find I’ve been posting under this handle since 2007. I moderate a number of boards and comment on many. It’s only on Seeking Alpha that I’m restricted to this one due to their share price rules. Plus, I’m new here. Give me time. ;)

    Most people like writing only about sure things since they don’t like looking bad when they are wrong. With so many biotechs imploding the easiest way to write is about all of the negatives in the sector. However, with the changing FDA regulations surrounding Breakthrough Technologies, a lot of money will be made by finding companies that qualify before they explode to the upside. That’s the trick. Many investors wait for a PDUFA date, but, that will cost a lot of great potential to be missed.

    My first article here was to correct some misinformation that had been put out in three other articles. As an investor it drove me nuts to see the misinformation and I decided it might be a great idea to put out correct information. Then, I noticed a lot of people didn’t understand the Aspire deal and understand how that wasn’t typical death spiral financing found in many of these companies. I also noticed that most of the focus was on Kevetrin, thus, the article comparing the two emerged. Apparently, the CEO liked what I’d written and agreed to do an interview. I may be anonymous to you, but, he knows exactly who I am and he likes my work. I'm independent from the company and haven't taken any payment in any form from them.

    The risk with ctix is whether or not Kevetrin and/or Prurisol work in humans as they do in animals. We will find the answer out this year. The current phase I trial at Dana Farber should end in late 2013. It is testing for both safety and efficacy using terminally ill patients. For both the patients and the investors I truly hope all goes well in this trial. We should also have an answer on Prurisol by year end.

    As with all biotech and/or stem cell sector stocks I strongly suggest to friends and family to only invest what you can afford to lose. And, to take profit along the way. That’s what I do. I never go all in on any one stock since there are no guarantees you won’t lose all of your money if trials go wrong.

    When all is said and done, I’m very impressed with the CEO of ctix. The company has kept the dilution under control. There are very few shares out for a biotech at this stage. Especially, for one that hasn’t done a reverse split. Most of the liabilities owed are due to officers for loans and salaries. These officers have done extremely well to manage finances and utilizing Kard Scientific, a CRO that is used by some of the biggest pharmaceutical companies in the U.S. Is it better if they pay an outside institution?

    The Progressive probably posts under the same name he uses on iHub for the same reasons I do. Many know us by these names.

    Good luck in your trading.
    May 15 02:50 PM | 1 Like Like |Link to Comment
  • High But Well-Managed Risk, This Company Is One To Watch Out For [View article]
    JJmill2... I'm not so sure the Geron asset acquisition was as huge a deal as many think. A large part of the assets are from the human embryonic stem cell programs.

    With that said, I like the overall direction BTX research is going in. I also like the way they've created multiple subsidiaries.

    I hold some shares in BTX.
    May 13 12:18 AM | Likes Like |Link to Comment
  • Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived [View article]
    Moon Kil Woong.... You are correct in that many companies are working to control p53. It's a very heavily researched arena. Kevetrin has demonstrated in animals the ability to activate p53 without the major toxic effects Roche Holding (RHHBY.OB) ran into when they tried it. Many have been able to activate it, but, not without serious side effects.

    We will find out very soon whether or not Kevetrin works in humans as well as in animals since Cellceutix has a phase I trial going at Dana Farber that is testing both safety and efficacy in humans. They are testing on terminally ill patients.

    We may also get some clues from the ASCO poster presentation that is coming up. Dr Shapiro, the lead investigator for the trial will be presenting. ASCO runs May 31 to June 4, 2013.

    See following links for more information:

    http://bit.ly/ZGMNfY

    http://1.usa.gov/RCqTcC

    http://bit.ly/14e0H9D
    May 12 01:13 AM | Likes Like |Link to Comment
  • Watch Cellceutix Closely For Potential Catalysts In 2013 [View article]
    umiak... We are facing another catalyst now. The ASCO meeting is coming up and $CTIX was selected to present a poster there.

    http://bit.ly/ZGMNfY

    ASCO is a major oncology event taking place May 31 to June 4
    http://bit.ly/14e0H9D
    May 11 06:38 PM | Likes Like |Link to Comment
  • Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived [View article]
    _juggernaut_ ... In looking at the FDA trial site and the company site, I don’t see enough information allowing you to come to your guesstimate of equivalent human dosing.

    The following site may be of interest to you:

    Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers
    http://1.usa.gov/138h2KH

    Good luck in your trading. ;)
    May 11 02:40 PM | Likes Like |Link to Comment
  • Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived [View article]
    noobie107... The FDA rules on Breakthrough Therapies changes the timeline on drugs intended to treat serious conditions. Anything life threatening will be considered serious.

    With the new rules, the FDA has to issue a decision in 60 days as to whether or not a drug is denied or granted the Breakthrough Therapy designation. See http://1.usa.gov/YhojKL

    Many investors have become accustomed to waiting for later stage trials to get involved in biotech stocks. That is changing as the regulatory landscape changes with the adoption of new breakthrough therapies standards by the FDA. If Kevetrin is shown to work in humans it may be one of the first drugs to come to market using these new regulations.

    My understanding is that a drug can go directly from Phase 1/2a trials to approval for an unmet need, if the data from the human study aligns with data from animal efficacy and toxicity studies.

    This particular phase I trial of kevetrin is testing for both safety and eficacy. We'll know whether or not it works by the end of the year. If it does work, I'm expecting a Breakthrough Therapy designation.
    May 10 01:39 PM | 1 Like Like |Link to Comment
  • Cellceutix Corporation: The Next Generation Of Cancer Treatment Has Arrived [View article]
    _juggernaut_... The current phase I trial of kevetrin is testing for both safety and efficacy. We shall have an answser as to whether or not kevetrin works in humans as it does in animals by the end of this year. Terminal patients are in this trial.

    We'll also have an answer on how Prurisol works in humans by the end of this year. ;)

    Share price will skyrocket if either one of them works in humans as they do in animals.

    The upcoming ASCO presentation may give us a good clue as to how the kevetrin phase I trial is progressing. ;)

    Good luck to all. ;)
    May 10 11:58 AM | 3 Likes Like |Link to Comment
  • Which Drug Moves Cellceutix First: Kevetrin Or Prurisol? [View article]
    mgpagan... if a member of an Australian pharma knows about Kevetrin it's being watched by all major pharma.

    Let's hope these patients in the current trial at Dana Farber are doing well. ;)
    May 4 12:43 PM | 1 Like Like |Link to Comment
  • Potential 200% Return With Cellceutix [View article]
    pgathua... the risk here is whether or not kevetrin and/or prurisol work in humans as they do in animals. Most phase I trials only test for safety. The current trial at Dana Farber is testing terminal patients for both safety and efficacy. We will have a good idea of how Kevetrin works on humans by the end of this trial. See the FDA clinical website for the primary and secondary outcome measures:
    http://1.usa.gov/RCqTcC
    ~~~~~~~~~~
    The annual ASCO meeting is being held in Chicago, Illinois from May 31 through June 4, 2013. CTIX is presenting a poster there. I doubt they’d be going to present failure. Odds are high the trial at Dana Farber is proceeding as expected. We just won’t know for sure until trial end. This is where the risk is and why CTIX is trading so low now.
    http://bit.ly/ZGMNfY
    ~~~~~~~~~~
    Biotech stocks are very risky and most trials fail. It’s very difficult to ferret out the drugs that work at this stage without spending a lot of time in research. I may be wrong, but, I fully believe the odds of this company coming out with a successful drug are much higher than normal. We won’t have long to wait.
    ~~~~~~~~~~
    Edit to add: Insiders are majority shareholders. They have helped finance the company instead of diluting it for their salaries. That’s usually another good sign.
    ~~~~~~~~~~
    Good luck in all of your investments. Actually, good luck to all of us. ;)
    Apr 23 02:34 PM | 1 Like Like |Link to Comment
  • Potential 200% Return With Cellceutix [View article]
    It's a fully reporting company that went from under $1 to $2.40 a bit too fast and had a normal pullback from a spike. It's only an issue if you are a trader. I look at the risk/reward here and decided to hold a chunk.

    Those employees have submitted a multi-thousand page IND to the FDA and applied for a trial at Dana Farber and Beth Israel, advanced Kevetrin into clinical trials at Dana-Farber and Beth Israel Deaconess, received FDA guidance to advance Prurisol into a Company-sponsored Phase II/III Proof of Concept trial. They have been approached to study Kevetrin in combination with Pfizer drugs, aligned clinical trials in Europe with another leading pharmas cancer drugs. The University of Bologna in Italy (the “University”) and The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) are sponsoring clinical trials of Kevetrin. And, they’ve been approached by another leading cancer center in the United States who wants to pay for more clinical trials. The name of the southwestern cancer center should be announced soon.

    How much are two guys worth? Ideas and technologies can be worth billions. Ask Mark Zuckerberg how much his idea for Facebook was worth. Further, compounds are not merely ideas, they have intrinsic value.

    They don't need more employees since they contract the work out to Kard Scientific. Dr Menon has a relationship with Kard and it's saving the company a lot of money. Realize, Cellceutix is really a holding company for patents, licenses, etc.

    The Aspire deal gives them a $10 million equity line which means they've acheived their financial goal at reasonable terms. The first 2 1/2 or 3 million shares are non dilutive since they are already in the treasury. My guess is they will be bought out or partnered up before they need to use all of it. It gives them bargaining strength once offers start showing up.
    http://bit.ly/WicBeA

    Plus, these guys have been self funding the company over the years instead of paying themselves via dilution.

    There is risk since the human trials aren't complete, but, if Kevetrin works in humans as well as it has done in multiple cancers on animals we'll see the share price skyrocket.
    Apr 23 01:59 AM | 2 Likes Like |Link to Comment
  • An Interview With Leo Ehrlich, Cellceutix CEO [View article]
    I called Leo last week to ask if he had the data yet and if so, when would he release it. The answer was he's still waiting on it. He's as anxious as everyone else to see the data.

    It's possible he has it now, but, I wouldn't count on it. Dana Farber is in control of when testing for P21 is actually done.

    He said he'd release something to shareholders once he has it.

    This testing will be earlier than originally expected. My gut feeling is that the trial is going well and they are seeing something positive in order to decide to test early. We shall see.

    Leo quote from interview on this subject:
    "A: We are anticipating the tests to be run in mid-March and the results to follow shortly thereafter. Honestly, we were extremely pleased that the Dana-Farber laboratory is running these tests so early in the trial. It is a "no lose" situation for us as we did not anticipate biomarker testing, nor did we expect to see any activity, at this early stage and low dosing levels. If p21 activity is shown, we think that we have hit a home run, but if activity is not demonstrated, we will not be the least bit disappointed at this juncture in the trial. We will simply then wait for the testing at higher doses as we expected, where we are very optimistic that we will see p21 expression at that time."
    Apr 13 12:35 PM | Likes Like |Link to Comment
  • The Stem Cell Revolution Can Jump Start Your Portfolio: Jason Kolbert [View article]
    Jxiao8423… A quick scan of the 10k filed on 3.11.13 gave some information you may find of use.

    http://1.usa.gov/10K9orb

    “We outsource all of our drug discovery research, process development, manufacturing and clinical development to third parties with expertise in those areas as we believe it to be a more capital efficient solution.”

    Here's one such agreement:

    “In January 2011, we entered into a sponsored research and vaccine production agreement with the University of Pennsylvania, which had helped us optimize the formulation of ICT-107 that we are using in the Phase IIb trial. The University of Pennsylvania is assisting us in the Good Manufacturing Practice (GMP) production of ICT-107 for the Phase IIb trial. In October 2011, we entered into an agreement with Progenitor Cell Therapy, LLC to serve as a second manufacturer of ICT-107 for the Phase IIb study.”

    ~~~~~~~~~~~~~~~~~~~~~~...

    Collaboration agreements:
    Search the document for George Mason University, or GMU, Cedars-Sinai , Molecular Discoveries, University of Pennsylvania, The Johns Hopkins University, and Aptiv Solutions (formerly Averion International Corp.), a clinical research organization. You’ll find agreements with all of them.

    ~~~~~~~~~~~~~~~~~~~~~~...

    “In June 2011, we entered into an agreement with BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd., under which BioWa provided us with access to BioWa’s patented POTELLIGENT® technology platform for the development of antibody-dependent cellular cytotoxicity-enhanced antibodies, and, in turn, BioWa received a non-exclusive license to our DIAAD technology. Caerus Discovery LLC, a biotechnology company using proprietary methods for drug target discovery and antibody development, was launched with program support from BioWa and with certain antibody technologies from us. As part of this transaction, we received an approximately 19% equity interest in Caerus Discovery.”

    I don’t have much time to fully search the document at the moment, however, this should help you with your questions. ;)
    Apr 8 02:25 AM | 1 Like Like |Link to Comment
  • CLSN Daily Chart Ringing The Bell? [View instapost]
    zzlangerhans.... Interestingly, many on this thread were alerted to celsion when it was under $2. The trader that made the call strongly suggested that the basis should be taken off the table before the binary event. Many actually made money on it. No point in making assumptions regarding the way others trade.

    None of us is right in all of our trades. The key is to be right in the majority of them and to minimize risk by taking that basis off as soon as possible.

    Some came in later and lost. Why would you want to make fun of them? How professional is that?

    Good luck in your trading. ;)
    Apr 5 01:58 AM | Likes Like |Link to Comment
  • An Interview With Leo Ehrlich, Cellceutix CEO [View article]
    moobydoo... I made a point to not publish anything on ctix while it was on it's low. The fact is, the stock has a lot going on that leads me to believe this is about as good a bet as one can make in the oncology sector. Biotechs are high risk. There are no guarantees. All one can do is conduct research and try to minimize risk.

    The major downside on this one should be obvious to everyone. Kevetrin has to be shown to work on humans as it does in animals. The trial at Dana Farber will tell us that. The CEO can't.

    Prurisol needs to work in it's upcoming trial too. Those are the two big potential downsides. But, we won't get that info from the CEO either. We need trial results.

    This is why the shares are under $2 now. Once either is shown to work in humans as well as animals these prices will be long gone.
    Mar 19 02:06 AM | Likes Like |Link to Comment
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