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  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    According to the latest 10Q, Kevetrin's combo trial with Pfizer in humans at Beth Israel Deaconess will start in a few months.

    "BIDMC initiated combination studies with multikinase inhibitors which activate pro-apoptotic activity by translocation of p53 in mitochondria thereby inducing apoptosis. Apoptosis is enhanced by MDM2 inhibitors by stabilizing p53. As presented at the American Association for Cancer Research (AACR) meeting in April, Kevetrin phosphorylates MDM2 which activates and stabilizes p53 by monoubiquitination inducing apoptosis. Prior data from the BIDMC laboratory showed that agents of this class can augment the pro-apoptotic and antitumor effects of MDM2 antagonists and is expected to have a synergistic effect with Kevetrin. BIDMC will test the effects of Kevetrin alone and in combination with FDA-approved VEGFR antagonists in the renal cell carcinoma and melanoma studies. In vitro study endpoints include apoptosis by measuring caspase activation and PARP cleavage. In vivo endpoints include efficacy in a xenograft model, tumor vascularity, p53 levels, p21 expression and apoptosis. This study will provide vital insight to exploit the nuclear and/or mitochondrial pro-apoptotic function by Kevetrin in combination with other multikinase inhibitors in treatment of these difficult to treat malignancies. At this time the study is in progress. We expect human trials to begin on this study only after a few months have passed in our Kevetrin study on solid tumors."
    Nov 19 02:23 PM | Likes Like |Link to Comment
  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    Pfizer owns those two multikinase inhibitor compounds. Harvard does not. If Harvard wants to do additional studies on them, they certainly need Pfizer's permission.
    Oct 18 03:44 PM | Likes Like |Link to Comment
  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    Robert, have you read this interview at all?

    "We want to advance the clinical trials on our own and are very fortunate that other parties approached us to sponsor clinical trials on Kevetrin. The European trials on Kevetrin as well as a second clinical trial at Beth Israel Deaconess are being funded by other parties, which will provide us with unprecedented data at no cost to our company."

    Notice the phrase "second clinical trial at Beth Israel Deaconess". Not first, not preclinical, and certainly not in vitro/in vivo. If you have any more doubts, you can contact Leo directly. I have many times, and he responded each time in a timely fashion.
    Oct 18 03:43 PM | Likes Like |Link to Comment
  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    Robert, the following is from "From the CEO's Desk":

    "Our flagship compound, Kevetrin, is a novel drug that has shown extremely promising laboratory data as a new cancer treatment. Clinical trials are starting at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center, arguably the pinnacle of cancer research hospitals in the world, to test Kevetrin against advanced solid tumors. Additional studies are being conducted at Beth Israel Deaconess to research Kevetrin in conjunction with two Pfizer multikinase inhibitors as potential new therapies for renal cancer and melanoma. In 2013, we expect to start a clinical trial against blood tumors, sponsored by a European university."

    The recent delay was due to some differences in protocols between the two hospitals, thus required another IRB approval. This following is from the September 24 PR:

    "As noted in the press release on September 4, the clinical protocol was amended which required Institutional Review Board (IRB) approval. Cellceutix has been informed that the IRB meeting has taken place and hospital preparations are now underway at the respective institutions to allow for the commencement of the clinical trials. “This is a unique clinical trial and institutions such as Dana-Farber and Beth Israel Deaconess are extremely meticulous in their protocol. It is this level of excellence that compelled us to sponsor the trials at these clinical sites,” commented Dr. Krishna Menon, President and Chief Scientific Officer at Cellceutix."
    Oct 18 12:32 AM | Likes Like |Link to Comment
  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    Reg, let's assume that you are right about the people at CTIX don't know what they are doing. But does Harvard's DF Cancer Institute know about cancer research? Does Pfizer know about drug development? Please explain to me why Pfizer agreed to do a combo trial with Kevetrin and Harvard is paying for it.
    Oct 18 12:32 AM | Likes Like |Link to Comment
  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    Robert, the combo trial with Pfizer will not start until the MTD of Kevetrin is determined. That's why you cannot find it on clinicaltrials.gov yet. You can find the official PR on the Cellceutix website. It is under the Cellceutix News section (March 19, 2012 | Press Releases).
    Oct 17 02:02 AM | Likes Like |Link to Comment
  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    Although the drugs are different, the drug development process is the same. You still have to go from preclinical to clinical to market. Why would Dr. Menon receive the most prestigious award if his contribution is not important to the success of Gemzar and Alimta? As for strategies, I think CTIX is doing pretty well so far. Kevetrin will start phase I at Harvard’s Dana-Farber later this month. Try to find another company with CTIX’s market cap that Harvard agreed to host their clinical trials. Harvard’s teaching hospital, Beth Israel Deaconess Medical Center, is paying for a clinical trial of Kevetrin in combo with Pfizer’s multikinase inhibitors to treat melanoma and renal cell carcinoma. In addition, a major university in Europe is paying for a clinical trial of Kevetrin in combo with another big pharma’s drug to treat leukemia. Both universities will save CTIX millions of dollars. And let’s not forget Prurisol. FDA allowed CTIX to skip phase I and go straight to phase 2/3. This will save lots of money and time as well. No one is claiming Pfizer is paying for Kevetrin’s phase I. According to the latest 10-Q, the funding for Kevetrin’s phase I is in place. FDA would not approve the INDA if funding is not sufficient.
    Oct 10 03:07 PM | Likes Like |Link to Comment
  • Interview With Leo Ehrlich, CEO Of Cellceutix [View article]
    Dr. Menon, the inventor of Kevetrin, has developed two billion dollar drugs, namely Gemzar and Alimta, at Eli Lilly. He received Lilly's President’s Recognition Award for his contributions. So I would say the experts at CTIX have a clue or two about bringing a drug to the market.
    Oct 9 04:11 PM | Likes Like |Link to Comment
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