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Clinical Trials updated B-OM to recruiting:
2 Recruiting Phase 2 Study to Evaluate the Safety & Efficacy of Brilacidin Oral Rinse in Patients With Head and Neck Cancer
Conditions: Head and Neck Neoplasms; Mucositis; Stomatitis; Mouth Diseases
Intervention: Drug: Brilacidin
I figured it out.
George is Leo incognito! I should never have doubted you. Keep shouting from the rooftops, Le - I mean - George!
My Fellow Cellceutix Shareholders,
We are pleased to inform you that Cellceutix Chief Medical Officer Dr. Daniel Jorgensen is presenting this morning at an educational investor breakfast, "Understanding QIDP and Other 21st Century Incentives for Developing and Marketing Anti-Infective Medicines," being held at the Palace Hotel in New York City from 8:30 AM – 12:00 PM ET. This investor event is focused on the effect of the GAIN (Generating Antibiotic Incentives Now) Act, QIDP (Qualified Infectious Disease Product) designation and other efforts supporting development of anti-infective products.
Dr. Jorgensen will be speaking along with other scientists, legislators and industry executives. Dr. Jorgensen will be presenting during the portion of the meeting titled, “Current Anti-Infectives Products in Development” discussing Cellceutix’s novel class of antimicrobials called Host Defense Protein (HDP) mimetics, which includes Brilacidin, our lead HDP mimetic that recently completed a Phase 2 trial for the treatment of Acute Bacterial Skin and Skin Structure Infections. The PowerPoint presentation can be viewed on the Cellceutix website under the “Investors, Events and Presentations” tab (http://cellceutix.com/events/#sthash.QpoOxpUu.dpbs).
Interested parties may also view the event via a live webcast at: http://psav.rampard.com/20150521/reg.jsp. The event will also remain available following the live broadcast.
Sincerely,
The Cellceutix Team
Thanks for posting. I love the part about: shortly, K will be advancing rapidly.
It makes sense that there are a lot of other applications at the nasdaq... probably others trying to get on the Russell index as well...
That's hysterical. Nice.
Please fix me up a dose of Ocular Brilacidin to set me straight.
Something is wrong with Scottrade...
It is showing CTIX green. Anyone else having this problem?
Sound reasoning. I appreciate you sharing your thoughts.
Scottrade now has 18K.
Thanks biodoc. I will keep this info handy.
Just got an email:
My Fellow Cellceutix Shareholders,
We are pleased to inform you that Cellceutix Chief Medical Officer Dr. Daniel Jorgensen’s presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) on our completed Phase 2b trial comparing Brilacidin to daptomycin in the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) has become public on the ECCMID website. Shareholders are encouraged to view the presentation at: http://eccmidlive.org/resources/a-randomized-double-blind-study-comparing-single-dose-and-short-course-brilacidin-to-daptomycin-in-the-treatment-of-acute-bacterial-skin-skin-structure-infections-absssi--2
We’d also like to point shareholders to an informative video created by BioCentury titled, “The Future of Cancer Therapies.” We found particularly interesting the discussion with the FDA’s Dr. Richard Pazdur and Dr. Amy McKee on the approval of the PARP inhibitor Lynparza to treat advanced ovarian cancer associated with defective BRCA genes. We are encouraged in the development of our anti-cancer drug Kevetrin by the FDA’s willingness to incentivize the regulatory processes for hard-to-treat diseases like ovarian cancer. The video is available at: http://www.biocenturytv.com/currentshows2 bcpid=4179652879001&bclid=4178277878001
Sincerely,
The Cellceutix Team
When I did some homework* months ago to better understand tumors and efficacy, I remember an article that talked about tumors not being characterized by 1 single cell type, but instead made of several diverse mis-functioning cell types. One of the criticisms of using single cell line tumor for in vitro testing (like the ones CTIX uses for lung cancer, breast cancer etc.) is that these are homogenous tumors which won’t exist in the real world (in patients). If K activates p53, it will never destroy entire tumors unless the tumor is primarily comprised of dysfunctional p53, which may be common, but certainly not always the case. That, I think, is why you get Menon saying the clinical trial is progressing on par with the preclinical trials, because it is. It’s just that real world tumors are not homogenous, so in many instances, it will not and cannot completely eliminate the tumor, yet is still having a significant impact, leading to stabilization.
*Disclaimer – this is from a layman.
You are correct!
Wolanski, Andrew P.,N.P. <AWOLANSKI@partners.org>
1:25 PM (0 minutes ago)
to me
Not sure why it disappeared from that website, we are still recruiting.
You and me both. My mind likes to speculate...
Any guess why DF no longer has the trial on their site? I've linked to it a dozen times in the past.
"no longer available"
Darwinian - just for fun I did. no results. my point is I used to be able to find the trial with a simple search for "kevetrin" in their search box. Now it says "Clinical Trial not available". Also my link has a trial number "3057". It's as if the trial has been taken down.
Not sure what to make of this...
I am trying to do one of my many searches for rogue Kevetrin info online and I am trying to look for the K trial at DF's website. When I search the DF website, I no longer get the trial (I am almost positive it used to hit three links all for the same trial, now I get none).
If you google "Dana Farber Kevetrin", you will see the trial name. If you click the link it goes nowhere. See my results of clicking on the link here: https://www.dana-farber.org/research/clinical-trials/clinical-trial.aspx?tid=3057
I can also not find the trial under solid tumors at DF. There are like 40 trials ongoing, none for K.
Any thoughts here?
I have no position here, but that was REALLY funny. LMFAO. HA!
What an awesome list. Thanks for this.
Ultimate - read the two sections again. The criteria did not change at all. Not a positive or a negative thing. They just removed the explanation of the reasoning behind the exclusion.
If you look at a lot of the western blot tests on this poster, you will see that the preclinicals suggest efficacy will not level out at this point. Some show more efficacy at 400 mg/kg (roughly converts to 1200mg/m2). So results should only continue to get better, with higher doses.
If they do go to 900mg, it should produce SAEs such that the trial may be over real quick (potentially before the end of April). Then the fun begins, like UofBologna, Spore Grant combo trial and phase 2 trials.
If they go with 600mg, we might have to hunker down for an additional cohort. I'm okay with either path as they both heading in the right direction.
600 at a minimum.
BEVERLY, MA--(Marketwired - Mar 24, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the tenth cohort in the Company's Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center has been completed. Patients in the tenth cohort were treated with 450 mg/m2 of Kevetrin with no adverse events reported.
Cellceutix has been advised that the tenth cohort is being included in the latest testing for the effect of Kevetrin on the biomarker p21, a key downstream protein and proxy for reactivation of the tumor suppressor protein p53. The data on p21 are expected to be received in mid-April.
Cellceutix had several options on the table moving forward with the trial. After meeting with the trial's Principal Investigator and Cellceutix consultants, the Company has decided to take dosing even higher due to the wide bandwidth of Kevetrin and enroll an eleventh cohort. The Safety Committee will meet in the coming weeks to determine the new dosing level, which, theoretically, could be increased up to 100 percent in a bid to define the maximum tolerated dose of Kevetrin.
"This is great news that the tenth cohort has been completed, once again demonstrating the safety of Kevetrin. Our team is excited by the fact that no dose limiting toxicity (DLT) has been seen even at these higher levels, as DLT has historically been a significant hurdle for any biotech targeting p53. As such, we're going to continue to push our novel drug as far as possible for maximum therapeutic effect and to collect the most robust data set possible," commented Dr. James Alexander, Chief Operating Officer at Cellceutix. "We have seen some encouraging data in different types of cancer to date and the eleventh cohort gives us the opportunity to add to our knowledge base in preparation for future clinical studies."
Thanks for posting.
I'll stock the message board with imported silk handkerchiefs when we are range-bound crying at 7.50.
I was thinking the same thing today. I've ridden from 2.40 down to 1.40 (did manage 1K purchase at 1.47 ), so I don't complain one iota about 3.50. Next stop $7, then back to crying at 5.50.
Wow, what medical journal did you find that information in?
TIP - you could save this board a lot of clutter by becoming pen pals with George rather than posting a message under Dr. Jerry, logging out, then logging back is as George to respond. You could just snail mail yourself and have the return address as almost anyone including George, the President or Elvis. Then you could brag to the mailman and tell him how you got more mail from the president, thanking you for all of your economic and foreign affairs advice.
New PR on website.
Cheer up TOB. I spent a long time analyzing the last updated trial dates and it turned out I was reading into those dates, way too much. Before you draw conclusions, let's wait to see what we learn with the next K update. Have a nice weekend.
Two thumbs up from me (one on each).
According to this document, six weeks is the max it should take to uplist. So if we use a start date of Feb. 5th, that means uplist by March 19th. WOW.
Bye the way, thanks for the PM. You are most welcome.
Count me in too.
HA! Thanks Sox. I actually live in RI. I was returning from a week of vacation. GOOOOOOOOOOOO CTIX!
We arrived on time 4:45pm. I think we were the only ones. Bunch of the people from our flight were all
Taking pictures of the arrival screens. About 20 cancelations, two delayed flights and our lowly green arrival time.
Flying into Boston today from a week long trip in the Azores. Snow or not, life goes on in New England. Things might get thrown off by a day or two, but not much more.
Awesome. Thanks Karin.