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Pain in the ass or PIA for short.
And, ASCO ends tomorrow at 12:45 pm. Based on his wording, we might get that update before the end of the day...
http://am.asco.org/tuesday-june-2-2015
I might be a dummy, but I'm no idiot...
Another dummy here. Count me in.
Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM For Oral Mucositis Expanding to Additional Centers
BEVERLY, MA--(Marketwired - June 01, 2015) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that last week a second site opened enrollment in the Company's Phase 2 clinical trial of Brilacidin-OM for the prevention and treatment of oral mucositis in head and neck cancer patients undergoing chemoradiation. Clinical sites in Oregon and South Dakota are now enrolling patients to evaluate Brilacidin-OM for efficacy with additional sites to be added in June to keep the trial progressing in a timely manner.
More information on the trial can be found at https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=2.
Besides targeting the huge unmet medical need for an effective therapeutic for oral mucositis, the Brilacidin-OM trial has significant implications for Cellceutix shareholders. Should the anti-inflammatory properties of Brilacidin-OM work in the trial as anticipated, Cellceutix will immediately turn its attention to inflammatory diseases, such as hidradenitis suppurativa (HS) and gastrointestinal diseases, as planned. Cellceutix believes the potential market size for its defensin mimetics as anti-inflammatory compounds is even greater than the substantial market for antibiotic applications.
"We expect this trial of Brilacidin-OM to move efficiently and are very pleased to see another clinical site already open for enrolling patients," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "As this trial is underway we are completing the formulation work for treating hidradenitis suppurativa. Actually, the timing couldn't be better with the U.S. Food and Drug Administration recently granting AbbVie an orphan drug designation for HUMIRA® (adalimumab) for the investigational treatment of moderate-to-severe HS. The designation answered many questions for us and is certainly something we will apply for as well in order to try and shave millions of dollars and years off the clinical trials."
Cellceutix will be issuing a separate update on the events at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting shortly after its conclusion on Tuesday, June 2, 2015.
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.VNkn7FY9.dpbs.
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix has begun a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Contact:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
Email contact
Thank you for this explanation.
Don't you have through tomorrow?
New Article, I haven't even read it yet...
http://ir.baystreet.ca/article.aspx?id=132&1432818006
Not the answer I was hoping for, but for those who were wondering if there was more flexibility for the Russell index...
My question: "I am following a company that is uplisting to the NASDAQ exchange and expect the market cap to make them eligible for the Russell 2000 index. If they have not been accepted by NASDAQ by Friday (May 29), will they be excluded from this year's index reconstitution? Is there any flexibility for companies uplisting in early June?"
Answer: "Thank you for contacting Russell Indexes. A stock must be listed and trading on NASDAQ or NYSE at $1 or more on the last trading day in May to be eligible, along with our other eligibility rules.
The first few pages of our methodology document has information on our inclusion criteria.
Let me know if you have further questions.
Thanks,
Jessica Wu
Client Service Associate | Russell Indexes
p: 212-702-7975 | jwu@russell.com"
Wrong person?
They are doing the trial at multiple sites. This is just the first one to start enrolling. Others will be added as it ramps up over the next few weeks. This is what I would expect considering the B 2b started the same way.
Locations
United States, South Dakota
Rapid City Regional Hospital, Regional Cancer Care Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Michael Robinson, MD
Contact: Jana Isabell 605-755-2345
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."