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Yes those are corporate examples but in this case Leo commented the following - "we will be announcing significant corporate developments pertaining to our programs in oral mucoitsis, and antibacterial and antifungal infections."
Anyone have an idea to the upfront cost to make this large quantity?
Could Leo be producing this for clinical sales and not trials. Thanks.
Thanks for clarification, looks like the filing date to be around Sept 30.
Cellceutix 10-Q due soon, possibly tomorrow. Last 10-Q May 12 brought nice volume.
January 24, 2013 PR. Research by BIDMC combined Kevetrin with sunitinib (marketed as Sutent by Pfizer), on cell line 786, a drug-resistant renal cancer. Cellceutix was advised by the researchers that “the Kevetrin/sunitinib combination is the first we’ve used in which actual tumor shrinkage is noted.”
I love the quote: “the Kevetrin/sunitinib combination is the first we’ve used in which actual tumor shrinkage is noted.”
I believe the phase2 spells it all out. Brilacidin tested and proved as effective as dapto. This new defensin mimetic technology could be all the rage by the Centers of disease control.
I hope..
http://r.search.yahoo.com/_ylt=AwrBTzdTQOBTtnsAqOhXNyoA;_ylu=X3oDMTEzN2FuMG1nBHNlYwNzcgRwb3MDMQRjb2xvA2JmMQR2dGlkA1ZJUDA3N18x/RV=2/RE=1407234261/RO=10/RU=http%3a%2f%2fwww.medscape.com%2fviewarticle%2f772087/RK=0/RS=90Dyq_CEjoxDH47fRC0FOErpeWc-
The few short weeks quote may be Dr Menon referring to ASCO in early Sept. Possibly a lot of good news upcoming.
Sound science. He just described Cellceutix!!
Exactly BK, and since little patient follow up in the phase B 2a study one could "surmise" the 1 dose worked.
Hey wild, Congratulations on the beautiful new grand baby you have there.
Google search Kevetrin radiation combo mice study.
https://docs.google.com/file/d/0BzCMnkQtKcypMjBlNmRiYjctNmZmMS00ZjZkLTkwZGUtOTI1OGRiYjEwMTRh/edit?hl=en&pli=1
Informative well written SA article I like to periodically go back over.
http://seekingalpha.com/article/1473151-as-pfizer-eyes-it-celgene-calls-cellceutix
Thanks wild for sharing your awesome email. Besides soon getting the important safety data we will actually see some initial observations. By the sounds of it the study is obviously going in CTIX favor.
First of the month Aspire selling?? Twice as many shares changing hands today.
Kevetrin displayed a broad spectrum anticancer activity in xenograft
tumor models (lung, breast, colon, prostate, squamous cell,
and leukemia),while being well tolerated with low toxicity.
IMO. Since oustanding results and low toxicity was demonstrated in human xenograft mouse studies, Dr Frei with DF knew Cellceutix had a winner with Kevetrin for testing on late stage multi drug resistant cancer patients.
Thanks updating DD and pushing forward.
Eighth paragraph--
We’ve had a very successful launch of POMALYST in the U.S. we now are into our second year with that product going with its first full year impact in the U.S. this year are in the middle of the launch for the product its straight down of IMNOVID in Europe and it has been even more successful than we expected it to be trajectory is very strong and you could see some of the things going on there. We also have plans to study the product in combination with proteasome inhibitors, monoclonal antibodies or HDAC inhibitors also with the view to potentially moving it up into second line therapy and again life cycle of the product creates the most value with that.
http://finance.yahoo.com/news/celgenes-management-presents-sanford-c-004609823.html
So possibly Celgene or Pfizer could update ASCO with their CTIX collaboration using Kevetrin.
Thanks, I see the link finally bubbled up on yahoo finance.
Nothing reported on yahoo since the 3/21 report. I notice the CTIX website reports todays PR as 3/24. Was the press release actually posted to the news sites?
Pill form or injection. What would patients prefer?
Interesting article saying people with psoriasis are more likely protected against effects of HIV-1.
http://www.huffingtonpost.com/2012/03/06/psoriasis-hiv-1-protection_n_1324054.html?
Orphan drug designation means that the sponsor qualifies for certain benefits, such as reduced taxes, from the federal government to help in development of pharmaceuticals to specifically treat rare medical condition of <200,000 people. Since Brilacidin is a developed proven drug it may not or even need to qualify for orphan status to bring it to market. IMO
Leo said in Dec 20 PR:
Brilacidin-OM, a defensin mimetic compound has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo.
Thank you Progressive
I went back a re-looked and did find the FDA approved dosing in a Jan15 PR.
As disclosed in December (See press release dated December 9, 2013), the Company had filed an amendment with the U.S. Food and Drug Administration (“FDA”) to modify the trial protocol to limit the dosing infusion timeframe to a maximum of six hours, versus the current protocol of 30 mg/m2 without a maximum infusion timeframe. As dosing continued to increase without yet reaching a MTD, the infusion duration became a concern as it could become quite lengthy. We are pleased to report that yesterday the FDA accepted our amendment. The FDA approval now allows for enrollment to begin of the seventh cohort under the amended protocol. The safety committee overseeing the trial has approved dosing to be increased to 165 mg/m2 with a 6-hour maximum infusion timeframe for the seventh cohort.
Hey grizzlyman
I checked previous PR's and did not see in written word a statement from Leo saying cohort7 would commence mid-January. The following is from a Dec9 PR..
Kevetrin: The sixth cohort has completed dosing in the Phase 1 clinical trial of the Company’s anti-cancer drug Kevetrin being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee is scheduled to meet in mid-December to define the increased dose for the seventh cohort. Maximum tolerated dose of Kevetrin has not yet been reached. Further, Cellceutix has filed an amendment to the trial protocol with the FDA to limit the dosing duration of Kevetrin to six hours. Cellceutix filed the amendment to keep the dosing time frame within a reasonable number of hours as the dosing level increases as the trial progresses.
Unless I missed something. Nothing further mentioned on increased dosing progress.
According to research, RO5429083 was developed by Roche. Testing with this drug is also found at clinicaltrials.gov.
Found no tests on this site linking Kevetrin. Re-reading Jan15 PR, Leo says "we are now in the process of manufacturing a formulation of Kevetrin for this trial". Could be that it's still too early.
Per Leo's Jan15 PR: Cellceutix has been advised that requisite documentation is prepared for the planned Phase 1b/2 clinical trial of Kevetrin in combination with Cytarabine for Acute Myelogenous Leukemia to be sponsored by the University of Bologna in Italy, The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) and hosted at European clinical sites. We are now in the process of manufacturing a formulation of Kevetrin for this trial.
I believe price would move up sharply on Leo posting the latest Kevetrin results. It is my opinion with all the interest in this drug that there is more evidence of increased p21 protein and tumor shrinkage. Investors looking at this company have seen a lot of growth in drug collaboration, upcoming testing and possibilities but whats really needed now is evidence.
Study of Kevetrin in Patients With Advanced Solid Tumors.
First post. Hello all. I stumbled across IHUB back in February last year. First invested in CTIX April 2012. Have accumulated since then.
I want to thank all of you for all the smart and thoughtful posts I read here daily. I know there are hundreds of investors just like me that are viewing these posts while quietly waiting on the sidelines. For some other possible newbie out there I wanted to post the Kevetrin clinical study web address.
http://clinicaltrials.gov/ct2/show/study/NCT01664000?term=cellceutix&rank=1
Thanks again,