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I agree and with you and others that when B bottom line data is revealed it may be not be heard or seen. We need a national publication revealing our new drug and that the end of bacterial resistance is here, not just a PR.
TimeWillTell,
Hang in there chief I bought in heavily May 2013 @ $2.20 then watched my position fall back to $1.60. For over a year I sweated the price but was calmed by the progress. My opinion is Leo has constantly pulled through for us in the past and will keep doing so going foreword.
Regarding Leo's PR on bottom line data. Leo said:
"After discussion with FDA later this year, Cellceutix plans to disclose additional information regarding the Phase 2b trial results."
I'm thinking protocol may call for bottom line data to be viewed by FDA first then after made public.
I would think if Leo had bottom-line data it would have be been PR'd yesterday. According to Leo Based upon top-line data CTIX has decided that a pivotal Phase 3 trial in 2015 will be for a single-dose of Brilacidin for ABSSSI. Holding back even mediocre data would reflect poorly to Leo's credibility. I just don't see the latter. There's a lot riding on B at this juncture.
faraifarai, thanks I did not know that.
The University of Bologna sponsored Phase 1b/2 trial of Kevetrin in combination with cytarabine for Acute Myelogenous Leukemia is expected to commence in the fourth quarter 2014. It's also possible to get an update very soon regarding the start date.
We know the PR put out on the 13th was by Dr Menon, so it's possible that Leo may be on travel.
The Dalvance website reported dosage as a Two-dose regimen of 1000 mg followed one week later by 500 mg.
Clearly a three dose regimen.
Completely agree. Thanks.
We have 3of4 test arms in Brilacidin favor. Leo already reported manufacturing 30kg (66 lbs) of Brilacidin material. Brilacidin in it self could spark many more unique pharmaceuticals.
"Cellceutix is pleased to update shareholders that the data from all trial sites has been locked and top-line data is expected this month".
Results could be revealed any day now.
Possibly Leo is on travel to University of Bologna test site.
Darwiniwn maybe this will help. Fund your Roth with money you will not need until your 59 1/2. If you do need the money you will be charged the 10% penalty plus tax on any gains you made above your contributions(taxed going in taxed coming out). The IRA would also have the 10% penalty plus any income tax that would be owed on pretax money, the income tax will be owed regardless of age. If you need money early the IRA may be your best source. Consult with your tax adviser to see what works for you.
July 7 PR
Cellceutix Brilacidin ABSSSI Trial Gets Positive Review by Data Safety Monitoring Board; Best Possible Outcome, No Treatment-Related Serious Adverse Events (SAEs)after approx 50% enrollment.
Question? What did the Safety Monitoring Board report upon completion of second half of test.
Sure. And if there actually was an SAE I'm thinking it came from the dapto arm.
A single “possible” treatment-related serious adverse event (SAEs) was reported, but no other serious adverse events were reported in the trial,”
From Wikipedia-
Adverse drug reactions associated with daptomycin therapy include:[11]
Cardiovascular: hypotension (2.4%), hypertension (1.1%), edema, cardiac failure, supraventricular tachycardia
Central nervous system: headache (5.4%), insomnia (4.5%), dizziness (2.2%), anxiety, confusion, vertigo, paraesthesia
Dermatological: rash (4.3%), pruritus (2.8%), eczema
Endocrine: hypokalaemia, hyperglycemia, hypomagnesemia, increased serum bicarbonate, other electrolyte disturbances
Gastrointestinal: constipation (6.2%), nausea (5.8%), diarrhea (5.2%), vomiting (3.2%), dyspepsia (0.9%), abdominal pain, decreased appetite, stomatitis, flatulence
Hematological: anemia (2.1%), leukocytosis, thrombocytopenia, thrombocytosis, eosinophilia, increased international normalised ratio (INR)
Hepatic: abnormal liver function tests (3%) (including alkaline phosphatase and lactate dehydrogenase), jaundice
Musculoskeletal: elevated creatine kinase (CK) levels (2.8–10.5%), limb pain (1.5%), arthralgia (0.9%), myalgia, muscle cramps, muscle weakness, osteomyelitis
Renal: acute renal failure (2.2%)
Respiratory: dyspnea (2.1%)
Other: injection site reactions (5.8%), fever (1.9%), hypersensitivity.
From Clinicaltrials.gov ARMS-
Low Single Dose Brilacidin
0.6mg/kg Brilacidin IV (single dose) on Day 1, followed by placebo Daily Days 2-7
High Single Dose Brilacidin
0.8mg/kg Brilacidin IV (single dose
3-Day Regimen Brilacidin
0.6mg/kg Brilacidin IV on Day 1, followed by 0.3mg/kg Brilacidin IV on Days 2 & 3
Active Comparator: Standard dosing regimen Daptomycin
4mg/kg Daptomycin IV daily for 7 Days.
We have 3of4 in Brilacidin favor. The worst out come is still better then the dapto 7 day. I believe Leo knows he's got it in the bag.
The fed is not going to undermine the the markets by raising interest rates this election year. The only nose dive has been what your doing to your credibility on this board. JMHO
B-OM testing is unblinded while being compared to a placebo right?? I was hoping we would hear some dynamite comparison data early on.
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?