CTIX Stock Alert 08/19/2014 08:23:03 $CTIX
"Breakout Boards" #17, and rising.
WE ARE NOW in the process of manufacturing 30 kg of brilacidrin for future clinical trials.
why would they do that simply because enrollment has met its goal?
they would do that because the trial has met its goal successfully which is efficacy at lower dose. imo
gov
That is a shit tonne of product. The best is yet to come.
This information may be what caused the leak and subsequent increase in volume. Thanks BK
Great observation in the math BK!
Being an expert in Deductive Reasoning (DR) I assume you think, because 30kg is not enough for the 3 dose regimen, and Leo said they are making 30 kg, they know the single dose is going to do the trick?
If so, Hallelujah!
(Been watching Elementary, the Sherlock series...good show)
Good figuring! Possibly great detective work!!!
The Dane, you got me thinking, and the following is not for you, but some newer investors:
Recommend to all small cap shareholders, place mental and not actual stops if at all possible. MM's will take out stops to supply shares for the countertrade. It can be very profitable for them on quick moves from one direction to the other. This is especially common at the opening of sessions. A large percent of the time, MM's will go counter trend, taking out stops; before accommodating the true trend.
Also, I know it is difficult, and goes against human nature; but, I have learned the hard way not to write off stocks that I get stopped out of. Just step back and reevaluate. Each trade should stand on its own merits. If a new buy opportunity arises in a stock that you get stopped out on, think of the prior experience as a sunk cost (learning experience). As an example, it is commonly known that most investors that time the market make their biggest mistake by delaying their reentry after exiting. They usually avoid some of the pain, but lose by missing a good part of the gain.
Jok, yes. That's what I assume. It would make it really handy in a Primary care office for a shot or IV. *** secondly and I believe more importantly, it may facilitate topical preparations thereby further expanding the market.
Yes, that's a PILE of Brilla. Which makes me think of a good slogan for it..."Feeling the effects of ABSSSI? A Little Brilla Will Do Ya!"
30 kg at .8mg/kg x 70 kg average = ~550 patients.
30 kg at .6 mg/kg x 70 kg average = ~700 patients.
Phase 3 single dose here we come? The three day regimen at .6 mg/kg would yield ~230 courses which IMO is not a sufficient enrollment for a Phase 3 trial.
I know I am not doing this right but here goes...
by definition kg/mg
mg/kg
Web definitions
A milligram of medication per kilogram of the body weight of the person taking the medication
so let say the average person's weight is 150 lbs or about 69 kg
69kg x 1.2 mg/kg dose ~ 83mg
1,000,000 mg = 1 kg
1000000/83 = about 12000 doses
12000 x 30 = about 360,000 doses???
Bingo!
Thanks from a "pounds and inches" guy!
Ultimate, That is interesting in that all the formulations, otic and opthalmic would be liquid applications. Is it possible that this stuff could be mixed in a saline solution prior to administration via Iv infusion?
When you see how little the patients in the Phase 2b test have been taking ,... it seems like alot.
.6mg/kg or .8mg/kg per for one day
one milligram is 1/1000th of a gram,...
1000 grams in a kilogram
1 gram = 1000 mg
It's a smart play to tout the benefits to patients and society and avoid chest beating and "better than" comments.
Cellceutix Completes Enrollment in Phase 2b Clinical Trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Aug 19, 2014 08:30:00 (ET)
Cellceutix Completes Enrollment in Phase 2b Clinical Trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
BEVERLY, MA--(Marketwired - Aug 19, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, has announced the completion of enrollment in its Phase 2b trial comparing Brilacidin(TM) to daptomycin (Cubicin(R)) in patients with acute bacterial skin and skin structure infections (ABSSSI). Overall, 215 patients were randomized to one of three dosing regimens of Brilacidin (single dose 0.6mg/kg; single-dose 0.8mg/kg; 1.2mg/kg over 3 days) or 7 days of once daily daptomycin.
Brilacidin is the lead compound among a novel class of antibiotics known as defensin-mimetics. These compounds have shown great promise in preclinical and early clinical studies as potent antibiotics that can kill Staph aureus, including methicillin-resistant Staph aureus (MRSA). Moreover, given the unique mechanism of action, among other attributes, there is low, if any, potential for the development of resistance. Finally, the results of the current study may demonstrate that Brilacidin could be given as a single-dose, which provides benefits for both patients and society.
This combination of properties makes Brilacidin unique among antibiotics recently approved or in development for the treatment of MRSA. Because these other compounds come from existing classes of antibiotics, there is the potential for cross-resistance; this is not the case for Brilacidin.
"This is an important milestone for Cellceutix and for the field of infectious diseases," said Leo Ehrlich, the company's CEO. "There is no other antibiotic with these properties, which can treat infection and potentially decrease the burden of antibiotic resistance. Resistance, the antibiotic slayer. We are now in the process of manufacturing 30 kg of Brilacidin for future clinical trials which we plan for multiple forms of serious infections."
The company expects data from the trial to be available in the fourth quarter of 2014.
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 antibiotic 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 is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. 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. 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 key antibiotic, Brilacidin, has completed enrollment in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than most currently marketed antibiotics for 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.
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
Email Contact
(MORE TO FOLLOW) Dow Jones Newswires
August 19, 2014 08:30 ET (12:30 GMT)
I sure hope we can avoid a gap. Easy does it. Check your GTC sells and stops, etc. you don't want to get sold out at $1.87 and not be able to get back in under $2.00, or sell at $2.03 and watch as the stocks gaps to $3.50!
"Breakout Boards" #17, and rising.
WE ARE NOW in the process of manufacturing 30 kg of brilacidrin for future clinical trials.
why would they do that simply because enrollment has met its goal?
they would do that because the trial has met its goal successfully which is efficacy at lower dose. imo
gov
That is a shit tonne of product. The best is yet to come.
This information may be what caused the leak and subsequent increase in volume. Thanks BK
Great observation in the math BK!
Being an expert in Deductive Reasoning (DR) I assume you think, because 30kg is not enough for the 3 dose regimen, and Leo said they are making 30 kg, they know the single dose is going to do the trick?
If so, Hallelujah!
(Been watching Elementary, the Sherlock series...good show)
Good figuring! Possibly great detective work!!!
The Dane, you got me thinking, and the following is not for you, but some newer investors:
Recommend to all small cap shareholders, place mental and not actual stops if at all possible. MM's will take out stops to supply shares for the countertrade. It can be very profitable for them on quick moves from one direction to the other. This is especially common at the opening of sessions. A large percent of the time, MM's will go counter trend, taking out stops; before accommodating the true trend.
Also, I know it is difficult, and goes against human nature; but, I have learned the hard way not to write off stocks that I get stopped out of. Just step back and reevaluate. Each trade should stand on its own merits. If a new buy opportunity arises in a stock that you get stopped out on, think of the prior experience as a sunk cost (learning experience). As an example, it is commonly known that most investors that time the market make their biggest mistake by delaying their reentry after exiting. They usually avoid some of the pain, but lose by missing a good part of the gain.
Jok, yes. That's what I assume. It would make it really handy in a Primary care office for a shot or IV. *** secondly and I believe more importantly, it may facilitate topical preparations thereby further expanding the market.
Yes, that's a PILE of Brilla. Which makes me think of a good slogan for it..."Feeling the effects of ABSSSI? A Little Brilla Will Do Ya!"
30 kg at .8mg/kg x 70 kg average = ~550 patients.
30 kg at .6 mg/kg x 70 kg average = ~700 patients.
Phase 3 single dose here we come? The three day regimen at .6 mg/kg would yield ~230 courses which IMO is not a sufficient enrollment for a Phase 3 trial.
I know I am not doing this right but here goes...
by definition kg/mg
mg/kg
Web definitions
A milligram of medication per kilogram of the body weight of the person taking the medication
so let say the average person's weight is 150 lbs or about 69 kg
69kg x 1.2 mg/kg dose ~ 83mg
1,000,000 mg = 1 kg
1000000/83 = about 12000 doses
12000 x 30 = about 360,000 doses???
Bingo!
Thanks from a "pounds and inches" guy!
Ultimate, That is interesting in that all the formulations, otic and opthalmic would be liquid applications. Is it possible that this stuff could be mixed in a saline solution prior to administration via Iv infusion?
When you see how little the patients in the Phase 2b test have been taking ,... it seems like alot.
.6mg/kg or .8mg/kg per for one day
one milligram is 1/1000th of a gram,...
1000 grams in a kilogram
1 gram = 1000 mg
It's a smart play to tout the benefits to patients and society and avoid chest beating and "better than" comments.
Cellceutix Completes Enrollment in Phase 2b Clinical Trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Aug 19, 2014 08:30:00 (ET)
Cellceutix Completes Enrollment in Phase 2b Clinical Trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
BEVERLY, MA--(Marketwired - Aug 19, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, has announced the completion of enrollment in its Phase 2b trial comparing Brilacidin(TM) to daptomycin (Cubicin(R)) in patients with acute bacterial skin and skin structure infections (ABSSSI). Overall, 215 patients were randomized to one of three dosing regimens of Brilacidin (single dose 0.6mg/kg; single-dose 0.8mg/kg; 1.2mg/kg over 3 days) or 7 days of once daily daptomycin. Brilacidin is the lead compound among a novel class of antibiotics known as defensin-mimetics. These compounds have shown great promise in preclinical and early clinical studies as potent antibiotics that can kill Staph aureus, including methicillin-resistant Staph aureus (MRSA). Moreover, given the unique mechanism of action, among other attributes, there is low, if any, potential for the development of resistance. Finally, the results of the current study may demonstrate that Brilacidin could be given as a single-dose, which provides benefits for both patients and society.
This combination of properties makes Brilacidin unique among antibiotics recently approved or in development for the treatment of MRSA. Because these other compounds come from existing classes of antibiotics, there is the potential for cross-resistance; this is not the case for Brilacidin.
"This is an important milestone for Cellceutix and for the field of infectious diseases," said Leo Ehrlich, the company's CEO. "There is no other antibiotic with these properties, which can treat infection and potentially decrease the burden of antibiotic resistance. Resistance, the antibiotic slayer. We are now in the process of manufacturing 30 kg of Brilacidin for future clinical trials which we plan for multiple forms of serious infections."
The company expects data from the trial to be available in the fourth quarter of 2014.
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 antibiotic 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 is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. 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. 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 key antibiotic, Brilacidin, has completed enrollment in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than most currently marketed antibiotics for 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.
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
Email Contact
(MORE TO FOLLOW) Dow Jones Newswires
August 19, 2014 08:30 ET (12:30 GMT)
I sure hope we can avoid a gap. Easy does it. Check your GTC sells and stops, etc. you don't want to get sold out at $1.87 and not be able to get back in under $2.00, or sell at $2.03 and watch as the stocks gaps to $3.50!
