CTIX Discussion 08/25/2014 05:26:58 $CTIX
That was an interesting study and shows why CTIX management chose to test Brilacidin against Daptomycin.
From your post:
Quote:
Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.
In Reply to 'Orion Nebula'
Pharmacotherapy
Daptomycin versus Vancomycin for Complicated Skin and Skin Structure Infections: Clinical and Economic Outcomes
Susan L. Davis, Pharm.D., Peggy S. McKinnon, Pharm.D., Levi M. Hall, Pharm.D., George Delgado, Jr., Pharm.D., Warren Rose, Pharm.D., Robert F. Wilson, M.D., Michael J. Rybak, Pharm.D., M.P.H.
Disclosures
Pharmacotherapy. 2007;27(12):1611-1618.
Study Objective. To assess the effect of daptomycin compared with vancomycin on the clinical and economic outcomes in patients with complicated skin and skin structure infections.
Design. Prospective, open-label study.
Setting. Level 1 trauma center in Detroit, Michigan.
Patients. Fifty-three adult patients with complicated skin and skin structure infections at risk for methicillin-resistant Staphylococcus aureus (MRSA) infection who were treated with daptomycin and a matched cohort of 212 patients treated with vancomycin.
Intervention. Patients in the prospective arm received intravenous daptomycin 4 mg/kg every 24 hours for at least 3 days but not more than 14 days. Historical controls received at least 3 days of vancomycin dosed to achieve trough concentrations of 5–20 µg/ml.
Measurements and Main Results. Outcomes evaluated included blinded assessments of clinical resolution, duration of therapy, and costs. The most common diagnoses were cellulitis (31%), abscess (22%), and both cellulitis with abscess (37%). Microbiology differed significantly between groups, with S. aureus found in 27 patients (51%) in the daptomycin group and 167 patients (79%) in the vancomycin group and MRSA in 22 (42%) and 159 (75%), respectively (p<0.001). The proportions of patients with clinical improvement or resolution of their infections on days 3 and 5 were 90% versus 70% and 98% versus 81% in the daptomycin versus vancomycin groups, respectively (p<0.01 for both comparisons), and 100% at the end of therapy in both groups. Among patients with complete resolution of their infections (41 patients [77%] with daptomycin vs 89 patients [42%] with vancomycin, p<0.05), median duration of intravenous therapy was 4 and 7 days, respectively, (p<0.001), and hospital costs were $5027 and $7552 (p<0.001).
Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.
Skin and skin structure infections are frequently encountered in medical practice. In 2004, these infections were the primary diagnosis in approximately 562,000 hospital discharges, with an average length of stay of 4.7 days, according to the most recent survey from the Centers for Disease Control and Prevention (CDC).[1] Bacterial skin diseases encompass a wide spectrum of clinical manifestations, ranging from local superficial infections to life-threatening aggressive infections. Prompt treatment with an appropriate antibiotic is an important factor in limiting the subsequent complications associated with skin infections.[2]
Skin and skin structure infections are most commonly caused by gram-positive organisms, including Staphylococcus aureus and Streptococcus species. The increasing prevalence of methicillin-resistant S. aureus (MRSA) in the hospital and community complicates the treatment of skin and skin structure infections. An important concern is that MRSA is associated with a significant increase in cost of care. In a case-control study of staphylococcal bloodstream infections, MRSA was associated with an additional 8 days of hospitalization and $17,400 when compared with methicillin-susceptible S. aureus.[3] Another group reported similar results in an observational cohort of patients with surgical site infections, in which MRSA was independently associated with an additional $13,900 in hospital costs/infection.[4] Further, in an analysis of clinical trial data in patients with complicated skin and soft-tissue infections, it was reported that treatment of MRSA with vancomycin resulted in total treatment costs of more than $6000.[5]
Daptomycin (Cubicin; Cubist Pharmaceuticals, Lexington, MA) is a novel lipopeptide antibiotic recently approved by the United States Food and Drug Administration for the treatment of complicated skin and skin structure infections caused by susceptible strains of gram-positive bacteria, such as Streptococcus species and S. aureus including MRSA. Daptomycin demonstrates bactericidal activity and is more rapidly bactericidal than vancomycin against staphylococci and enterococci.[6] In a randomized, investigator-blinded, clinical trial, clinical success rates at the end of therapy were similar between patients treated with daptomycin and those treated with standard therapy.[7] However, among patients who were successfully treated with daptomycin, a significantly greater (p<0.001) proportion of patients (63% vs 33%) required only 4–7 days of intravenous therapy compared with the control group (semisynthetic penicillins and/or vancomycin). This was supported by further analyses of the same trial, which revealed that patients with complicated skin and skin structure infections who were treated with daptomycin demonstrated a more rapid response than those treated with standard therapy.[7]
Quote:
VANCOMYCIN is currently the DRUG OF CHOICE
Please provide your source, if there is one.
Sounds like someone forgot about Leo's PR already.
"Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance."
http://cellceutix.com/cellceutix-prepares-for...ZqDPl.dpbs
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
I just finished reading 2 days worth of IHub catch up and realized that I could check in here every so often and not miss a beat. Not that it matters, as I haven't posted much, but I challenge all you future millionaires to DONATE $10,000 or more if you will to the Wounded Warriors Project when our stock hits $10 a share. I juat received news of a fellow Vietnam Vet's passing and in my melancholy moments, I thought we might fund a worthy cause in our soon to be windfall. Thanks if you do, and Semper Fi to any "jarheads" on the board.
Go CTIX and go Gamecocks!!!!
Jerry, Vanco is the primary, cheap treatment for MRSA. As I said, the Dapto vrs. Brila study is for general ABSSSI. Vanco is almost exclusively used for MRSA because 1) its cheap, 2) it does cause resistant strains if over prescribed for use against other bacterial infections, and 3) because it is currently effective against MRSA, until it's not. Dapto is the lead treatment for ABSSSI with over $1 billion a years in sales. Dapto was a good choice for the control arm. Brilacidin may soon replace Vanco for MRSA when Vanco eventually loses its efficacy.
Edit, thanks Orion Neb for that comparative study between Dapto and Vanco. I didn't know Dapto was superior against MRSA.
He's looking for cheaper shares again to cover his shorts.
It will change again after he consults his colleagues (google).
Pharmacotherapy
Daptomycin versus Vancomycin for Complicated Skin and Skin Structure Infections: Clinical and Economic Outcomes
Susan L. Davis, Pharm.D., Peggy S. McKinnon, Pharm.D., Levi M. Hall, Pharm.D., George Delgado, Jr., Pharm.D., Warren Rose, Pharm.D., Robert F. Wilson, M.D., Michael J. Rybak, Pharm.D., M.P.H.
Disclosures
Pharmacotherapy. 2007;27(12):1611-1618.
Study Objective. To assess the effect of daptomycin compared with vancomycin on the clinical and economic outcomes in patients with complicated skin and skin structure infections.
Design. Prospective, open-label study.
Setting. Level 1 trauma center in Detroit, Michigan.
Patients. Fifty-three adult patients with complicated skin and skin structure infections at risk for methicillin-resistant Staphylococcus aureus (MRSA) infection who were treated with daptomycin and a matched cohort of 212 patients treated with vancomycin.
Intervention. Patients in the prospective arm received intravenous daptomycin 4 mg/kg every 24 hours for at least 3 days but not more than 14 days. Historical controls received at least 3 days of vancomycin dosed to achieve trough concentrations of 5–20 µg/ml.
Measurements and Main Results. Outcomes evaluated included blinded assessments of clinical resolution, duration of therapy, and costs. The most common diagnoses were cellulitis (31%), abscess (22%), and both cellulitis with abscess (37%). Microbiology differed significantly between groups, with S. aureus found in 27 patients (51%) in the daptomycin group and 167 patients (79%) in the vancomycin group and MRSA in 22 (42%) and 159 (75%), respectively (p<0.001). The proportions of patients with clinical improvement or resolution of their infections on days 3 and 5 were 90% versus 70% and 98% versus 81% in the daptomycin versus vancomycin groups, respectively (p<0.01 for both comparisons), and 100% at the end of therapy in both groups. Among patients with complete resolution of their infections (41 patients [77%] with daptomycin vs 89 patients [42%] with vancomycin, p<0.05), median duration of intravenous therapy was 4 and 7 days, respectively, (p<0.001), and hospital costs were $5027 and $7552 (p<0.001).
Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.
Skin and skin structure infections are frequently encountered in medical practice. In 2004, these infections were the primary diagnosis in approximately 562,000 hospital discharges, with an average length of stay of 4.7 days, according to the most recent survey from the Centers for Disease Control and Prevention (CDC).[1] Bacterial skin diseases encompass a wide spectrum of clinical manifestations, ranging from local superficial infections to life-threatening aggressive infections. Prompt treatment with an appropriate antibiotic is an important factor in limiting the subsequent complications associated with skin infections.[2]
Skin and skin structure infections are most commonly caused by gram-positive organisms, including Staphylococcus aureus and Streptococcus species. The increasing prevalence of methicillin-resistant S. aureus (MRSA) in the hospital and community complicates the treatment of skin and skin structure infections. An important concern is that MRSA is associated with a significant increase in cost of care. In a case-control study of staphylococcal bloodstream infections, MRSA was associated with an additional 8 days of hospitalization and $17,400 when compared with methicillin-susceptible S. aureus.[3] Another group reported similar results in an observational cohort of patients with surgical site infections, in which MRSA was independently associated with an additional $13,900 in hospital costs/infection.[4] Further, in an analysis of clinical trial data in patients with complicated skin and soft-tissue infections, it was reported that treatment of MRSA with vancomycin resulted in total treatment costs of more than $6000.[5]
Daptomycin (Cubicin; Cubist Pharmaceuticals, Lexington, MA) is a novel lipopeptide antibiotic recently approved by the United States Food and Drug Administration for the treatment of complicated skin and skin structure infections caused by susceptible strains of gram-positive bacteria, such as Streptococcus species and S. aureus including MRSA. Daptomycin demonstrates bactericidal activity and is more rapidly bactericidal than vancomycin against staphylococci and enterococci.[6] In a randomized, investigator-blinded, clinical trial, clinical success rates at the end of therapy were similar between patients treated with daptomycin and those treated with standard therapy.[7] However, among patients who were successfully treated with daptomycin, a significantly greater (p<0.001) proportion of patients (63% vs 33%) required only 4–7 days of intravenous therapy compared with the control group (semisynthetic penicillins and/or vancomycin). This was supported by further analyses of the same trial, which revealed that patients with complicated skin and skin structure infections who were treated with daptomycin demonstrated a more rapid response than those treated with standard therapy.[7]
That's his opinion for the moment. Go back and look at Dr. Jerry's posts from June, I've haven't seen so much flopping since the World Cup ended.
don't matter, important thing is, how long are people willing to give for the scientific part to complete. IMO.
It's your opinion that the medical community will focus on it. And given your previous track record this is pretty convincing evidence that they likely won't focus on it (because you're usually wrong).
Vancomycin is a safe and cheap drug. Given that Daptomycin makes significantly more revenue because it isn't a generic (among other reasons), I'm glad we picked a drug for our control arm to show non-inferiority or superiority to that actually generates revenue.
VANCOMYCIN is currently the DRUG OF CHOICE and resistance does exist in very small amounts in genetically susceptible people.
About 30 % of all people test positive for MRSA when their nasal septum's are swiped.( carriers)
Yes I think they should have used vancomycin for the control arm since it is the DRUG of Choice for MRSA and thats what the medical community will focus on after the data is unblinded.
Daptomycin is a 3rd or 4th line drug..
The study is against bacterial caused ABSSSI requiring treatment by intravenous therapy. Nothing mentioned about MSRA as a criteria.
Detailed Description:
This is a randomized, multi-center, double-blind study to evaluate the efficacy and safety of three regimens of brilacidin compared to an active control, daptomycin, in subjects with ABSSSI. Subjects must have infections that warrant intravenous therapy but may be treated as either inpatients or outpatients.
http://clinicaltrials.gov/ct2/show/NCT0205238...amp;rank=3
There will be no criticism from the medical community.
I'm confused, are you saying that B going against Dapto is bad? Isn't Vancomycin considered inferior to Daptomycin, and progressively developing resistant? My belief is that CTIX is being touted for going against a more superior drug than Vancomycin, rather than taking the easy route. I wanna go against the best, and beat the best, that's how you get your name in the paper.
I followed the sistership way back when and had my eyes on it for some quite time between 1.00 - 2.00. Maybe I was just looking for trade or did not understand it well enough. Then I lost sight of it. Until I woke up one day and said to myself, you just can't chase this now............................ya, right.
Critics in the medical community will be quick to point out that CTIX went against the grain by choosing to pit Brilacidin against daptomycin instead of the current standard for skin infections caused by MRSA.
When the data is unblinded, I am confident that a single dose of Brilacidin .8mg/kg will be equal to daptomycin for 7 days based on the Polymedix data.
The medical community will be very critical of Leo's choice to use the daptomycin arm as the standard and may explain all this anticipatory anxiety by many of the posters present.
If you google MRSA skin infections your fist hit will be VANCOMYCIN not daptomycin or tedizolide !!!
jok, there definitely are a ton of variables. That's one reason I enjoy the markets so much. From your post:
Quote:
i knew beforehand that there are a tone of variables that would have too be taken into account.
I did find your use of "hope" a bit interesting:
Quote:
The reasoning behind was to give me an idea of what i should hope for and what i am hoping of is a slow steady rise based on positive material events.
From my experience, hope = market loses from emotional decisions. I've always had better gains when trying to understand what the market has to say. I may hope a company is successful and achieves this or that, but I never count on hope to determine where a share price is going to be from time to time.
I gather you are a longer term CTIX investor, and have done research to your satisfaction. From your post:
Quote:
I believe great things are coming for those that have patience and i have a lot.
Good up front research (fundamental analysis) can definitely reduce risk. But, for all the research, most of us do not know near, all the important information. Often, technical deviations from fundamental expectations can manifest. I never downplay the technical, because it is reality in the markets. I never write off good fundamental analysis, I just know it is incomplete information.
I got involved in CTIX at a good time. My initial investments were late in 2012, were the basis of my long term holdings, and I am way up since then. Following the board since then, I have listened to many grumbling about their own investment. I was happy while others grumbled. The main reason is timing. I entered at a good time, some have not.
You have had bad experiences with shorter term trading and made this statement:
Quote:
I have tried timing my trading in the past thinking i was smarter that the market and that has never been a great proposition based on results. getting caught with your pants down around your ankles can be costly.
Remember the saying: When running from a bear, one needs to be faster than the other guy, not faster than the bear. That is my experience with trading. I will never be smarter than the market, but I am not competing against the market, just that other trader.
I have done well trading CTIX too. Although, not much this year because of the lack of volatility. Yet, I have made several 20% gains from short weekly positions.
Which is better: A 100% gain over a year, or several 20% gains (compounded and reinvested) over a biweekly time frame. I don't really have the answer. But, over the past few years I have had much higher percentage gains in my trade account. While the largest dollar gains have come from my longer term account. This because, I have substantially more in the longer term account.
Part of the reason I invest/trade as I do, is because I find it difficult to manage trading with larger sums. So, as my trade account gets to a certain size, I divert some to long term and some to income.
All this leads me to a point: Each of us must find our own successful ways to invest/trade. Don't be too quick to criticize, to objectify, to discount, or assume. Fundamental and technical analysis each have their place. Choose one over the other, and get an incomplete picture. Combine the two and get a much richer picture.
I really liked this statement from another of your recent posts:
Quote:
I looked at Gilead's chart about a year and some time ago
Tells me you are learning, researching, questioning, looking for relevance.
Me too.
By the way, anyone crossing the finish line is a winner:
I'd be most worried if I were the guy carrying the extra spare tire:
CTIX has been likened to PCYC from time to time on this board. The chart link below shows the original escalation from the 1.16 low set in August of 2009 to a rise ending at 2.41 (almost exactly as CTIX), only to fall back and form a slightly downward sloping/horizontal consolidation to a 1.71 low, bottoming aprox 3 months later. Again, price wise very similar to CTIX price/consolidation. From the 1.71 low, PCYC stair stepped over the next four and a half months up to 8.60. For those unaware, PCYC share price closed at $119.32 on Friday.
What caused the the 1.71 march to 8.60 in just four plus months? I,m guessing it was precipitated by Clinical Trial, Phase 1 and 2 results announced in early Dec, 2009. (see second link below)
Some interesting commonality in this young CTIX.
http://scharts.co/YSlKli
http://ir.pharmacyclics.com/releases.cfm?Rele...Descending
I appreciate your time to reply. I would prefer a slow and steady with an occasional spike that makes people pause and say WOW! I looked at Gilead's chart about a year and some time ago and said that is what i want and i think that is what we have hear plus some.
Thank your sir
Thank you sir.
Jok
That was an interesting study and shows why CTIX management chose to test Brilacidin against Daptomycin.
From your post:
Quote:
Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.
In Reply to 'Orion Nebula'
Pharmacotherapy
Daptomycin versus Vancomycin for Complicated Skin and Skin Structure Infections: Clinical and Economic Outcomes
Susan L. Davis, Pharm.D., Peggy S. McKinnon, Pharm.D., Levi M. Hall, Pharm.D., George Delgado, Jr., Pharm.D., Warren Rose, Pharm.D., Robert F. Wilson, M.D., Michael J. Rybak, Pharm.D., M.P.H.
Disclosures
Pharmacotherapy. 2007;27(12):1611-1618.
Study Objective. To assess the effect of daptomycin compared with vancomycin on the clinical and economic outcomes in patients with complicated skin and skin structure infections.
Design. Prospective, open-label study.
Setting. Level 1 trauma center in Detroit, Michigan.
Patients. Fifty-three adult patients with complicated skin and skin structure infections at risk for methicillin-resistant Staphylococcus aureus (MRSA) infection who were treated with daptomycin and a matched cohort of 212 patients treated with vancomycin.
Intervention. Patients in the prospective arm received intravenous daptomycin 4 mg/kg every 24 hours for at least 3 days but not more than 14 days. Historical controls received at least 3 days of vancomycin dosed to achieve trough concentrations of 5–20 µg/ml.
Measurements and Main Results. Outcomes evaluated included blinded assessments of clinical resolution, duration of therapy, and costs. The most common diagnoses were cellulitis (31%), abscess (22%), and both cellulitis with abscess (37%). Microbiology differed significantly between groups, with S. aureus found in 27 patients (51%) in the daptomycin group and 167 patients (79%) in the vancomycin group and MRSA in 22 (42%) and 159 (75%), respectively (p<0.001). The proportions of patients with clinical improvement or resolution of their infections on days 3 and 5 were 90% versus 70% and 98% versus 81% in the daptomycin versus vancomycin groups, respectively (p<0.01 for both comparisons), and 100% at the end of therapy in both groups. Among patients with complete resolution of their infections (41 patients [77%] with daptomycin vs 89 patients [42%] with vancomycin, p<0.05), median duration of intravenous therapy was 4 and 7 days, respectively, (p<0.001), and hospital costs were $5027 and $7552 (p<0.001).
Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.
Skin and skin structure infections are frequently encountered in medical practice. In 2004, these infections were the primary diagnosis in approximately 562,000 hospital discharges, with an average length of stay of 4.7 days, according to the most recent survey from the Centers for Disease Control and Prevention (CDC).[1] Bacterial skin diseases encompass a wide spectrum of clinical manifestations, ranging from local superficial infections to life-threatening aggressive infections. Prompt treatment with an appropriate antibiotic is an important factor in limiting the subsequent complications associated with skin infections.[2]
Skin and skin structure infections are most commonly caused by gram-positive organisms, including Staphylococcus aureus and Streptococcus species. The increasing prevalence of methicillin-resistant S. aureus (MRSA) in the hospital and community complicates the treatment of skin and skin structure infections. An important concern is that MRSA is associated with a significant increase in cost of care. In a case-control study of staphylococcal bloodstream infections, MRSA was associated with an additional 8 days of hospitalization and $17,400 when compared with methicillin-susceptible S. aureus.[3] Another group reported similar results in an observational cohort of patients with surgical site infections, in which MRSA was independently associated with an additional $13,900 in hospital costs/infection.[4] Further, in an analysis of clinical trial data in patients with complicated skin and soft-tissue infections, it was reported that treatment of MRSA with vancomycin resulted in total treatment costs of more than $6000.[5]
Daptomycin (Cubicin; Cubist Pharmaceuticals, Lexington, MA) is a novel lipopeptide antibiotic recently approved by the United States Food and Drug Administration for the treatment of complicated skin and skin structure infections caused by susceptible strains of gram-positive bacteria, such as Streptococcus species and S. aureus including MRSA. Daptomycin demonstrates bactericidal activity and is more rapidly bactericidal than vancomycin against staphylococci and enterococci.[6] In a randomized, investigator-blinded, clinical trial, clinical success rates at the end of therapy were similar between patients treated with daptomycin and those treated with standard therapy.[7] However, among patients who were successfully treated with daptomycin, a significantly greater (p<0.001) proportion of patients (63% vs 33%) required only 4–7 days of intravenous therapy compared with the control group (semisynthetic penicillins and/or vancomycin). This was supported by further analyses of the same trial, which revealed that patients with complicated skin and skin structure infections who were treated with daptomycin demonstrated a more rapid response than those treated with standard therapy.[7]
Quote:
VANCOMYCIN is currently the DRUG OF CHOICE
Please provide your source, if there is one.
Sounds like someone forgot about Leo's PR already.
"Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance."
http://cellceutix.com/cellceutix-prepares-for...ZqDPl.dpbs
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
I just finished reading 2 days worth of IHub catch up and realized that I could check in here every so often and not miss a beat. Not that it matters, as I haven't posted much, but I challenge all you future millionaires to DONATE $10,000 or more if you will to the Wounded Warriors Project when our stock hits $10 a share. I juat received news of a fellow Vietnam Vet's passing and in my melancholy moments, I thought we might fund a worthy cause in our soon to be windfall. Thanks if you do, and Semper Fi to any "jarheads" on the board.
Go CTIX and go Gamecocks!!!!
Jerry, Vanco is the primary, cheap treatment for MRSA. As I said, the Dapto vrs. Brila study is for general ABSSSI. Vanco is almost exclusively used for MRSA because 1) its cheap, 2) it does cause resistant strains if over prescribed for use against other bacterial infections, and 3) because it is currently effective against MRSA, until it's not. Dapto is the lead treatment for ABSSSI with over $1 billion a years in sales. Dapto was a good choice for the control arm. Brilacidin may soon replace Vanco for MRSA when Vanco eventually loses its efficacy.
Edit, thanks Orion Neb for that comparative study between Dapto and Vanco. I didn't know Dapto was superior against MRSA.
He's looking for cheaper shares again to cover his shorts.
It will change again after he consults his colleagues (google).
Pharmacotherapy
Daptomycin versus Vancomycin for Complicated Skin and Skin Structure Infections: Clinical and Economic Outcomes
Susan L. Davis, Pharm.D., Peggy S. McKinnon, Pharm.D., Levi M. Hall, Pharm.D., George Delgado, Jr., Pharm.D., Warren Rose, Pharm.D., Robert F. Wilson, M.D., Michael J. Rybak, Pharm.D., M.P.H.
Disclosures
Pharmacotherapy. 2007;27(12):1611-1618.
Study Objective. To assess the effect of daptomycin compared with vancomycin on the clinical and economic outcomes in patients with complicated skin and skin structure infections.
Design. Prospective, open-label study.
Setting. Level 1 trauma center in Detroit, Michigan.
Patients. Fifty-three adult patients with complicated skin and skin structure infections at risk for methicillin-resistant Staphylococcus aureus (MRSA) infection who were treated with daptomycin and a matched cohort of 212 patients treated with vancomycin.
Intervention. Patients in the prospective arm received intravenous daptomycin 4 mg/kg every 24 hours for at least 3 days but not more than 14 days. Historical controls received at least 3 days of vancomycin dosed to achieve trough concentrations of 5–20 µg/ml.
Measurements and Main Results. Outcomes evaluated included blinded assessments of clinical resolution, duration of therapy, and costs. The most common diagnoses were cellulitis (31%), abscess (22%), and both cellulitis with abscess (37%). Microbiology differed significantly between groups, with S. aureus found in 27 patients (51%) in the daptomycin group and 167 patients (79%) in the vancomycin group and MRSA in 22 (42%) and 159 (75%), respectively (p<0.001). The proportions of patients with clinical improvement or resolution of their infections on days 3 and 5 were 90% versus 70% and 98% versus 81% in the daptomycin versus vancomycin groups, respectively (p<0.01 for both comparisons), and 100% at the end of therapy in both groups. Among patients with complete resolution of their infections (41 patients [77%] with daptomycin vs 89 patients [42%] with vancomycin, p<0.05), median duration of intravenous therapy was 4 and 7 days, respectively, (p<0.001), and hospital costs were $5027 and $7552 (p<0.001).
Conclusions. Patients receiving daptomycin achieved more rapid resolution of symptoms and clinical cure and had a decreased duration of inpatient therapy compared with those receiving vancomycin. This study suggests that daptomycin is a cost-effective alternative to vancomycin for complicated skin and skin structure infections.
Skin and skin structure infections are frequently encountered in medical practice. In 2004, these infections were the primary diagnosis in approximately 562,000 hospital discharges, with an average length of stay of 4.7 days, according to the most recent survey from the Centers for Disease Control and Prevention (CDC).[1] Bacterial skin diseases encompass a wide spectrum of clinical manifestations, ranging from local superficial infections to life-threatening aggressive infections. Prompt treatment with an appropriate antibiotic is an important factor in limiting the subsequent complications associated with skin infections.[2]
Skin and skin structure infections are most commonly caused by gram-positive organisms, including Staphylococcus aureus and Streptococcus species. The increasing prevalence of methicillin-resistant S. aureus (MRSA) in the hospital and community complicates the treatment of skin and skin structure infections. An important concern is that MRSA is associated with a significant increase in cost of care. In a case-control study of staphylococcal bloodstream infections, MRSA was associated with an additional 8 days of hospitalization and $17,400 when compared with methicillin-susceptible S. aureus.[3] Another group reported similar results in an observational cohort of patients with surgical site infections, in which MRSA was independently associated with an additional $13,900 in hospital costs/infection.[4] Further, in an analysis of clinical trial data in patients with complicated skin and soft-tissue infections, it was reported that treatment of MRSA with vancomycin resulted in total treatment costs of more than $6000.[5]
Daptomycin (Cubicin; Cubist Pharmaceuticals, Lexington, MA) is a novel lipopeptide antibiotic recently approved by the United States Food and Drug Administration for the treatment of complicated skin and skin structure infections caused by susceptible strains of gram-positive bacteria, such as Streptococcus species and S. aureus including MRSA. Daptomycin demonstrates bactericidal activity and is more rapidly bactericidal than vancomycin against staphylococci and enterococci.[6] In a randomized, investigator-blinded, clinical trial, clinical success rates at the end of therapy were similar between patients treated with daptomycin and those treated with standard therapy.[7] However, among patients who were successfully treated with daptomycin, a significantly greater (p<0.001) proportion of patients (63% vs 33%) required only 4–7 days of intravenous therapy compared with the control group (semisynthetic penicillins and/or vancomycin). This was supported by further analyses of the same trial, which revealed that patients with complicated skin and skin structure infections who were treated with daptomycin demonstrated a more rapid response than those treated with standard therapy.[7]
That's his opinion for the moment. Go back and look at Dr. Jerry's posts from June, I've haven't seen so much flopping since the World Cup ended.
don't matter, important thing is, how long are people willing to give for the scientific part to complete. IMO.
It's your opinion that the medical community will focus on it. And given your previous track record this is pretty convincing evidence that they likely won't focus on it (because you're usually wrong).
Vancomycin is a safe and cheap drug. Given that Daptomycin makes significantly more revenue because it isn't a generic (among other reasons), I'm glad we picked a drug for our control arm to show non-inferiority or superiority to that actually generates revenue.
VANCOMYCIN is currently the DRUG OF CHOICE and resistance does exist in very small amounts in genetically susceptible people.
About 30 % of all people test positive for MRSA when their nasal septum's are swiped.( carriers)
Yes I think they should have used vancomycin for the control arm since it is the DRUG of Choice for MRSA and thats what the medical community will focus on after the data is unblinded.
Daptomycin is a 3rd or 4th line drug..
The study is against bacterial caused ABSSSI requiring treatment by intravenous therapy. Nothing mentioned about MSRA as a criteria.
Detailed Description:
This is a randomized, multi-center, double-blind study to evaluate the efficacy and safety of three regimens of brilacidin compared to an active control, daptomycin, in subjects with ABSSSI. Subjects must have infections that warrant intravenous therapy but may be treated as either inpatients or outpatients.
http://clinicaltrials.gov/ct2/show/NCT0205238...amp;rank=3
There will be no criticism from the medical community.
I'm confused, are you saying that B going against Dapto is bad? Isn't Vancomycin considered inferior to Daptomycin, and progressively developing resistant? My belief is that CTIX is being touted for going against a more superior drug than Vancomycin, rather than taking the easy route. I wanna go against the best, and beat the best, that's how you get your name in the paper.
I followed the sistership way back when and had my eyes on it for some quite time between 1.00 - 2.00. Maybe I was just looking for trade or did not understand it well enough. Then I lost sight of it. Until I woke up one day and said to myself, you just can't chase this now............................ya, right.
Critics in the medical community will be quick to point out that CTIX went against the grain by choosing to pit Brilacidin against daptomycin instead of the current standard for skin infections caused by MRSA.
When the data is unblinded, I am confident that a single dose of Brilacidin .8mg/kg will be equal to daptomycin for 7 days based on the Polymedix data.
The medical community will be very critical of Leo's choice to use the daptomycin arm as the standard and may explain all this anticipatory anxiety by many of the posters present.
If you google MRSA skin infections your fist hit will be VANCOMYCIN not daptomycin or tedizolide !!!
jok, there definitely are a ton of variables. That's one reason I enjoy the markets so much. From your post:
Quote:
i knew beforehand that there are a tone of variables that would have too be taken into account.
I did find your use of "hope" a bit interesting:
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The reasoning behind was to give me an idea of what i should hope for and what i am hoping of is a slow steady rise based on positive material events.
From my experience, hope = market loses from emotional decisions. I've always had better gains when trying to understand what the market has to say. I may hope a company is successful and achieves this or that, but I never count on hope to determine where a share price is going to be from time to time.
I gather you are a longer term CTIX investor, and have done research to your satisfaction. From your post:
Quote:
I believe great things are coming for those that have patience and i have a lot.
Good up front research (fundamental analysis) can definitely reduce risk. But, for all the research, most of us do not know near, all the important information. Often, technical deviations from fundamental expectations can manifest. I never downplay the technical, because it is reality in the markets. I never write off good fundamental analysis, I just know it is incomplete information.
I got involved in CTIX at a good time. My initial investments were late in 2012, were the basis of my long term holdings, and I am way up since then. Following the board since then, I have listened to many grumbling about their own investment. I was happy while others grumbled. The main reason is timing. I entered at a good time, some have not.
You have had bad experiences with shorter term trading and made this statement:
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I have tried timing my trading in the past thinking i was smarter that the market and that has never been a great proposition based on results. getting caught with your pants down around your ankles can be costly.
Remember the saying: When running from a bear, one needs to be faster than the other guy, not faster than the bear. That is my experience with trading. I will never be smarter than the market, but I am not competing against the market, just that other trader.
I have done well trading CTIX too. Although, not much this year because of the lack of volatility. Yet, I have made several 20% gains from short weekly positions.
Which is better: A 100% gain over a year, or several 20% gains (compounded and reinvested) over a biweekly time frame. I don't really have the answer. But, over the past few years I have had much higher percentage gains in my trade account. While the largest dollar gains have come from my longer term account. This because, I have substantially more in the longer term account.
Part of the reason I invest/trade as I do, is because I find it difficult to manage trading with larger sums. So, as my trade account gets to a certain size, I divert some to long term and some to income.
All this leads me to a point: Each of us must find our own successful ways to invest/trade. Don't be too quick to criticize, to objectify, to discount, or assume. Fundamental and technical analysis each have their place. Choose one over the other, and get an incomplete picture. Combine the two and get a much richer picture.
I really liked this statement from another of your recent posts:
Quote:
I looked at Gilead's chart about a year and some time ago
Tells me you are learning, researching, questioning, looking for relevance.
Me too.
By the way, anyone crossing the finish line is a winner:
I'd be most worried if I were the guy carrying the extra spare tire:
CTIX has been likened to PCYC from time to time on this board. The chart link below shows the original escalation from the 1.16 low set in August of 2009 to a rise ending at 2.41 (almost exactly as CTIX), only to fall back and form a slightly downward sloping/horizontal consolidation to a 1.71 low, bottoming aprox 3 months later. Again, price wise very similar to CTIX price/consolidation. From the 1.71 low, PCYC stair stepped over the next four and a half months up to 8.60. For those unaware, PCYC share price closed at $119.32 on Friday.
What caused the the 1.71 march to 8.60 in just four plus months? I,m guessing it was precipitated by Clinical Trial, Phase 1 and 2 results announced in early Dec, 2009. (see second link below)
Some interesting commonality in this young CTIX.
http://scharts.co/YSlKli
http://ir.pharmacyclics.com/releases.cfm?Rele...Descending
I appreciate your time to reply. I would prefer a slow and steady with an occasional spike that makes people pause and say WOW! I looked at Gilead's chart about a year and some time ago and said that is what i want and i think that is what we have hear plus some.
Thank your sir
Thank you sir.
Jok
