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Comparing with "randomised" (in-label use patient category) clinical trial under ENDEAVOR III whereby Endeavor VS Cypher, the results are as follows:
*Late loss : 0.34mm VS 0.13mm
*Binary Restenosis: 11.7% VS 4.3%
*Overall TLR : 9.8% VS 3.5%
*MACE (30 days) : 7.6% VS 7.1%
*Late-thrombosis : Nil for both DESs
Now compare the figure with LEADERS results, bearing in mind that Endeavor III is "randomised" and in-label use while LEADERS is "real world all comers patient group" which include mostly "off-label" use patient group. Tell me which DES is the Best Of The Best???
Biomatrix / Cypher / Endeavor??? The answer is obvious.
*Late loss : 0.34mm VS 0.13mm
*Binary Restenosis: 11.7% VS 4.3%
*Overall TLR : 9.8% VS 3.5%
*MACE (30 days) : 7.6% VS 7.1%
*Late-thrombosis : Nil for both DESs
Now compare the figure with LEADERS results, bearing in mind that Endeavor III is "randomised" and in-label use while LEADERS is "real world all comers patient group" which include mostly "off-label" use patient group. Tell me which DES is the Best Of The Best???
Biomatrix / Cypher / Endeavor??? The answer is obvious.
You need to have very wide margin of difference to show statistical P value superiority. Biomatrix also show statistical superiority against Taxus. Taxus is so easy to beat. Only Endeavor find it very challenging to beat. In fact, i find clinical data of Endeavor IV horrible. The only CE approved DES that cannot beat Taxus is Costar from Conor (now under JNJ).
Lets have an anology. Say if in football we need to have at least a 2 goals difference to show a superior performance against another football team, then which team can show clear cut "superiority" against a top team like Machester United? If a football team can win by just one goal difference or win by penalty shootout against Manchester United, the winning team is already the cream of the crop.
I certainly love your enthusiasm Bengster, but no, you cannot
conclude from this trial that Biomatrix is superior to Cypher or that
it is the Best of the Best.
The trial results are pretty much what I expected. Biomatrix preformed well but was not able to show a statistically significant superiority in the 9 month data. I am actually a little disappointed that the MACE rates did not show a larger difference in favour of Biomatrix due to its' thinner struts. All we can conclude from this trial is that Biomatrix preformed as well as Cypher at the 9 month follow-up.
Yes, clinical trials are designed to show non-inferiority, but they are also designed to show superiority as well. An example of this is that Xience was able to show superiority over Taxus in the SPIRIT trials.bengster68 ( Date: 01-Sep-2008 21:48) Posted:
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Is there any information available as to how the 2 study population groups matched up? It is very important that the lesion characteristics and patient populations for both the Cypher group and the Biomatrix group be very similar. In an 'all comers' trial, I would imagine that this would be more difficult to obtain, although it is a large study with 1700 patients enrolled which should help.
A few things to note about this trial.
81 % of the patients are 'off-label' as opposed to normal clinical trials where it is 100 % 'on-label'.
'Off -label' implies that the situation is more complex, and is officially not approved for treatment.
31 % of patients have lesion length > 20 mm (As compared to other normal trials where the ave lesion length is 13-15mm). 68 % of patients have small vessels < 2.75.
THe only clinical trials that I know that have these complexities is probably the Taxus V and VI trials, for long lesions, and their mace rates are something like 15 - 19 %, and their TLR is probably also in the teens. (maybe 12 % or so, if my memory serves me right).
So actually, in this trial, both the Bio-matrix and the Cypher performs very well. (THat is why so few trials dare to go against the Cypher).
Authors: Windecker, Stephan & Mauri, Laura
Presenter report: Windecker, Stephan (Switzerland)
Although first generation drug-eluting stents (DES) have profoundly reduced clinical and angiographic measures of restenosis, they have been associated with a small increased risk of very late stent thrombosis, potentially related to the durable polymer component.
The biolimus-eluting stent (BIOMATRIX) is a new DES releasing biolimus, a sirolimus analogue, from a biodegradable polymer, polylactic acid, which completely degrades into carbon dioxide and water during a period of 6-9 months. This new stent platform was compared against a widely used sirolimus-eluting stent (CYPHER) with durable polymer in 1707 patients with 2472 lesions with both on- and off label characteristics in a randomized, multi-centre, single-blind, non-inferiority trial (LEADERS).
The primary endpoint, a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months, occurred in 9.2% of patients treated with biolimus-eluting stents and 10.5% of patients treated with sirolimus-eluting stents, thus establishing non-inferiority (Pnon-inferiority=0.003; rate ratio 0.88, 95%-CI 0.64-1.19, Psuperiority=0.39). Rates of cardiac death (1.6% versus 2.5%, P=0.22), myocardial infarction (5.7% versus 4.6%, P=0.30), and clinically-indicated target vessel revascularisation (4.4% versus 5.5%, P=0.29) were similar for both stent types. Biolimus-eluting stents were also non-inferior to sirolimus-eluting stents in in-stent percent diameter stenosis (20.9% versus 23.3%, Pnon-inferiority=0.001, Psuperiority=0.26), the principal angiographic endpoint of the study.
In summary, biolimus-eluting stents with biodegradable polymer represent a safe and effective alternative to sirolimus-eluting stents with durable polymer in patients with on- and off-label indications. Longer-term follow-up and studies in larger populations will be necessary to determine whether the biodegradable polymer is associated with a reduced risk of late stent thrombosis or different duration of dual antiplatelet therapy.
Discussant report: Mauri, Laura (United States of America)
The LEADERS study deserves congratulations. The study was well-designed, quick to enroll, and the data collection was independent and adjudicated. The stent platform is unique – with a fully biodegradable polymer releasing the sirolimus analogue, biolimus. The trial design is also unique.
This is the first truly “All-comers” randomized controlled trial of drug-eluting stents, with the only notable exclusion criteria being stent diameters less than 2.25 or greater than 3.5 mm or the inability of patients to take dual antiplatelet therapy for 6 months after the procedure. Such a study design seeks to overcome the main limitations of randomized trials (generalizability) and of observational studies (selection bias), and are a logical extension as drug-eluting stent technologies mature. However, there are still some fundamental limitations to drug-eluting stent studies that apply.
First, regarding generalizability, although myocardial infarction and multivessel stenting were common presentations in this patient population, there is not sufficient power to determine the safety or efficacy in each of these subgroups. Nonetheless, the consistency across the multiple subroups, all either balanced or favoring the biolimus-eluting stent is reassuring. Second, the durability of the clinical results is unknown. A fully biodegradable polymer might have a unique advantage over a durable polymer, particularly once the polymer is no longer present (after 6-9 months). Recent experience has shown the value of following drug-eluting stent patients beyond the restenosis period in randomized trials – with sirolimus-eluting stent trials soon reaching 6 years of follow up. The LEADERS trial reports 9 month follow up. Therefore, the hypothesis that the new biolimus-eluting stent has improved late safety and preserved efficacy compared to sirolimus-eluting stent – remains to be proven in further follow-up.
Presenter report: Windecker, Stephan (Switzerland)
Although first generation drug-eluting stents (DES) have profoundly reduced clinical and angiographic measures of restenosis, they have been associated with a small increased risk of very late stent thrombosis, potentially related to the durable polymer component.
The biolimus-eluting stent (BIOMATRIX) is a new DES releasing biolimus, a sirolimus analogue, from a biodegradable polymer, polylactic acid, which completely degrades into carbon dioxide and water during a period of 6-9 months. This new stent platform was compared against a widely used sirolimus-eluting stent (CYPHER) with durable polymer in 1707 patients with 2472 lesions with both on- and off label characteristics in a randomized, multi-centre, single-blind, non-inferiority trial (LEADERS).
The primary endpoint, a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months, occurred in 9.2% of patients treated with biolimus-eluting stents and 10.5% of patients treated with sirolimus-eluting stents, thus establishing non-inferiority (Pnon-inferiority=0.003; rate ratio 0.88, 95%-CI 0.64-1.19, Psuperiority=0.39). Rates of cardiac death (1.6% versus 2.5%, P=0.22), myocardial infarction (5.7% versus 4.6%, P=0.30), and clinically-indicated target vessel revascularisation (4.4% versus 5.5%, P=0.29) were similar for both stent types. Biolimus-eluting stents were also non-inferior to sirolimus-eluting stents in in-stent percent diameter stenosis (20.9% versus 23.3%, Pnon-inferiority=0.001, Psuperiority=0.26), the principal angiographic endpoint of the study.
In summary, biolimus-eluting stents with biodegradable polymer represent a safe and effective alternative to sirolimus-eluting stents with durable polymer in patients with on- and off-label indications. Longer-term follow-up and studies in larger populations will be necessary to determine whether the biodegradable polymer is associated with a reduced risk of late stent thrombosis or different duration of dual antiplatelet therapy.
Discussant report: Mauri, Laura (United States of America)
The LEADERS study deserves congratulations. The study was well-designed, quick to enroll, and the data collection was independent and adjudicated. The stent platform is unique – with a fully biodegradable polymer releasing the sirolimus analogue, biolimus. The trial design is also unique.
This is the first truly “All-comers” randomized controlled trial of drug-eluting stents, with the only notable exclusion criteria being stent diameters less than 2.25 or greater than 3.5 mm or the inability of patients to take dual antiplatelet therapy for 6 months after the procedure. Such a study design seeks to overcome the main limitations of randomized trials (generalizability) and of observational studies (selection bias), and are a logical extension as drug-eluting stent technologies mature. However, there are still some fundamental limitations to drug-eluting stent studies that apply.
First, regarding generalizability, although myocardial infarction and multivessel stenting were common presentations in this patient population, there is not sufficient power to determine the safety or efficacy in each of these subgroups. Nonetheless, the consistency across the multiple subroups, all either balanced or favoring the biolimus-eluting stent is reassuring. Second, the durability of the clinical results is unknown. A fully biodegradable polymer might have a unique advantage over a durable polymer, particularly once the polymer is no longer present (after 6-9 months). Recent experience has shown the value of following drug-eluting stent patients beyond the restenosis period in randomized trials – with sirolimus-eluting stent trials soon reaching 6 years of follow up. The LEADERS trial reports 9 month follow up. Therefore, the hypothesis that the new biolimus-eluting stent has improved late safety and preserved efficacy compared to sirolimus-eluting stent – remains to be proven in further follow-up.
Those who don't understand biomedical devices will never be able to anticipate the market. What competitive advantage do you have in understanding this stock that will position you for above-average chances in making money from it? And with so many other cheap stocks everywhere, are you incurring opportunity cost in putting your money with this company? All points to be considered.
BIG should info SGX to halt trading of BIG shares tomorrow for one full day until the analyst briefing is over and investors have a clearly picture about analysis of LEADERS data. There are many people still unable to fully comprehend this landmark achievement of Biosensors LEADERS results. Let the management of Biosensors explain the LEADERS results in detail, then resume share trading. This is just like one week ago BIG didn't do a timely SGX announcement on upcoming LEADERS results and ESC2008 which result in some kanchiong investors sold off cheap to other investors who are more well-informed about medical conferences and clinical trial presentation.
Looking at all the measurements comparing Biomatrix VS Cypher, Biomatrix definitely is more superior than Cypher in most of the areas although statistically not powerful enough to give a clear cut superiority "P value".
*In-stent late-loss (0.13mm VS 0.19mm),
*In-stent binary restenosis (5.5% VS 8.7%),
*Overall TLR (5.4% VS 5.9%),
*Overall TVR (5.7% VS 7.3%),
*MACE (9.2% VS 10.5%),
*Late stent thrombosis - Definite cases at > 30 days (0.2% VS 0.5%).
Most of these measurements are about 20% lower than Cypher's.
Clinical trials are meant to show "Non-Inferiority" and not conducted to show "Superiority". The "P Value" statistics are tuned towards proving of "Non-Inferiority". Overall, I can safely conclude Biomatrix beat Cypher. Biosensors is proven to be the Best of the Best. Its never easy to beat a top limus eluting drug like Cypher. Endeavor didn't make it and failed primary end-point. But Biomatrix did it!!! If LEADERS trial is conducted for the purpose of submission to USA FDA for Pre-Marketing Approval (PMA), definitely Biomatrix will get unanimous vote for FDA approval.
Next thing to watch will be the O.C.T scan on endothelial recovery. This measurement is one of the main factor that will affect late-thrombosis blood clots (> 30 days but < 1 year) and very late thrombosis (> 1 year). For acute thrombosis (blood clots that occur < 30 days), we should not put too much emphasis on it as even BMS commonly also has acute thrombosis cases.
*In-stent late-loss (0.13mm VS 0.19mm),
*In-stent binary restenosis (5.5% VS 8.7%),
*Overall TLR (5.4% VS 5.9%),
*Overall TVR (5.7% VS 7.3%),
*MACE (9.2% VS 10.5%),
*Late stent thrombosis - Definite cases at > 30 days (0.2% VS 0.5%).
Most of these measurements are about 20% lower than Cypher's.
Clinical trials are meant to show "Non-Inferiority" and not conducted to show "Superiority". The "P Value" statistics are tuned towards proving of "Non-Inferiority". Overall, I can safely conclude Biomatrix beat Cypher. Biosensors is proven to be the Best of the Best. Its never easy to beat a top limus eluting drug like Cypher. Endeavor didn't make it and failed primary end-point. But Biomatrix did it!!! If LEADERS trial is conducted for the purpose of submission to USA FDA for Pre-Marketing Approval (PMA), definitely Biomatrix will get unanimous vote for FDA approval.
Next thing to watch will be the O.C.T scan on endothelial recovery. This measurement is one of the main factor that will affect late-thrombosis blood clots (> 30 days but < 1 year) and very late thrombosis (> 1 year). For acute thrombosis (blood clots that occur < 30 days), we should not put too much emphasis on it as even BMS commonly also has acute thrombosis cases.
MUNICH (Dow Jones)--A newer type of drug-coated stent made by Singapore-based Biosensors International Group Ltd. (B20.SG) has shown it is as safe and as effective as an older, widely used drug-coated stent made by healthcare giant Johnson & Johnson (JNJ), according to a study presented Monday at the European Society of Cardiology meeting in Munich, Germany.
Swiss researchers found the number of deaths, heart attacks and repeat interventions were equivalent in both groups of patients in the trial, nine months after they underwent surgery.
The study involved a total of 1,707 patients.
Swiss researchers found the number of deaths, heart attacks and repeat interventions were equivalent in both groups of patients in the trial, nine months after they underwent surgery.
The study involved a total of 1,707 patients.
By Ben Hirschler MUNICH, Sept 1 (Reuters) - A new heart stent from Biosensors International
The news is a boost for Singapore-based Biosensors, which believes its product may avoid some of the problems seen with conventional drug-coated stents -- tiny scaffolds used to prop open clogged coronary arteries.
Its BioMatrix product represents a novel approach because it is made with a bioabsorbable polymer.
After nine months, the drug and polymer dissolve completely, leaving patients with bare metal that should be less likely to cause late stent thrombosis -- a rare condition in which blood clots form inside stents a year or more after implantation.
In a clinical study involving 1,700 patients followed for nine months, no significant difference was seen in the performance of BioMatrix compared to J&J's Cypher, Stephan Windecker of Bern University Hospital, Switzerland, told the annual meeting of the European Society of Cardiology.
A total of 9 percent of patients given the new stent suffered cardiac death, experienced a heart attack or needed reopening of arteries. That compared to 11 percent of those using Cypher.
Cardiologists said the results were encouraging but they pointed out that the study had followed patients for less than a year and BioMatrix had simply shown "non-inferiority" to an existing drug stent, rather than proving itself better.
Windecker acknowledged longer-term follow-up studies were needed to confirm the theory that BioMatrix could reduce the risk of late blood clots.
Biosensors won approval to sell BioMatrix in Europe at the beginning of this year -- a key step in the company's planned return to profitability. It is also on sale in Asia.
Chief Executive Mike Kleine said the clinical trial was the first of a series of pivotal studies that could make its product a new industry standard.
This i agree, to a pharma co, great clinical trials is very impt in getting sales. Advertising hardly helps if your competitor can come up with a much better product especially in stents when it involves lives. Won't everyone be interested about the best product available if a life's at stake?
bengster68 ( Date: 01-Sep-2008 11:45) Posted:
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Anyone can help on the following:
1) So what is Singapore time for the presentation? At 12.12pm today?
2) BIG only present for today ONLY ???
3) Is there any access for the public on the outcome of the presentation ???
Or is there anyone over here that have access to the result being presented by BIG ..... ??
Hope BIG can reward all his supporters soonest .....
cwwan1 ( Date: 31-Aug-2008 17:27) Posted:
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ha ha, QB few at 0.60 to test the market x to x. tks for the observation.
DJ Market Talk said that "doing well in clinical trials doesn't necessarily translate into doing well in sales and profits."
- All the medical device companies are mainly using "Clinial trial based marketing" and a lot of emphasis will be on efficacy and safety of the medical product in question. Doing well in LEADERS will definitely bring in more international recognition and accelerate the sales for BIG. Ask the analyst if LEADERS results show that Biomatrix is a more superior stent, will he use Biomatrix or Cypher if he ever needed one?
DJ MARKET TALK: Biosensors +1.6%; Market Eyes Trial Results
0301 GMT [Dow Jones] Biosensors (B20.SG) heading higher, bucking falling market as investors hope update on clinical trials will be positive; shares +1.6% at S$0.63 vs FTSE ST All Share Index down 1.1%. Medical device maker set to reveal results of key clinical trial for flagship drug-eluting stent BioMatrix in Munich later today, trial compares BioMatrix with rival Johnson & Johnson Cypher stent. Charts show share price rise supported by decent traded volume, suggests stock may build on gains if trial results please market. But local brokerage analyst cautions against getting too excited; "doing well in clinical trials doesn't necessarily translate into doing well in sales and profits." Upside may also be capped by worries over pending transaction to acquire remaining 50% of China-based stent company JW Medical Systems; company said last month that delays in receiving necessary approvals from Chinese government and others is causing concern as agreement expires on Sept. 30. Resistance tipped at Aug. 8 intraday high of S$0.685. (KIG)
0301 GMT [Dow Jones] Biosensors (B20.SG) heading higher, bucking falling market as investors hope update on clinical trials will be positive; shares +1.6% at S$0.63 vs FTSE ST All Share Index down 1.1%. Medical device maker set to reveal results of key clinical trial for flagship drug-eluting stent BioMatrix in Munich later today, trial compares BioMatrix with rival Johnson & Johnson Cypher stent. Charts show share price rise supported by decent traded volume, suggests stock may build on gains if trial results please market. But local brokerage analyst cautions against getting too excited; "doing well in clinical trials doesn't necessarily translate into doing well in sales and profits." Upside may also be capped by worries over pending transaction to acquire remaining 50% of China-based stent company JW Medical Systems; company said last month that delays in receiving necessary approvals from Chinese government and others is causing concern as agreement expires on Sept. 30. Resistance tipped at Aug. 8 intraday high of S$0.685. (KIG)
tis baby trading patern repeat from x to x than again,,,,,,so,,,,,,,,,,,
congrate, if u picked this burger at .525 on 22 last mth. Of course u can pack up n chow loh. cheers.
jianhao jiusou................run rd liao 64cts,,,,,,,,,,,,,,,,,,my main target zooooooooooooom to china counter,,,,,,,,,,,,,,,cheers
lets it cool down for a while, for AK .645 is a bit exp. says .63 may buy some for avg.
If u don't even hv one, then any price below .65, your choice. Ha harm, to buy one lot for testing the water.