Readers of this should post be warned, I've just bought more in EpiCept. Maybe the text will be an illustration of just that. We'll see.
I have previously discussed Amikets results from February. Since then, EpiCept's CEO have been beaten the drums on the company's webcast on the extended annual meeting: This is a block-buster (oms. least 1 billion USD). "Make No mistake about it!" He adds. He calls the results "excellent" and a "breakthrough".
I have also previously kept the actual painscores that Amiket have in this study open. I will now test if there is grounds to be more positive. The prerequisite for the text below is that Amiket for every new one added therapy weeks show greater reduction in pain compared to placebo. (I add a post from Avanza that illustrate this below.)
Amiket has in two previous Phase II studies showed "Gabapentin-like-results". (Ie, 60%, 30% pain relief, 30% of patients have 50% pain relief or more.) The first two studies lasted 4 weeks, the last 6 weeks.
So, excuse a little bit more strecht writing, which is not yet confirmed. The last six-week trial: Of course it is, at least, on Gabapentin levels. And, we k n o w is that it makes it on compared to placebo, with a probability of 1:1000.
The first phase II had 200 participants and a p-value of 0.07, the next phase II had 340 participants and a p-value of 0.034 and the last 460 participants and a p-value of 0.001 (slightly more than half the them was the Taxane (chemo) patients, p-value 0034). The latter study progressed, as I said, s i x weeks.
Some statistics basic: The more times we throw a coin / dice the lower the p-value we get. So it is. But what about the painscores in absolute figures for the the six week trial, the amount of pain reduction, for how many patients?
We can add one more observation here: that it took 100 fewer patients to achieve the same p-value as the PHNs four-week trial of taxanes patients, p-value 0.034. Amiket after 4 weeks gives "Gabapentin-like-results", at six weeks, at least not worse. It is probably an understatement.
What we look for now is the result of the 50% longer treatment with Amiket. We already know that it is significant...
EpiCept is sitting in a golden chair for two reasons:
1st Amiket have results, with braces: after eight (8) weeks of treatment will outshine Gabapentin. Save this and use against me if it is not true.
2nd Management has ensured that the Company is in a position where Big Pharma must expect that the Company can drive themselves through Phase III backed by NCI, and the CO might finance themselves over to 2013.
Här skriver jag om betydelsen av behandlingstidens längd för Amiket:
"Amiket har efter f y r a (4) veckors behandling samma efficacy som generikan Gabapentin i PHN.
O c h: Smärtlindringen ökar signifikant mot placebo för varje tillagd vecka.
Behandlingstiden för neuropatisk smärta i fas III är mellan 8-12 veckor. Gabapentin, som har biverkningar, valde, inte förvånande, den korta varianten 8 veckor i sin fas III-studie.
Den aktuella fas IIb-studien om cancersmärta är på s e x (6) veckor. Lika många deltagare som Pfizers fas III, 460. Preliminära omdömen är att resultaten är ett "breakthrough" och att de är "excellent". P-value 0,001 .
Båda de tidigare två fas II-studierna med Amiket har visat ungefär samma pain-scores efter f y r a veckor: 60% av patienterna upplever 30% smärtlindring och 30% av patienterna upplever mer än 50% smärtlindring.
Nu har vi, som sagt, en studie om s e x veckor.
Så: 1. Vad blir effekten av en kräm utan bieffekter som ska/kan ha d u b b l a tiden i en fas III? Vilka pain-scores kommer Amiket att få i skarpt fas III-läge?
Jag menar, det är ju nästan inte schysst - borde inte gabapentin-knarket ges en liten chans? Där ser vi: Ju längre behandling ju fler problem, men ingen ökad efficacy, Amiket, ämnena i krämen når knappt alls ut i blodomloppet. Biverkningar i kroppen blir därför nära noll."
"Amiket has f o u r (4) weeks of treatment, the same efficacy as generikan gabapentin in PHN.
A N D: The pain relief is significantly increased versus placebo for each added week.
The duration of treatment for neuropathic pain in a Phase III trial is between 8-12 weeks. Gabapentin, which has side effects, chose, not surprisingly, the short version of 8 weeks for its Phase III trial.
The current Phase IIb study of cancer pain is s i x (6) weeks. Just as many participants as Pfizer's Phase III, 460. Preliminary review is that the results are a "breakthrough" and that they are "excellent". P-value 0.001.
Both of the previous two Phase II studies with Amiket have shown similar pain-scores after four weeks: 60% of patients experiencing 30% pain relief and 30% of patients experiencing more than 50% pain relief.
Now we have, as I said, a study of s i x (6) weeks.
So: 1st What will the effect of a cream without the side effects that should / could have d o u b l e the time in a Phase III? What pain-scores will Amiket get in a sharp phase III trial?
I mean, it's almost not fair - should not gabapentin-dope be given a chance? What we see is: The longer the treatment the more problems, but no increased efficacy for Gabapentin. On the contrary about Amiket: the substances in the cream reaches barely into the bloodstream. Adverse reactions in the body is therefore close to zero. "