ARC 250 - recruiting patients in Ausralia

[Bob0620]

Arrowhead is recruiting patients in Australia

Blog about ARC 250 :

http://rnaitherapeutics.blogspot.com/2014/03/potency-concerns-and-tekmira-could-be.html

Trial details is linked to this blog. Click on " clinicaltrial.gov entry "

[Seattledude]

There were no issues with toxicity, that data has been reported. He surmises the reason they are going for higher dosing in Aus is due to efficacy, however they just released that dosing has just begun so that info would be available yet.

My belief is they are just wanting to see the safety profile with higher doses in case they are required for greater knockdown. That is the simplest and most likely explanation given what we know

[djxpress]

the RNAi Therapeutics blog is reporting some possible issues with the Phase I trials/toxicity that just happened?  Maybe that is what Arrowhead's stock has gone down 16-20% in the last day?

[makeadifferencenow]

Lets hope its positive results in humans without many nasty side effects

[Seattledude]

2 things on that 1 out of 20 stat, first most trials are not on animals so closely related to humans. While I don't have data, I would imagine that monkey studies have a much better success rate. In addition RNA interference is a new process that is very promising and if delivery works will be very effective

[makeadifferencenow]

The only thing is if something has worked in animal its only got a 1 in 20 chance of working on humans. I hope they can get results similar to Replicor because at least they seem to be moving forward and funding is not a problem!

[SafiSifa]

no hope from ARC-250 :(

[FlyingHippo]

I also doubt this since P2 was just approved on March but the P1 extension was drafted on Feb. Or ARWR is preparing a higher dose safety profile just because they wanna secure a high cure rate  to build a leading role by trying to increase dosing?

[Seattledude]

They just started recruiting that a few weeks ago, isn't it a bit early for that info? I know the monkey showed immediate knockdown, they should have comparable mg per kg info to start with based in that. I am hopeful that they decided to expand the safety profile by using higher doses they should have tested before.

If the higher doses pass safety, then it conceivably would lead to higher knockdown and clearance. Maybe with the increased competition Arrowhead knows it must be able to clear at a very high rate to stand out

[FlyingHippo]

Not a good news, may be a potency issue. Or already sniffed something from the first Phase2 test result?

[Mrt79]

Another non sense article.
Phase one clinical trial is not for people with disease, rather healthy people with no pre-existing medical conditions (healthy people) and the objection is usually to find the most effective dose of the drug and how much can be given safely and the possible side effects of the drug. Only except in certain disease category such as cancer will the new drug be tested on the patient.

[Seattledude]

Seems like good news for HBV cure potential to me, why not see what the higher doses can do in the safety profile and extend them to phase 2. As Dirk mentions a 95+ knockdown should translate well to a cure especially in a combo therapy

[StephenCastlecrag]

Interesting, thanks for the post. Hope we can have a response from Arrowhead.