updates on birinapant

[Royal36]

TetraLogic Pharma (TLOG) Gives Update on Hep B Program

July 20, 2015 4:03 PM
TetraLogic Pharmaceuticals Corporation (NASDAQ: TLOG) a clinical-stage biopharmaceutical company focuses on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today provided an update on the status of its hepatitis B virus (HBV) clinical program.

The company intends to initiate a combination single ascending dose/multiple ascending dose clinical trial, with birinapant as a single agent, in chronic HBV subjects. These subjects will not be taking other antiviral medication.

In the single ascending dose phase of the trial, subjects will be given a single dose of birinapant. The dose of birinapant will be escalated until at least one of the subjects shows evidence of activity, defined as an increase in liver transaminases and/or a decline in circulating viral DNA. At that point the cohort will be expanded and additional subjects will each receive four weekly administrations, at that dose, of birinapant. The starting dose of birinapant will be 2.8 mg/m2.

The company has retained a clinical research organization and currently expects to initiate this trial at multiple sites in India in early 2016. Timing of results will depend upon enrollment rates and upon the cohort in which activity, if any, is seen

[Royal36]

Stef2011 i spoke with the principal investigators in Moldova they just assured me they are not going to recruits any other foreigners beside their own ppl.

[stef2011]

what for?it doesn t work probably

go to moldavia and see if you can get on replicor trial, thats the only drug combo that has the highest potential to cure hbv

[SerregaRa]

I have chronic hepatitis B.
I live in Russia.
I`m twenty two years old. do not use drugs and alcohol !
Please tell me
How to get to treatment birinapant ?

[sorte]

So why they didn't inform about the results from phase one, HBsAg decline etc .. whatever ? Even if the trial has been stopped there were some results for sure.

[StephenCastlecrag]

Tetralogic has stopped the human clinical trial of Birinapant with an existing antiviral(before it was just suspending new recruitment). They are planning a new clinical trial with Birinapant alone next year in India. The keyword here is "planning".

Tetralogic is a listed company on the stock market in America, they cannot withheld information, good or bad, from the public investors.

[Ram1982]

They might be having already something good news for human trials, because of which they might have got Eureka prize.

No wonder if they give some surprise on Sep 24 for HBV cure with Replicator.

[StephenCastlecrag]

The Eureka prize is awarded to Australian scientists. Birinapant is not yet proven to be a cure for Hepatitis B in human, only in animal models. I believe the prize was awarded because Australians believe in their own hype. There may be some justification in rewarding their effort to try to find a cure. For what it is worth, the press release did not even mention Birinapant.

[sorte]

that's a nice news, thanks :) they deserved !

[Jatashankar]

Yes may be, and this small happiness of hope gives a shine in eyes. 2016 here in India they ll redo the trials, lets c when. Cuban vaccine is on its way to reach us next year.

[manjuvolunteer]

Hi Shankar, is this trail going on in india now in DEC2017 ? any idea where exactly in india , iam intrested to participate pls ..if any you can mail
me  ***@**** ..thanks

[Ram1982]

Jatashankar,

They might be trying to apply it on Human being again with lower dose. No wonder if it starts curing for us also :)

[Jatashankar]

Eureka prize given to birinapant inventing team for hbv cure.
Why r they rewarded when the drug is debilating for humans and can't be used. Is it for curing the poor mice :D

http://vaccinenewsdaily.com/stories/510635470-eureka-prize-goes-to-hepatitis-b-cure

[Jatashankar]

I won't risk myself participating that risky trial. Better wait for 3-4years more than to risk my brain to debilating palsy. But it's Gud to hear trial will be cunducted in India.

[hepbcurepls]

always with cancer medication, the medication works but its hard to get it into the tumor. this girl figured a way in mice and shes pretty smart. it is dated 2012 but shes short of amazing.

http://www.cbsnews.com/news/calif-hs-student-devises-possible-cancer-cure/

[twinboys1girl4me]

This is all I found.  I'm guessing with them starting at the dose level 2, dose 1 was not impressive.  I do not know dosage the cohort that experienced the palsy, but as you can see they went much higher than the 2.8.  Usually palsy resolves, so let's hope that happened, especially since they are continuing trials elsewhere.
 Birinapant will be administered once weekly for 4 doses
 Dosing cohorts: up to 6 cohorts with 8 subjects per cohort treated with drug or placebo in a 3:1 ratio at the following dose levels:
 Dose Level (1): 1.4 mg/m2
 Dose Level (2): 2.8 mg/m2
 Dose Level (3): 5.6 mg/m2
 Dose Level (4): 8.4 mg/m2
 Dose Level (5): 12.6 mg/m2
 Dose Level (6): 18.9 mg/m2

[hepbcurepls]

what was the last dosage amount that caused the palsy?

[twinboys1girl4me]

I haven't been able to find anything about the cohort that had the cranial nerve palsy.  What I did find is this particular study used high doses of Birinapant.  

From what I can guess of this new trial the 2.8mg/m2 is starting lower and will build from that.  Also what I found interesting is in the first study they were adding Birinapant to already used Entecavir and in this trial they will not be taking any antiviral medication.  

[mike9111]

What happen to the ones that had issues with older trial did they resolve the side effect?

[sorte]

that's great news :) thanks

[Royal36]

We can't wait to hear a cure from India.