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Tetralogic shares fell 75% in one day
This might be a a problematic day for the planned birinapant hbv trial in India as well.
the stock lost its value due to a negative result on the use of birinapant in combo with a chemotherapeutic agent in the treatment of myelodysplastic syndrome.
while this has nothing to do with the potential efficacy against hepatitis B, it might weaken the company to the extent, that they are unable to finance the hbv trial.
the stock lost its value due to a negative result on the use of birinapant in combo with a chemotherapeutic agent in the treatment of myelodysplastic syndrome.
while this has nothing to do with the potential efficacy against hepatitis B, it might weaken the company to the extent, that they are unable to finance the hbv trial.
I am only aware of anti pd1 monoclonals at this time. These are high tech antibodies that cannot be made as generics as is the case with chemicals.
Birinapant could be a future generic, but that is in the future, if birinapant ever makes it to the msrket. This is a sad situation, since birinapant has shown dramatic positive results when it was added at the right time in a non published small research study.
Birinapant could be a future generic, but that is in the future, if birinapant ever makes it to the msrket. This is a sad situation, since birinapant has shown dramatic positive results when it was added at the right time in a non published small research study.
2 Comments
any hipothesis what has happend so they do not publish results but plan another trials anyway ?
what do you mean added right time ?
No news on the use of pd1 antibodies in chronic hep b. But pembrolizumab is on the market and used in advanced melanoma. It is difficult to gauge the effect it might have on hbv, but it might well have a breakthrough effect when used in combo with naps. Prescription is very limited and I don't see a trial for this use coming anytime soon. Side effects are not horrible, but still intense. I spoke with a melanoma researcher, that is currently using it to treat advanced patients.
Not sure what you mean by Indian generics. For which drug?
Not sure what you mean by Indian generics. For which drug?
what about pdl1 are there any news on that?
i think some indian generics are also available or will be soon, that might be a good/easy add on for those with low hbsag and on very expert supervision due to the possible sides.what do you think?
thanks
i think some indian generics are also available or will be soon, that might be a good/easy add on for those with low hbsag and on very expert supervision due to the possible sides.what do you think?
thanks
Birinapant forces cells that have initiated a preliminary apoptosis program into final apoptosis.
it has the capacity to kill and eliminate infected cells OR cells with just hbv dna integration. But it needs a sufficient dose and a cell stress initiated apoptosis propensity, enhanced by tumor necrosis factor alpha to finally do the killing.
It does not focus on ccccDNA, it just kills stressed cells. This is much more effective than just temporarily blocking the production of viral products as is the case with arrowhead, naps, or antivirals.
naps block the release of surface antigen subviral particles, but not the synthesis of the hbsag monomers. The key effect is the removal of the immun blocking action of the hbsag. If the drug is stopped the hbsag can slowly rebound.
Anti virals work only to slow the synthesis of new hbv dna. Since some of the assembled cores are shuttled back into the nucleus, strongly reducing these dna containing cores will slowly reduce the cccDNA amount in the nucleus. This is only a moderate effect, thus the hbsag reduction under antivirals is quite modest. Furthermore and quite importantly antivirals will have zero effect on hbsag produced from integrated hbv dna.
it has the capacity to kill and eliminate infected cells OR cells with just hbv dna integration. But it needs a sufficient dose and a cell stress initiated apoptosis propensity, enhanced by tumor necrosis factor alpha to finally do the killing.
It does not focus on ccccDNA, it just kills stressed cells. This is much more effective than just temporarily blocking the production of viral products as is the case with arrowhead, naps, or antivirals.
naps block the release of surface antigen subviral particles, but not the synthesis of the hbsag monomers. The key effect is the removal of the immun blocking action of the hbsag. If the drug is stopped the hbsag can slowly rebound.
Anti virals work only to slow the synthesis of new hbv dna. Since some of the assembled cores are shuttled back into the nucleus, strongly reducing these dna containing cores will slowly reduce the cccDNA amount in the nucleus. This is only a moderate effect, thus the hbsag reduction under antivirals is quite modest. Furthermore and quite importantly antivirals will have zero effect on hbsag produced from integrated hbv dna.
I cannot imagine that anybody but the companies themselves can finance the larger trials needed. And they all focus on their own drug, collaborations are rare.
Correct me if im wrong but doesnt birinapant focuses on cccdna where as NAPS + Anti virals only focus on HBSAG?
So they dont think naps + anti viral will wipe out cccdna do they?
So they dont think naps + anti viral will wipe out cccdna do they?
This is unlikely to happen, since the nap company believes that it's own combo with ifn or thymosin with antivirals will be sufficient plus they dont really understand the power of birinapant plus they would not have the financial strength for this purchase at this time.
BTW there was a typo above, it was 15mg per sqm not 1.5.
BTW there was a typo above, it was 15mg per sqm not 1.5.
1 Comments
Any chance that there will be more trials with naps, birinapant and immunomodulators ? Is there any institution interested with running those trials ?
Surely it would be more beneficial if a pharma who has technology that could work in combo or sequential purchase the hep b stuff from tretra as their resources are limited?
Per day and the palsy completely disappeared after 10 days, then dosing was restarted under methylcobalamin protection and maintained for 8 month weekly with no more problems.
As can be seen on tetralogics website, the Indian trial is designed with extremely low starting doses and without any comedication or preselected condition. The emphasis seems to be totally on avoiding bells palsy cases. But this design is not likely to lead to meaningful results. The key is indeed to avoid bells palsy. In the trial mentioned bells palsy occurred after only 3 weeks of moderately high doses of 1.5mg per sqm per week iv infusion. But it was treated with sc methylcobalamin 1000ug per d
i don't know if we can consider this as bad news... nothing left now Tetralogic... EXCEPT finding the sources to prove that birinapant works for HBV...
We know that birinapant works against HBV it is just a matter of finding the right dosage so as not to cause the reversible-when-stopped palsies. and as studyforhope stated a matter of using t at the right time to see 100% cure rate and not only functional cures...
am optimistic and i know that in max 10 years a final cure will be here...
We know that birinapant works against HBV it is just a matter of finding the right dosage so as not to cause the reversible-when-stopped palsies. and as studyforhope stated a matter of using t at the right time to see 100% cure rate and not only functional cures...
am optimistic and i know that in max 10 years a final cure will be here...
The study was not done by tetralogic, but by an independent research group.
it was added at the right time after sequential naps, thymosin alpha and the Cuban vaccine together did not seem to produce a truly stable hbsag seroconversion. But the infection degree in the liver was very low, so there was no danger of excessive apoptosis in the liver. Thus it was added at the right time.
it was added at the right time after sequential naps, thymosin alpha and the Cuban vaccine together did not seem to produce a truly stable hbsag seroconversion. But the infection degree in the liver was very low, so there was no danger of excessive apoptosis in the liver. Thus it was added at the right time.
Lets hope Tetralogics fortunes change.
Maybe a bigger pharma might buy them?
Maybe a bigger pharma might buy them?
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