More all-oral research .including genotypes 1,2 and 3.

[willbb]

Pharmasett anounces three new Inf. free Phase III trials for all geno types:

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=619564

[curiouslady1]

I didn't get back to you.  I think that is positively wonderful.  Can you please post the NCT number of the trial and where you are located?  Puppylvr really would like to get into a study with 7977 for null responders.  You may help her by contacting her directly too.  

[UKgirl55]

Just asked you this question on the other forum page...so here it is again. Did they already open the PSI-7977 and TMC-435 trial? And if they didn't open it already....Isn't it for nulls only?

[Juttutin]

There are good graphics explaining the Phase III PSI trials at

http://files.shareholder.com/downloads/VRUS/1479878974x0x513707/5ed40e14-87f7-4606-9434-31b4a908dfcd/VRUS%20P3%20deck_11111_final.pdf

FISSION is GT 2&3, PSI-7977+RBV or SOC,   250 in each arm, no placebos

POSITRON is GT 2&3, Interferon free, 7977+RBV (150) or placebo (75) arms

NEUTRINO is like POSITRON, Study design still to be finalised, but across genotypes, including (probably) relapsers and non-responders.   7977+RBV (around 210) or placebo (around 70)

Also being discussed are Stage II trials:

ATOMIC - Mainly GT1, also GT4,5,6.  7977+RBV+IFN, testing out 12 vs 24 week treatments, no placebo, 300 patients total.

ELECTRON 2nd Cohort (EXPANDED) (NEW ZEALAND) 7977 MONOtherapy GT 2&3 (10 patients); 7977+IFN+RBV for only EIGHT WEEKS tx GT2&3 (10); 7977+IFN+RBV GT1 non-responders (10)

Graphics for these two can be found in http://files.shareholder.com/downloads/VRUS/1479878974x0x491164/0f22f336-b35d-4c0c-b516-058caa039c4d/Corp%20Presentation_Canaccord_81011.pdf

[UKgirl55]

Is this the NIH trial Susie?

[SusieS2010]

Everyone will get 7977. 50% will get ribavirin with it and 50% will get placebo for ribavirin.

[curiouslady1]

No idea.  But I think it's all good.  But Pharmasset is not just looking at GT 2 and 3.  They have plenty of trials out there for GT1.  I don't think this company has a lot of discretionary money though as it is not big but rather little Pharma so it makes some sense to me that some trials will be run under other auspices, like government entitities etc.  In fact, although I feel that the principal drug in my trial is PSI 7977 (because of its high barrier to resistance), the trial is sponsored by Bristol Myers which has the second drug in my combo (lessee, it has a new name declasovir? BMS 790052).

Is this NIH trial close to where you live UKgirl?