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VRTX +28% on Telaprevir EASL abstract with
preliminary data from an open-label extension of
PROVE-1/PROVE-2 for control-arm patients who
failed to obtain an SVR.

http://www.sec.gov/Archives/edgar/data/875320/000110465908020972/a08-8996_1ex99d1.htm

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A Study of Telaprevir With Peginterferon Alfa-2a and Ribavirin in Subjects With Well-Documented Prior P/R Null Response, Non-Response Or Relapse: Preliminary Results

Fred Poordad, Mitchell Shiffman, Kenneth Sherman, Jill Smith, Min Yao, Shelley George, Nathalie Adda, John McHutchison for the VX06-950-107 Study Team

Background: VX06-950-107 is an ongoing open-label study of TVR/P/R in genotype 1 HCV subjects who failed to achieve SVR in the control arms (P/R) of the TVR Phase 2 studies. Study 107 provides a unique opportunity to correlate within individual subjects the anti-viral response to TVR/P/R with that of their original response to P/R. In this preliminary analysis we evaluated the anti-viral response to TVR/P/R at week 4 in non-responders to P/R.

Methods: Null-responders (NR) (<1 log10 decrease at week 4 or < 2 log10 decrease at week 12), non-responders at W24 (HCV RNA detectable) and relapsers from the P/R arms of PROVE studies were eligible. Study dosing consisted of 12 weeks TVR 750 mg q8 hour + P/R at standard doses, followed by 12 weeks P/R. In this study, subjects with HCV RNA >25IU/mL (Taqman™ assay; LOQ 25 IU/mL) at Week 4 met a stopping rule and discontinued.

Results: To date 54 subjects were enrolled, 52 were dosed and 32 completed Week 4 assessment: 24 male/8 female with median age of 51.5 years, 28 Caucasians, 3 Blacks, 1 Hispanic. Median baseline HCV RNA was 6.9 Log10IU/ml. 1 subject discontinued TVR and R due to fatigue. Results by prior virologic response to P/R regimen are summarized below:

Prior P/R Virologic Responses
in Phase 2 Studies HCV RNA at Week 4 on TVR/P/R
(12+12 regimen)
N <25 IU/mL
n (%)
Did not meet
Stopping Rule >=25 IU/mL
n (%)
Met Stopping
Rule
Week 4 NR 17 12 (71) 5(a) (29)
Week 12 NR 3 2 (67) 1(b) (33)
Week 24 detectable 7 7 (100) 0
Week 20 Breakthrough 1 1 (100) 0
Relapsers 4 4 (100) 0
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(a) 1 with 33, 1 with 43, 3 with >100 IU/mL
(b) 1 with 28 IU/mL

Conclusions: With TVR/P/R, 70% (14/20) of null responder subjects, 100% (7/7) of Week 24 detectable and 100% (4/4) relapsers to P/R achieved < 25 IU/mL at week 4. Only one subject had a virologic breakthrough. These results are promising, however SVR rates are yet to be determined.
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