Replies to post #28023 on Biotech Values

[DewDiligence]

IDIX CC notes (addendum):

--In 400 patients treated to date in all trials, NM283 has shown no sign of inducing resistance.

--Given that NM283 was tested in conjunction with Pegasys, the one SAE and two dropouts seen in 31 patients in the of 200mg arm of the treatment-naïve phase-2b trial (#msg-10883778) should be compared to the 10% rate of SAEs listed on the FDA Pegasys label. In other words, the rates of SAEs and dropouts in this trial arm were less than would be expected for patients treated with Pegasys alone.

[kcalt]

Dew - IDIX Question:

<5. Comparative efficacy of ifn+NM283 vs ifn+ribavirin (Yarone Werber please take note): In phase-2/phase-3 trials in the peer-reviewed literature, ifn+riba produced viral clearance at 12 weeks by the Amplicor test in 38-57% of patients, while the clearance rate was 66% in the 200mg arm of the phase-2b NM283 arm reported at EASL last weekend.>

Which limit are they using for viral clearance? In the EASL data I'm seeing this:

"At 12 and 16 weeks, 71 percent and 73 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 600 copies/mL compared to 73 percent and 74 percent in the pooled 800 mg/day arms. After 12 and 16 weeks, 45 percent and 62 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 20 copies/mL..."