Replies to post #27846 on Biotech Values

[mskatiescarletohara]

Dew...Actilon...

Dr. McHutchison of Duke University is a world reknowned GI specialist,...and advises VRTX and PPHM on their candidates, actually, I think he's probably involved in about every new investigational therapeutic for HCV in some fashion. One should take note that he is clearly hinting or even suggesting that HCV "standard of care" may be changing to triplet therapy for non-responders. Do not underestimate the market potential for a new HCV regimen for the 50% who fail treatment, the results are so-so, but they have a response from non-responders which is not too shabby.

The ability of ACTILON to improve the number of patients with HCV RNA undetectable levels and Early Virological Responses in a relapsed, treatment-refractory patient population is noteworthy as these patients lack alternative treatment options. Of the approximately 50 percent of chronic Hepatitis C patients who fail initial treatment with pegylated interferon and ribavirin, re-treatment is typically unsuccessful. The higher incidence of early responses observed in this study suggests that the triplet combination including ACTILON now requires further exploration and confirmation in subsequent clinical trials in terms of safety and efficacy," said Dr. McHutchison.

[Praveen]

Dew/Coley,

The results are not Ok. They are very good though I don't class them as excellent. Relapsed, treatment-refractory patient population is the key.

PS:I have a position in Coley.

Regards,
Praveen

PS: Also note the mechanism of action. Actilon operates through a dual method of action consisting of both innate and adaptive immunity antiviral mechanisms. Actilon was designed to induce not only the early short-term innate immune effects that temporarily control the virus, but also to trigger adaptive immunity, with a strong killer T cell response, that we believe may provide sustained anti-infective effects. We believe Actilon therapy may allow the duration of HCV therapy to be reduced significantly, thereby resulting in reduced toxicity and improved patient compliance.

[DewDiligence]

COLY webcast notes from Bear Stearns re Actilon in HCV:

1. All told, 200 patients have been treated in Actilon trials to date, some for as long as 40 weeks.

2. SVR data for the 20 continuing patients (out of a total of 74 patients) in the phase-1b relapsed-responder trial will be available in 1H07. (12-week data for this trial were reported in Apr 2006: #msg-10881211.)

3. Some 12-week interim data from the lead Actilon trial, the phase-2 for null responders, will be available by the end of 2006. (This is the most challenging HCV indication—one which no other company has yet tackled.)

4. “Stay tuned” for plans in the treatment-naïve setting, which will be announced at an upcoming scientific conference. COLY has not yet undertaken any trials in this setting.

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p.s. There was discussion, but no updated info, on the PF-35 12676 NSCLC program being conducted by PFE.