VPHM- HCV796 fast tracked

[Proactive]

Not sure if this was mentioned here or not, hard to weed through all the babble posted here lately.. I will say one thing, and maybe I'm just a cold fish (no offense fishdoc), when I finish up my 72 weeks, you won't see my ass here making multiple postings on a daily basis....Take back your life and move on already!!! ( I know, here to support others etc., etc., yada, yada....I still suspect forum addiction for many)
Kudos to JmJm, maybe he has decided to start living again out in the "real world".. Everytime I think of jim and his scooter, I have visions of peewee herman on his bike


FDA Grants Fast Track Status for HCV-796 for Treatment of Hepatitis C Virus Infection

EXTON, Pa., June 27, 2007 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for HCV-796 for treatment of hepatitis C virus infection. HCV-796, a unique orally dosed non nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently undergoing Phase 2 evaluation and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

Under the FDA Modernization Act of 1997, fast track designation may potentially expedite the review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. Fast track designation allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package. However, the designation does not guarantee approval or expedited approval of any application for the product.

"The receipt of fast track designation for HCV-796 is an important regulatory step forward as we continue to work closely with the FDA and our Wyeth colleagues throughout the development process," commented Robert Pietrusko, Pharm.D, ViroPharma's vice president of global regulatory affairs and quality.

[willing]

thanks for the update - some background on 796 from a medscape article posted by Mike a while back (search the site for "stat-c agents" to find the article).

"The nonnucleoside polymerase inhibitor HCV-796 (ViroPharma, Exton, Pennsylvania and Wyeth Research, Philadelphia, Pennsylvania) has been studied in a phase 1 clinical trial at doses ranging from 50 mg per day to 1500 mg per day. Approximately a 1.2-log drop in the HCV RNA viral load was observed among patients receiving the higher doses (500-1500 mg/day). However, this drug seems to be associated with an increase in HCV RNA levels, which may be the result of the emergence of HCV variants.[22] A phase 2 clinical trial of this agent given in combination with pegylated interferon alfa-2a with or without ribavirin in both treatment-naive and nonresponder patients is currently underway."

ref 22 is :
Villano SA, Raible D, Harper D, et al. Anitviral activity of the non-nucleoside polymerase inhibitor, HCV-796, in combination with pegylated interferon ALFA-2b in treatment-naive patients with chronic HCV. J Hepatol. 2007;46:S24.

I assume the concern re vl increase referenced above was resolved to the FDA's satisfaction but if anyone has additional information please post. Presumably this will be used as an adjunct to ifn/vx-750.

(for better or worse some of us, including me, have been here for years and, rather depressingly, expect to be here for years to come - but yes, I  agree completely that forgetting you have a liver is very much something to look foward to...)

[Proactive]

"forgetting you have a liver is very much something to look foward to...)"
Exactly!! After all that's why we put ourselves through this tx ordeal. I know I'm to critical of others, but sometimes I just can't understand....We strive through tx to become svr and get our lifes back, and yet for some of those fortunate enough to attain it they continue to spend huge amounts of time here..(and of course their's and everyone's opinions are valueable to the forum)
Let's say 1 hr /day is spent here (and I know some spend far more than that).
1 hr/day=7hrs/week=364hr/yr
let's say the average person is awake for 16hr/day.
that's 22 3/4 days while awake /yr of freedom spent here...I guess I'm to selfish to give that much hard fought for time away..;^)

I did read that foofighter was doing the HCV-796 trials