Avid Bioservices Inc (CDMO)

[cjgaddy]

Nice Bavi/HepC find, DJ – here it is in orig. format…

The Flying Publisher Guide to
Hepatitis C Treatment
2011 Edition
Cernescu – Ruta – Gheorghe – Iacob – Popescu – Wanless
http://www.scribd.com/doc/59691852/45/What-does-the-future-hold

Table 4.3 (pg. 75):

NOTE: For more information, see http://hcvdrugs.com and the manufacturers' web sites presented at the end of the chapter.
• Peregrine Pharmaceuticals: http://www.peregrineinc.com

PREFACE: Affecting around 200 million people worldwide, chronic Hepatitis C is the leading cause of cirrhosis & liver cancer and the first reason for liver transplants. The current standard therapy for chronic HCV infection – combined pegylated interferon and ribavirin – is successful in only 50% of the cases and is associated with frequent and sometimes serious side effects. Fortunately, there is huge potential to increase the number of successfully treated patients if we take into account pre-treatment and on-treatment host and virus characteristics that may lead to therapy failure. This Guide will discuss the available strategies for those who interrupt, fail or relapse after treatment, in particular
• the benefits and risks of current therapeutic options
• the categories of patients with therapeutic failure that should be re-treated
• the appropriate measures for therapy monitoring and outcomes assessment
As a growing number of non-responders and relapsers are seen in clinical practice there is a permanent search for new antiviral, anticellular and immunomodulator drugs. Year 2011 has brought the approval of the first generation of viral protease inhibitors that will offer higher cure rates for non-responders and open the door for the eventual testing of interferon-free regimens.
The Editors, June 2011

= = = = = = = = =
BAVITUXIMAB HEP-C PHASE1+2 TRIALS: (see http://PeregrineTrials.com & http://www.peregrineinc.com/pipeline/cot.html )

D. PHASE II BAVI+RIBA VS. FRONTLINE-HEPC (RANDOMIZED, OPEN-LABEL):
Protocol (init=1-2011): http://clinicaltrials.gov/ct2/show/NCT01273948
1-13-11: Info&Quotes on Bavi's positioning as potential Interferon replacement in HCV cocktails: http://tinyurl.com/6zq5q69
1-10-11: Bavi+Ribavirin/HepC Ph.2 trial initiated http://tinyurl.com/4uz97tv
......"~66 patients with previously untreated genotype-1 chronic HCV, 1 of 3 arms (.3Bavi+R / 3.0Bavi+R / PEGIFN+R) for 12 wks, testing for safety & antiviral activity."

C. PHASE 1B HCV-HIV CO-INFECTED'S MONO REPEAT-DOSE TRIAL:
Protocol (init=7-2007): http://clinicaltrials.gov/ct/show/NCT00503347
…4-2-11: Ph.1B trial data presented at EASL-2011/Berlin on 4-2-11 http://tinyurl.com/3mmwy5d
…1-31-11: Enrollment Complete in HCV-HIV trial http://tinyurl.com/4tagpz2
...7-10-07: Enrollment begins at St.Michaels (Peter Ho Mem. Clinic, NJ) http://tinyurl.com/2g7rdp
......Ascending dose levels of Bavi weekly for 8 wks; ~24 pts; designed to assess Safety & PK, but "HCV & HIV viral titers & other biomarkers will be evaluated".
...5-17-07: New Clinical Protocol filed with FDA: http://tinyurl.com/2lpacm
These 2 completed Ph.1 Bavituximab Hep-C Trials archived to: http://tinyurl.com/27f58fc
1. Phase 1A Bavi/Mono Single-Dose HCV Trial: (init=8-2005 comp=2-2006 n=30)
2. Phase 1B Bavi/Mono Repeat-Dose HCV Trial: (init=6-2006 comp=1-2007 n=24)