Replies to post #76213 on Avid Bioservices Inc (CDMO)

[cjgaddy]

N40K, same thing with Vertex’ drug…

Here’s what Telaprevir (VX-950) did in a repeat-dose monotherapy Ph.1B trial (5-17-05 PR):
After 750 mg x 3 times a day x 14 days = 31,500mg of VX-950:
• Median reduction in HCV-RNA after 14 days treatment [42 doses] was [a very impressive] 4.4 log10.
• Following completion of the 14-day dosing period a slow increase in HCV-RNA levels was observed during a 28-day post-dosing period in these patients.
• 28 days after receiving their last dose of VX-950, there were 2 patients [of 24] that had viral levels of more than 1 log10 below their pre-treatment levels.
http://www.prnewswire.co.uk/cgi/news/release?id=146300

Not a negative against Telaprevir/VX950. It just confirms that Telaprevir’s ultimate role is to be combined with an effective immunotherapeutic to get those SVR’s to HOLD. Same thing with curr. SOC Ribavirin & Merck’s Boceprevir (SCH503034), and the other in-dev. “direct anti-virals”. They all (at the moment) need to be combined with an immuno-stimulatory agent to improve efficacy and increase the % of SVR’s that HOLD.
At the moment that SOC immunotherapeutic is IFN.
Enter stage-right (hopefully) a kinder & gentler immunotherapeutic: Bavituximab.
Time will tell.

= = = = = = = =
BAVITUXIMAB HEP-C PHASE1+2 TRIALS: (see http://PeregrineTrials.com)
9-9-11: PPHM is positioning Bavi as potential Interferon replacement in HCV cocktails: http://tinyurl.com/3novgzk
12-2011: Nature Medicine article lists Peregrine among 11 co's dev. interferon-free treatments for HCV: http://tinyurl.com/87ltkmt
7-2011: Nature Biotechnology article quotes Dr. Thorpe on Bavi's goal to elim. IFN-A: http://tinyurl.com/3n8qluq
6-2011: Flying Publisher 'Guide to HepC Treatment' highlights Bavituximab: http://tinyurl.com/3srbzl5

D. Phase II Bavi+Riba vs. Frontline-HEPC (randomized, open-label):
Protocol (init=1-2011): http://clinicaltrials.gov/ct2/show/NCT01273948
12-29-11: HCV Ph.2 Trial Update http://tinyurl.com/bmbevyu
……SK: " this is a good time to seek partners for the antiviral pgm. which has shown promise in this study."
9-26-11: Enrollment Complete in Bavi+Riba/HCV trial http://tinyurl.com/3j9bba8
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."