Replies to post #23605 on Avid Bioservices Inc (CDMO)

[cjgaddy]

EZ, the $64k question: what effect on efficacy will we see moving from Ph.1B “very ill patients with advanced cancer who had often failed mult. attempts to treat their disease” to Ph.2 “One and only one prior chemotherapy regimen (no prior docetaxel)” ??

SK says, “So, we do believe this will be a healthier patient population. The status of their immune systems will probably vary from patient to patient, but again, receiving less rounds of chemo & rad. therapy should result in essentially a healthier immune system in the new [Ph.2] patient population.”

We know they’re healthier. Now, how will that impact efficacies in the Bavi+Chemo Ph.2 Georgia & India trials? Fingers X’d.

= = = = = = = = =
PHASE 1B COMBO-THERAPY TRIAL IN INDIA: (INIT=11-2006 COMP=5-2007)
5-31-07: …”advanced cancer patients with metastatic disease who had failed prior therapy”
…"We are very encouraged by these results… demonstrating the ability to shrink tumors or achieve stable disease in half of these very ill patients with advanced cancer.”
…ALL12: 50%=OTR/SD
…Bavi+GEM: 75%=OTR/SD
…Bavi+CARB: 50%=OTR
…OTR=Objective-Resp(>30% Red.), SD=Stable-Disease(20% Inc. – 30% Red.)
http://tinyurl.com/2rzeen
7-11-07 CC: SK, “With regard to the patient population in the upcoming Ph.2 studies, this will be a, if I can use the term, a healthier patient population. Typically in Ph.1 studies you’re looking at patients who have already failed not just 1 attempt to treat their disease, but often mult. attempts to treat their disease. So, we do believe this will be a healthier patient population. The status of their immune systems will probably vary from patient to patient, but again, receiving less rounds of chemo & rad. Therapy should result in essentially a healthier immune system in the new [Ph.2] patient population.”
http://tinyurl.com/2c9kwr
.
PHASE II BAVI+DOCETAXEL VS. METASTATIC BREAST CANCER IN E.EUR.(GEORGIA):
Protocol (init=1-2008): http://clinicaltrials.gov/ct2/show/NCT00669591
= = > Inclusion Criteria: ‘One and only one prior chemotherapy regimen (no prior docetaxel)’