Replies to post #7574 on Avid Bioservices Inc (CDMO)

[magicatlast]

jb, I had come to a similar conclusion, but could not possibly have presented it as well as you have.

Thanks, Magic

[Big On Tarvy]

JB -- You make a good point.

In fact my comment, "(indeed 40% likely)", was added as an after-thought on my part and was not part of my conversation. I need to use more than a parenthesis ( ) to distinguish my personal thoughts from what I hear. Thanks for the correction.

Here is a personal observation on my part. The important point to take away is that SK's comment during the CC about many exciting possibilities to study HCV/HIV co-infected patients was just the tip of the iceburg. I suspect Duke is doing the preclinical work right now to support a trial of co-infected patients. The fact that an HIV screening test is not required for admission to the repeat dose trial, and therefore a SMALL percent of the patients are likely to be co-infected, is consistent with plans to begin clinical trials of co-infected patients in the near future.

All we know for sure right now is that the Company hopes to make co-infected HCV/HIV patients a major strategic focus of its its anti-viral program and several biotech analysts applaud this approach. That's the take-home point.

[cjgaddy]

JB, trying to find out if the Bavi Repeat trial is different, but here are 3 examples of trials with the simple statement “No Known HIV” listed as an Exclusion on Clinicaltrials.gov (just like Bavi’s Repeat HepC), and all 3 do not actually test for HIV – they simply ask the applicant:

NCT00348153: “Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and GE Junction Carcinomas”
http://clinicaltrials.gov/ct/show/NCT00319735
Study Chair comments:
“Not mandatory to ask or to test. The study simply excludes patients if they have known HIV, because of the potential risks involved with giving an antibody that may modulate the immune system in someone with potentially decreased immune function.”

NCT00348153: “Adalimumab in Uveitis Refractory to Conventional Therapy (ADUR Trial)”
http://www.clinicaltrial.gov/ct/show/NCT00348153
Study Chair comments:
“As in all studies with TNFalpha Inhibitors a test is not mandatory, but the patients are asked if they have HIV and if a test was performed at any time.

NCT00350025: “Randomized Phase II Study for Patients With Previously Treated Advanced Urothelial Cancer”
http://www.clinicaltrial.gov/ct/show/NCT00350025
Director of Center’s comments:
”Participation in this study does not require an HIV test. Potential participants are all asked if they know if they are HIV positive or part of a high risk population where the physician may want to consider asking the participant to undergo an HIV test to determine their HIV status.”

Whether Peregrine’s HepC/Repeat Exclusion of “Known chronic infection with HIV” operates any differently than the above 3 regarding Testing vs. Asking remains to be seen, but I do see a trend developing.

Also, I remind you of these 11-2003 comments by Dr. Eliot Godofsky (PI, Bavi/Repeat Trial, Bradenton FL) of the prevalence of HCV/HIV Co-Infection:

Dr. Eliot W. Godofsky - 11/24/2003
Grand Rounds: Div. of Infectious Diseases at Univ. of Miami, School of Medicine/Jackson
“Issues Related to Treatment of HCV in Patients co-infected with HIV”
• Discuss HCV-related liver disease and the hepatotoxicity associated with HAART in co-infected patients
• Summarize complications of combined HIV and HCV therapy in co-infected patients including drug interactions and adverse events such as anemia.
• How common is HIV/HCV co-infection?
• How can co-infected patients best be treated?
• How are the major side effects of HIV/HCV therapy managed ?
Video: http://www.med.miami.edu/med/infectiousdiseases/grandrounds.asp?mode=view&id=9
EG: “HepC & HIV are somewhat of a natural mix… the vast majority or at least a sizable % of all your patients that have HCV are co-infected with HIV… HepC & HIV together constitute the 2 most common viral infections in the world…”

[mskatiescarletohara]

JB---Ring a ding ding ding!!!!

They'll get no pre-post data to learn anything about HIV infection and the co-infection will just complicate analysis of bavi's affect on HCV.

This is precisely why the protocol excludes patients with known HIV. Also, the results may not yield the efficacy which needs (HAS ) to be established in this protocol treating HCV non-responders. Safety and efficacy has to be established in HCV mono patients first before treating coinfection. It's a fact. Ask the experts.

katie....