Re: Combining the existing Phase 1 with a Therapeutic Portion

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1. 2014-07-30 00:39 unattributed
   I've inserted comments and discussion points. please see attached Deb On Tuesday, July 29, 2014 1:53 PM, Mike Hensley EEG icloud.com<mailto f@icloud.com><mailto HO icloud.com>> wrote: As discussed toward the end of the call today, I took a shot at combining the objectives of your phase 1 protocol submitted to FDA with the objective of separating the vaccine and ZMapp products into two separate protocols. See attached. I've done nothing more with the vaccine portion but I like Deb's suggestion of doing a vaccine study in Canada or as someone suggested today, in Geneva. Logical, since Health Canada apparently controls the drug product. In combining the two objectives I constructed an initial phase to be done in HCW's not yet deployed. In this group we can do the pK and immunogenicity work needed. Assuming we get reasonable data there we cold move into HCW's deployed and exposed. I could sympathize with a larger group in the first phase but was taking into account limited supplies of ZMapp when I made my choices. Some details I calculated from or extrapolated from your pre-IND package. Doses I chose based on the NHP trials. Once again this is a clinical synopsis but gives us a set of talking points and probably anticipates most issues. Lots of detail missing but easy to complete with a little q&a if this looks reasonable Mike Hensley [attachment "Revised Phase 1 ZMapp Study Protocol Synopsis jb ds(2).docx" deleted by Trina Racine/HC-SC/GC/CA] [attachment "TREATMENT_OF_EBOLA_Report_for_Clinicians_ver_4_External.docx" deleted by Trina Racine/HCSC/GC/CA} Casco, Tony (NIH/NIAID) [C]
2. 2014-07-30 12:55 Larry Zeitlin open
   Hi all, This is coming together very nicely. I'd like to suggest a follow-up call to discuss this in more detail and have cc'd our colleagues at CBR who have been leading the regulatory and clinical planning effort for ZMapp. Assuming everyone agrees a call would be worthwhile, can I trouble CBR to arrange it? Best, Larry
3. 2014-08-03 03:12 unattributed open
   Dear Colleagues, I am writing on behalf of the Ebola clinical management team at WHO and am forwarding this working version of a document on potential therapeutics. Comments, corrections, and additions are welcome- forward these to Aaruni Saxena, Nikki Shindo, and me at your earliest opportunity. Please note that this document is a draft and should be held in confidence. Thanks for your help, fgh From: Marshall Hoke (6 cbrintl.com<mailto Fe cbrint!.com>] Sent: 31 July 2014 22:24 To: Larry Zeitlin; Trina Racine; deborah scott Cc: Hayden, Frederick G *HS; Gary (Public Health Agency of Canada) Kobinger; nih.gov<mailto {BO nih.gov> [C] Olinger; Peter (NIH/NIAID) [E] Jahrling; Mike Hensley; Lisa (NIH/NIAID) [E] Hensley; Miles Brennan; Tara Nyhuis Subject: RE: Combining the existing Phase 1 with a Therapeutic Portion Dear All, Due to limited availability tomorrow, we would like to postpone our discussion until next Tuesday (8/5/14) at 7 AM PDT/ 8 AM MDT/ 9AM CDT/ 10 AM EDT/ 4 PM CEST. We will distribute an agenda and dial-in information on Monday, and please let us know of any questions or requests in the meantime. Thank you, Marshall Marshall Hoke, B.A. Technical Associate CBR International Corp. (r) www.cbrintl.com<http://www.cbrintl.com><https://email.healthsystem.virginia.edu/owa/UriBlockedError.aspx><http:/ /www.cbrintl.com/> This electronic transmission (including any and all attachments) is intended solely for the use of the individual or entity to whom it is addressed and may contain information that is privileged and/or confidential. If you are not the intended recipient of this electronic transmission, you are hereby notified that any disclosure, copying or distribution, or the taking of any action in reliance upon the contents of this electronic transmission, is strictly prohibited, and you are further requested to purge this electronic transmission and all copies thereof from your computer system.

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