Avid Bioservices Inc (CDMO)

[cjgaddy]

Mojo, the ASCO’11 abstracts, created in late’10 or early’11, won’t have the latest MOS results from the Cotara/GBM Ph.2 trial. It’s just like last year, ASCO’10 – for the Ph.2/India+USA NSCLC trial, the orig. “Abstract” which ASCO released in mid-May only had data for n=21, whereas the 6-4-10 ASCO PR (and Dr. Digumarti’s Poster that was posted to PeregrineInc.com) had updated data for the entire trial, n=49 – see http://tinyurl.com/2g5cqof . Bottom Line: Big diff. in what we see in the ASCO’11 (5-6mos. old) Abstracts that will be posted May 18th, and the updated data that will be announced when ASCO’11 finally gets here, June3-7.

As far as the Ph.2 n=40 Cotara/GBM, trial [ http://clinicaltrials.gov/ct2/show/NCT00677716 enroll-comp 12-20-10], recall that Dr. Gupta presented his “n=14/1Site MOS=86wks” interim update at CNS’10 on 10-18-10, so perhaps the init. ASCO Abstract may give a better glimpse of how that 86wks moves as we expand to all 40 patients. Remember, they’ll be using the std. “Kaplan-Meier Estimate” (for staggered enrollments) until final, official MOS is known - http://cancerguide.org/scurve_km.html .

10-18-10: INTERIM PH.2 UPDATE (N=14) AT CNS’10: http://tinyurl.com/349kvca
...PI Dr. Deepak Gupta, "MOS of 86 weeks far exceeded our expectations in this very difficult to treat patient pop. where treatment options are few and rarely extend med.survival beyond 6mos."
…Roth’s Joe Pantginis: “Physicians know how long these patients are expected to survive on avg. and that's why these data are very, very promising. Because there is a huge unmet medical need for new treatments for this type of brain cancer, Peregrine may seek an accelerated approval that could avoid lengthy Phase III clinical trials.”
...Link to Dr. Gupta's CNS'10 Poster (6pg PDF): http://tinyurl.com/26b8sp9

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JUN3-7: “ASCO ANNUAL MEETING 2011”, CHICAGO http://chicago2011.asco.org
...Peregrine Pharmaceuticals, Booth #19127 (Featured-Exhibitor=Yes): http://apps.asco.org/ePlanner/AM2011.aspx
...Abstracts to be Released on ASCO.org May18 at 6pmET. http://chicago2011.asco.org/Abstracts.aspx
...…6-3-11 2-6pm Poster Discussion: Dr. William R. Shapiro [Barrow Neurological Inst./Phoenix. PI of Ph.2 Cotara/GBM Trial], “Open-label, Dose Confirmation Study of Cotara for the Treatment of GBM at 1st Relapse: Interim Results” (Abstract #2035) http://tinyurl.com/3pubpbh