Replies to post #271532 on Avid Bioservices Inc (CDMO)

[cjgaddy]

2nd NCCN Trial (GBM Bavi+RAD+Temodar) hits ClinicalTrials.gov. “Not Yet Recruiting”, Start=6/30/17. Note it’s a Phase II N=36, not Ph.I-II as originally stated in the 9-6-16 NCCN PR. 2 Sites: Mass Gen & Dana Farber Cancer Institute. (both Boston).

NCCN Bavituximab Trials Announced 9-6-16 - To Begin "Early 2017" http://tinyurl.com/gutgwb5
...#1: Ph1/HepC-Related Hepatocellular(Liver) (Bavi+RAD+Bayer’s Nexavar=Sorafenib), MOFFITT CC (N=18)
. . . . . . .PI: Jessica Frakes, MD https://clinicaltrials.gov/ct2/show/NCT02989870 <=Recruiting a/o 3-27-17
...#2: Ph2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. & DANA FARBER (N=36)
. . . . . . .PI: Elizabeth Gerstner, MD https://clinicaltrials.gov/ct2/show/NCT03139916 <=Added 5-2-17
...#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHNS-HOPKINS(Sidney Kimmel CC)
. . . . . . .PI: Ranee Mehra, MD https://clinicaltrials.gov/ct2/show/XXXXXXXXX - See Dr. R.Mehra Jan'17/IFN-y Biomarker: http://tinyurl.com/h8gzkww

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3-13-17/CC JOE SHAN (VP/Clin.&Reg. Affairs) http://tinyurl.com/grhwjvy
“…Now turning to new trials, I’m happy to report that the 3 clinical trials to be funded through our collaboration with the NCCN [http://tinyurl.com/gutgwb5 ] are advancing as expected. The first study, expected to begin patient enrollment shortly, is being conducted by Dr. Jessica Frakes, at the Moffitt Cancer Center. This study, which builds upon a prior investigator sponsor trial [3-25-15/Dr. Adam. Yopp(UTSW) http://tinyurl.com/opkh5qy ], will evaluate the combination of Stereotactic Body Radiation Therapy, sorafenib, and bavituximab, for the treatment of Unresectable Hepatocellular [Liver] Carcinoma. We are interested in this trial design as radiation has been shown to increased PS expression on the surface of tumor cells, induce immunogenic tumor cell depth, and increase tumor specific T-cell activity. In addition, NCCN has recently communicated that both the study of bavituximab, temozolomide, and radiation in newly diagnosed Glioblastoma and the trial of bavituximab & temozolomide in recurrent Head & Neck cancer, which has progressed on checkpoint inhibitor treatment, are on track to be initiated by mid-year.”