Avid Bioservices Inc (CDMO)

[cjgaddy]

Thx/CP: 1st (of 3) NCCN Trial hits ClincalTrials.gov.
That’s this one:
#1: Ph1/HepC-Related Hepatocellular (Bavi+RAD+Sorafenib), MOFFITT CANCER CENTER - PI: Jessica Frakes, MD
"A Phase I Trial of Sorafenib & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
=> 9-8-16/CC/JoeShan: “The 1st award is for a Phase I trial of Sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]”
- - - - - - -
9-6-16: NCCN to Initiate 3 Bavi-Trials Early’17 (Moffitt,MassGEN,JohnHopkins) http://tinyurl.com/gutgwb5
1. Ph1/HepC-Related-Hepatocellular/MOFFITT (Bavi+RAD+Sorafenib)
2. Ph1-2/Glioblastoma/MASS-GEN (Bavi+RAD+Merck’s Temodar)
3. Ph2/Head+Neck/JOHN-HOPKINS (Bavi+Merck’s Keytruda)
NCCN PR:
https://www.nccn.org/about/news/newsinfo.aspx?NewsID=785
”NCCN is excited to initiate 3 studies by accomplished investigators at Member Institutions that will explore the effect of this novel immunotherapy in 3 different cancers with significant unmet need,” said Robert C. Young, MD, Interim VP, NCCN ORP.

= = = = = = = = = = = = =
12-12-16: First Bavituximab clinical trial with NCCN on ClinicalTrials.gov:
Sorafenib & Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma”
Entered 12-8-16: NCT02989870 https://clinicaltrials.gov/ct2/show/NCT02989870
This study involves a course of radiation to up to 5 tumors in the participant's liver followed by systemic therapy. (Treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body.) The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the systemic therapies, sorafenib and bavituximab. The researchers want to see which dose of radiation will work best in stimulating the immune response and provide local control to the participant's liver. The usual treatment for hepatocellular carcinoma that is unresectable can be transarterial therapy, sorafenib alone and/or clinical trial.
Sponsor: H. Lee Moffitt Cancer Center & Res. Institute
Collaborator: National Comprehensive Cancer Network
Info provided by (Responsible Party): H. Lee Moffitt Cancer Center & Res. Institute