Avid Bioservices Inc (CDMO)

[dia76ca]

It is a Phase I/II trial. Cj posted the following about how it is coming. It is interesting that SK has mentioned it many times. It is open label so the management and interested BP's will know how it is going. We could receive an interim report any time now.

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Wed, Apr 4, 2012 8:00AM-12:00PM Poster Session
AACR’12 #5591 – “A Phase I [IST] Study of Bavituximab and Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)”
Adam Yopp, Yull Arriega, Amit Singal, John Mansour, Glen Balch, Phillip Thorpe - UTSW-MC/Dallas
PO.CL02.01. Drug Resistance & Phase I Studies
ABSTRACT:
Background: HCC is the fastest growing cause of cancer-related deaths in the US, with the majority of patients presenting with advanced stage disease. Despite sorafenib being the only systemic therapy with proven efficacy in advanced HCC, the median survival for these patients is still less than one year. Sorafenib, in pre-clinical HCC models, upregulates phosphatidylserine (PS) exposure on tumor vascular endothelium. The phosphatidylserine (PS)-targeting antibody, bavituximab, given in combination with sorafenib has greater efficacy in pre-clinical HCC models than either therapy alone. Bavituximab acts by directing immune cells to destroy the PS-expressing tumor vasculature, and by reactivating tumor immunity. The aim of our study was to evaluate the maximum tolerated dose (MTD) of bavituximab in combination with 400 mg bid of sorafenib in patients with advanced HCC.
Methods: In this single institution, phase I study (NCT01264705), sorafenib-naive adult patients with measurable, advanced HCC, ECOG PS <= 2, and Child-Pugh (CP) class A cirrhosis received escalating doses of bavituximab weekly (0.3, 1.0, and 3.0 mg/kg) and sorafenib 400 mg bid for 28 days.
Results: Median age of patients was 61(range 43-76) years and seven patients were male. Five patients had CP A5 and 4 patients had CP A6 cirrhosis. The majority of patients had underlying HCV (7/9), one patient had HBV and one patient had NASH. Five patients (4 TACE, 1 resection) received prior treatment. Four patients had metastatic disease at initiation of treatment. No dose limiting toxicities were seen at any dose level. No grade 3/4 treatment-related events in the first 28 days were noted. Common toxicities at all grades were related to sorafenib and included hand-foot syndrome (33% grade I, 22% grade II), fatigue (33% grade I) and anorexia (22% grade I).
Conclusions: Bavituximab and sorafenib can be given safely in patients with advanced HCC at 3.0 mg/kg weekly and 400 mg bid, respectively. Hand-foot syndrome, fatigue and anorexia were the most common adverse events and are consistent with known adverse events with sorafenib therapy. These doses are currently being evaluated in an ongoing phase II study in this population.
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[ Obviously the above #5591 is regarding this Peregrine IST Ph.1/2 Trial at UTSW:
H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer=HCC)
...Note: Sorafenib = Bayer's Nexavar - see http://www.nexavar.com
Protocol: http://clinicaltrials.gov/ct2/show/NCT01264705 UTSW: http://tinyurl.com/2che4us (4 sites: 3/UTSW, 1/Parkland-Hosp.)
...2-14-12: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia: http://tinyurl.com/7cvlql6
......Articles & Data describe Liver Cancer challenges in Asian populations: http://tinyurl.com/7z7o8j9 & http://tinyurl.com/7z99cy4
...12-1-10: PPHM's 1st IST (Liver Cancer=HCC) initiated at UTSW, ~56 patients - http://tinyurl.com/3xd3e6c
…Steve King, 5-18-10/R&R, "We've had a lot of interest in running clinical trials with the compound from investigators who have either had prior experience with the drug or would like to study the drug in various settings. Potential IST indications include all the major solid tumor types. Of particular interest is Liver Cancer, in which we have a natural tie-in with our HCV program, Ovarian Cancer and Pancreatic Cancer, also very nicely supported by the prior data." ]
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PPHM 4-4-12 PRESS RELEASE COMMENTS RE: #5591:
“ In [this] presentation, clinical investigators presented data from a Phase I/II trial investigating bavituximab with sorafenib in patients with advanced hepatocellular carcinoma (liver cancer). Of the 9 patients enrolled in the phase I portion of the study, no dose-limiting toxicities or serious adverse events were observed and the trial is now enrolling in the phase 2 part of the study. "Sorafenib has been shown to increase the exposure of bavituximab's PS target on tumor blood vessel cells, and combination therapy with the 2 agents has shown synergistic efficacy in preclinical models," said Adam Yopp [UTSW], the lead investigator of the trial. "As the only approved therapy for advanced liver cancer, attempts have been made to extend survival in this patient population by combining sorafenib with common anti-angiogenesis drugs, but unfortunately these drug combinations have resulted in unacceptable toxicities. We are excited by the promising safety profile to date in our bavituximab trial, and look forward to reporting on potential anti-tumor effects observed in this IST at a future oncology conference."
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=661779
PDF of AACR’12 Poster #5591 (Liver/HCC IST) :
http://www.peregrineinc.com/images/stories/pdfs/aacr_2012_hcc_ist.pdf