Odd1, some of my notes on Safety – Avastin vs. Bavi…
AVASTIN 2-26-08: The most serious, and sometimes fatal, bevacizumab [Avastin] adverse events have been previously described in product labeling and include gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, nephrotic syndrome, congestive heart failure, and neutropenic sepsis. The most common bevacizumab adverse events previously described in product labeling include asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis, and proteinuria. http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab
BAVI ASCO’08: “The Ph.1 study results showed that the safety profile of bavituximab and chemotherapy appeared consistent with chemotherapy alone and that the pharmacokinetic properties of bavituximab were not impacted by co-admin. with conventional chemotherapies.” http://tinyurl.com/5xll6f
PPHM 4-4-12 PR/AACR’12: On #5591 HCC/Liver Cancer IST (PI: Dr. Adam Yopp, UTSW): 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)… 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
PPHM 2-19-13 PR: Update on 2nd-Line NSCLC Trial – 60% improvement in MOS: 3mg=11.7mos. vs. 7.3mos. for CTL-arm(combined 1mg & Doxy+placebo arms), HR=.73, p=.217… http://tinyurl.com/ansqcea “…The results also demonstrated that bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.”
I mentioned previously that a very ill cousin was put on Avastin. He improved for a month but then succumbed to intestinal bleeding caused by the drug. He was very sick when they gave him the Avastin and it was understood that it was a last resort and that it could have terrible side effects which it did, unfortunately.
Bavi has minimal side effects and safety is never an issue. Since safety is key to Phase II success leading to Phase III as well as efficacy that is a big plus for Bavi.
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