Vascular Biogenics Ltd (VBLT)

[gr8db8]

Another data point to confirm VB-111's safety, which has been mentioned in the rGBM, Ovarian and Thyroid trials. The adverse effects in other rGBM drugs can be serious but patients have little choice but to take them. Even Avastin has serious (fatal) GI side effect.

Gilead recently announced this on the conference call: "As you may know there were two recent setbacks with JAK1 inhibitors, one of them was a discontinuation of a Phase 3 program because of CNS toxicity and the other one was withdrawal of an NDA because of cardiovascular adverse events."

So getting DSMC approval is huge.

More information on the DSMC:

The Data and Safety Monitoring Plan (DSMP) was developed referencing Food and Drug Administration (FDA), National Institutes of Health (NIH), and National Cancer Institute (NCI) guidelines.
The Data and Safety Monitoring Committee (DSMC) oversees internal monitoring functions by reviewing study conduct for consistency with Good Clinical Practice (GCP), compliance with federal regulations, and production of high quality scientific data. The DSMC is comprised of physician investigators, internal monitors, and administrative staff. The DSMC monitored studies are reviewed based on their assigned risk level and, at minimum, will receive annual reviews. The DSMC monitors will routinely assess study conduct, reviewing all study aspects according to the monitoring plan. Such reviews include informed consent documentation, eligibility criteria, protocol compliance, and source document verification for data accuracy. Additionally, query resolution (clarification or correction of inaccurate data), occurrence and reporting of adverse events, test article accountability, and maintenance of essential documentation will be reviewed.

https://winshipcancer.emory.edu/research/clinical-trials-office/data-and-safety-monitoring-committee.html