Independent Data Safety Monitoring Board Gives “Go-Ahead” to Complete Dosing in First Leg of Advaxis’ Phase II Cervical Dysplasia Trial
- Category: Vaccines
- Published on Friday, 14 January 2011 02:00
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Low Dose Group To Be Fully Enrolled
NORTH BRUNSWICK, NJ, USA | January 14, 2011 | The science team from Advaxis, Inc., (OTCBB:ADXS.ob - News), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, met with the Data Safety Monitoring Board (DSMB), an independent group of medical experts, yesterday and received approval to dose all remaining patients in the initial forty (40) patient leg of the 120-patient, cervical dysplasia clinical trial being conducted in the United States.
This meeting was a required step in the protocol agreed to with the U.S. Food and Drug Administration.
The protocol, agreed to by the FDA, required that an initial group of patients be treated and assessed by a DSMB prior to enrolling the full complement of patients in each forty (40) patient group.
“We are pleased with the pace of enrollment and the continued finding of safety in all Phase II participants,” commented Advaxis EVP of Science and Operations Dr. John Rothman. “Our lead construct, ADXS11-001, was well tolerated in all treated patients. The DSMB found no safety issues that warranted any change in the conduct of the trial.”
Overall, thirty-eight (38) patients have been dosed in two (2) trials. By year end, it is anticipated that there will be a database of more than 200 dosed patients.”
About the Data Safety Monitoring Board (DSMB)
It is the policy of the National Institutes of Health (NIH) that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials. The establishment of the data safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).
About Advaxis, Inc.
Advaxis is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) vaccines that deliver engineered tumor antigens, which stimulate multiple, simultaneous immunological mechanisms to fight cancer. Today, the Company has nine (9) distinct, cancer-fighting constructs in various stages of development, directly and through strategic collaborations with such recognized sites of excellence as the City of Hope, the Roswell Park Cancer Institute, the National Cancer Institute, the University of Pittsburgh, Cancer Research – UK and the Department of Homeland Security. Advaxis’ technology was developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board. Please visit the Company’s portals: advaxis.com | facebook | twitter | LinkedIn
SOURCE: Advaxis, Incorporated