Advaxis’ Phase II Clinical Trial "HOLD" Lifted
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Advaxis Inc has received permission from the U. S. Food and Drug Administration (FDA) to test its lead drug candidate, Lovaxin C, in patients with grade 2/3 cervical intraepithelial neoplasia (CIN). With this approval of the Investigational New Drug (IND) application for Lovaxin C, the FDA “HOLD” on Advaxis’ clinical program has been lifted.
Advaxis submitted its IND application to the FDA in May 2008, which outlined the proposed protocol for a Phase II clinical trial safety study targeting CIN – a precursor condition to cervical cancer, commonly diagnosed by PAP smears.
The Company explained that, the proposed trial, unlike Advaxis’ Phase I cervical cancer trial, will target the disease at a much earlier stage of development and recruit CIN patients living in the U. S. that are otherwise healthy. Due to the different patient population, the FDA requested more information to support the safety of Lovaxin-C and the methods used in its manufacture, which prompted the clinical trial “HOLD.”
Regarding the FDA’s acceptance of the Company’s IND application, Advaxis’ Executive Director of Product Development, Dr. Christine Chansky, MD, JD, said, “Advaxis’ clinical and scientific team comprehensively responded to the FDA’s questions. There were well over 700 pages of documentation submitted, which included results from our Phase I clinical trial study as well as animal research conducted specifically for the response. It was a great job by the team and a fine start to our regulatory relationship with the FDA. The FDA has requested additional information regarding our manufacturing processes as they develop, which we will provide as the processes are validated.”
“The FDA’s approval of Advaxis’ IND application to conduct the first US based clinical trial of a live Listeria monocytogenes vaccine that secretes an LLO-tumor specific antigen fusion is a major milestone for the Company as well as for the entire field of immunotherapy,” commented Advaxis Inc.’s Chairman and CEO, Thomas A. Moore.
Moore continued, “Our technology enables the delivery of a tumor specific antigen fused to the highly adjuvant Listeria protein, Listeriolysin O (“LLO”), which has a very powerful, anti-tumor effect. Although we have an active clinical program in invasive cervical cancer planned, the safety and efficacy results in the CIN indication will enable us to pursue a U. S. market of about 250,000 patients per year; 50 times the market size of cervical cancer.”
Advaxis submitted its IND application to the FDA in May 2008, which outlined the proposed protocol for a Phase II clinical trial safety study targeting CIN – a precursor condition to cervical cancer, commonly diagnosed by PAP smears.
The Company explained that, the proposed trial, unlike Advaxis’ Phase I cervical cancer trial, will target the disease at a much earlier stage of development and recruit CIN patients living in the U. S. that are otherwise healthy. Due to the different patient population, the FDA requested more information to support the safety of Lovaxin-C and the methods used in its manufacture, which prompted the clinical trial “HOLD.”
Regarding the FDA’s acceptance of the Company’s IND application, Advaxis’ Executive Director of Product Development, Dr. Christine Chansky, MD, JD, said, “Advaxis’ clinical and scientific team comprehensively responded to the FDA’s questions. There were well over 700 pages of documentation submitted, which included results from our Phase I clinical trial study as well as animal research conducted specifically for the response. It was a great job by the team and a fine start to our regulatory relationship with the FDA. The FDA has requested additional information regarding our manufacturing processes as they develop, which we will provide as the processes are validated.”
“The FDA’s approval of Advaxis’ IND application to conduct the first US based clinical trial of a live Listeria monocytogenes vaccine that secretes an LLO-tumor specific antigen fusion is a major milestone for the Company as well as for the entire field of immunotherapy,” commented Advaxis Inc.’s Chairman and CEO, Thomas A. Moore.
Moore continued, “Our technology enables the delivery of a tumor specific antigen fused to the highly adjuvant Listeria protein, Listeriolysin O (“LLO”), which has a very powerful, anti-tumor effect. Although we have an active clinical program in invasive cervical cancer planned, the safety and efficacy results in the CIN indication will enable us to pursue a U. S. market of about 250,000 patients per year; 50 times the market size of cervical cancer.”
