Will Accelerate Enrollment in Mid Dose Leg by up to 5 Months
PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has submitted a protocol revision that has passed FDA review for the enrollment of the next 40 subject “mid strength” dose cohort in the dose-ranging Phase II study of ADXS-HPV, an immunotherapy for Cervical Intraepithelial Neoplasia (CIN).
The revised protocol eliminates a staggered dosing design that required two pauses in recruitment to evaluate the safety of all three doses in two successive small groups of patients. The pauses consumed about 5 months in the recently completed low dose cohort that took about 14 months to complete.
The ADXS-HPV CIN study is a randomized, single blind, placebo controlled Phase II dose-ranging study designed to assess the safety and efficacy in up to 3 different dose cohorts.
“We proposed the changes to FDA based on the encouraging safety profile that has emerged after 110 patients have been dosed with ADXS-HPV. This change, combined with the learning curve associated with any clinical study, should bring our mid dose results in much more quickly,” commented Advaxis Executive Vice President John Rothman, PhD. “Recruitment for the mid dose cohort is well underway. Our plan continues to be to release the low dose results in early 2012.”
About Cervical Intraepithelial Neoplasia (CIN)
CIN is caused by the human papilloma virus and is diagnosed in approximately 500,000 women annually in the US. If left untreated, CIN2/3 is likely to progress to invasive cervical cancer. There is currently no alternative to surgery. Today, there are approximately 250,000 surgical procedures conducted annually to treat CIN 2/3.
About Advaxis, Inc.
Advaxis is a biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Our novel platform technology generates a more comprehensive immune response by serving as its own adjuvant, directing antigen presentation, increasing tumor infiltrating killer T-cells, and decreasing Tregs/MDSCs in the tumor. Today, the Company has over fifteen (15) distinct constructs in various stages of development, directly developed by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, and the Department of Homeland Security among others. Additional information can be found at: advaxis.com | facebook | twitter | LinkedIn
Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company’s current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements.
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