Advaxis Expects No Delay in Filing IND for ADXS-PSA
PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has completed a pre-IND (Investigational New Drug) meeting with the FDA on August 10 to discuss the development plan for ADXS-PSA, a construct for the treatment of prostate cancer. The FDA addressed the company’s questions and provided guidance on the requirements to file an IND to initiate clinical trials. This IND is expected to be filed before the end of the year.
A pre-IND meeting is conducted to develop mutual understanding and agreement between the FDA and the Company regarding the content needed to assess manufacturing, toxicology, pre-clinical and rationale to support a first in humans clinical trial. Based on FDA input, the planned toxicology studies will be completed on schedule for a filing by year end. Once an IND is filed, FDA has 30 days to comment before the Company can begin Phase I trials
“The FDA has consistently been very helpful. It is critical for Advaxis to understand the regulatory perspective, and the guidance we have received has improved our development program in many ways,” commented Advaxis Executive Vice President John Rothman. “Because each new construct is based on live attenuated Listeria monocytogenes, every successful interaction with the FDA strengthens the regulatory framework for this entire new class of immunotherapies.”
About Prostate Cancer
Prostate Cancer is newly diagnosed in over 200,000 American men, annually. Over 2,000,000 Americans are currently afflicted (NCI SEER statistics for 2008). Advanced prostate cancer requires aggressive treatment with side effects such as incontinence and impotence. Provenge from Dendreon (DNDN:NYSE), has demonstrated effectiveness for immunotherapy in very late stage disease. The Advaxis approach uses different technology that is vastly simpler, less expensive and may prove to be more effective.
About Advaxis Technology
Advaxis immunotherapies are based on a novel platform technology using live attenuated Listeria monocytogenes (Lm) that are bio-engineered to secrete an antigen/adjuvant fusion protein. The vectors safely infect the key elements of the immune system and the secreted antigen/adjuvant fusion protein redirects the powerful immune response all human beings inherit to Lm against the cancer, itself. The adjuvant also reduces the cancer’s defense against this immune attack by 80%. ADXS-HPV, Advaxis’ first construct is in Phase II trials for HPV-associated CIN (cervical intraepithelial neoplasia) and for recurrent cervical cancer. Over 100 patients have been dosed to date in Advaxis clinical trials.
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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