PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB:ADXS) a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been granted a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”) on November 22nd, 2011 to discuss the initial clinical development plan for ADXS-HER2, a construct for the treatment of HER2 expressing cancers.
ADXS-HER2 is manufactured by Vibalogics, located in Cuxhaven, Germany.
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. Once an IND is submitted, the FDA has 30 days to comment before the Company can begin Phase 1 trials. The Company plans to file the IND application early in 2012 to initiate a Phase 1/2 safety study in humans.
“ADXS- HER2 immunotherapy is the third Lm-LLO agent Advaxis is advancing to the clinic,” commented Dr. John Rothman, Executive VP of Advaxis. “It uses a proprietary chimeric form of the HER2 antigen (cHER2) that gives it the potential to overcome “escape mutations” in cancer, and has shown encouraging results in mouse models for HER2 positive breast cancer and preliminary data in brain cancer. Advaxis constructs are designed to redirect the powerful immune response we all have to Listeria to selected tumor associated antigens such as those over expressing HER2.”
HER2 (human epidermal growth factor receptor 2) is a gene which is over expressed in a percentage of certain types of cancers such as breast, stomach, bladder, pancreatic, brain, and ovarian. The American Cancer Society estimates that in 2011 in the US there will be 230,480 diagnoses of invasive breast cancer, 21,520 new cases of stomach cancer, 69,250 new cases of bladder cancer, 44,030 new cases of pancreatic cancer, 22,340 new cases of brain/spinal cord cancer, and 21,900 new cases of ovarian cancer.
About Advaxis, Inc.
Advaxis is a biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. 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 that redirects the powerful immune response all human beings have to Lm to the cancer, itself.
ADXS-HPV, Advaxis’ first construct is being evaluated in 4 Phase 2 clinical trials for HPV associated diseases (CIN 2/3, cervical cancer, and head & neck cancer) with over 130 patients dosed to date. Over fifteen (15) distinct constructs are in various stages of development, either developed directly 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.
Diana Moore, 609-452-9814
Director, Investor Relations & Business Development
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