PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, completed a pre-IND (Investigational New Drug) meeting with the FDA on November 22, 2011 to discuss the development plan for ADXS-HER2, an immunotherapy for the treatment of HER2 expressing cancers. 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 submitted in the first half of 2012.
“In our second pre-IND meeting of the year, the FDA continued to be collegial, receptive, and helpful as we take the necessary steps to expand our oncology pipeline,” said Dr. John Rothman, EVP of Science & Operations at Advaxis.
About Pre-IND Meetings
A pre-IND meeting is conducted to develop mutual understanding and agreement between the FDA and the Company regarding the content of the IND needed to assess manufacturing, toxicology, pre-clinical, and rationale to support the Company’s initiation of human clinical trials. Once an IND is filed, the FDA has 30 days to comment before the Company can begin Phase I trials.
About HER2 Cancers
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, gastric, 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 to reach the clinic is being evaluated in 4 Phase II 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, and the University of Pennsylvania, among others. For more information please visit: advaxis.com | Facebook | twitter | LinkedIn
This news release contains forward-looking statements, including, but not limited to: statements as to the anticipated timing of clinical studies and other business developments, statements as to the development of new constructs, expectations as to the adequacy of our cash balances to support our operations for specified periods of time and as to the nature and level of cash expenditures, expectations as to market opportunities, our ability to take advantage of those opportunities, and the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2010, which is available at http://www.sec.gov. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
Diana Moore, 609-452-9814
Director, Investor Relations & Business Development
KEYWORDS: United States North America New Jersey
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical Research FDA Science