Daily News: Disease

Advaxis Requests Orphan Drug Designation for Treatment of Cervical Cancer with ADXS-HPV

Business Wire

06-07-13

Orphan Drug Designation Could Provide Significant Financial Incentives and Serve an Unmet Medical Need

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has submitted an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of invasive cervical cancer. Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and potentially a seven year market exclusivity period.

"We are optimistic about our request for Orphan Drug Designation for ADXS-HPV in the indication of invasive cervical cancer," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Data recently presented at the 2013 ASCO Annual Meeting from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this disease and has the potential to become a non-chemotherapy treatment option capable of improving survival for women with cervical cancer. We believe that ADXS-HPV will become an important new treatment for this unmet medical need. Orphan Drug Designation could expedite our ability to help women with cervical cancer worldwide, including the 12,340 U.S. women the American Cancer Society estimates will be newly diagnosed in 2013."

"If granted, Orphan Drug Designation for our lead product candidate, ADXS-HPV, for the treatment of human papillomavirus, or HPV, associated cervical cancer, would provide the opportunity to gain several very key incentives for Advaxis, including the potential for seven years of market exclusivity for ADXS-HPV if the product is approved by the FDA, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain significant administrative filing fees," commented Daniel J. O'Connor, Executive Vice President of Advaxis. "These incentives, if achieved, will increase the potential value of ADXS-HPV."

About Orphan Drug Designation

Under the Orphan Drug Act (ODA), the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product. The benefits of orphan drug designation can be substantial and include federal grants, tax credits, and potentially a seven year market exclusivity period once the product is approved, provided that the product is first to market.

In order for a sponsor to obtain orphan designation for a drug or biological product, an application must be submitted to OOPD, and the designation approved. The approval of an application for orphan designation is based upon the information submitted by the sponsor. A drug that has obtained orphan designation is said to have "orphan status." Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same indication as a previously designated product must submit their own data in support of their designation request. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy of a compound must be established through adequate and well-controlled studies.

About ADXS-HPV

ADXS-HPV is an immunotherapy that is designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues. Eliminating these cells can eliminate the dysplasia or malignancy. ADXS-HPV is designed to infect antigen-presenting cells and direct them to generate a powerful, cellular immune response to HPV E7. The resulting cytotoxic Tcells infiltrate and attack the tumors while specifically inhibiting tumor Tregs and MDSCs in the tumors that are protecting it.

About Cervical Cancer

According to the WHO Human Papillomavirus and Related Cancers in the World Summary Report 2010, there are 500,000 new cases of cervical cancer caused by HPV worldwide every year. Current preventative vaccines cannot protect the 20 million women who are already infected with HPV; and of the high risk oncogenic strains, only HPV 16 and 18 are present in these vaccines. Challenges with acceptance, accessibility, and compliance have resulted in only a third of young women being vaccinated in the United States and even less in other countries around the world. HPV is associated with 20-50% of oral squamous cell carcinomas. HPV-associated head and neck cancer is growing at an epidemic rate in western countries; and occurs more frequently (3:1) in men than women. In the United States, the number of HPV-positive head and neck cancer cases has already equaled the number of cases of cervical cancer and continues to increase in frequency. HPV is associated with 80-100% of anal cancers and is also increasing in frequency.

About Advaxis, Inc.

Advaxis is a clinical-stage 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 bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein(s) that is designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.

ADXS-HPV is currently being evaluated in four clinical trials for human papillomavirus (HPV)-associated diseases: recurrent/refractory cervical cancer (India), locally advanced cervical cancer (GOG/NCI U.S. study, Clinical Trials.gov Identifier NCT01266460), head & neck cancer (CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (BrUOG study, Clinical Trials.gov Identifier NCT01671488). Advaxis has over 15 distinct immunotherapies in various stages of development, developed directly by Advaxis 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, the University of British Columbia, the Karolinska Institutet, and others. For more information please visit: advaxis.com | Facebook | twitter | LinkedIn

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding ADXS-HPV becoming an important new treatment for cervical cancer, the ability of Orphan Drug Designation to expedite Advaxis' ability to help women with cervical cancer worldwide, an increase in the potential value of ADXS-HPV due to the incentives of Orphan Drug Designation, as well as whether or not ADXS-HPV will obtain Orphan Drug Designation. These forward-looking statements are subject to a number of risks, including 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, 2012, which is available at www.sec.gov. Advaxis 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.

Advaxis, Inc. Diana Moore, 609-452-9814 Director, Investor Relations & Business Development dmoore@advaxis.com

Source: Advaxis, Inc.

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