Advaxis Requests Orphan Drug Designation for Treatment of HPV-Associated Head and Neck Cancer with ADXS-HPV
-- Orphan Drug Designation Could Provide Significant Financial Incentives and Serve an Unmet Medical Need --
-- Second Orphan Drug Designation Application Filed by Advaxis This Month --
PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCQB: 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 human papillomavirus (HPV)-associated head and neck cancer. There are about 50,000 new cases of head and neck cancer annually, with about 15,000 deaths. HPV infection is estimated to account for 20-50% of current incidence.
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 a seven year market exclusivity period.
"HPV-associated head and neck cancer is growing at an epidemic rate in the United States and other regions throughout the world. According to the U.S. Centers for Disease Control and Prevention (CDC), over 80% of new cases occur in men, who are not typically part of HPV vaccination programs," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Data from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this HPV-associated cancer. We believe that ADXS-HPV immunotherapy will show similar activity in HPV-associated head and neck cancer, given the shared causality of the cancers. We have one ongoing Phase 1/2 study in HPV-positive head and neck cancer in the United Kingdom and plan to initiate another in the United States in 2013. We believe ADXS-HPV could become an important new non-cytotoxic treatment for patients with HPV-associated head and neck cancer."
"If granted, Orphan Drug Designation (ODD) for our lead drug candidate, ADXS-HPV, could expedite our ability to help the over 10,000 Americans that the American Cancer Society estimates will be newly diagnosed with HPV-associated head and neck cancer in 2013. ODD would also provide seven years of market exclusivity for ADXS-HPV if it is approved by the FDA, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of the $1.9 million regulatory application filing fee," commented Thomas A. Moore, Chairman and CEO of Advaxis. "It is believed that the number of new HPV-caused head and neck cancers in the United States now approaches the number of new cervical cancer cases. This indication, with these incentives, if achieved, could substantially increase the potential value of the ADXS-HPV franchise."
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 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.
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 Head and Neck Cancer
Cancer of the head and neck includes cancers arising from mucosa lining the oral cavity, oropharynx, hypopharynx, larynx, sinonasal tract, and nasopharynx. The most common histologic type observed is squamous cell carcinoma; therefore, the term 'head and neck squamous cell carcinoma' (HNSCC) is frequently used to imply squamous cell carcinomas involving these anatomical sites. Excessive tobacco and alcohol are important risk factors for HNSCCs overall, but human papillomavirus (HPV) is now recognized as the causative agent in a subset of HNSCCs.
While the incidence of head and neck cancers that are linked to alcohol and tobacco use as the primary risk factor has fallen in the past three decades, a trend attributed to decreasing tobacco use in the United States, the incidence of HPV-associated head and neck cancer has been increasing. The increase was observed particularly among young individuals (<60 years of age), men, and Caucasians. Studies have shown that oral HPV infection is likely to be sexually acquired, as the increase in the incidence of HPV-associated head and neck cancers may be attributed to changing sexual practices. According to the World Health Organization's Human Papillomavirus and Related Cancers in the World Summary Report 2010, 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 cervical cancer cases.
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 bacteriumto 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 & neckcancer (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
This news release contains forward-looking statements, including, but not limited to: statements regarding ADXS-HPV demonstrating similar safety and efficacy in HPV-associated head and neck cancer, ADXS-HPV becoming an important new treatment for head and neck cancer, the ability of Orphan Drug Designation to expedite Advaxis' ability to help people with head and neck 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.
Diana Moore, 609.452.9814
Director, Investor Relations & Business Development
KEYWORDS: United States North America New Jersey
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