Advaxis, Inc., (NASDAQ:ADXS), a leader in developing the next generation
of cancer immunotherapies, announced that it has been granted Orphan
Drug Designation from 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.
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 very pleased to have been granted an orphan drug designation for
ADXS-HPV in this unmet medical need,” commented Dr. Robert Petit, Chief
Scientific Officer of Advaxis. “Patients with head and neck cancer have
limited treatment options and we hope to improve their survival by
developing ADXS-HPV for this indication. We plan to initiate an
additional Phase 1/2 study in early stage head and neck cancer for
ADXS-HPV with a nationally recognized center of excellence, and we will
continue the ongoing Phase 1 study being sponsored by the University of
Liverpool and Aintree University Hospitals NHS Foundation Trust that is
evaluating the safety and efficacy of ADXS-HPV when combined with
standard chemotherapy and radiation treatment in patients with head and
neck cancer.”
“Receiving orphan drug designation for ADXS-HPV in head and neck cancer
is excellent news for a technology that may offer the potential to treat
an indication with few therapy options, and, importantly, it helps
define a clear path forward to registration,” commented Daniel J.
O’Connor, President and Chief Executive Officer of Advaxis.
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 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 bacterium to
the cancer itself.
ADXS-HPV is currently being evaluated in four clinical trials for human
papillomavirus (HPV)-associated cancers: 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 University
of Pennsylvania, the Georgia
Regents University Cancer Center, Brown
University Oncology Group, and others.
For more information please visit: www.advaxis.com
Forward-Looking Statements
This news release contains forward-looking statements, including,
but not limited to: statements regarding the potential of ADXS-HPV to
treat an indication with few therapy options and improve survival of
patients by developing ADXS-HPV for this indication. 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 http://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.
Copyright Business Wire 2013