Advaxis, Inc., (NASDAQ:ADXS)(NASDAQ:ADXSW), a leader in developing the
next generation of immunotherapies for cancer and infectious diseases,
announced that the first patient has been dosed in REALISTIC, a
Phase 1 study being funded by Cancer Research UK (CRUK) to investigate
the use of ADXS-HPV for the treatment of HPV-positive head and neck
cancer.
This trial is sponsored by the University of Liverpool and Aintree
University Hospitals NHS Foundation Trust, Liverpool, UK and is being
conducted at the The Royal Liverpool University Hospital, Liverpool, UK,
the Royal Marsden Hospital, London, UK, and the University Hospital of
Wales, Cardiff, UK. The study will investigate the safety and efficacy
of ADXS-HPV in patients presenting with HPV related oropharynx cancer
and who have been treated with surgery, radiotherapy, and/or
chemotherapy; alone or in combination. A maximum of 27 patients are to
be enrolled in this study, and the study is funded by Cancer Research UK.
“This important milestone is the first step in understanding the
potential of ADXS-HPV, our lead drug candidate, in the fight against the
growing epidemic of HPV-associated head and neck cancer,” commented Dr.
Robert Petit, Chief Scientific Officer of Advaxis.
About Head and Neck Cancer
Cancer of the head and neck includes cancers arising from the tissues
lining the oral cavity, throat, nose, and sinuses. Excessive tobacco and
alcohol are important risk factors for HNSCCs overall, but human
papillomavirus (HPV) is now recognized as the causative agent in a
growing subset of HNSCCs arising from the tonsil and base of tongue.
While the incidence of head and neck cancers not caused by HPV has
fallen in the past three decades, in the United States the incidence of
HPV-associated head and neck cancer has been increasing. The increase is
highest among young individuals (<60 years of age), men, and
Caucasians. Studies have shown that oral HPV infection is most 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 at
approximately 12,000 new cases per year.
About Cancer Research UK
Cancer Research UK is the largest single funder of cancer research in
the UK and the world’s largest charity dedicated to cancer research. It
funds research on all aspects of cancer, from basic cell biology to
large clinical studies of entire populations. The organization funds the
work of more than 4,500 scientists, doctors, and nurses across the UK
and runs specialized institutes dedicated to cancer research. Cancer
Research UK currently funds more than 180 clinical trials.
Since the early 1980s, Cancer Research UK has taken over 100 new drugs
into clinical trials with more than 100,000 patients taking part in
trials since 1995.
For more information, please visit: http://www.cancerresearchuk.org.
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 National
Cancer Institute, Cancer
Research – UK, the University
of Pennsylvania, the Georgia
Regents University Cancer Center, 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
fight against the growing epidemic of HPV-associated head and neck
cancer. 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