Advaxis, Inc., (NASDAQ:ADXS), a leader in developing the next generation
of cancer immunotherapies, announced that the first patient has been
dosed in a Phase 1/2 “window of opportunity” study being conducted by
the Icahn School of Medicine at Mount Sinai. Patients diagnosed with
HPV-associated head and neck cancer will receive ADXS-HPV immunotherapy
during the “window” of time between initial diagnosis and minimally
invasive transoral robotic surgery (TORS) to remove their tumors.
HPV-associated head and neck cancer is the most rapidly growing form of
head and neck cancer, and is caused by the same virus that causes
cervical cancer.
“This study will characterize the potential of ADXS-HPV to stimulate the
patient’s own immune system to fight cancer prior to receiving TORS,”
commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. “The
short and long-term side effects of surgery followed by chemotherapy and
radiation can be disfiguring and interfere with the patient’s ability to
swallow and eat. We have partnered with experts at one of the top head
and neck cancer treatment centers in the world who share our goal of
making more effective and less toxic treatments available for patients
with this terrible disease. It is our shared hope that adding the power
of our newly emerging immunotherapy to technological advances like TORS
may significantly improve the treatment options and long-term outcomes
for head and neck cancer patients and survivors.”
This investigator-initiated clinical study is designed to enroll 25
patients with human papillomavirus (HPV)-positive stage II-IV squamous
cell carcinoma of the oropharynx who are scheduled to undergo TORS. TORS
is an FDA-approved technology developed at Mount Sinai for patients with
head and neck cancer and is considered to be the standard of care
therapy in appropriate patients. Fifteen patients will receive ADXS-HPV
treatment followed by TORS and ten patients will serve as the control
group and receive only TORS. The primary objective of this study is to
assess the safety, efficacy, and immunogenicity of ADXS-HPV in this
patient population prior to undergoing surgery. The Mount Sinai
immunology core lab will fully characterize the immunologic effects of
ADXS-HPV treatment on both the patient and his or her tumors. If
successful, ADXS-HPV could potentially be used before surgery or other
cytotoxic treatments to reduce the dose of cytotoxic therapies, decrease
toxicities, and enhance long-term disease control.
About ADXS-HPV in Head and Neck Cancer
ADXS-HPV is Advaxis’ lead immunotherapy product candidate for the
treatment of HPV-associated cancers. It is currently under investigation
in three HPV-associated cancers: cervical cancer, head and neck cancer,
and anal cancer. In cervical cancer, a recently completed Phase 2 study
of ADXS-HPV demonstrated improved survival and a manageable safety
profile alone or in combination with chemotherapy. Clinical trials in
head and neck cancer and in anal cancer are ongoing. Advaxis has
received Orphan Drug Designation from the US Food and Drug
Administration for ADXS-HPV for HPV-associated head and neck cancer and
for anal cancer.
HPV-associated Head and Neck Cancers
More than 90% of head and neck squamous cell oropharyngeal cancers
originate from the mucosal linings of the oral cavity, pharynx, or
larynx. Currently, 60-80% of these cancers are caused by HPV. Head and
neck cancers are treated by surgical removal of the cancer and lymph
nodes, often followed by radiation and chemotherapy based on the extent
of the disease. While patients may achieve good long-term survival,
standard treatments can change their physical appearance and are
associated with significant short and long-term toxicities which may
interfere with salivary gland function, taste, smell, and the ability to
swallow.
The incidence of HPV-associated head and neck cancers has been
increasing at an epidemic rate, while head and neck cancers from other
causes have been decreasing. According to the WHO, approximately 15-20%
of the 400,000 new cases of head and neck cancer are HPV-related. In the
US, there are about 12,000 new cases of HPV-associated head and neck
cancer per year and it affects men about 3 times more frequently than
women. HPV-associated head and neck cancer is growing fastest in
developed countries like the US.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next
generation of cancer immunotherapies. Advaxis’ immunotherapies are based
on a novel platform technology using live, attenuated bacteria to
stimulate the immune system to selectively target cancer cells while
reducing tumor defenses.
ADXS-HPV, Advaxis’ lead immunotherapy for the treatment of
HPV-associated cancers, has improved survival and objective tumor
responses in a Phase 2 trial in 110 patients with recurrent cervical
cancer. Advaxis is now planning the registrational program for ADXS-HPV.
ADXS-HPV is also being evaluated in other HPV-associated cancers
including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and
neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has Orphan
Drug Status for both anal and head and neck cancers. As part of its
global commercialization strategy to enter into regional licensing deals
with other market dominant biopharmaceutical companies in territories
where there is a high prevalence of HPV-associated cancers, Advaxis has
granted an exclusive license for the development and commercialization
of ADXS-HPV in Asia.
ADXS-cHER2 is an immunotherapy for the treatment of HER2 overexpressing
cancers (such as breast, gastric, and other cancers in humans and for
osteosarcoma in canines). Advaxis’ lead animal-health immunotherapy,
ADXS-cHER2, has demonstrated encouraging survival data in a Phase 1
trial in canine osteosarcoma. These data provide the rationale to
advance this same immunotherapy into a Phase 1 clinical trial in women
with HER2-positive breast cancer. The Company is preparing to submit an
IND for ADXS-cHER2 in breast cancer in 2014.
Advaxis has created over 15 distinct immunotherapies based on its
platform either directly or through strategic collaborations with
recognized centers of excellence such as: the University
of Pennsylvania, Brown
University, the Georgia
Regents University Cancer Center, the Icahn
School of Medicine at Mount Sinai, and others.
For more information please visit www.advaxis.com
or connect with us on Facebook,
Twitter,
Google+
and LinkedIn.
Forward-Looking Statements
This news release contains forward-looking statements, including,
but not limited to: statements regarding Advaxis’ ability to develop the
next generation of cancer immunotherapies; the safety and efficacy of
Advaxis’ proprietary immunotherapy, ADXS-HPV; whether Advaxis
immunotherapies can redirect the powerful immune response all human
beings have to the bacterium to cancers. 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 2014