Advaxis,
Inc., (NASDAQ: ADXS), a leader in developing the next generation of
cancer immunotherapies, announced that ADXS-cHER2, its proprietary
immunotherapy for the treatment of breast cancer and canine
osteosarcoma, was featured on ABC News in an article titled “Bone
Cancer Vaccine for Dogs Shows Promise for Breast Cancer”.
Advaxis sponsored a Phase 1 canine osteosarcoma study, conducted by Dr.
Nicola Mason at the University of Pennsylvania School of Veterinary
Medicine, evaluating the safety and efficacy of Advaxis’ proprietary
immunotherapy, ADXS-cHER2, in companion dogs. The study has shown that
the dogs that received the Advaxis immunotherapy are living
significantly longer than the dogs whose owners elected not to
participate in the study. Even with standard of care (SOC) treatment
(affected limb amputation and follow-up chemotherapy) dogs have a median
survival rate of only 1 year. Sasha, a 13 year old American Bulldog and
the first dog treated in the study, has survived over 600 days.
“The proven ability of ADXS-cHER2 to extend the lives of companion dogs
that have received Advaxis’ immunotherapy is a very exciting development
not only for the owners who care so deeply about their pets, like Sasha,
but for the potential of this drug product candidate in humans as well,”
commented Daniel J. O’Connor, Chief Executive Officer of Advaxis.
“Specifically, the encouraging preliminary data shown in these dogs
provide strong rationale supporting the clinical development of
ADXS-cHER2 to treat women with HER2+ breast cancer. We believe this is a
potentially important value-creating opportunity for Advaxis to provide
our immunotherapies to the veterinary market and to women facing the
growing global issue of breast cancer. We are actively planning a
clinical research program in the indication of HER2+ breast cancer in
humans.”
About ADXS-cHER2
ADXS-cHER2 is an Lm-LLO immunotherapy for HER2 overexpressing
cancers (such as breast, gastric and other cancers in humans and for
osteosarcoma in canines). ADXS-cHER2 secretes the cHER2 antigen, fused
to LLO, directly inside APC that are capable of driving a cellular
immune response to HER2 overexpressing cells. In preclinical analysis,
localized effect is the inhibition of the Treg and MDSC cells that we
believe may promote immunologic tolerance of the HER2 overexpressing
cancer cells of the tumor.
About Canine Osteosarcoma
Osteosarcoma is the most common primary bone tumor in dogs, accounting
for roughly 85% of tumors on the canine skeleton. Approximately
8,000-10,000 dogs a year (predominately middle to older-aged dogs and
larger breeds) are diagnosed with osteosarcoma in the United States.
This cancer initially presents as lameness and oftentimes visible
swelling on the leg. Current standard of care treatment is amputation
immediately after diagnosis, followed by chemotherapy and sometimes
radiation for palliative care. Invariably, however, the cancer
metastasizes to the lungs, eventually leading to death.
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 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 Phase 1 and 2 clinical trials
for HPV-associated cancers: recurrent cervical cancer (completed Phase 2
study conducted in 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 U.S. 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, Icahn
School of Medicine at Mount Sinai, 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 Advaxis’ ability to develop the
next generation of cancer immunotherapies; the safety and efficacy of
Advaxis’ proprietary immunotherapy, ADXS-cHER2, in companion dogs; the
survival of dogs that receive the Advaxis immunotherapy; whether the
preliminary data shown in canines provide strong rationale supporting
the clinical development of ADXS-cHER2 to treat women with HER2+ breast
cancer; the timing associated with clinical research in the indication
of HER2+ breast cancer; whether ADXS-cHER2 may promote immunologic
tolerance of the HER2 overexpressing cancer cells of tumors; 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 2013