Advaxis Announces ADXS-cHER2 Demonstrates Significant Survival Advantage in Ongoing Canine Osteosarcoma Study
Advaxis, Inc., (OTCQB: ADXS and ADXSD), a leader in developing the next
generation of immunotherapies for cancer and infectious diseases,
announced updated preliminary data from a dose escalation Phase 1 study
evaluating the safety and efficacy of ADXS-cHER2 in the treatment of
dogs with osteosarcoma that overexpress human epidural growth factor
receptor-2, or HER2.
Osteosarcoma is an aggressive malignant bone tumor that affects dogs
that overexpress HER2. Dogs undergoing standard of care (SOC) treatment
(affected limb amputation and follow-up chemotherapy) have a median
survival rate of only 1 year. Updated preliminary data from the first
two of three dose groups (6 dogs/3 dogs per dose group) show a
significant survival advantage for dogs that received SOC plus
ADXS-cHER2 compared to 11 dogs whose owners elected not to participate
in the trial but who were followed for survival (p=0.04). At this point
in the study, 8 of 9 dogs treated with ADXS-cHER2 are alive (mean
survival undefined), compared with 5 of 11 dogs in the control group
(mean survival 265 days).
ADXS-cHER2 continues to be well-tolerated with the dogs experiencing
only mild, easily managed side effects (fever, increased heart rate, and
vomiting) consistent with immune activation (cytokine release syndrome)
observed at the time of treatment. There is no evidence of any
cumulative or long-term side effects on the dogs, including their
cardiovascular systems.
“Preliminary results so far are very encouraging,” commented Dr. Nicola
Mason, the lead investigator of the study at UPenn Veterinary School.
“The side effects at the time of infusion are very mild and we are now
treating the dogs on an outpatient basis.”
Once the dose has been selected, the study is intended to expand into
Phase 2 and additional collaborative academic centers will be added.
“These early results are significant on several levels,” commented Dr.
Robert Petit, Chief Scientific Officer of Advaxis. “This is the first
demonstration of clinical activity with a second Advaxis immunotherapy
(in addition to ADXS-HPV) in a naturally developing cancer. These data
serve as the foundation for validating Advaxis immunotherapy constructs
as a true platform technology, and set the groundwork for future
development of a variety of immunotherapies targeting different cancers
and infectious diseases. Improving survival in HER2 overexpressing
canine osteosarcoma provides direct and important rationale supporting
clinical studies in human HER2 overexpressing cancers. As we continue to
find the best ways to treat canine osteosarcoma with ADXS-cHER2, the
experience we gain will serve to accelerate our development of
treatments for similar human cancers.”
Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis added,
“We believe there is a significant commercial opportunity for Advaxis in
the veterinary medical market and we are discussing these data with
several veterinary health companies.”
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 secrets the cHER2 antigen, fused to
LLO, directly inside APC that are capable of driving a cellular immune
response to cHER2 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. We currently are conducting a Phase 1 study
in companion dogs evaluating the safety and efficacy of ADXS-cHER2 in
the treatment of canine osteosarcoma and plan to meet with the U.S.
Department of Agriculture, or USDA, to discuss the requirements to
proceed forward with our first immunotherapy in the veterinary market.
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 the UPENN Canine Osteosarcoma Study
Nine dogs have been vaccinated in the Phase 1 portion of the study and
seven additional dogs are due to be vaccinated within the next 2 months.
Three dogs in each dose group received 3 doses of ADXS-cHER2 at 1 x 108,
5 x 108 or 1 x 109 cfu three weeks apart. The
primary endpoint of the study is to determine the maximum tolerated dose
of ADXS-cHER2. Secondary endpoints for the study are progression-free
survival and overall survival. The study has been amended to allow for
maintenance dosing and is intended to expand to additional sites.
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 Wistar
Institute, the University
of Pennsylvania, the University
of British Columbia, the Karolinska
Institutet, and others. For more information please visit: advaxis.com
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Forward-Looking Statements
This news release contains forward-looking statements, including,
but not limited to: statements regarding expanding into Phase 2 with
additional collaborative academic centers, future development of a
variety of immunotherapies targeting different cancers and infectious
diseases, clinical studies in human HER-2 overexpressing cancers, the
acceleration of development of treatments for similar human cancers, and
that there is a significant commercial opportunity for Advaxis in the
veterinary medical market. 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