Advaxis Announces ADXS-cHER2 Demonstrates Significant Survival Advantage in Ongoing Canine Osteosarcoma Study
July 17 2013 - 8:45AM
Business Wire
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 | Facebook | twitter
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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.
Advaxis, Inc.Diana Moore, 609-452-9814Director, Investor
Relations & Business Developmentdmoore@advaxis.com
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