Advaxis Reports Encouraging Preliminary Data from Penn Phase 1 ADXS-cHER2 Canine Osteosarcoma Study
Advaxis,
Inc., (OTCBB: ADXS) (“Advaxis” or the “Company”), a leader in
developing the next generation of immunotherapies for cancer and
infectious diseases, reports encouraging preliminary data from the Phase
1 dose escalation study evaluating the safety of ADXS-cHER2 in companion
dogs with Her2/neu overexpressing canine osteosarcoma being conducted at
the University of Pennsylvania School of Veterinary Medicine.
The primary endpoint of the study is to determine the maximum tolerated
dose of ADXS-cHER2. Preliminary data from the first two dose groups (3
dogs each) show that ADXS-cHER2 at either 1 x 108 or 5 x 108
cfu is well-tolerated. 100% of dogs experienced 1 or more mild
(Grade 1) side effects consistent with cytokine release syndrome
observed at the time of administration (fever, increased blood pressure,
malaise, nausea, and/or vomiting). Early data also suggest that Her2/neu
expression in canine osteosarcoma may denote a more aggressive phenotype.
Secondary endpoints for the study are progression-free survival and
overall survival. Early results from the first two dose groups (6 dogs)
show a significant survival advantage in dogs that received ADXS-cHER2
compared to 6 dogs whose owners elected not to participate in the trial
but who were followed for survival (p=0.01).
Dr. Nicola Mason, lead investigator in the Penn canine osteosarcoma
study, plans to expand the trial to three additional sites in the United
States. ADXS-cHER2 booster vaccinations will be given to evaluate the
effects of maintenance immunotherapy.
“The preliminary data from this study are encouraging,” commented Dr.
Nicola Mason. “The dogs that have been treated with ADXS-cHER2 are doing
very well and although the numbers of vaccinated dogs are small, they do
appear to be doing better than dogs with Her2/neu overexpressing tumors
that did not receive the vaccine. I am extremely excited to expand this
trial, make the vaccine available to more dogs, and determine its
therapeutic benefit in dogs with this highly aggressive tumor type.”
“These preliminary findings suggest that the second Advaxis
immunotherapy to be evaluated in a clinical setting (in addition to
ADXS-HPV) may also improve survival in cancer. Furthermore, a veterinary
oncology indication could potentially open an entirely new market for
Advaxis Lm-LLO immunotherapies and further validates the
versatility of our technology platform and constructs,” commented Thomas
A. Moore, Chairman and Chief Executive Officer of Advaxis.
About Canine Osteosarcoma
Canine osteosarcoma, a cancer of the long (leg) bones, affects
approximately 8,000 dogs a year in the United States and is a leading
killer of large dogs over the age of 10 years. Standard treatment is
amputation immediately after diagnosis, followed by chemotherapy.
Invariably, however, the cancer metastasizes to the lungs. With
chemotherapy, dogs survive about 18 months compared to 6-12 months,
without treatment.
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
antigen/adjuvant fusion protein(s) designed to redirect the powerful
immune response all human beings have to the bacterium to the
cancer itself.
ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated
diseases: recurrent/refractory cervical cancer (India), locally advanced
cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier
NCT01266460), CIN 2/3 (US study, Clinical Trials.gov Identifier
NCT01116245), head & neck cancer (CRUK study, Clinical
Trials.gov Identifier NCT01598792), and anal cancer (BrUOG study,
Clinical Trials.gov Identifier NCT01671488). Over fifteen (15) distinct
constructs are in various stages of development, developed directly by
the Company 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 ADXS-cHER2, its clinical stage
product candidate, and immunotherapies, and their effect on cancer
(including survival rates), and statements regarding plans to expand the
canine osteosarcoma trial, statements regarding the administration of
booster vaccinations of ADXS-cHER2, and statements as to the therapeutic
benefit of the treatment, as well as potential new markets for Lm-LLO
immunotherapies. Such forward-looking statements are subject to a number
of risks and uncertainties, such as those described in the “Risk
Factors” section in Advaxis’ Annual Report on Form 10-K for the fiscal
year ended October 31, 2012, which is available at www.sec.gov,
as well as its other filings with the Securities and Exchange Commission.
Advaxis undertakes no obligation to revise these forward-looking
statements 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.