Advaxis’ Immunotherapy in Combination with Chemoradiation Highlighted as Potential Treatment for Anal Cancer in Internation...
January 25 2018 - 8:00AM
Business Wire
All patients who completed treatment had
complete clinical response
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, today announces that data from the
investigator-initiated study evaluating the Company’s
proprietary Lm-based antigen delivery product, axalimogene
filolisbac (ADXS11-001), in combination with chemoradiation as a
treatment for high-risk, locally advanced anal cancer were
published in the International Journal of Radiation Oncology in an
article titled, “Tolerability of ADXS11-001 Lm-LLO Listeria Based
Immunotherapy With Mitomycin, Fluorouracil and Radiation for Anal
Cancer.”1 The abstract is available on-line here.
The Phase 1 study, led by Dr. Howard Safran at Brown University,
evaluated the safety and preliminary efficacy of the combination of
ADXS11-001 with mitomycin, FU and intensity modulated radiation
therapy in 10 patients with locally advanced, non-metastatic
squamous cell anal cancer. Results showed that 9 patients achieved
a complete response, and 8 patients (89%) remained disease free at
a median follow-up of 42 months. One patient progressed,
approximately 6 months post completion of study treatment and
subsequently died from progressive disease, and one patient expired
early in the study unrelated to study treatment.
Treatment-related adverse events were consistent with the
observed safety profile of ADXS11-001, and consisted of mostly
grade 1-2 cytokine-release related events such as chills, headache
and fever. Two patients experienced grade 3 treatment-related
toxicities. There were no grade 4 events and ADXS11-001 did not
cause any additive chemoradiation related toxicities. All adverse
events occurred within 24 hours of treatment and resolved with
standard care.
These data show that ADXS11-001 can be safely administered with
standard chemoradiation for patients with locally advanced,
non-metastatic anal cancer.
“We are delighted to have these promising data highlighted in
this prestigious, peer-reviewed journal. The complete clinical
response demonstrated in patients who completed the combination
treatment is very encouraging, particularly as there are limited
treatment options or therapies under development for patients
suffering with anal cancer,” said Anthony Lombardo, interim Chief
Executive Officer of Advaxis. “We look forward to advancing this
promising therapy for anal cancer through investigator-led
studies.”
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on
the discovery, development and commercialization of
proprietary Lm-based antigen delivery products. These
immunotherapies are based on a platform technology that utilizes
live attenuated Listeria monocytogenes (Lm) bioengineered to
secrete antigen/adjuvant fusion proteins. These Lm-based
strains are believed to be a significant advancement in
immunotherapy as they integrate multiple functions into a single
immunotherapy and are designed to access and direct antigen
presenting cells to stimulate anti-tumor T-cell immunity, activate
the immune system with the equivalent of multiple adjuvants, and
simultaneously reduce tumor protection in the tumor
microenvironment to enable the T-cells to eliminate tumors. Advaxis
has four franchises in various stages of clinical and preclinical
development: HPV-associated cancers, neoantigen therapy, hotspot
mutation therapy and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook, and YouTube.
Advaxis Forward-Looking Statement
This press release contains forward-looking statements,
including, but not limited to, statements regarding Advaxis’
ability to develop and commercialize the next generation of cancer
immunotherapies, and the safety and efficacy of Advaxis’
proprietary immunotherapies. 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, 2017, which is available at www.sec.gov.
Any forward-looking statements set forth in this presentation
speak only as of the date of this presentation. We do not intend to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof other than as
required by law. You are cautioned not to place undue reliance on
any forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20180125005406/en/
Company:Advaxis, Inc.Noelle Heber, 609-250-7575Sr.
Director Corporate Communications and Government
AffairsHeber@advaxis.comorMedia:Stern Strategy GroupBrian
Hyland, 908-325-3891Bhyland@sternstrategy.comorRachel Auerbach,
908-325-3898Rauerbach@sternstrategy.comorInvestors:LHA
Investor RelationsAnne Marie Fields,
212-838-3777afields@lhai.com
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