Advaxis Announces Publication of Phase 2 Results Evaluating Axalimogene Filolisbac for the Treatment of Recurrent Metastatic ...
February 12 2018 - 9:15AM
Business Wire
Peer-reviewed published article shows treatment
with axalimogene filolisbac resulted in an overall 12-month
survival rate of approximately 35%
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, announces that data from an earlier
Phase 2 clinical study of axalimogene filolisbac (ADXS11-001) as a
treatment for persistent or recurrent metastatic (squamous or
non-squamous cell) carcinoma of the cervix (PRmCC) was accepted for
publication in the May edition of peer-reviewed International
Journal of Gynecological Cancer. The article is titled, “A
Randomized Phase 2 Study of ADXS11-001 Listeria
monocytogenes-Listeriolysin O Immunotherapy With or Without
Cisplatin in Treatment of Advanced Cervical Cancer.”
This multicenter, randomized Phase 2 study conducted in India
compared axalimogene filolisbac as a monotherapy with axalimogene
filolisbac in combination with chemotherapy (cisplatin) in 110
patients with PRmCC. The primary endpoint was overall survival
(OS), and patients were followed every three months for up to 18
months for tumor response and survival status.
The 12-month OS rate was approximately 35% (n = 38/109). Median
OS was 8.28 months in the axalimogene filolisbac monotherapy arm
and 8.78 months in the combination arm (p=non-significant).
Overall, approximately 25% of patients (n = 27/109) reached the
18-month survival milestone. There were 3 confirmed complete
responses (RECIST 1.1) and 1 confirmed partial response.
The most commonly reported treatment related adverse events were
mild-to-moderate and related to cytokine release symptoms (chills,
fever, vomiting and nausea), consistent with the observed safety
profile in later clinical studies.
“These compelling results led to the conduct of the Phase 2
GOG-0265 study, where the 12-month OS rate with axalimogene
filolisbac was subsequently replicated in a more heavily-pretreated
PRmCC population in the U.S. In addition, these data are supportive
of our upcoming planned submission of a conditional Marketing
Authorization Application with the European Medicines Agency for
axalimogene filolisbac for the treatment for metastatic cervical
cancer, and give us added confidence in our immunotherapy as a
treatment for these patients with limited treatment options,”
stated Anthony Lombardo, interim Chief Executive Officer of
Advaxis.
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria monocytogenes
(Lm)-based immunotherapy that attacks HPV-associated cancers by
altering a live strain of Lm bacteria to generate
cancer-fighting T cells against cancer antigens while neutralizing
the tumor’s natural protections that guard the tumor
microenvironment from immunologic attack. In a Phase 2 trial
evaluating axalimogene filolisbac for the treatment of PRmCC, the
product candidate showed a 12-month overall survival rate of 38%
observed in 50 patients in the trial. This is a 55% improvement
over an expected, model-predicted, 12-month survival rate of
24.5%.
Axalimogene filolisbac has achieved multiple regulatory
milestones, including classification as an EMA advanced
therapy-medicinal product for the treatment of cervical cancer,
receipt of the U.S. Food and Drug Administration (FDA) Fast Track
Designation as an adjuvant therapy for treating high-risk, locally
advanced cervical cancer (HRLACC), receipt of a Special Protocol
Assessment agreement with the FDA for the Phase 3 AIM2CERV trial,
and orphan drug designations in three HPV-associated indications
(PRmCC, head and neck, and anal cancer).
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 near-clinical
development: HPV-associated cancers, individualized neoantigen
immunotherapy, cancer-specific hotspot mutation immunotherapies and
prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook, and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements regarding Advaxis’
ability to develop and commercialize 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 press release
speak only as of the date of this press release. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180212005740/en/
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
Ayala Pharmaceuticals (QX) (USOTC:ADXS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ayala Pharmaceuticals (QX) (USOTC:ADXS)
Historical Stock Chart
From Apr 2023 to Apr 2024