Phase II Cervical Cancer Study with Advaxis’ Axalimogene Filolisbac Selected for Poster Discussion Session at the 2016 ASCO...
April 28 2016 - 11:46AM
Poster Discussion Sessions highlight the
most clinically applicable and novel posters
Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology
company developing cancer immunotherapies, today announced that the
Company’s immunotherapy agent will be featured in a poster
presentation and discussion at the American Society of Clinical
Oncology’s (ASCO) Annual Meeting. The poster, “ADXS11-001
immunotherapy in squamous or non-squamous persistent/recurrent
metastatic cervical cancer: Results from stage I of the phase II
GOG/NRG0265 study” (Abstract #5516), was selected as one of 12
abstracts to be featured in the ASCO oral poster discussion session
on gynecologic cancer, where expert discussants highlight the most
clinically applicable and novel posters. The Phase 2 study of
lead Lm immunotherapy candidate in HPV-associated cervical cancer,
axalimogene filolisbac (AXAL), will focus on how the findings apply
to clinical practice and future research.
The poster session will highlight the
GOG/NRG-0265 study, a two-stage phase 2 study led by Warner K. Huh,
M.D., Professor and Division Director of Gynecologic Oncology and
Senior Scientist at the University of Alabama at Birmingham,
evaluating the potential of AXAL as an immunotherapy for patients
with pretreated metastatic cervical cancer. The poster will include
efficacy and safety results from the completed Stage 1 of the study
and preliminary data from Stage 2. The study is being performed in
a collaboration between Advaxis and the GOG Foundation, Inc.
(GOG), now a member of NRG Oncology.
This year’s ASCO annual meeting will focus on
“Collective Wisdom: The Future of Patient-Centered Care,” and will
take place in Chicago, Illinois June 3-7, 2016 at McCormick Place.
The poster will be presented at the Gynecologic Poster Session on
June 6, 2016 at 1:00 PM CT, and the poster discussion will be from
4:45 – 6:00 PM CT. Please visit www.asco.org for additional
information.
About Cervical Cancer
Cervical cancer is the fourth most common cancer
in women worldwide. In the United States, nearly 13,000 new cases
are diagnosed, and approximately 4,100 deaths are reported because
of cervical cancer. According to the WHO/ICO Information Centre on
HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are
estimated to harbor high-risk cervical HPV infection at a given
time, and 71.7 percent of invasive cervical cancers are attributed
to high-risk HPV strains.
About Axalimogene
Filolisbac
Axalimogene filolisbac (AXAL) is Advaxis' lead
Lm Technology™ immunotherapy candidate for the treatment of
HPV-associated cancers and is in clinical trials for three
potential indications: invasive cervical cancer, head and neck
cancer, and anal cancer. In a completed randomized Phase 2 study in
recurrent/refractory cervical cancer, AXAL showed apparent
prolonged survival, objective tumor responses, and a manageable
safety profile alone or in combination with chemotherapy,
supporting further development of the Company’s Lm Technology™.
AXAL has Orphan Drug Designation in the U.S. for the treatment of
anal cancer.
About The GOG Foundation,
Inc.
The GOG Foundation, Inc. (GOG), now part of NRG
Oncology, is a non-profit international organization with the
purpose of promoting excellence in the quality and integrity of
clinical and basic scientific research in the field of gynecologic
malignancies. The GOG is committed to maintaining the highest
standards in clinical trials development, execution, analysis and
distribution of results. Continuous evaluation of its processes is
utilized in order to constantly improve the quality of patient
care. The GOG conducts clinical trials for patients with a variety
of gynecologic malignancies, including cancers that arise from the
ovaries, uterus, cervix, vagina and vulva. General information on
many of these trials for medical professionals and the lay public
can be obtained from ClinicalTrials.gov.
NRG Oncology is one of four adult cooperative
groups funded under the newly structured NCI National Clinical
Trials Network. NRG Oncology is comprised of three legacy
cooperative groups, the National Surgical Adjuvant Breast and Bowel
Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and
the Gynecologic Oncology Group (GOG).
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a
clinical-stage biotechnology company developing multiple cancer
immunotherapies based on its proprietary Lm Technology™. The Lm
Technology™, using bioengineered live attenuated Listeria
monocytogenes (Lm) bacteria, is the only known cancer immunotherapy
agent shown in preclinical studies to both generate cancer-
fighting T cells directed against cancer antigens and neutralize
Tregs and myeloid-derived suppressor cells (MDSCs) that protect the
tumor microenvironment from immunologic attack and contribute to
tumor growth. Advaxis' lead Lm Technology™ immunotherapy,
axalimogene filolisbac (AXAL), targets human papillomavirus
(HPV)-associated cancers and is in clinical trials for three
potential indications: Phase 2 in invasive cervical cancer, Phase
1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S.
Food and Drug Administration (FDA) has granted AXAL orphan drug
designation for each of these three clinical settings. Advaxis has
two additional immunotherapy products in human clinical
development: ADXS-PSA in prostate cancer and ADXS-HER2 in
HER2-expressing solid tumors.
For additional information on Advaxis, visit
www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube
and Google+.
Advaxis Forward-Looking
Statement
This media statement contains forward-looking
statements, including, but not limited to: statements regarding
Advaxis’ ability to develop 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, 2015, 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.
CONTACTS:
Company:Advaxis, Inc.Greg
Mayes, Executive Vice President and
COOmayes@advaxis.com609.250.7515
Media Contact:JPA Health
CommunicationsSally BainSally@jpa.com617.417.3554
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