Advaxis’ Phase 3 AIM2CERV Study Placed on Partial Clinical Hold by FDA Related to CMC Requests
January 23 2019 - 4:05PM
Business Wire
Enrolled Patients Continue to be
Treated
Advaxis, Inc. (NASDAQ:ADXS), a late-stage
biotechnology company focused on the discovery, development and
commercialization of immunotherapy products, today announced
receipt of notification from the U.S. Food and Drug Administration
(FDA) that the Company’s ongoing Phase 3, randomized,
double-blinded, placebo-controlled, pivotal study of axalimogene
filolisbac (AXAL) in high-risk, locally advanced cervical cancer
(AIM2CERV) has been placed on partial clinical hold. The FDA’s
recent communication, received late last week, states that the
partial hold is related to their requests for additional
information pertaining to certain AXAL chemistry, manufacturing and
controls (CMC) matters. The Agency did not cite any safety
issues related to the trial and all currently enrolled patients
will continue to receive treatment, per the trial protocol.
However, no new patients can enroll in AIM2CERV until resolution of
this partial hold.
“FDA’s review of the AXAL Investigational New Drug (IND)
application was prompted by our proposal to modify the AIM2CERV
trial’s analysis plan to include, among other things, allowance for
a second formal interim analysis for both safety and efficacy,”
said Kenneth A. Berlin, President and Chief Executive Officer of
Advaxis. “The primary focus of the items raised by the Agency
relates to providing additional clarifying details for CMC
information previously provided in support of Phase 3 development
and which will help support a future Biologics License Application.
We have already begun efforts to address the Agency’s requests for
information and are working to respond as promptly as we can.” He
concluded, “Our AXAL product has demonstrated a manageable safety
profile in the over 400 patients we have dosed to date and we look
forward to enrolling new patients in our AIM2CERV trial after FDA
agrees that the information we submit is responsive to its
requests.”
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/cancer antigens and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook and YouTube.
Advaxis Forward-Looking Statement
Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. The factors that could
cause our actual results to differ materially include: the success
and timing of our clinical trials, including subject accrual; our
ability to avoid any clinical holds; our ability to obtain and
maintain regulatory approval and/or reimbursement of our product
candidates for marketing; our ability to obtain the appropriate
labeling of our products under any regulatory approval; our plans
to develop and commercialize our products; the successful
development and implementation of our sales and marketing
campaigns; the size and growth of the potential markets for our
product candidates and our ability to serve those markets; our
ability to successfully compete in the potential markets for our
product candidates, if commercialized; regulatory developments in
the United States and other countries; the rate and degree of
market acceptance of any of our product candidates; new products,
product candidates or new uses for existing products or
technologies introduced or announced by our competitors and the
timing of these introductions or announcements; market conditions
in the pharmaceutical and biotechnology sectors; our available
cash; the accuracy of our estimates regarding expenses, future
revenues, capital requirements and needs for additional financing;
our ability to obtain additional funding; our ability to obtain and
maintain intellectual property protection for our product
candidates; the success and timing of our preclinical studies
including IND-enabling studies; the timing of our IND submissions,
the ability to resolve FDA’s partial clinical hold, the ability to
get FDA approval for study amendments, the timing of data
read-outs, the ability of our product candidates to successfully
perform in clinical trials; our ability to initiate, enroll, and
execute pilots and clinical trials; our ability to maintain
collaborations; ; our ability to manufacture and the performance of
third-party manufacturers; the performance of our clinical research
organizations, clinical trial sponsors and clinical trial
investigators; our ability to successfully implement our strategy;
and other risk factors identified from time to time in our reports
filed with the SEC. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190123005736/en/
Investors:LHA Investor RelationsMiriam Weber Miller,
(212) 838-3777mmiller@lhai.com
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