Data Safety and Monitoring Board Recommends Celldex’s Phase 3 Study of RINTEGA® (rindopepimut) in Newly Diagnosed Glioblas...
March 09 2016 - 7:46PM
--Conference Call Scheduled for 8:00 AM ET
Today--
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the
independent Data Safety and Monitoring Board (DSMB) has determined,
based on a preplanned interim analysis, that continuation of the
Phase 3 ACT IV study of RINTEGA® (rindopepimut) in patients with
newly diagnosed EGFRvIII-positive glioblastoma will not reach
statistical significance for overall survival in patients with
minimal residual disease, the primary endpoint of the study, as
both the RINTEGA arm and the control arm are performing on par with
each other. In the ACT IV study, RINTEGA has performed consistently
with prior Phase 2 studies but the control arm has
significantly outperformed expectations (Hazard ratio = 0.99;
median OS: RINTEGA 20.4 months vs. control 21.1 months). Based on
this recommendation, Celldex is discontinuing the study and does
not anticipate incurring substantial additional costs related to
RINTEGA at this time. All patients on the RINTEGA arm of the ACT IV
study, prior Phase 2 studies and existing compassionate use
recipients will be offered ongoing access to RINTEGA on a
compassionate use basis. Celldex first received the data after
market close on Friday, March 4th and is in the process of
reviewing the results.
“We are extremely disappointed for patients that the ACT IV
study was not successful,” said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. “On
behalf of Celldex, I want to express our gratitude to the ACT IV
investigators, patients and families who participated in this
trial. While this is certainly not the desired outcome, we remain
steadfast believers in the power of immunotherapy to transform the
future of cancer treatment.”
Celldex currently has seven company-led clinical trials across
five product candidates ongoing. The Company expects to report data
from a number of these studies over the next three to 18 months,
including a registration study in triple negative breast cancer and
a number of Phase 1 and 2 cancer immunotherapy combination
trials.
Conference Call Details: Celldex executives
will host a conference call at 8:00 a.m. ET today. It will be
webcast live over the Internet and can be accessed by going to the
"Events & Presentations" page under the "Investors & Media"
section of the Celldex Therapeutics website at www.celldex.com. The
call can also be accessed by dialing (866) 743-9666 (within the
United States) or (760) 298-5103 (outside the United States). The
passcode is 66780816.
A replay of the call will be available approximately two hours
after the live call concludes through March 14, 2016. To access the
replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 66780816. The
webcast will also be archived on the Company's website.
About Celldex Therapeutics, Inc. Celldex is
developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline is
built from a proprietary portfolio of antibodies and
immunomodulators used alone and in strategic combinations to create
novel, disease-specific therapies that induce, enhance or suppress
the body's immune response. Visit www.celldex.com.
Forward Looking Statement This release contains
"forward-looking statements" made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including those related to the Company's discontinuation of the ACT
IV study of RINTEGA® (rindopepimut), future costs associated with
RINTEGA, the Company’s ability to offer RINTEGA on a compassionate
use basis; and research and development related to the Company’s
other product candidates, and our expectations that data will be
reported over the next 18 months with respect to other product
candidates. Forward-looking statements reflect management's current
knowledge, assumptions, judgment and expectations regarding future
performance or events. Although management believes that the
expectations reflected in such statements are reasonable, they give
no assurance that such expectations will prove to be correct and
you should be aware that actual results could differ materially
from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to
successfully continue or complete research and further development
of product candidates; our ability to obtain additional capital to
meet our long-term liquidity needs on acceptable terms, or at all,
including the additional capital which will be necessary to
complete the clinical trials that we have initiated or plan to
initiate; the uncertainties inherent in clinical testing and
accruing patients for clinical trials; our ability to manage and
successfully complete multiple clinical trials and the research and
development efforts for our multiple products at varying stages of
development; the availability, cost, delivery and quality of
clinical and commercial grade materials produced by our own
manufacturing facility or supplied by contract manufacturers, who
may be our sole source of supply; the timing, cost and uncertainty
of obtaining regulatory approvals; the failure of the market for
the Company's programs to continue to develop; our ability to
terminate, reduce or cancel any contractual agreement or
arrangement relating to RINTEGA; our ability to protect the
Company's intellectual property; the loss of any executive officers
or key personnel or consultants; competition; changes in the
regulatory landscape or the imposition of regulations that affect
the Company's products; and other factors listed under "Risk
Factors" in our annual report on Form 10-K and quarterly reports on
Form 10-Q.
Company Contact: Sarah Cavanaugh Vice President
of Investor Relations & Corp Communications (781) 433-3161
scavanaugh@celldex.com
Charles LilesManager of Investor Relations & Corp
Communications(781) 433-3107cliles@celldex.com
Media Inquiries:Dan Budwick Pure
Communications, Inc. (973) 271-6085
dan@purecommunicationsinc.com
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