--Results presented at ASH 2012--
NEEDHAM, Mass.--(BUSINESS WIRE)--
Celldex
Therapeutics, Inc. (NASDAQ: CLDX) announced positive results from a
Phase 1 multi-dose study of CDX-301 (FMS-like tyrosine kinase-3 ligand)
demonstrating that CDX-301 was well-tolerated and can safely and
effectively mobilize hematopoietic cell populations in healthy
volunteers. The data support future development of CDX-301 in a number
of indications, including hematopoietic stem cell transplant and cancer
immunotherapy. Results were presented in a poster entitled "A Phase 1
Trial of the Hematopoietic Growth Factor CDX-301 (rhuFlt3L) in Healthy
Volunteers" on Monday, December 10, 2012 at 6:00 pm ET at the American
Society of Hematology 54th Annual Meeting and Exposition. The lead
author was Niroshana Anandasabapathy, MD, PhD, Laboratory of Cellular
Physiology and Immunology, The Rockefeller University, New York, NY.
"The data presented today confirm previous studies and support continued
development of CDX-301, both alone and in combination with other Celldex
assets across a broad range of indications," said Thomas Davis, MD,
Senior Vice President and Chief Medical Officer. "In particular, we
believe CDX-301 holds significant potential for use in hematopoietic
stem cell transplant, where it has demonstrated improvement of blood
cell reconstitution in preclinical in vivo models. Data from the
Phase 1 study will enable us to define an appropriate dosing regimen for
this indication and future indications. We intend to work with
collaborators, including academic institutions and government agencies,
to conduct future studies."
Study Results:
30 healthy volunteers were enrolled across seven cohorts. The first five
cohorts assessed escalating doses of CDX-301 (from 1 ug/kg to 75 ug/kg)
as a five-day regimen, while the final two cohorts assessed CDX-301 (at
25 ug/kg) as seven- and 10-day regimens. All volunteers completed dosing
and safety follow-up. Short-term dosing of five days resulted in
significant mobilization of dendritic and stem cells, with the highest
levels of mobilization achieved at the maximum dose. Ten-day dosing
significantly enhanced the circulation of white blood cells and
monocytes compared to the five-day regimen. Analysis on the expansion of
stem cells, dendritic cells and other cell populations are still being
conducted and will be presented at a future medical meeting. CDX-301 was
generally well-tolerated. Transient Grade 1 lymphadenopathy was observed
in five volunteers and Grade 1 diarrhea was observed in two volunteers.
One possible dose-limiting toxicity (DLT) was observed in a volunteer
with a remote history of community acquired pneumonia (CAP) who
developed CAP on study day 12. The volunteer responded rapidly to
antibiotics and fully recovered. No additional infections or DLTs were
observed in the study. No anti-CDX-301 antibodies were detected in any
volunteers through the end of study follow-up.
About CDX-301
CDX-301 or Flt3L is a potent hematopoietic cytokine that stimulates the
expansion and differentiation of hematopoietic progenitor and stem
cells. Flt3L has demonstrated a unique capacity to increase the number
of circulating dendritic cells in both laboratory and clinical studies.
In addition, Flt3L has shown impressive results in models of cancer,
infectious diseases and inflammatory/autoimmune diseases. Celldex
believes this ligand may hold significant opportunity for synergistic
development in combination with other proprietary molecules in the
Company's portfolio.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination
immunotherapy company. Celldex has a pipeline of drug candidates in
development for the treatment of cancer and other difficult-to-treat
diseases based on its antibody focused Precision Targeted Immunotherapy
(PTI) Platform. The PTI Platform is a complementary portfolio of
monoclonal antibodies, antibody-targeted vaccines and immunomodulators
used in optimal combinations to create novel disease-specific drug
candidates. For more information, please visit www.celldextherapeutics.com.
Safe Harbor Statement Under the Private Securities Litigation
Reform Act of 1995: 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 strategic focus and the future development and
commercialization of CDX-011 or any of our other drug candidates,
including rindopepimut (CDX-110), CDX-1135 (formerly TP10), CDX-1401,
CDX-1127, CDX-301, Belinostat and any future action we or the FDA (or
any other regulator) might take with respect to regulatory approvals.
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, future
actions that the FDA and other regulators might take or not take with
respect to CDX-011 or any drug candidate, the market for CDX-011 or any
other drug candidate or assay, future clinical testing which will be
necessary before FDA approval could be sought, our ability to obtain
additional capital on acceptable terms, or at all, including the
additional capital which will be necessary to complete the clinical
trials that we initiated in 2012 and plan to initiate in 2013; our
ability to adapt APC Targeting TechnologyTM to
develop new, safe and effective vaccines against oncology and infectious
disease indications; our ability to successfully complete product
research and further development of our programs; the uncertainties
inherent in clinical testing; our limited experience in bringing
programs through Phase 3 clinical trials; our ability to manage research
and development efforts for multiple products at varying stages of
development; the timing, cost and uncertainty of obtaining regulatory
approvals; the failure of the market for the Company's programs to
continue to develop; our limited cash reserves and our ability to obtain
additional capital on acceptable terms, or at all; 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 risks detailed from time to time in the
Company's filings with the Securities and Exchange Commission, including
the Company's Form 10-K for the fiscal year ended December 31, 2011,
and its Forms 10-Q and 8-K.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the
date of this release. We have no obligation, and expressly disclaim any
obligation, to update, revise or correct any of the forward-looking
statements, whether as a result of new information, future events or
otherwise.
Celldex Therapeutics, Inc.
Sarah Cavanaugh, 781-433-3161
Vice
President of IR & Corp Comm
scavanaugh@celldextherapeutics.com
or
For
Media:
BMC Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com
Source: Celldex Therapeutics, Inc.
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