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Celldex Therapeutics Announces Initiation of Phase 1 Clinical Trial of CDX-301
Jan 17, 2012
The Phase 1 study of CDX-301 is a dose-escalating clinical trial aimed
at determining the appropriate dose for further development based on
safety, tolerability and biological activity. The trial will evaluate
seven different dosing regimens of CDX-301 and will accrue approximately
30 healthy subjects at
“This clinical trial represents the first step in the continued clinical
development of this biologically active molecule,” said
About CDX-301 (Flt3L)
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 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, vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit http://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 (by Celldex and others) of rindopepimut (CDX-110),
CDX-011, CDX-1135 (formerly TP10), CDX-1401, CDX-1127, CDX-301,
Belinostat and other products. 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 obtain additional capital
on acceptable terms, or at all, including the additional capital which
will be necessary to complete the clinical trials that we plan to
initiate in 2011; 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
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.
Source:
Celldex Therapeutics, Inc.
Anthony S. Marucci, 781-433-0771
President
and CEO
or
Avery W. Catlin, 781-433-0771
Chief Financial
Officer
IR@celldextherapeutics.com
or
BMC
Communications
Brad Miles, 212-477-9007 x17
brad@bmccommunications.com