Archemix Corp. announced the
successful initial dosing with ARC1779 in its first-in-human Phase I study.
ARC1779 represents a novel therapeutic principle the reduction of
platelet aggregation and thrombosis by inhibition of von Willebrand Factor
(vWF). Previously completed experiments in human blood samples and in
animal models of disease have shown that ARC1779 binds specifically to
activated vWF and blocks the binding of vWF to blood platelets, resulting
in the inhibition of platelet-dependent clot formation at sites of arterial
vessel injury, while preserving normal platelet function and blood clotting
in the remainder of the body.
The Phase I clinical development program began with first-in-human
dosing in an initial healthy volunteer study on December 18, 2006, and is
expected to continue into 2Q07. The Phase I program consists of two
studies:
ARC1779-06-001 will investigate the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of single intravenous
bolus and bolus plus infusion administration of ARC1779 in healthy
volunteer subjects.
ARC1779-06-002 will study the potential PK and PD interactions of
intravenous bolus ARC1779 with two standard anti-thrombotic drug
therapies — orally administered aspirin and clopidogrel — in healthy
volunteer subjects.
Planning is now underway to enable the start of Phase II in both
cardiology- and hematology-related indications in 4Q07. The Phase II
program will be based upon both the forthcoming results of the Phase I
program as well as the results of ongoing laboratory studies of the effect
on thrombosis and platelet function when ARC1779 is added to blood samples
drawn from those patient populations.
“The clinical data derived from the Phase I program will not only
characterize the safety and pharmacokinetics of ARC1779, but will also
validate in man the anti-thrombotic activity of ARC1779 previously observed
in pre-clinical models,” stated Dr. James Gilbert, Chief Medical Officer at
Archemix. “The goal of ARC1779 development is to improve upon the present
standard of care for patients with life-threatening thrombosis, thereby
addressing an important unmet medical need. We believe that vWF inhibition
will offer a superior risk/benefit ratio in terms of the balance between
anti- thrombotic efficacy and treatment-related bleeding complications than
is possible with currently available treatments.”
About Aptamers
Aptamers are single-stranded nucleic acids that form well-defined three
dimensional shapes, allowing them to bind target molecules in a manner that
is conceptually similar to antibodies. Aptamers combine the optimal
characteristics of small molecules and antibodies, including high
specificity and affinity, chemical stability, low immunogenicity and the
ability to target protein-protein interactions. In contrast to monoclonal
antibodies, aptamers are chemically synthesized rather than biologically
expressed, offering a significant cost advantage.
About Archemix Corp.
Archemix Corp. is a privately-held biopharmaceutical company based in
Cambridge, Massachusetts. The company’s mission is to develop aptamers as a
class of directed therapeutics for the prevention and treatment of human
disease. Because of their unique properties and proven efficacy, aptamers
offer an alternative to biologics and small molecules in numerous
applications and offer the potential to be a major class of drugs for the
treatment of unmet medical needs.
Archemix’s aptamer expertise is complemented by a robust patent estate
comprised of over 220 issued and 230 pending patents covering the
identification, composition, and use of therapeutic aptamers. In addition
to the company’s core aptamer generation technology, Archemix possesses
strong expertise in both pre-clinical and clinical drug development.
Archemix Corp.
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