Archemix Announces Initiation of Phase I Clinical Trial for Novel, Selective Anti-Platelet Aptamer (ARC1779)
- Category: DNA RNA and Cells
- Published on Thursday, 04 January 2007 02:00
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CAMBRIDGE, MA, USA | Jan 03, 2007 | 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.”
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.
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. Further information on Archemix can be found at www.archemix.com.
SOURCE: Archemix Corp.