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Celldex Therapeutics Inc Announces Phase 1 Multi-Dose Study Of CDX-301


Tuesday, 11 Dec 2012 08:03am EST 

Celldex Therapeutics Inc 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. 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 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. 

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