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Celldex Therapeutics (CLDX) Begins Phase 1 Clinical Trial of CDX-301

January 17, 2012 8:01 AM EST
CLDX Hot Sheet
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Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that dosing has initiated in a Phase 1 study of its hematopoietic growth factor, CDX-301, in healthy subjects. The study is being conducted in collaboration with Rockefeller University. CDX-301 is soluble, recombinant human FMS-like tyrosine kinase 3 ligand (Flt3L) and previous experience has shown that it increases the numbers and activity of blood stem cells and immune cells. CDX-301 is a potent stem cell mobilizer and dendritic cell growth factor. While there are multiple possible indications for CDX-301, Celldex’s first priority is to develop this molecule for hematopoietic stem cell transplant, where it has demonstrated improvement of blood cell reconstitution in preclinical in vivo models.

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 Rockefeller University.


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