Completion of a “First in Human” Clinical Phase I Study Using CAP® Cells
News Nov 05, 2013
CEVEC Pharmaceuticals (“CEVEC”) has announced that a Dutch consortium led by TNO reported the safe completion of a clinical Phase I study with recombinant human Alkaline Phosphatase (hRESCAP®) derived from CEVEC’s CAP® cells.
The consortium consisting of TNO and Alloksys Life Sciences B.V., among others, performed a dose escalating investigative Phase I study to determine the safety and pharmacokinetics of parenterally delivered hRESCAP® in healthy volunteers.
Paving the path to ultimately treat chronic inflammatory diseases like Rheumatoid Arthritis in AMRIF B.V., a recently founded sister company to Alloksys Life Sciences, the study represents a major milestone for CEVEC since it establishes the CAP® cell line as a regulatory-proven expression host for the broader production of therapeutic proteins, antibodies and vaccines.
CAP® cells are immortalized suspension cells for stable protein production developed by CEVEC. This non-tumor origin cell line exhibits high protein expression, has been adapted to serum-free suspension culture and shows post-translational modifications that are human-like, including authentic human glycosylation patterns.
The Technology allows for superior yields of complex (glyco) proteins in a shorter time frame than traditional methods.
“We’re proud that our long-standing collaboration with Alloksys Life Sciences B.V. to produce recombinant human alkaline phosphatase at high yields and consistent quality in CAP® has succeeded to enter the clinic. The safe and very promising outcome of this study underlines the potential of our human CAP® cells to become a standard expression host for therapeutic and clinically relevant proteins. TNO obtained regulatory approval to conduct a single ascending dose study with hRESCAP® produced with CEVECs expression system. This will certainly facilitate the regulatory acceptance and pave the way for clinical development of all other CAP® -derived therapeutics that are currently at preclinical stage or entering clinical development” stated Wolfgang Kintzel, CEO at CEVEC.