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4 Nov 2013

Completion of a 'First in Human' Clinical Phase I Study with a Therapeutic Protein Derived from CAP Cells

CEVEC Pharmaceuticals, a developer of a novel human expression system derived from amniocytes (CAP Cells), 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 BV, 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 such as Rheumatoid Arthritis in AMRIF BV, 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 immortalised suspension cells for stable protein production developed by CEVEC. This non-tumour 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 BV 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.

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