Date: 2013-11-01
Type of information:
phase: 1
Announcement: completion of the study
Company: TNO (The Netherlands) Alloksys Life Sciences (The Netherlands)
Product: hRESCAP® (recombinant human Alkaline Phosphatase)
Action mechanism:
Disease:
Therapeutic area:
Country:
Trial details:
Latest
news: * On November 1, 2013, CEVEC Pharmaceuticals, the 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 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.Development of recombinant human RESCAP was initiated by Alloksys under a European Trans Bio program together with CEVEC Pharma (Germany) and in cooperation with Ibet/GenIbet (Portugal) and AgentschapNL , and is now transferred to a sister biotech company (AMRIF B.V.) for application in chronic diseases.
