Completion of a “First in Human” clinical Phase I study using CAP Cells
Cologne, Germany, November 1st, 2013
CEVEC Pharmaceuticals, the developer of a novel human expression system derived from amniocytes (CAP Cells), announced today 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.
About CEVEC Pharmaceuticals GmbH - www.cevec.com-
CEVEC Pharmaceuticals GmbH, operational since 2004 and located in Cologne, Germany, is a biopharmaceutical company that specializes in developing and producing therapeutic proteins, vaccines and monoclonal antibodies with human glycosylation patterns. CEVEC's novel proprietary and patent-protected human CAP and CAP-T Expression systems are ideal for manufacturing complex biopharmaceutical molecules and various vaccines. CEVEC is licensing out its human cell-based expression platform as well as its own biobetter candidates through partnerships with renowned pharmaceutical and biotech companies.
About Alloksys Life Sciences B.V. - www.alloksys.com-
Alloksys Life Sciences (www.alloksys.com) is a bio-pharmaceutical company, focusing to the development of RESCAP for the short term and long-term prevention and treatment of ischemia- and hypoxia mediated (inflammatory) injury and its complications, such as occurring peri-and post surgically. Currently bovine derived RESCAP has progressed to clinical phase 3a in patients undergoing invasive cardiac valve surgery. 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.
About AMRIF B.V. - www.alloksys.com-
AMRIF was founded in June 2013 and is a bio-pharmaceutical company, focusing its R&D programs on the development of the RESCAP platform technology on innovative targets and therapies towards the treatment of patients debilitating chronic diseases. According to AMRIF this phase I study is a first step towards programs that gain access to the development of RESCAP as compound fulfilling unmet medical needs.
About TNO -www.tno.nl-
The 3800 TNO professionals put their knowledge and experience to work in creating smart solutions to complex issues. These innovations help to sustainably strengthen industrial competitiveness and social wellbeing. We are partnered by some 3000 companies and organisations, including SMEs, in the Netherlands and around the world.
Wolfgang Kintzel, CEO
CEVEC Pharmaceuticals GmbH
Gottfried-Hagen Straße 62
D-51105 Köln, Germany
phone +49 (0) 221-46 02 08 – 00
fax +49 (0) 221-46 02 08 – 01