Jul 27 2011
Ceridia Pty Ltd., a biotechnology company focused on reformulating and developing therapeutic drugs, announce the successful completion of Phase 1 Proof-of-Concept study of its novel LipoCeramic ibuprofen formulation, CER006. CER006 was designed to be a model formulation to establish safety and tolerability of Ceridia's LipoCeramic reformulation technology but also to attain pharmacokinetic information in humans.
Trial demonstrates that the technology is safe and well tolerated. Study also suggests fast and improved delivery of ibuprofen when comparing with branded market leader.
Based on the safety and pharmacokinetics data from this 4-arm blinded study, Ceridia plans to commence a number of bio-equivalence and bioavailability trials which will include anti-inflammatory, anti-infective and oncology drugs.
"We are very pleased to demonstrate that Ceridia's LipoCeramic platform technology is safe and well tolerated in humans. It is a clinical validation of more than 10 years of research and development," said Dr Gregor Rozenberg, Ph.D., CEO, Ceridia. "We are now poised to initiate a number of Phase 2 studies with the aim of reformulating and improving the clinical profiles of several therapeutic drugs. Commercialisation can now be accelerated."
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