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Posted: Jul 26, 2011
Australian Biotech Ceridia Pty Ltd Completes Successful Human Clinical Trial
(Nanowerk News) 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."
Ceridia Pty Ltd is supported by ITEK, the intellectual property commercialisation arm of UniSA and has entered into collaborations with Pharma and Biotech using its innovative reformulation technology to improve existing and novel drugs. The company is seeking additional investment and partnerships.
Reformulating approved drugs enables reprofiling or repurposing of therapeutic agents. This in turn provides new commercial opportunities in an abbreviated regulatory environment. This reduces development times significantly and produces better drugs quicker and cheaper.
Ceridia is a privately owned spin-out company of the University of South Australia. Ceridia is commercializing a novel method of reformulating oil-soluble compounds. A silica-lipid nano-encapsulation platform technology has been developed and protected by patents worldwide. This technology enables the pharmaceutical and biotechnology industry to improve efficacy, bio-availability and stability of drugs and help reduce their time to market. The technology is clinically proven to be completely safe, uses no synthetic, toxic or corrosive solvents. The manufacturing process is straightforward and can be quickly transferred into most API manufacturing sites and requires no additional capital expenditure. Human clinical trials indicate improved clinical profile and quicker drug uptake.