Phase 1b insulin clinical trial commenced
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- Published on Wednesday, 23 May 2007 04:00
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MELBOURNE, Australia | May 22, 2007 | Phosphagenics Limited (ASX: POH) (AIM: PSG) (ADR/OTC: PPGNY) announced today that it has commenced the Phase 1b clinical trial of its transdermal insulin product, TPM-02/Insulin.
The trial will assess the bioavailability and pharmacodynamics of transdermally delivered insulin in combination with TPM-02. The primary objective of this trial is to determine the pharmacodynamics of insulin after single dosing from a novel transdermal drug delivery vehicle (TPM-02) in healthy volunteers.
The trial, to be conducted by CMAX at the Royal Adelaide Hospital in South Australia, will be a double blinded, three-way pharmacodynamics study in up to 45 volunteers.
Dr Esra Ogru, Executive Vice President, Research & Development, at Phosphagenics, said: “This trial will lead to the start of a multi-phased Phase 2 trial, which is likely to include up to several hundred patients. It is planned to commence in 2H, 2007, and it will provide supporting data for an Investigational New Drug application to the U.S. Food and Drug Administration”.
“We are working diligently with our medical advisers, Assistant Professor William Hsu from the Joslin Diabetes Center, Harvard Medical School, and Professor Thomas Rades from the University Of Otago, New Zealand, to develop our optimised insulin formulation,” Dr Ogru said.
According to Harry Rosen, President and CEO of Phosphagenics, “These are exciting times for Phosphagenics as the commencement of this trial brings us one step further down the path to commercialisation.
“With millions of diabetic suffers worldwide dependant on insulin injections, our insulin gel formulation, which provides a non-invasive and effective treatment, has the potential to eventually transform the global $US7 billion insulin market,” Mr Rosen said.
SOURCE: Phosphagencis Limited