Phosphagenics Limited (ASX: POH; AIM: PSG; BNY/ADR: PPGNY) (“Phosphagenics”) advises that it has been awarded a A$2.1 million AusIndustry Commercial Ready grant to conduct clinical trials using its novel transdermal delivery system, TPM-02. This follows Phosphagenics’ recently announced A$3.2 million Pharmaceuticals Partnerships Program (P3) grant from AusIndustry.
There are currently no commercially-available technologies for the transdermal delivery of large molecules such as insulin. Unlike other systems that are in development for the delivery of large molecules through the skin, Phosphagenics’ TPM transdermal delivery system does not cause disruption or irritation.
Dr Esra Ogru, Executive Vice President R&D at Phosphagenics, said the successful Phase 1a study last year and the planned completion of the Phase 1b clinical trial, which commenced earlier this month, should see Phosphagenics undertake its Phase 2 trial in the second half of 2007.
“Phosphagenics’ Phase 1a study demonstrated that a single application of TPM-02/Insulin gel applied to human skin, delivered insulin across the skin and into the bloodstream. Additionally, it significantly lowered blood glucose and c-peptide levels,” Dr Ogru said.
“On May 22, CMAX commenced our Phase 1b clinical trial at the Royal Adelaide Hospital, South Australia. This trial will assess the efficacy and safety of our new and optimised formulation containing long-acting insulin. Commercially, this innovation is important as the leading insulin product sold worldwide is long-acting.
“This trial will lead into the start of a multi-phased Phase 2 trial, which is likely to include up to several hundred patients. It will also provide supporting data for an Investigational New Drug application to the U.S. Food and Drug Administration,” Dr Ogru said.
Phosphagenics’ President and CEO, Harry Rosen, said: “The confirmation of the A$2.1 million Commercial Ready grant and the recently announced A$3.2 million P3 grant from AusIndustry are healthy examples of the government’s commitment to Australia’s biotech industry.
“As a company, we’re in a strong financial position as we move towards our Phase 2 clinical trials,” he said.
