Positive Phase 1b transdermal insulin clincial trial results
- Category: Proteins and Peptides
- Published on Thursday, 09 August 2007 04:00
- Hits: 2050
MELBOURNE, Australia | August 7, 2007 | Phosphagenics Limited (“Phosphagenics”) (ASX: POH, AIM: PSG, OTCQX: PPGNY) today announced the successful completion of its Phase 1b transdermal insulin trial. The positive results of this trial demonstrated that its TPM technology delivered insulin into the bloodstream in a non-invasive manner without causing adverse reactions.
The Phase 1b clinical trial, conducted at the Royal Adelaide Hospital by CMAX, an independent clinical research organisation, assessed the efficacy and safety of two improved TPM/Insulin formulations in 45 volunteers. Blood glucose, endogenous insulin and C-peptide levels were measured to assess efficacy.
The results for the lead formulation showed the blood endogenous insulin and C-peptide responses over time were highly statistically different (p <0.001) in subjects that received the improved TPM/Insulin formulation when compared to subjects that received the placebo formulation. Similarly, blood glucose concentrations were significantly lower (p = 0.016) in subjects treated with the improved TPM/Insulin formulation. The effect of the treatment lasted for up to 8 hours after application of the gel.
Similar responses to TPM/Insulin were achieved in the 2006 Phase 1a trial, but as a consequence of the research to improve the technology, the Phase 1b results showed a more sustained effect and greater statistical significance.
Dr Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said: “The Phase 1b trial showed that our TPM/Insulin formulation safely penetrated through the human skin and delivered insulin into the blood stream over a sustained period of time, without causing adverse reactions. The improved formulation demonstrated that we have made significant progress in our goal of delivering insulin through the skin in a non-invasive manner.”
“We believe that these results are indicative of Phosphagenics’ potential to provide the millions of insulin-dependent diabetics with a non-intrusive alternative to multiple needle injections each day,” said Dr Ogru.
Phosphagenics intends to continue clinical development of its transdermal insulin. Preparations are underway for a Phase 2 trial to be conducted by CMAX at the Royal Adelaide Hospital under the guidance and supervision of Associate Professor William Hsu of the Joslin Diabetes Centre (Harvard Medical School) and Dr Sepehr Shakib (Director, Department of Clinical Pharmacology Royal Adelaide Hospital).
An application for the commencement of a Phase 2 trial has been submitted for ethics approval. The trial will commence as soon as possible following ethics approval. The Phase 2 study will be a single-blinded, placebo controlled, randomised trial, which will assess the pharmacodynamics and pharmacokinetics of transdermally delivered insulin using TPM technology in diabetic patients. The trial is expected to be completed by the end of the first quarter, 2008.
Phosphagenics is also currently in the process of compiling an Investigational New Drug package that would allow the Company to continue its Phase 2 clinical trial program in the U.S. after the completion of the Australian trials.
SOURCE: Phosphagenics Limited