for eMaxHealthTransdermal Insulin Clinical Trial
Phosphagenics announced the successful completion of a Phase 1b transdermal insulin trial. The positive results of the trial demonstrated the ability of the Company's TPM technology to deliver insulin into the bloodstream in a non-invasive manner without causing any adverse events. Phosphagenics' TPM-02/Insulin formulation is being developed as a novel "needle-free" way of administering insulin to patients with diabetes.
The Phase 1b clinical trial, conducted at the Royal Adelaide Hospital in South Australia by CMAX, an independent clinical research organization, assessed the efficacy and safety of two TPM/Insulin formulations in 45 volunteers. Blood glucose, endogenous insulin and C-peptide levels were measured to assess efficacy.
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 bloodstream over a sustained period of time, without causing adverse reactions."
"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, randomized trial that 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 completion of the Australian trials.
eMaxHealth welcomes yourcomments and feedback on this story without registration, but keep the comments meaningful please. Links are not accepted.
