Ethics approval was granted on the basis of data generated from previous trials and the first arm of the Phase II trial, which involves the treatment of patients with type 2 diabetes. The Phase II trial in type 1 patients is due to commence next month and will be conducted at QPharm in Queensland, Australia.
The trial is a randomized, single-blinded trial which aims to assess the efficacy of TPM/Insulin. The results of this trial will be used to assist in obtaining an IND from the FDA. This will enable Phosphagenics to commence the next phase of its clinical development program for TPM/Insulin at the Joslin Diabetes Centre. It is anticipated that the US portion of the study will start this year.
Esra Ogru, executive vice president of R&D at Phosphagenics, said: “The Australian clinical trials conducted to date have demonstrated that our TPM/Insulin formulation can safely penetrate through human skin and deliver insulin into the blood stream over a sustained period of time without any adverse events.”