Phosphagenics gets OK for Ph I TPM-02/insulin study

Melbourne, Australia-based Phosphagenics says that it received Ethics Committee approval for a Phase I clinical trial of its transdermal insulin delivery product, TPM-02/Insulin. This is being developed as a novel way of administering insulin to diabetics, and this trial - which is planned to commence this month - follows on from the successful preclinical studies that were reported to the market in May, the firm added.

In the proposed study, 20 healthy male volunteers will be randomly assigned to receive either TPM-02/Insulin or a placebo, applied in a single dose directly to the skin. The primary objective of this study is to assess the safety and tolerability of this unique delivery platform. Blood glucose and insulin levels will also be measured.

Esra Ogru, executive director of R&D at Phosphagenics, said: "Ethics Committee approval of a Phase I clinical trial of insulin formulated with our proprietary transdermal carrier is an important milestone in the development of our topical insulin product. The Phase I trial will also provide clinical evidence of the effectiveness of Phosphagenics' technology in delivering larger peptide or protein drugs through the skin."