Phospagenics gets ethics nod for lead product trial

Phosphagenics (ASX:POH) has been cleared to commence clinical trials of its lead product, an oxycodone delivery patch, at the end of November.

The Victorian drug delivery company has received ethics approval to trial the chronic pain management treatment, which uses its proprietary targeted penetration matrix (TPM) delivery technology.

Phosphagenics will conduct a pharmacokinetic study of the safety and tolerability of the TPM patch at the CMAX facilities at the Royal Adelaide Hospital.

The trial will involve 65 healthy subjects. In the first stage, the subjects will be given a single dose patch, while the second stage will examine the effects of repeat dosing.

The results will influence the design of phase III trials, which are due to commence in Q3 next year, as well as the content of the IND application for the product with the US FDA.

Phosphagenics last week revealed it had raised a total of $27.1 million – through a $3 million share purchasing plan and an earlier institutional placement – to steer the TPM/oxycodone patch through clinical trials.

CEO Dr Esra Ogru said based on the results of a recent Physicians' Survey, the company projects demand for the product to exceed $1 billion per annum.

In October, the company signed an exclusive licensing deal for the Indian market for another of its TPM products, an over-the-counter TPM/diclofenac anti-inflammatory treatment. This deal will entitle the company to royalty payments as well as an upfront fee.

Phosphagenics (ASX:POH) shares fell 2.94% on Monday, and – in contrast to every trading day last week – less than 1 million shares changed hands.