Phosphagenics claims success in morphine trial

Phosphagenics (ASX:POH) -– formerly Vital Capital -– has announced the successful completion of animal studies for its transdermal delivery system for morphine.

The studies – conducted by the Victorian Department of Primary Industries at the Werribee Pig Research Centre – showed that Phosphagenics’ formulation successfully passed though pigs’ skin. As pigs are physiological similar to humans, this bodes well for coming studies of transdermal deliver in humans.

“Morphine is currently delivered orally, intravenously or intramuscularly but can produce severe side effects including nausea, constipation and dizziness,” said Phosphagenics' managing director Dr Ian Pattison. “Also, the greatest limitation in current morphine delivery technology is providing users with a steady amount of morphine over a long period of time.”

Pattison said he was unaware of any published success of other systems for delivering morphine transdermally.

Phosphagenics uses d-alpha tocopherol combined with a phosophate molecule to create an enhanced form of Vitamin E which acts as a carrier for morphine across the dermis.

Although this formulation looks to be “very, very penetrative” Pattison said the mode of action for the transdermal deliver was unclear. “[It is] yet to be explained of how it functions in the tissues," he said. “Results show that morphine was still active six hours after a single application. There were no signs of skin damage or irritation.”

Pattison said tocopherol-phosphate had also been found to have specific functions in heart health and atherosclerosis. “[German researchers have] observed that it is very effective at stopping the LDL transfer at the CD36 receptors and preventing the buildup of foam cells involved in atherosclerosis. [It also] inhibits smooth muscle formation,” he said.

Phoenix-based heathcare company Zila has licensed Phosphagenics’ tocopherol-phosphate technology for use in the neutraceutical market. It is due to launch its ‘Ester-E’ formulation aimed at the dietary supplement marketplace this year.

Phosphagenics’ vice-president of R&D, Dr Esra Ogru, said Phase I human safety trials for the morphine delivery system would be conducted in late 2004 or early 2005 depending on regulatory and ethics approvals. Meanwhile, Pattison has scheduled a pre-IND meeting with the US Food and Drug Administration later this year.

The synthetic opioid fentanyl is currently the largest selling transdermal drug, with sales of over US$1.3 billion per year. When introduced as a patch delivery system, sales of fentanyl grew 30 times within 10 years.