Classification and commercialisation

One of the issues phage therapy will face in the future is its categorisation for human health purposes. There are already phage therapy products on the market, but they are for plant health and to treat foodstuffs such as meat and cheese.

Those products were approved by the US FDA as Generally Regarded as Safe (GRAS), and this designation is expected for any future phage therapy product for humans.

“When it comes to treating patients, they aren’t a pharmaceutical so there is a lot of discussion around the world as to where they actually sit,” Smithyman says. “It may be that they will end up in their own category.

“They are extremely safe with no side-effects and no toxins, so there is no real need to go through animal studies, but the jury is still out on how they will be classified. It will probably be as a biological, not a chemical, but they might have to have their own category.”

Special Phage Holdings is one of a number of companies planning clinical trials for phages. The therapy has been used in parts of Europe, particularly in the world’s centre of excellence for phage therapy, Georgia, for most of the 20th century.

Smithyman says there are several American and UK companies in the Phase II trial stage, and there are university and clinical groups in France, Germany, the UK and Poland who are treating patients.

This is why both the successfully treated patient and the BioFirst Commercialisation award have come at exactly the right time for SPH. Smithyman says his company is at the stage of developing cocktails of phages for prototype products and was planning for the trial stage when the patient at Westmead came up.

SPH has strong research links with both Westmead and Royal North Shore Hospital, and has many international collaborators, and is planning a number of trials.

“We are planning trials now and working on the protocols,” he says. “We have three trials planned – one in Australia, again through Westmead and Royal North Shore; one overseas; and one a veterinary trial, also here in Australia.”

The company is also undertaking a second round of fundraising, approaching the group of original shareholders who provided the initial seed money, as well as sophisticated private investors and select corporate investors. The NSW Government award has come as a nice bit of publicity at exactly the right time, Smithyman says.

“We are going to be able to use the award to travel, there is some legal and patent advice and some accounting advice, as well as PR, so we’ll use them all very judiciously. It has come at exactly the right time.”