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Wellcome Trust Award-Winning Company Phico Therapeutics Announces Success of Safety and Tolerability Trial

CAMBRIDGE UK, 9 June 2010 – Phico Therapeutics today announces the successful completion of a phase I trial showing that their new antibiotic, SASPject PT1.2 is safe and well tolerated in healthy human volunteers. Plans for a phase II trial to assess efficacy are already underway.

PT1.2 has been developed initially to treat nasal infections of the bacteria Staphylococcus aureus, including the superbug MRSA. It is the first in a new class of antibacterial therapy forming Phico Therapeutics’ antibiotic platform technology called SASPjectTM, which is specifically designed to combat the problem of drug resistance.

“The completely new SASPject technology has the capability to revolutionise antibiotic therapy and human trials are a crucial milestone in product development” explains Dr Heather Fairhead CEO, Phico Therapeutics.

“Successful completion of this trial means that we have met the first milestone laid down by the Wellcome Trust as part of Phico’s Strategic Translation Award, and triggers drawdown of our second tranche of funds to cover the phase II trial.”

The trial, involving 46 healthy volunteers, showed that PT1.2 was well tolerated at two different doses, with no reported safety issues.

SASPject is a novel antibiotic therapy that can be targeted to any bacteria including multi-drug resistant bugs. The active agent is an antibiotic protein called SASP which is coupled to delivery vectors that can be narrow spectrum to target selected individual bacterial species, or broad spectrum to target multiple species or genera of bacteria.

SASP works by binding to bacterial DNA and inactivating it. It switches off all primary functions in the bacterial cell and stops it from reproducing, thereby halting the spread of infection. Crucially, SASP can bind anywhere on the DNA so the development of resistance by bacteria is considered unlikely.

Each SASPject delivery vehicle is a virus that specifically infects bacteria, known as bacteriophage, which is modified to carry a gene encoding SASP. PT1.2 is designed to target Staphylococcus aureus, a common cause of infections ranging from the trivial to the life-threatening, and the forerunner of the superbug MRSA.

The Wellcome Trust has granted Phico a Strategic Translation Award of £1.03M that will fund SASPject PT1.2 through phase I and II clinical trials.

Richard Seabrook, Head of Business Development at the Wellcome Trust said: “Completion of Phico’s first human trial shows that SASPject is safe for the next step of finding out whether it will work in patients. The results from this trial will be pivotal. New antibiotics are urgently needed to combat the growing problem of antibiotic resistance and if SASPject works, it could open up the field to develop similar products for many other bacteria.”

The initial target indication for registration is the eradication of nasal carriage of S. aureus, including MRSA in adult patients and healthcare workers, as part of a comprehensive control programme to reduce the risk of infection among high risk patients during institutional outbreaks.

 

Website: www.phicotherapeutics.co.uk