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Wellcome Trust Award-Winning Company Phico Therapeutics Releases New SASPject PT1.2 Efficacy Data at ICCAC

9/15/2009 1:45:05 PM

SAN FRANCISCO, USA 15 Sept, 2009 – Phico Therapeutics has reached an important next stage of development with its novel antibiotic SASPject PT1.2 entering its Phase I clinical trial. Pre-clinical data presented at ICCAC show that SASPject PT1.2 is rapidly effective against methicillin-resistant Staphylococcus aureus, (MRSA) also known as “superbugs”.[1]

SASP, the active ingredient of SASPject PT1.2 showed a rapid bacterial killing action against S. aureus (MRSA) causing a 5-log drop in viable cells within one hour for the PT1.2 treated 10^7 cfu/ml cultures, despite the different growth conditions tested and the presence of mucin (a glycoprotein that is a part of mammalian mucus).[2]

PT1.2 is first in the new class of antibiotics forming Phico Therapeutics’ novel antibiotic platform technology called SASPjectTM.

Antibacterial proteins, SASP, comprise the active ingredient of SASPject act by binding to bacterial DNA and haltreplication and gene expression, resulting in rapid bacterial cell death.Crucially, SASP binds to the bacterial DNA in a non-sequence-specific manner and so does not allow the bacteria to evolve 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.

Phico Therapeutics’ PT1.2 001 trial is a Phase I, randomised, double-blind, placebo controlled, sequential single to multiple dose escalation study, with a planned enrolment of 46 subjects. The study aim is to assess the safety and tolerability of 2 different doses of PT1.2 in healthy subjects.

The primary objective of development of PT1.2 is to demonstrate that SASPject PT1.2 is effective for elimination of nasal carriage of S. aureus, including MRSA. The initial target indication for registration is the eradication of nasal colonisation of methicillin-resistant S. aureus (MRSA) in adult patients and healthcare workers as a part of a comprehensive infection control programme to reduce the risk of infection among patients at high risk of methicillin-resistant S. aureus during institutional outbreaks.

SASPject technology explained

SASPject is a novel antibiotic therapy that can be targeted to any bacteria including multi-drug resistant bugs. The first SASPject, PT1.2 has been developed initially for nasal decolonisation of S. aureus including MRSA. SASPject has two components, the first is antibiotic protein SASP which inactivates bacterial DNA, and the second is a target specific delivery vector.

In SASPject, the gene for the antibiotic protein SASP is delivered through the target bacterial cell wall by a bacteriophage (a virus that attacks only bacteria). SASP is produced inside the targeted bacterium where it binds to and inactivates the bacterial chromosome and plasmid DNA. In this way SASP prevents toxin production and cell reproduction thus halting the spread of the infection, and also stops bacterial metabolism, which kills the targeted bacteria. Crucially, SASP binds to the bacterial DNA in a non-sequence-specific manner and so does not allow the bacteria to evolve resistance.

SASPject is effective against S. aureus, a Gram positive bacterium and E. coli, a Gram negative bacterium. These findings mean that SASPject has the potential to be effective against all species of drug resistant bacteria.

About Phico Therapeutics

Founded in 2000 Phico Therapeutics has attracted over £6.5m in funding from multiple sources, including the Wellcome Trust.

With seed funding from Cambridge Research and Innovation Ltd. (CRIL), Phico Therapeutics succeeded in securing four subsequent rounds of funding from both government and private sources. In 2001 and 2002, Phico won DTI grants worth £45,000 and £105,000. Building on the success of the anti-MRSA SASPject system funded by these grants, the DTI granted a further £200,000 to adapt SASPject to fight the bacterium Clostridium difficile. In early 2009, Phico raised a further £1M from a group of Venture Capital and Business Angel funders including Emblem Technology Partners, Providence Investment Company, Parallel Ventures, Cambridge Capital Group, OION, Angels for Growth and London Business Angels.

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. SASPject PT1.2 has been shown in pre-clinical trials to eradicate S. aureus including drug resistant strains. (MRSA)

Phico’s offices and laboratory are located at the Babraham Research Campus in Cambridge, UK, in the Cambridge Cluster biotech hub. The company employs a staff of twelve, including ten post doctoral R&D scientists.

About MRSA

Methicillin resistant Staphylococcus aureus (MRSA), or "Staph" is a bacterium that has evolved resistance to commonly prescribed antibiotics. MRSA infections can cause life threatening blood poisoning, pneumonia and surgical site infections. MRSA is prevalent in nosocomial (hospital acquired) infections and it could be said that the pathogen’s incidence now constitutes a permanent “institutional outbreak” in many hospitals. Between 2004 and 2008, MRSA caused three per 1,000 deaths in England and Wales[3]. In the US, “healthcare-associated infections account for an estimated 1.7 million infections and 99,000 associated deaths each year.”[4] MSRA infections kill more people in the US than prostate and breast cancer combined.

In 2009 it is estimated that prostate and breast cancer will take the lives of 68,000 people.[5]

It is estimated that one third of people are colonized with S. aureus[6] but most are asymptomatic. An infection may break out when the body’s immune system is compromised by an illness or injury. S. aureus, including MRSA commonly colonise the nostrils and the microbes are transmitted from person to person through skin contact but the bacteria can survive on surfaces and textiles. It is therefore believed that a product shown to be effective in nasal decolonisation, with less risk of development of resistance is urgently required.

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