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May 26, 2011
Successful Proof of Concept for topical antimicrobial drug Lytixar™ (LTX-109): Completion of two Phase I/IIa clinical studies.

The Norwegian pharmaceutical company Lytix Biopharma today announces the successful completion of two Phase I/IIa studies with the topical antimicrobial drug Lytixar™ (LTX-109) – one for nasal decolonisation of MRSA / MSSA (methicillin-resistant and methicillin-sensitive Staphylococcus aureus) bacteria and one for treatment of Gram+ skin infections.

According to Lytix Biopharma CEO Gunnar Sælid, “We are delighted to announce the successful completion of two clinical studies for our novel antimicrobial drug Lytixar™ (LTX-109). The spread of antibiotic-resistant bacteria such as MRSA in hospitals and the community remains a serious health threat. For the Company this is a Milestone study, providing definitive Proof of Concept for the powerful bacteriological effect of the novel, broad-spectrum, antimicrobial drug Lytixar™. We are confident that our results will interest the medical community and we will actively pursue possible industrial partnerships for further drug development.”

Preclinical models have demonstrated that Lytixar™ is bactericidal, being equally effective against wild-type as well as drug-resistant bacteria such as MRSA. Because of its unique membrane-lysing mechanism of action, there is no cross-resistance to other drugs. It has also proven highly unlikely for bacteria to develop new resistance to the drug.

”The current studies clearly show that topical application of Lytixar™ (LTX-109) to the anterior nares or on infected skin is tolerated and safe. From both of these application areas, there is a negligible systemic uptake. In the nasal decolonisation study Lytixar™ (LTX-109) clearly demonstrates Proof of Concept in decolonisation of bacteria. This drug has the potential to become a valuable new antimicrobial agent”, concludes Dr. Wenche Marie Olsen, COO and Director of Product Development, Infectious diseases at Lytix Biopharma.

Corporate Inquiries:

Gunnar Sælid, CEO
Tel +47 911 92 330
Anders Fugelli, Head of Business Development
Tel +47 924 81 432

Media Inquiries:

Richard Hayhurst, Schwartz Communications
Tel +44 (0) 7711 821527, email: Richard(at)schwartz-pr.com


In Norwegian:
Det norske legemiddelselskapet Lytix Biopharma kunngjør i dag at Selskapet har gjennomført to klinisk Fase I/IIa studier med det topiske, antimikrobielle produktet Lytixar™ (LTX-109) - én for nasal dekolonisering av gule stafylokokker (antibiotikaresistente gule stafylokokker; MRSA – og antibiotikasensitive gule stafylokokker; MSSA), og én for behandling av Gram-positive hudinfeksjoner.

Spredningen av resistente bakterier som MRSA på sykehus og ute i samfunnet er et stort helsemessig problem. Takket være økt fokus på nasal dekolonisering og bruk av topikale antimikrobielle legemidler i risikoutsatte pasientgrupper er det mulig å redusere infeksjonsfaren.  “Resultatene fra de to kliniske Fase I/IIa er de første bekreftelsene på at Lytix’ antimikrobielle substans også virker på bakteriekolonier i menneske. Dataene viser at LTX-109 har potensial som et nytt legemiddel for behandling av Gram-positive hudinfeksjoner og til dekolonisering av resistente bakterier (MRSA) i nesen. Disse kliniske rapportene innebærer et såkalt “Proof of Concept” og vil danne grunnlaget for videre studier og kontakt mot industripartnere”, konkluderer Dr. Wenche Marie Olsen, COO og Utviklingsdirektør for Infeksjon hos Lytix Biopharma.

Notes to editors:

About Lytixar™ (LTX-109)
LTX-109 is an investigational antimicrobial drug with a novel membrane-lysing mechanism of action, based on the biological principle of innate immune effectors, lytic peptides. The drug has a rapid bacteriocidal lytic activity.  The drug has been tested in vitro and in vivo models, and has undergone a comprehensive nonclinical safety and toxicology program and been studied in man in a Phase I study, and two phase I/IIa studies. The drug is in development as a treatment for bacterial skin infections and nasal decolonisation of MRSA.

About Lytix Biopharma AS
Lytix Biopharma AS develops novel drugs for treatment of resistant bacterial and fungal infections, as well as first-in-class oncology treatments.  The Company was established in 2003 to commercialise world-class research in the field of lytic peptides spun out by the founding scientists working at the University of Tromsø and University Hospital in Norway. Operating out of Tromsø and Oslo and through a continued collaboration with the University of Tromsø the Company has access to state-of-the-art laboratories and staff with extensive experience of drug discovery research. Business and product development is driven from the subsidiary office in Oslo.
www.lytixbiopharma.com