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Sep 1, 2010
Approval to start Phase IIa clinical trial with Lytixar™ (LTX-109)

The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval in Hungary to commence a Phase IIa clinical trial with Lytixar™ (LTX-109) treatment of skin infections caused by Gram positive bacteria.

According to Lytix Biopharma CEO Gunnar Sælid, “We are delighted to announce the approvals by the Hungarian Regulatory Authorities and appropriate Ethics Committee to test our novel antimicrobial drug Lytixar™ (LTX-109) in patients whom have skin infections caused by Gram positive bacteria.  Skin infections caused by Gram positive bacteria are an ideal patient group in which to test our antimicrobial drug. Standard of care for these types of infections is generally topical drugs, representing a significant market. Since bacteria such as Staphylococcus aureus are often resistant to the exisiting drugs including methicillin-resistance (methicillin-resistant Staphylococcus aureus - MRSA), there is a clear need for a novel drug such as Lytixar™. For the Company this is an important study, validating the clinical utility of our novel, broad-spectrum, antimicrobial drug Lytixar™.”

Preclinical models have demonstrated that Lytixar™ is strongly 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 study will be run at four hospital dermatology clinics in Hungary. Patients with confirmed Gram positive skin infections will be included in the study and randomized to receive either active drug or placebo in cohorts at ascending dose levels. Lytixar™ (LTX-109) has the potential to become a valuable new antimicrobial agent for Gram positive skin infections as well as in a range of other indications”, concludes Dr. Wenche Marie Olsen, COO and Director of Product Development, Infectious diseases, at Lytix Biopharma AS.

In Norwegian:
Myndighetene i Ungarn har gitt sin tillatelse til å starte en studie med Lytixar™ (LTX-109) i pasienter med hudinfeksjoner forårsaket av Gram positive bakterier. Dette er en ideell pasientgruppe for å teste ut det nye antimikrobielle produktet LytixarTM. Denne pasientgruppen behandles med topiske (lokale) medikamenter, som er et verdifullt markedssegment. Bakterier som Staphylococcus aureus er ofte resistente mot eksisterende medikamenter, (methicillin-resistente Staphylococcus aureus - MRSA), og det er derfor et klart behov for nye produkter på markedet slik som Lytixar™. Dette er en viktig studie for Selskapet, hvor vi for første gang skal vise effekten av vårt nye, bredspektrede antimikrobielle produkt LytixarTM i pasienter. Den kliniske studien vil bli utført på fire dermatologiklinikker i Ungarn, og planlagt oppstart er høsten 2010. Studien, som vil inkludere 24 pasienter, vil dokumentere sikkerhet, toleranse og antimikrobiell effekt av Lytixar™ (LTX-109).

Gunnar Sælid, CEO / Daglig leder
Tel +47 911 92 330

Knut Eidissen, Chairman of the Board / Styreleder
Tel +47 916 17 707