Dec 14, 2009
Lytix Biopharma AS announces regulatory approval by Norwegian and Swedish authorities to commence Phase I clinical trial of OncoporeTM (LTX-315) in cancer

Approvals from the Norwegian Medicines Agency and the Swedish Medical Products Agency

The Norwegian pharmaceutical company Lytix Biopharma AS today announced approvals from the Norwegian Medicines Agency (”Statens legemiddelverk”) and the Swedish Medical Products Agency (”Läkemedelverket”) to commence Phase I clinical trials of OncoporeTM (LTX-315) for the treatment of cancer.

According to Lytix Biopharma CEO Gunnar Sælid, “We are delighted to announce the regulatory approval by the Norwegian and Swedish Authorities to test our very interesting experimental drug OncoporeTM (LTX-315) in the clinic.  I am extremely pleased with the efforts put in by our Drug Development teams this year, with all projects progressing well according to our plans. For the Company this is an important study, validating the attractiveness of our platform in oncology. We will now have two programs in clinical trials; on the one hand our topical antimicrobial drug, and now our novel treatment for cancer”.

In preclinical models LTX-315 has demonstrated the ability to effect necrotic killing of cancer cells. Simulatenously it also causes the release of danger signals from the stressed and dying cells that trigger a beneficial activation of the immune system.

”The study will start in the beginning of 2010 and will be run at two centers, The Norwegian Radium Hospital – National Hospital in Oslo, as well as the Karolinska University Hospital in Stockholm, Sweden. Initially, the Phase I study will establish a safe and tolerated dose of LTX-315 when given to solid tumours amenable to injection. OncoporeTM (LTX-315) has the potential to becoming a valuable new agent for the treatment of cancer”, says Jon Amund Eriksen, Director of Product Development, Oncology at Lytix Biopharma AS. The clinical trial is supported by grants from The Norwegian Cancer Association (“Kreftforeningen”), The Norwegian Research Council (“Forskningsrådet”) and Innovation Norway (“Innovasjon Norge”).

Corporate Inquiries:
Gunnar Sælid, CEO
Tel +47 911 92 330
Jon Amunds Eriksen, Director, Oncology Development
Tel +47 950 85 914

Media Inquiries:
Richard Hayhurst, Schwartz Communications
Tel +44 (0) 7711 821527

Notes to editors:

About OncoporeTM (LTX-315)
LTX-315 is an investigational treatment for cancer based on the biological principle of innate immune effectors, lytic peptides. The drug recognises charges in cell membranes and, in a dose dependent manner, induces immunogenic cell stressing and rapid cell lysis.  When injected intra-tumorally LTX-315 causes dramatic and rapid cell lysis and tumour necrosis. The drug has been tested in in vitro and in vivo models, and has undergone formal preclinical safety and toxicology studies. The Phase I/II study is expected to commence in the beginning of 2010.

About Lytix Biopharma AS
Lytix Biopharma AS develops novel drugs for the 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.