Jun 9, 2010
Lytix Biopharma and KAEL–GemVax announce approval of joint clinical trial to combine LTX-315 and GV1001 cancer vaccine immunotherapy

Lytix Biopharma and KAEL–GemVax announce approval of joint clinical trial

The Norwegian biopharmaceutical company Lytix Biopharma and Korean company KAEL-GemVax today announced approval by the Norwegian Medicines Agency (’Statens Legemiddelverk’) to test a combination of LTX-315 and GV1001 as vaccine therapy in patients with resected tumours. Lytix Biopharma CEO Gunnar Salid states, ”We are delighted to announce the approval of our joint study to test a combination of two very interesting experimental drugs. The main reason for choosing GV1001 for this combination study is that it is a peptide anti-cancer vaccine in Phase III trial, directed against the telomerase enzyme, and is one of the best documented therapeutic cancer vaccine currently in development. The telomerase-target for therapeutic vaccination is universally expressed in tumours, making a GV1001/LTX-315 combination treatment potentially useful in a wide range of cancer types.” The excellence of the GV1001 vaccine has previously been proven in studies at the Cancer Centre of Karolinska Institute in Stockholm, Sweden, Radium Hospital Medical Center in Oslo, Norway as well as University of Liverpool, UK.  KAEL-GemVax CEO, Jay Sangjae Kim, also commented on LTX-315 saying that, ”In preclinical models, LTX-315 causes release of cellular ’danger’ signals that trigger activation of the innate immune system. This creates an optimal environment in which to generate strong immune responses towards peptide vaccines.”

“There is a strong scientific rationale for combining these agents, providing a broad inflammatory response combined with a specific peptide vaccination – these two novel agents should have the potential to function as an efficient immunotherapy for the treatment cancer”, says Mr. Jon Amund Eriksen, Director of Product Development, Oncology at Lytix Biopharma. The clinical study is due to commence in 3Q2010 and will run at the University Hospital of Northern Norway in Tromsø. The study will include approximately 20 patients with resected solid tumours and document the safety, tolerability and anti-telomerase immune responses of LTX-315 together with GV1001.

Corporate Inquiries:
Gunnar Sælid, CEO
Tel +47 911 92 330
Jay Sangjae Kim, CEO, KAEL-GemVax
Tel +82-2 540 6221

Media Inquiries:
Richard Hayhurst, Schwartz Communications UK Ltd
Tel +44 (0)7950 878 218


In Norwegian:
Statens Legemiddelverk har gitt sin tillatelse til at en studie med en kombinasjon av LTX-315 og GV1001 kreftvaksine kan starte. Studien vil prøve ut en spennende kombinasjon av eksperimentell terapi i pasienter som har fått operert sin tumor. I dyr er det vist at behandling med lave doser av LTX-315 frigjør signaler fra celler som fører til stimulering av en meget gunstig immunitet mot vaksiner. GV1001 er en kreftvaksine rettet mot et enzym, telomerase, som er aktivt i cancerceller. Produktet er under fase III utprøving og er en av de best dokumenterte kreftvaksinenen under utvikling. Fordi svært mange typer av tumorer har telomerase enzyme, vil en kombinasjon av LTX-315 og GV1001 potensielt ha en bred anvendelse innen immunologisk behandling av kreft. Den kliniske studien vil starte i 3.kvartal 2010 ved Universitetssykehuset Nord-Norge (UNN) i Tromsø og inkludere omkring 20 pasienter som har fått operert sin svulst. Studien vil dokumentere sikkerhet, toleranse og immunrespons etter behandling med kombinasjonen av LTX-315 og GV1001.

Gunnar Sælid, CEO / Daglig leder
Tel +47 911 92 330
Knut Eidissen, Chairman of the Board / Styreleder
Tel +47 916 17 707