Lytix Biopharma, KAEL-GemVax granted approval for GV1001/LTX-315 combination cancer therapy study

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.

Source Lytix Biopharma AS and KAEL-GemVax