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Jun 18, 2009
Lytix Biopharma and KAEL–GemVax announce joint clinical trial

The Norwegian biopharmaceutical company Lytix Biopharma and Korean company KAEL-GemVax today announced the signing of a collaborative agreement to test lead compounds LTX-315 and GV1001 as a combination therapy for the treatment of cancer.

According to Lytix Biopharma CEO Gunnar Sælid and KAEL-GemVax CEO Jay Sangjae Kim, “We are delighted to announce this joint venture to test a combination of two very interesting experimental drugs. In preclinical models, LTX-315 has demonstrated the ability to effect necrotic killing of cancer cells. Simulatenously it also causes the release of warning signals from the stressed and dying cells that trigger activation of the immune system. On the other hand GV1001, a telomerase peptide vaccine in Phase III trials, is one of the best documented anti-cancer vaccines currently in development, with a potentially broad utility against a range of cancer types.
“There is a strong scientific rationale for combining these agents, providing a local inflammatory response combined with specific vaccination – these two novel agents should have the potential to function as an efficient immunotherapy for the treatment of cancer”, says Mr. Jon Amund Eriksen, Director of Product Development, Oncology at Lytix Biopharma. Mr. Eriksen is also one of the key persons together with Professor Gustav Gaudernack at the Norwegian Radium Hospital involved in the development of GV1001.
Speaking on behalf of their respective companies, business development spokespeople Anders Fugelli (Lytix Biopharma) and Michelle Kyunghee Kim (KAEL-GemVax) comment, “KAEL-GemVax and Lytix Biopharma will both contribute scientific and regulatory, as well as financial, support to the planned study in patients, sharing the results for use in the future clinical development programs for each proprietary agent. Lytix Biopharma will be responsible for the design, set-up and conduct of the clinical study, which will run at the University Hospital of Northern Norway in Tromsø. No further business commitments have been made at this stage.”

The clinical phase I study will document the utility of LTX-315 as an immune stimulator in patients vaccinated with GV1001, a vaccine directed against the catalytic subunit of human telomerase. Telomerase is a universal tumour antigen expressed in 85-90% of cancer tissues.

Corporate inquiries

Gunnar Sælid, CEO, Tel +47 911 92 330

Anders Fugelli, PhD, Head of Business Development, Tel +47 924 81 432

Jay Sangjae Kim, CEO, KAEL-GemVax, +82-2 540 6221

Michelle Kyunghee Kim, Vice President, Business Development, KAEL-GemVax, +82-2 540 6221

Media inquiries:

Richard Hayhurst, Hayhurst Media, Tel +44 (0) 7711 821527

Notes to editors:

About 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. Phase I/II studies are expected to commence in the second half of 2009.

About GV1001
GV1001 is a 16-amino acid peptide vaccine that comprises T cell epitopes from human telomerase. The vaccine ensures robust activation of both CD4+ (memory) as well as CD8+ (cytotoxic) T-cells. GV1001 has been tested in phase I/ II clinical  trials in patient with pancreatic cancer, non small cell lung cancer, malignant melanoma and liver cancer, and is currently  undergoing clinical trials in pancreatic cancer (Telovac- Phase III, UK) and Lung Cancer(Phase II, Norway).

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.  Lytix was established in 2003 to commercialise world-class research in the field of lytic peptides spun out by the founding scientists working in the University Hospital and University of Tromsø in Norway.
Operating out of Tromsø and Oslo and through our continued collaboration with the University of Tromsø the Company has access to state-of-the-art laboratories and staff with extensive experience of developing peptide based drugs, including preparation of peptidomimetics. Business and product development is driven from the subsidiary office in Oslo.
www.lytixbiopharma.com

About KAEL-GemVax Co., Ltd.

KAEL-GemVax is a Korean specialty biotechnology company, developing new cancer therapies that harness the selective power of the immune system to seekout and destroy tumor cells. KAEL-GemVax is committed to the commercialization of novel therapies (cancer vaccines) that enhance survial while maintaining a high quality of life for patients. Business and product development is driven from both Seoul and the subsidiary office in Oslo.
www.kaelgemvax.com