Dec 6, 2010
Lytix Biopharma and KAEL–GemVax announce first patient treated in clinical trial to combine LTX-315 and GV1001 cancer vaccine immunotherapy

Lytix Biopharma and KAEL–GemVax announce first patient treated in clinical trial

The Norwegian biopharmaceutical company Lytix Biopharma and the Korean biotechnology company KAEL-GemVax announced today the successful first treatment in the study of a combination of LTX-315 and GV1001 as anti-cancer vaccine therapy.

According to Lytix Biopharma CEO Gunnar Sælid and KAEL-GemVax CEO Jay Sangjae Kim, “We are delighted to announce the inclusion of the first patient in our previously announced joint study to test LTX-315 as an adjuvant for the GV1001 anti-cancer peptide vaccine. LTX-315 causes release of cellular ’danger’ signals triggering activation of the innate immune system, seems to create an optimal environment in which to generate strong immune responses towards peptide vaccines. GV1001 is a peptide anti-cancer vaccine in Phase III TeloVac trial, directed against the telomerase enzyme, and is one of the best documented therapeutic cancer vaccines currently in development. The telomerase-target for therapeutic vaccination is universally expressed in tumours, giving the LTX-315/GV1001 combination a potentially broad utility against a range of cancer types.”

“We are very happy that the first patient has been vaccinated in our combination trial. There is a strong scientific rationale for combining these agents and we believe they should have potential to function as an efficient immunotherapy for the treatment of cancer”, says Mr. Jon Amund Eriksen, Director of Development, Oncology at Lytix Biopharma. The clinical study is running at the University Hospital of Northern Norway in Tromsø, under clinical supervision of the Primary Investigator Dr. Tone Nordøy. The study will include approximately 20 patients and will document the safety, tolerability and anti-telomerase immune responses of GV1001 together with LTX-315.

Corporate Inquiries:

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

Media Inquiries:

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

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 interacts with cell membranes and induces immunogenic cell stressing and rapid cell lysis.  When injected intra-tumourally LTX-315 causes cell stressing and lysis and tumour necrosis. A Phase I/II study is ongoing at the Radium Hospital, Oslo and Karolinska University Hospital, Stockholm.

About GV1001
GV1001 is a 16-amino acid peptide vaccine that comprises T-cell epitopes from the catalytic subunit of human telomerase. Telomerase is a universal tumour antigen expressed in 85-90% of cancer tissues. 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 is a clinical-stage drug development company developing 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 at the University Hospital and University of Tromsø in Norway.
The Company maintains strong links with centers of academic excellence in Tromsø as well as in the Oslo Cancer Cluster based around the Radium Hospital – National Hospital in Oslo. Lytix is based out of offices in Tromsø and Oslo, Norway.

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