Interim progress from Phase III TeloVac study of GV1001 vaccine announced

KAEL-GemVax, a leading oncology vaccine company, today announced, through its subsidiary GemVax A.S, encouraging interim progress from the UK-based Phase III TeloVac study of its anti-telomerase therapeutic cancer vaccine GV1001 in pancreatic cancer. The company also strongly believes GV1001 has major "blockbuster" potential as a universal therapeutic cancer vaccine and is developing a strong pipeline for other indications, including lung and liver cancer and melanoma.

“GV1001 is the most advanced therapeutic cancer vaccine currently in development and we are extremely pleased with the progress of trials so far. Patient recruitment across our centres continues and we are seeing some good immunological responses.”

The largest cancer vaccine therapy trial ever in the UK, currently funded by Cancer Research UK, the TeloVac study is being run by the Liverpool Cancer Trials Unit. KAEL-GemVax has just received the second interim report noting that the number of patients recruited reached 755 out of 1110 in 52 centres in the UK in June. This means recruitment is now almost 70% complete and remains well on schedule for LPFV in October 2011 and NDA filing soon after. A recent Datamonitor report forecasted the market for therapeutic cancer vaccines to reach $4.7 billion by 2018 in 7 major markets.

Director of the LCTU, Professor John Neoptolemos commented: "GV1001 is the most advanced therapeutic cancer vaccine currently in development and we are extremely pleased with the progress of trials so far. Patient recruitment across our centres continues and we are seeing some good immunological responses."

The primary trial objective is length of survival. The TeloVac study was initiated in 2007 after the Phase I/II study showed overall survival of 8.6 months, compared to the 5.6 months of current standard treatment Gemcitabine. It is a prospective, controlled, multicentre, randomised clinical trial comparing combination Gemcitabine and Capecitabine therapy with concurrent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancreatic cancer.

KAEL-GemVax CEO Dr Jay Sangjae Kim added: "These results from the independent Data Monitoring Committee on the TeloVac trial in the UK are extremely encouraging. Currently pancreatic cancer is one of the most difficult cancers to treat and there are only a few approved treatments on the market. However, we believe that the improved overall survival and favourable safety profile that GVI001 has shown in previous studies creates a strong rationale for providing it with standard care, and thus creating the first therapeutic vaccine for patients with pancreatic cancer. In addition, we strongly believe that GV1001 has the potential to overcome the limits of other current cancer vaccines and become part of the standard of care not only for pancreatic cancer but for various other types of cancers. In other words a truly "universal" vaccine will be available in the near future."

SOURCE KAEL-GemVax