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GV1001 results in pancreatic cancer published in the British Journal of Cancer


Summary: Clinical results from a Phase I/II study of GV1001 in pancreatic cancer have now been published in the British Journal of Cancer (BJC).

Pharmexa has previously announced top line data from the Phase I/II trial of GV1001 in pancreatic cancer. The recently published article in BJC describes the data in further detail. As announced previously, the study found the telomerase vaccine GV1001 to be safe and immunogenic.

Survival data from the Phase I/II trial indicate that induction of an immune response is correlated with prolonged survival. The observed median survival was 7.2 months for the responders and 2.9 months for the non-responders, giving a statistically significant p value of 0.001.

The results also showed a significant increase in survival in the intermediate dose group compared to the two other groups. Survival in the low, median and high dose groups were 4.0, 8.6 and 5.1 months, respectively, with the largest fraction (75%) of immune responders in the median dose group.

Survival is therefore correlated with vaccine dose and immune response in a statistically significant manner. Significantly, after 300 days, only immune responders remained alive. Gemcitabine treatment, which is the standard treatment in many countries, generally results in a median survival of 4.8 - 5.6 months.

“Considering that inoperable pancreatic cancer patients normally are strongly immune suppressed and have a short life expectancy, the results are very encouraging,” said Jakob Schmidt, Chief Executive Officer of Pharmexa.

Hørsholm, October 31, 2006
Jakob Schmidt
Chief Executive Officer

Note to editors: Pharmexa A/S is a leading company in the field of active immunotherapy and vaccines for the treatment of cancer, serious chronic and infectious diseases. Pharmexa’s proprietary technology platforms are broadly applicable, allowing the company to address critical targets in cancer, rheumatoid arthritis, bone degeneration and Alzheimer’s disease, as well as serious infectious diseases such as HIV, influenza, hepatitis and malaria. Its leading programs are GV1001, a peptide vaccine that has entered phase III trials in pancreatic cancer and is expected to enter a phase II trial in liver cancer soon, as well as a number of HIV and hepatitis vaccines in phase I/II. Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma, ImmunoVaccine Technologies and Bavarian Nordic. With operations in Denmark, Norway and USA, Pharmexa employs approximately 100 people and is listed on the Copenhagen Stock Exchange under the trading symbol PHARMX.


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