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Phase II trial of GV1001 in lung cancer started |
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13 Dec 2006 |
The first patients have been treated in a new Phase II trial of GV1001 in lung cancer. The trial is planned to include 20 patients in Norway.
HØRSHOLM, Denmark | Dec 12, 2006 | Rigshospitalet-Radiumhospitalet (the Radium Hospital) in Norway has treated the first patients in a Phase II trial with GV1001 in non-small cell lung cancer (NSCLC). The trial is an investigator sponsored trial, designed and led by Krefklinikken, Rigshospital-Radiumhospitalet in Olso in collaboration with St. Olav's Hospital in Trondheim. Pharmexa has agreed to supply GV1001 for the trial, which is partly funded by Norges Forskningsråd (the Norwegian Research Council).
Trial design
The trial is an open label exploratory Phase II trial in patients with stage IIIA and stage IIIB non-small cell lung cancer. In the trial, GV1001 together with the adjuvant GM-CSF is tested in patients that prior to the treatment have been treated with chemotherapy and radiation therapy. The patients start on the treatment no later than four weeks after their last radiation treatment. Patients are immunized 3 times in the first week and then once a week in week 2, 3, 4, 6, 8 and 10. Thereafter patients are immunized once a month for three months and in month 6 and 9.
The primary end-point in the trial is immune response measured by specific T-cell responses and DTH. Secondary end-points include safety and "time to progression", the time lapsed until the patients are obviously worse, measured by objective criteria (RECIST). Depending on the speed at which patients can be recruited, the results from the trial will be available in 2009.
Briefly on NSCLC
Non-small cell lung cancer is one of the most frequent cancers and its incidence is rising. More people die of lung cancer in the western world than any other cancer type. 75-80% of all lung cancers are the non-small cell type.
Patients diagnosed with advanced stage III or IV NSCLC have a very poor prognosis and more than half of the patients die within a year. NSCLC is treated with operation, radiation therapy and chemotherapy, but unfortunately with limited and transient effect. There is therefore a great need for a better treatment of this cancer.
GV1001: A cancer vaccine targeting telomerase
GV1001 is a peptide vaccine that activates the immune system - primarily the immune system's T-cells - to recognize and kill cancer cells. GV1001 targets an enzyme called telomerase. Telomerase is seldom found in normal cell types but is over expressed in most cancer cells. In scientific circles, telomerase activity is considered a key factor in the process whereby cancer cells lose their normal mortality, which is a common feature for all cancers. In theory, GV1001 could therefore turn out to be a universal cancer vaccine and Pharmexa's development strategy for GV1001 reflects this.
Hørsholm, December 12, 2006
Jakob Schmidt
Chief Executive Officer
Additional information:
Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525
Claude Mikkelsen, Head of Investor Relations, telephone +45 4516 2525 or +45 4060 2558
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 phase II trials in liver cancer, and 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.
SOURCE: Rigshospitalet-Radiumhospitalet |
