Phase II application for GV1001 in lung cancer submitted
June 15, 2006
Summary: Kreftklinikken (The Cancer Clinic) at Rikshospitalet-Radiumhospitalet in Norway has submitted an application to initiate an investigator sponsored phase II trial with GV1001 in lung cancer. The trial is planned to include 20 patients.
Radiumhospitalet (the Radium Hospital) in Norway has with Dr. Steinar Aamdal as principal investigator submitted an application to the Norwegian authorities and ethical committees for approval to start 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). If the trial is approved, it is expected to be started in Q3 2006.
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).
The trial finishes 12 months after the recruitment of the last patient. Depending on the speed at which patients can be recruited, the results from the trial will be available in early 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 has 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 form.
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, including lung cancer. 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.
Pharmexa has initiated a phase III trial with GV1001 in pancreatic cancer, based on promising results in this indication and has recently submitted an application to start a phase II trial with GV1001 in liver cancer.
Hørsholm, June 15, 2006
Chief Executive Officer
Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525
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, HER-2 AutoVacä Protein, a recombinant protein vaccine in phase II against breast cancer, and HIV and hepatitis vaccines in phase I/II. Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma 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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