Transgene begins phase 2b trial for cancer vaccine TG4010 in lung cancer patients

By E. Janene Geiss

Philadelphia, Nov. 30 - Transgene announced Wednesday the opening of the first sites for its phase 2b clinical study of the therapeutic cancer vaccine TG4010 in patents with advanced non-small cell lung cancer.

The trial is a randomized, open-label and controlled study designed to assess the efficacy of TG4010 in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone, according to a company news release.

The trial will enroll 140 patients with stage 3b or stage 4 non-small cell lung cancer and no prior systemic treatment for advanced disease. Treatment efficacy will be assessed by evaluation of progression-free survival at six months, response rate, time to progression and overall survival, officials said.

The trial will be conducted at several centers located in France and other European Union countries. End of recruitment is planned for the third quarter of 2006 with preliminary results in the first quarter of 2007, officials said.

The company also gave updates on other ongoing trials and products.

TG1042 is in a 38-patient phase 1, 2 clinical trial in primary cutaneous lymphoma. Final results of this trial and next development steps will be presented at the upcoming annual meeting of the American Society of Hematology. Interim results from 16 evaluable patients were released in February 2005 and showed 56% global response rate with six complete and three partial responses, officials said.

TG4001 is in a phase 2 trial with women diagnosed with precancerous lesions of the cervix related to type-16 human papillomavirus. Based on the favorable data obtained from the previous phase 2 trial, this current trial will evaluate efficacy of the high-dose vaccine after a six-month observation period. The 21st and first patient completed treatment and final data are expected in the second quarter of 2006, officials said.

Transgene is a Strasbourg, France, biopharmaceutical company focused on development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases.

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