PARIS ¿ Transghne SA has embarked on Phase II clinical trials of its Vero IL-2 gene therapy vector in the treatment of advanced mesothelioma, a form of lung cancer that occurs in the pleura. The trials are being carried out in Germany and the first two of an ultimate cohort of 20 patients have already been enrolled. No cure exists for mesothelioma.
The Strasbourg-based gene therapy company¿s Vero IL-2 vector consists of a line of genetically modified immortal cells that produce interleukin-2 (IL-2), a natural cytokine that stimulates the immune system. The first Phase II trials of the product started last spring in the treatment of advanced melanoma, the most aggressive of the skin cancers. Earlier tests on dogs and cats demonstrated the effectiveness of the product in the treatment of spontaneous tumors. More recently, two Phase I clinical trials conducted in France and Switzerland have shown signs of antitumor activity in humans and demonstrated good tolerance of the treatment.
Altogether, Transghne now has four Phase II clinical trials under way for the treatment of various cancers using three of the five different vectors it has developed, as well as one for cystic fibrosis. Two of its products, the adenovirus IL-2 as well as the Vero IL-2 vector, are designed to stimulate the immune system for eliminating cancerous cells and thus offer a less toxic alternative to chemotherapy or radiotherapy for the treatment of metastatic cancers. The company is also developing anticancer vaccines, which deliver a virus that stimulates the production of specific tumoral antigens designed to induce an immune response.
Also, in the second half of this year, Transghne is due to embark on the first clinical trial in humans of a gene therapy for two forms of muscular dystrophy ¿ Becker¿s dystrophy and Duchenne¿s disease. That treatment entails the injection of naked DNA into muscle tissue. The trials will be largely financed by the French Muscular Dystrophy Association (AFM, or the Association Frangaise contre les Myopathies), with which Transghne signed a second cooperation agreement last Nov. 30.
Transghne¿s financial results for 1998 show a sharply higher net loss of FFr229.5 million (US$41.1 million), up from FFr77.4 million in 1997.