Transgene Begins New Phase II Gene Therapy Trial

STRASBOURG, Fr—Transgene, a biotechnology company, announced on Wednesday its plan to launch of a new phase II trial of its Vero-IL2 product for the treatment of mesothelioma.
Transgene reported in a statement that Vero-IL2 consists of an immortal cell line genetically modified in order to produce interleukine-2. Animal testing demonstrated the effectiveness of the treatment on spontaneous tumors. The phase I clinical trials, which took place in France and Switzerland, indicated antitumor activity with good tolerance to the treatment.

Phase II trials started in the spring of 1998 in the treatment of advanced melanoma. “We are pleased to continue the development of this product for the mesothelioma indication, a disease for which no treatment exists at this stage,” commented general manager Bernard Gilly. “This new trial brings to four the number of phase II clinical trials for the treatment of various cancers in progress at Transgene.”

Transgene’s Phase II clinical trial will evaluate the efficacy of subcutaneous injections of MVA-Muc1-IL2 as a single agent administered to patients with metastatic renal cell carcinoma expressing Muc1 as a first line treatment for metastatic disease.

Metastatic renal cell carcinoma is characteristically unresponsive to chemotherapy. Standard therapy, with immunomodulators, induces objective responses in approximately 15-20 percent of patients and higher response rates in some patients with favorable prognosis factors.

Tumor response is evaluated every 12 weeks. Patients experiencing progressive disease will then receive standard therapy based on immunomodulators in addition to vaccination with MVA-Muc1-IL2.

This trial allows the advantage of testing the vaccine candidate in a monotherapy as well as a combination setting.

The trial will be initiated in Belgium and be extended in Europe.

A total of 25 patients will be included, in four to six cancer centers.