PARIS ¿ The Strasbourg-based gene therapy company Transghne S.A. launched the first Phase I clinical trial of its Adenovirus-IFN-y vector, which is being tested in advanced, metastatic melanoma. The multicenter trial has started at the University of Rochester hospital in New York, and the company said a hospital in London will be the next to participate.
The Adenovirus-IFN-y virus, which works by triggering an immune system response against cancerous cells, incorporates a gene coding for the interferon-y gene, a natural cytokine that stimulates the immune system. Preclinical studies on animals demonstrated the therapy¿s efficacy both as a single-use treatment and in combination with other immunotherapeutic compounds.
This is the second gene therapy for cancer for which Transghne obtained FDA approval for a multicenter clinical trial, the first being one for prostate cancer, which is now in Phase II. The company now has four Phase II clinical trials under way, three of which are for the treatment of various cancers and one for cystic fibrosis.
One of the cancer therapies is being tested in advanced melanoma. It uses Transghne¿s Vero-IL2 vector, which is based on the same principle as Adenovirus-IFN-y except that it consists of a line of genetically modified immortal cells that produce interleukin-2, another natural cytokine that stimulates the immune system. A second version of the Vero-IL2 vector is being tested for the treatment of advanced mesothelioma, Phase II trials of which got under way in March. According to Transghne, these vectors offer a less toxic and potentially more effective alternative to chemotherapy and radiotherapy for the treatment of metastatic cancers.
A few weeks ago, the company unveiled what managing director Bernard Gilly described as the ¿very encouraging preliminary results of our Phase II trial for the treatment of breast cancer.¿
In that trial, which is taking place in centers in London, France, Belgium, the Netherlands and Israel, one three-to-eight-month test involving 22 patients found tumor regression in two and stabilization in 10 others, while the other 10 are still being evaluated. In addition, T-cell proliferation response was observed in all patients, and there were virtually no side effects. However, enrollment for this trial was completed only recently and the final results will not be known before the end of this year.