BioWorld International Correspondent
PARIS - The European Commission has designated an immunotherapy product candidate of Transgene SA, adeno-interferon gamma (Ad-IFN), as an orphan drug for the treatment of cutaneous T-cell lymphoma, following the recommendation of the Committee for Orphan Medicinal Products of the European Medicines Evaluation Agency (EMEA).
That will enable the Strasbourg-based gene therapy company to push ahead with its fast-track development program for the product, which it hopes to have on the market by late 2007 or early 2008, the company's medical and regulatory affairs director, Patrick Squiban, told BioWorld International.
The EMEA committee reached its decision on the strength of the results of a Phase I trial of Ad-IFNg completed early this year, which demonstrated the therapeutic efficacy of the product in terms of efficient gene transfer and cytokine expression. That outcome also led Transgene to extend the trial into a Phase I/II, entailing the enrollment of 10 more patients in addition to the nine who participated in the original phase.
That trial is ongoing, and Squiban said Transgene plans to let it run for some time to garner as much information as possible. It will be followed by a Phase IIb/III trial to be conducted in both Europe and the U.S. starting in 2004. To that end, the company is to file an IND application with the FDA similarly seeking orphan drug status for Ad-IFNg.
Meanwhile, the company plans to test the product in a second indication, cellular hepato-carcinoma. It hopes to initiate a Phase I clinical trial in China in early 2004, having already submitted a draft protocol to the Chinese authorities.