PARIS - Neurotech SA has embarked on a Phase I/II clinical trial of a cell therapy for the treatment of high-grade gliomas (tumors of the central nervous system). The therapy, designated NTC-121, involves the intratumoral delivery of stable endothelial cells that have been genetically modified to produce the human cytokine interleukin-2 (IL-2).
This is the first therapeutic application of endothelial cells in humans. The therapy exploits the migration and survival properties of endothelial cells for the local production of a therapeutic protein, in this case IL-2, which enables the organism to develop local antitumor immunity. It is an approach that avoids the side effects normally associated with systemic immunotherapy.
The trial, which is being carried out in Grenoble, in southeastern France, started two weeks ago and is due to entail multiple doses and 16 patients. Neurotech's CEO, Tom Shepherd, told BioWorld International the trial would take 12 to 18 months and that signs of positive activity would not be long in coming. "These aggressive gliomas are universally fatal, and the median survival time for patients is six to 11 months."
As Shepherd pointed out, Neurotech has brought its lead compound into clinical development less than three years after completing its first funding round. Moreover, he said the company had just started its third funding round with the aim of raising some $15 million to $20 million. That would be sufficient to finance its activities for a further three years, although "we don't have an urgent need of funds right now."
In the second round, completed in November 1998, Neurotech raised FFr82 million (US$14.5 million) from a group of 10 venture capital funds, mostly in Europe. While existing investors will provide part of the new funding, Shepherd said this time he was hoping to raise more development capital from institutions other than venture capital funds. He had already made two presentations to investment banks, he added, and the response was very positive.
Based at the French biotechnology science and business park in Evry, Neurotech is developing various cell therapies for the treatment of diseases of the central nervous system and the eye.