As was reported briefly in the Marketletter last week, GeneMedicine hasreceived clearance from the US Food and Drug Administration to begin Phase I clinical trials with its Interleukin-2 Cancer Gene Medicine for the treatment of head and neck cancer. The Investigational New Drug application was filed with the FDA in December 1996.
The trial, due to begin in the first half of this year, will investigate the safety and tolerability of the drug, which "is comprised of a plasmid encoding the human IL-2 gene and a proprietary non-viral gene delivery system," says the company. In animal models of head and neck cancer, the IL-2 gene therapy reduced the rate of tumor progression and increased survival.
The IND approval for the IL-2 gene therapeutic, the first product to result from GeneMedicine's collaboration with Boehringer Mannheim, sparks a $500,000 milestone payment from BM. Total research, development and equity funding to GeneMedicine could reach more than $47 million by the year 2000, it says.
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