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Genta to supply gallium nitrate injection for new cystic fibrosis trial
Sat. December 05, 2009; Posted: 05:17 AM

Dec 05, 2009 (Datamonitor via COMTEX) -- GETA News | PowerRating -- Genta, a biotechnology company, has reported that it will supply Ganite, a gallium nitrate injection, for a new clinical trial that will be initiated in patients with cystic fibrosis who may develop serious infections.

The initial clinical trial using a gallium compound for this purpose will involve patients with cystic fibrosis (CF) who will be treated at the University of Washington in Seattle, Washington and the University of Iowa, Iowa City, Iowa.

If initial results are promising, additional trials will be conducted with additional medical centers and a larger number of patients. Genta has provided cross-reference to its investigational new drug exemption for Ganite, and the company will supply the drug at no cost to patients in the trial. The study is also supported by grants awarded by the orphan products division of the FDA and by the Cystic Fibrosis Foundation.

Ganite is exclusively marketed by Genta and is approved in the US for the treatment of cancer-related hypercalcemia that is resistant to hydration.

Raymond Warrell, Jr, Genta's CEO, said: "This trial represents the rapid clinical translation of enormously promising observations. Initial results from our first CF patient showed that systemic treatment achieved target gallium levels in sputum, and that these levels could be sustained for a prolonged duration.

"Pseudomonas infections in CF are exceptionally difficult to eradicate. If initial results of the intravenous drug in this trial are promising, future patients might also benefit from extended therapy that could be afforded by one of our oral gallium compounds."

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