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Genta to Support Initiation of New Clinical Trial using Ganite®

Genta to Support Initiation of New Clinical Trial using Ganite®

Genta to Support Initiation of New Clinical Trial using Ganite®

Genta to Support Initiation of New Clinical Trial using Ganite®

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Genta Incorporated announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

Infection is the most common cause of death in CF patients. Frequently, these infections are due to bacteria known as Pseudomonas aeruginosa, and patients are commonly treated with years of antibiotic therapy to control such infections. However, prolonged antibiotic use has greatly increased resistance due to genetic mutations.

In addition, Pseudomonas has evolved protective mechanisms known as “biofilms” that encase colonies of bacteria and prevent antibiotics from reaching infection sites. Bacteria in biofilms are far more resistant to being killed. Recent information has suggested that gallium may be used as an anti-bacterial agent against Pseudomonas, in part due to its ability to disrupt biofilms.

The initial clinical trial using a gallium compound for this purpose will involve patients with cystic fibrosis who will be treated at the University of Washington in Seattle, WA and the University of Iowa, Iowa City, IA. 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 (IND) 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 Food and Drug Administration (FDA) and by the Cystic Fibrosis Foundation.

“Work from our center has established that gallium can be used as a 'Trojan horse' that interferes with how iron is used by Pseudomonas,” said Dr. Christopher H. Goss, Associate Professor of Medicine at the University of Washington, who is the Principal Investigator of the trial. “Our preliminary data suggest that gallium exploits potentially vulnerable mechanisms in Pseudomonas by disrupting biofilms and killing antibiotic-resistant strains of bacteria. This study is the first formal pharmacokinetic and safety evaluation of gallium in patients with cystic fibrosis.”

“This trial represents the rapid clinical translation of enormously promising observations,” said Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer. “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 IV 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.”