April 23, 2009 Madison, WI—The U.S. Food and Drug Administration (FDA) completed its regulatory review of ConjuGon’s Investigational New Drug (IND) application for the prevention of Catheter-Associated Urinary Tract Infections (CAUTI).
This decision clears the way for ConjuGon to begin its proposed Phase Ib clinical trials of C-1205 in indwelling catheterized patients who experience urinary tract infections. ConjuGon plans to begin enrolling patients in the study later this year. “We are extremely pleased that the FDA has cleared our IND,” said ConjuGon’s COO Steve Watt, Ph.D.
“Based on results from several previous studies, we have high hopes that C-1205 will help prevent bladder and other urinary tract infections (UTIs)” Watt said. “Normally, patients who are catheterized, such as those with spinal cord injuries or the disabled elderly, will experience several UTIs each year. With this product, our expectation is that the number of UTIs will be greatly reduced, treatment costs will be lowered, and patients’ quality of life will be increased.”
ConjuGon, Inc., based in Madison, WI, is a clinical-stage biopharmaceutical company developing novel antibacterial technologies using harmless bacteria as drugs. ConjuGon’s lead product, C-1205, uses bacterial interference technology to inhibit bladder infections in spinal cord injury patients and others with indwelling catheters. The active ingredient in the product has been previously tested in people for the prevention of urinary tract infections, and has been shown to be safe and effective.
“ConjuGon’s business strategy is to partner or sell drug candidates in its pipeline during Phase II human studies”, said Gary Greenwood, ConjuGon’s chairman and a founding partner of Rosetta Partners. “Approval of the IND for ConjuGon’s lead product is a significant step forward both for this product and for the company as a whole.” Rosetta Partners, based in Lake Forest, Illinois, is a private investment firm focused exclusively on biotechnology investments and is ConjuGon’s largest shareholder. For more information, please visit www.conjugon.com.