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lidocaine, is safe and tolerable for patients with the bladder disorder. Twenty women with moderate to severe cases of the disorder will be enrolled in the study. If all goes as planned in the trial, which Duddu expects to complete later this year, the company would pursue a larger, Phase II trial to gain more evidence of the treatment’s safety and to show whether it can address the pain and other symptoms of the disorder.
Citing a previous study, the company said last month that as many as 15 million Americans experience symptoms of interstitial cystitis. The disorder has no known cause and affects mostly women. The standard of care for the bladder disorder involves the use of catheters to fill the bladder with a solution containing lidocaine or other treatments. Yet the treatment exits a patient’s bladder when he or she urinates, limiting how long it can last in his or her system. With Taris’s device, which is shaped somewhat like a small pretzel, the lidocaine can be delivered continuously over the course of weeks, the company says.
Using an existing medical scope, called a cystoscope, Taris’s drug-delivery device is then removed after a period of time. Duddu says that both the placing and extraction of the device involve existing procedures. That means urologists wouldn’t have to be trained on new procedures to provide the treatment. The plan is also for the procedures related to the firm’s treatment to not require any additional anesthesia, meaning they could be done in a doctor’s office rather than a hospital.
Duddu, who took the CEO job at Taris in July 2010, says that he sees the opportunity to develop the treatment (which the company calls LiRIS) for several other bladder conditions as well. The lidocaine-releasing device, for example, could also be used to relieve symptoms such as pain in patients who get stents, after the removal of kidney stones, to prop open their ureters to keep urine flowing from their kidneys to their bladder.
There are also potential uses of the technology to overcome the challenges of delivering drugs for bladder cancer and overactive bladder, Duddu says. He says that Taris aims to find partners that are interested in developing the technology for these uses while the company focuses internally on advancing its lidocaine treatment form multiple disorders.
“We are getting very strong interest from the pharmaceutical companies because of the uniqueness of the platform and our focus on the product,” Duddu says.