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Phase II Study Design Approved by FDA for New Colon Cleansing Tablet
"We are pleased with the results of our meeting with FDA regarding the design of a Phase 2 study and the outline of a highly efficient development program for the regulatory approval of our new highly soluble colon cleansing tablets," said Martin Rose, M.D., J.D., Executive Vice President of Research and Development of InKine. "We will be working with a very experienced group of investigators to perform the study and are anxious to begin testing our new potential product at numerous dosing regimens, which should enhance acceptance by patients and physicians," added Dr. Rose.
The Phase 2 study is expected to begin in the first half of 2004 and will compare InKine's marketed purgative, Visicol® tablets, against several dosing regimens of the new product in patients undergoing colonoscopy. These regimens will include one similar to the approved regimen for Visicol as well as several lower dose regimens, including dosing regimens completed by patients entirely the evening before the colonoscopy procedure. The FDA has indicated that if results of the Phase 2 study are supportive, than only one pivotal study would be required for approval of the new tablets.
"We continue to look to expand our commercial operations through the development of our existing products and potential acquisitions. While our franchise product, Visicol, continues to gain market share, we look forward to advancing our new generation purgative through clinical development," said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief Executive Officer of InKine. "With the completion of a co-promotion deal in late 2003 and our development path in place for 2004, we expect to provide 2004 income statement guidance during our fourth quarter earnings call," added Dr. Jacob.
Source: InKine Pharmaceutical Company, Inc.