BLUE BELL, PA March 22, 2004 -- InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced the dosing of the first seven patients in a Phase II dose-ranging study using the Company’s advanced generation sodium phosphate purgative tablet, code named INKP-102. This study, the first using INKP-102, is a multicenter, investigator-blinded trial comparing several dosing regimens of the new tablets against the Company’s currently marketed VisicolÒ tablets in adults scheduled for colonoscopy. The study includes regimens of INKP-102 involving a reduced number of tablets and dosing that is completed the evening before the colonoscopy procedure, and will examine the safety, efficacy and patient acceptance of the new product. FDA has indicated to InKine that this study could be supportive of a single pivotal trial in a marketing application for INKP-102. Data from the Phase II dose-ranging study are expected to be available in the third quarter of this year. INKP-102 tablets are smaller than VisicolÒ tablets, should be easier to swallow, and contain no microcrystalline cellulose, an inert but highly insoluble substance in VisicolÒ tablets. InKine recently filed a provisional patent application with the U.S. Patent and Trademark Office, which, if granted, would protect INKP-102 until 2024.
“We expect that our new generation purgative being evaluated in this study will be even better accepted by patients and their gastroenterologists, and will provide colon cleansing that is superior to VisicolÒ tablets,” said Martin Rose, M.D., J.D., InKine’s Executive Vice President for Research and Development. “The results of this study will guide the selection of doses for our Phase III study that we will begin later this year,” added Dr. Rose.
About InKine Pharmaceutical
InKine Pharmaceutical Company, Inc. is a publicly traded specialty pharmaceutical company focused on developing and commercializing pharmaceutical products for the diagnosis and treatment of gastrointestinal disorders. The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. The Company's franchise product, Visicol® is the only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IB-Stat®, is an oral hyoscyamine spray for the treatment of a variety of indications. Additionally, the Company has filed a provisional patent application for the development of a new generation purgative, for which clinical trials are expected to initiate during 2004, and is developing Colirest, which is in clinical trials for the treatment of Crohn's disease. For further information, please visit InKine on its web site http://www.inkine.com.
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