BLUE BELL, PA September 9, 2004 - InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced the initiation of enrollment of patients in a Phase III study of the Company’s advanced generation sodium phosphate purgative tablet, INKP-102. This study is a multicenter, investigator-blinded trial comparing two dosing regimens of 32 and 40 tablets of INKP-102, against the Company’s currently marketed Visicol® at the labeled dose of 40 tablets in adults scheduled for colonoscopy. Both of the INKP-102 dosing regimens in the study utilize a more convenient dosing schedule than currently labeled for Visicol®. The study will examine the safety, efficacy and patient acceptance of the new product. FDA has reviewed the study protocol under the Agency’s “Special Protocol Assessment” procedure, and has indicated to InKine that this single Phase III study together with a single Phase II study (which was recently completed) could support approval of INKP-102. Data from the Phase III study are expected to be available in the first half of 2005.
“Our completed Phase II study suggested that 32 or 40 INKP-102 tablets, the same doses we are testing in the ongoing Phase III study, were well-tolerated and provided excellent colon cleansing. Also, the smaller INKP-102 tablet was easier to take,” said Martin Rose, M.D., J.D., InKine’s Executive Vice President for Research and Development. “We hope to confirm these findings in the Phase III study,” added Dr. Rose.
INKP-102 tablets are smaller than Visicol® tablets and contain no microcrystalline cellulose, an inert but highly insoluble substance in Visicol® tablets. InKine has filed a provisional patent application with the U.S. Patent and Trademark Office, which, if granted, would protect INKP-102 until 2024.
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. The Company is also promoting VSL#3®, a probiotic that is effective in treating certain gastrointestinal disorders. Additionally, the Company is developing INKP-102, an advanced generation purgative, which recently completed Phase II clinical trials for bowel cleansing prior to colonoscopy, Visicol® for use as a laxative in treating patients with constipation and Colirest™, which is in clinical trials for the treatment of Crohn's disease. For further information, please visit InKine on its web site
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