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InKine Announces Positive Results of Laxative Study Using Visicol Tablets.


Business Editors/Health/Medical Writers

BLUE BELL, Pa.--(BUSINESS WIRE)--April 24, 2003

InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced the results of the Company's post-marketing study using Visicol(TM) tablets as a laxative laxative, drug or other substance used to stimulate the action of the intestines in eliminating waste from the body. The term laxative usually refers to a mild-acting substance; substances of increasingly drastic action are known as cathartics, purgatives, . Visicol is currently marketed in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  for cleansing the bowel prior to colonoscopy in adults.

The study, which was performed in 31 adult, healthy volunteers, was a controlled, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, open label trial that compared the safety and laxative effects of either 8 or 12 Visicol(TM) tablets taken each morning to Miralax(R), the leading marketed prescription laxative. Following a seven day baseline observation period with no treatment, subjects were treated for seven days. Subjects in the Visicol arms took 4 tablets every 15 minutes with 8 ounces of any non-alcoholic beverage
See also:
A non-alcoholic beverage is a beverage that contains no alcohol. Such drinks are generally drunk for refreshment, or to quench people's thirst.
 until they completed their randomized dose amount (8 or 12 tablets), and the Miralax subjects were given the recommended dose of 17 grams daily. Subjects kept a diary of their bowel movements and various gastrointestinal symptoms, and had periodic assessments of their blood electrolyte electrolyte (ĭlĕk`trəlīt'), electrical conductor in which current is carried by ions rather than by free electrons (as in a metal).  levels. During treatment, subjects who had excessive laxative effects had mandatory reductions of their laxative dose.

The results of the study show a consistent statistically significant pattern of greater and more prompt laxative effects for Visicol over Miralax. Subjects randomized to either Visicol dose had significantly more daily bowel movements after just one day of dosing and also at the end of treatment compared to Miralax. The time to the onset of laxative effects was significantly shorter with Visicol than with Miralax. Every subject in both Visicol groups required at least one dose reduction for excessive laxative effects compared to none in the Miralax group, a highly significant difference. Visicol was well tolerated by study subjects. No one taking Visicol dropped out of the study, compared to one person in the Miralax group who left the study after vomiting on the second day of treatment. There were no significant differences between the study groups in changes from baseline in blood electrolyte levels at the end of study treatment.

"These results indicate that Visicol had prompt laxative effects in this study population," said Martin Rose, M.D., J.D., Executive Vice President for Research and Development at InKine. "The laxative effects of Visicol were seen significantly faster than with Miralax, which was expected since the labeling for Miralax indicates that laxative effects may not occur for two to four days. Visicol was well tolerated by these subjects, and electrolyte changes at the end of treatment were minor and did not differ significantly among the study groups. We now have the information needed to proceed to a study in patients with constipation, which we plan to launch early in the third quarter of 2003."

The constipation marketplace represents a potentially large extension of Visicol's utility. Over two million patients seek treatment each year for this condition, which generally requires chronic treatment, yielding over 3.5 million prescriptions.

About InKine Pharmaceutical

InKine Pharmaceutical Company, Inc. is a publicly traded biopharmaceutical company focused on the diagnosis and treatment of cancer and autoimmune diseases Autoimmune diseases
A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs.

Mentioned in: Complement Deficiencies, Premature Menopause
. The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. The Company's first product, Visicol(TM) is the first and only tablet purgative purgative /pur·ga·tive/ (purg´it-iv) cathartic (1, 2).

pur·ga·tive
n.
An agent used for purging the bowels.

adj.
Tending to cause evacuation of the bowels.
 preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IB-Stat(TM), is a novel oral hysocyamine spray for the treatment of Irritable Bowel Syndrome irritable bowel syndrome (IBS), condition characterized by frequently alternating constipation and diarrhea in the absence of any disease process. It is usually accompanied by abdominal pain, especially in the lower left quadrant, bloating, and flatulence.  (IBS IBS Irritable bowel syndrome, see there ) and spasm of the colon. Additionally, the Company has other development programs such as Colirest(TM), which is in clinical trials for the treatment of Crohn's disease

Main article: Crohn's disease


The treatment of Crohn's disease is sequential: to treat acute disease, and then to maintain remission. Treatment initially involves the use of medications to treat any infection and to reduce inflammation.
 and completed Phase II trials for the treatment of ulcerative colitis This article concerns the treatment of ulcerative colitis, a form of inflammatory bowel disease (IBD). Ulcerative colitis is a form of colitis, a disease of the intestine, specifically the large intestine or colon, that includes characteristic ulcers, or open sores, in the colon. . For further information, please visit InKine on their web site http://www.inkine.com.

In addition to historical facts or statement of current condition, this press release may contain forward-looking statements. Forward-looking statements provide InKine's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings projections, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. InKine's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties such as those set forth in its reports on Form 10-Q Form 10-Q

See 10-Q.
 and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, InKine does not intend (and it is not obligated ob·li·gate  
tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates
1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force.

2. To cause to be grateful or indebted; oblige.
) to update publicly any forward-looking statements. This discussion is permitted by the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995.
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Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 24, 2003
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