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InKine Announces FDA Publication of Science Backgrounder.


Business Editors/Medical Writers

InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) announced today that the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) placed a Science Backgrounder on the FDA web page (www.fda.gov/cder) clarifying several items in the FDA's letter published on Visicol(TM) - the Company's 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.
 product used for adult colonoscopy - in the June 27, 2002 New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world.  (NEJM NEJM New England Journal of Medicine ).

The web site publication followed a meeting among InKine officers and legal counsel, an Associate Commissioner of FDA, FDA's Deputy Chief Counsel and several other senior FDA officials. The meeting was in response to InKine's concern that several key facts had been misstated or omitted from the FDA's letter.

The initial letter, authored by three FDA staff members, describes the possible risks of seizure associated with the administration of Visicol and other purgative products including polyethylene glycol polyethylene glycol (PEG): see glycol.  (PEG). A second letter from senior physicians from InKine refutes the premise that the risk of seizure may be greater with Visicol than with other purgative products. This second letter was included in the online NEJM of June 27. The letter stated that to date, the incident rate of seizures associated with Visicol use has been .003% and that all purgative products, including PEG products, have a very small but well documented risk of seizure and other neurological adverse events that are most likely due to hyponatremia Hyponatremia Definition

The normal concentration of sodium in the blood plasma is 136-145 mM. Hyponatremia occurs when sodium falls below 130 mM. Plasma sodium levels of 125 mM or less are dangerous and can result in seizures and coma.
 (low blood sodium).

There were several critical omissions in the FDA authored letter including the fact that to date over 210,000 patients have received Visicol safely and no new seizures have occurred since August 2001. Also, relevant contributing factors were omitted in 3 of 4 cases. These factors include the presence of hypoparathyroidism Hypoparathyroidism Definition

Hypoparathyroidism is the result of a decrease in production of parathyroid hormones by the parathyroid glands located behind the thyroid glands in the neck. The result is a low level of calcium in the blood.
, strenuous exercise during hot weather, and the daily use of a PEG containing 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, , which independently has been reported to be associated with seizures. Additionally, no presumed mechanism for purgative products was discussed. Because all patients who had seizures following the use of Visicol had marked hyponatremia, and hyponatremia is a well-known cause of seizures, InKine believes that hyponatremia was the primary cause of seizures in these patients.

The FDA Science Backgrounder discussed risk factors in several of the patients with seizures after taking Visicol and also acknowledged that FDA was aware of published reports of seizures in patients who had taken over-the-counter sodium phosphate products.

Additionally, due to an administrative oversight at the NEJM, InKine was not notified of the original letter until 24 hours prior to the web page publishing deadline and long past the print publishing deadline. Officials at the NEJM apologized to InKine and have agreed to publish our response in the July 25 issue of the print edition of the NEJM.

About InKine Pharmaceutical

InKine Pharmaceutical Company, Inc. is a publicly traded biopharmaceutical company focused on the diagnosis and treatment of cancer and autoimmune diseases. The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. Support of early-stage product opportunities comes through its university-based sponsored research. The Company's first product, Visicol(TM) is the first and only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's portfolio also includes three late-stage product candidates, IBStat(TM) in development for the treatment of spasm in the colon, Hematrol(TM), in Phase III trials for the treatment of idiopathic thrombocytopenic purpura Idiopathic Thrombocytopenic Purpura Definition

Idiopathic thrombocytopenic purpura, or ITP, is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood.
 and Colirest(TM), in pivotal 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. . In addition, the Company is developing preclinical compounds from its two platform technologies, including Angiocidin(TM), a potent and specific angiogenesis inhibitor for potential use in cancer patients. 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 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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Publication:Business Wire
Geographic Code:1USA
Date:Jul 3, 2002
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