Results of T2000 Clinical Studies in Essential Tremor Published in the Journal Movement Disorders.Proprietary Taro Compounds Also Receive U.S. Patent for Essential Tremor Essential tremor An uncontrollable (involuntary) shaking of the hands, head, and face. Also called familial tremor because it is sometimes inherited, it can begin in the teens or in middle age. The exact cause is not known. and Parkinson's Disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) today announced that a paper titled, "Treatment of essential tremor with the barbiturate barbiturate (bärbĭch`ərāt'), any one of a group of drugs that act as depressants on the central nervous system. High doses depress both nerve and muscle activity and inhibit oxygen consumption in the tissues. T2000" has been posted to the website of Movement Disorders Movement Disorders Definition Movement disorders are a group of diseases and syndromes affecting the ability to produce and control movement. Description , the journal of the Movement Disorders Society, prior to its appearance in the print version of that publication. The paper discusses Phase II studies of T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid), the first of Taro's proprietary, non-sedating barbiturate compounds to undergo clinical trials. The paper is available at www.movementdisordersjournal.org in the "Early View" section. The paper reports the results of two brief, 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. , placebo-controlled, double-blind trials assessing the effectiveness of T2000 in treating essential tremor (involuntary shaking not related to Parkinson's disease). A total of 34 patients participated in the two trials. A statistically significant dose-dependent improvement was demonstrated, and four of the 23 patients treated with T2000 experienced marked improvement. The clinical trials were conducted in Montreal. The principal author of the paper and the lead investigator of the studies is Calvin Melmed, M.D. of the Department of Neurology and Neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. of McGill University, Montreal and Neurologist-in-Chief of SMBD-Jewish General Hospital, Montreal. Daniel Moros, M.D., and Howard Rutman, M.D., of Taro co-authored the paper. As noted in the published report of the studies, T2000 shows, "Olittle sedation Sedation Definition Sedation is the act of calming by administration of a sedative. A sedative is a medication that commonly induces the nervous system to calm. Purpose The process of sedation has two primary intentions. in animals and humans, which allows an exploration of the response to treatment at dosages not possible with other anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this. an·ti·con·vul·sant n. A drug that prevents or relieves convulsions. or hypnotic barbiturates Barbiturates Definition Barbiturates are medicines that act on the central nervous system and cause drowsiness and can control seizures. Purpose ." Estimates of the prevalence of essential tremor vary. For more information on essential tremor, visit www.essentialtremor.org, the website of the International Essential Tremor Foundation. As previously announced, T2000 is currently being studied for the treatment of moderate to severe essential tremor in a multi-center, randomized, double-blind, placebo-controlled trial in Canada. Details of this Phase II study are available at the www.clinicaltrials.gov website maintained by the U.S. National Institutes of Health. "The treatment of essential tremor remains challenging and frustrating for patients and physicians," said Barrie Levitt, M.D., Chairman of the Company. "This study demonstrates that additional trials are warranted to evaluate T2000 as a treatment option for this disorder." U.S. Patents Issued Taro also reported today that the U.S. Patent and Trademark Office has issued a patent to Taro for the use of the Company's proprietary, non-sedating barbiturate compounds in the treatment of essential tremor and Parkinson's disease. The patent will expire in June 2025. There can be no assurance as to the outcome of any current or future study of these compounds, or that the 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. or any foreign equivalent will approve any product based on these compounds, or that any approved product will be commercially successful. Taro is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For more information on Taro, please visit www.taro.com. SAFE HARBOR Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. STATEMENT Certain statements in this release are forward-looking statements within the meaning of 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, including statements regarding the Company's proprietary, non-sedating barbiturate compounds. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; results of future studies; scientific developments in the field of essential tremor; approval by the FDA or its foreign equivalent of a product based on any of the Company's proprietary compounds; physician, pharmacist and consumer acceptance of such a product; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise. |
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