Addiction Therapies, Inc. Presents Phase I/II Data on The Straw Nicotine Oral Delivery System, a New Smoking Cessation Treatment.Business Editors and Health/Medical Writers BioWire 2K WAYLAND, Mass.--(BW HealthWire)--Feb. 25, 2002 Study Supports ATI's Novel Approach to Treating Addiction by Combining Cognitive Enhancing Medication with Patient Controlled Drug The United Kingdom Misuse of Drugs Act 1971 aimed to control the possession and supply of numerous listed drugs and drug-like substances. The act allowed and regulated the use of some Controlled Drugs (designated CD) by various classes of persons (e.g. Delivery Addiction Therapies, Inc., (ATI (ATI Technologies Inc., Markham Ontario, http://ati.amd.com) A leading manufacturer of graphics chips and display adapters. Founded in 1985 by K. Y. Ho, Benny Lau and Lee Lau, ATI chips and boards are widely used by OEMs. ) today announced positive Phase I/II clinical data for The Straw(TM) Nicotine Oral Delivery System for tobacco dependence. Study results demonstrated that oral delivery of nicotine with The Straw(TM) was well tolerated at dose levels of 4, 8 and 12 mg, and achieved systemic nicotine levels comparable to currently marketed nicotine replacement therapies Nicotine replacement therapy A method of weaning a smoker away from both nicotine and the oral fixation that accompanies a smoking habit by giving the smoker smaller and smaller doses of nicotine in the form of a patch or gum. . The company presented results from the Phase I/II study over the weekend at the Society for Research on Nicotine and Tobacco, in Savannah, Georgia Savannah is a city located in (and the county seat of) Chatham County, Georgia (USA). The city's population was 128,500 in 2005, according to the most recent U.S. Census estimate. Savannah was the first colonial and state capital of Georgia. . The Straw(TM) is the first product in ATI's portfolio of active cognitive pharmacotherapy pharmacotherapy /phar·ma·co·ther·a·py/ (-ther´ah-pe) treatment of disease with medicines. phar·ma·co·ther·a·py n. Treatment of disease through the use of drugs. products with clinical data that support the company's approach to treating addiction by combining cognitive enhancing medication with patient controlled drug delivery. "These positive data establish the core feasibility of ATI's active cognitive pharmacotherapy approach to treating behavioral disorders such as tobacco dependence and other addictions. In addition, these results will allow ATI to move The Straw(TM) forward in the clinical process, one step closer to providing a potentially more effective product to the millions of smokers who are trying to quit," said David Dlesk, Chief Executive Officer of Addiction Therapies, Inc. The Straw(TM) is a novel form of nicotine replacement therapy for smoking cessation smoking cessation Public health Temporary or permanent halting of habitual cigarette smoking; withdrawal therapies–eg, hypnosis, psychotherapy, group counseling, exposing smokers to Pts with terminal lung CA and nicotine chewing gum are often ineffective. . It is expected to better address a smoker's behavioral needs than other products in the $1 billion nicotine replacement therapy market. Designed to be easy and pleasant to use, The Straw(TM) is a single-use plastic straw containing small beads of nicotine. An individual sips any beverage through The Straw(TM) and swallows the nicotine beads. The entire dose of nicotine is delivered in the first sip. The empty straw can then be thrown away or retained to occupy the individual's hand and mouth, replacing the stimuli associated with smoking. Early in the attempt to quit, patients may use The Straw(TM) every time they crave a cigarette - up to 10-12 times per day - to redirect the motor memories associated with craving away from a cigarette and toward The Straw(TM). Over a 12-week course of treatment, both the number of straws and the dose of nicotine per straw may be reduced until the individual has successfully stopped smoking. The nicotine is expected to serve a dual purpose of easing the smoker's cravings as well as enhancing the cognitive process by which the smoker learns not to smoke. Nicotine is a safe drug at low doses, and though it is the substance that contributes to tobacco dependence, it has not been linked to the life-threatening illnesses which result from smoking. The Straw(TM) is protected by an issued patent in-licensed on an exclusive basis from Duke University and a pending patent application from ATI. The Phase I/II clinical trial was a double-blind placebo-controlled safety and pharmacokinetic study of The Straw(TM) in 24 smokers. In part A of the study, subjects were given a single dose of nicotine in The Straw(TM) (placebo, 4, 8, or 12 mg nicotine); in part B, they received doses every 1.5 hours over a 10.5-hour period. Nicotine delivery via The Straw(TM) increased systemic levels of nicotine to levels comparable to or higher than those of currently marketed nicotine replacement therapy products. Early indications of efficacy were measured by the smokers' reduced cravings for cigarettes depending on the size of the dose and the time since the last dose was administered. No serious or unexpected adverse events were observed. Gastrointestinal disturbances (nausea, vomiting, diarrhea) were the most common adverse events and are typical of high systemic levels of nicotine. The core of ATI's approach to treating behavioral disorders such as addiction is active cognitive pharmacotherapy. "Addiction, like many other behavioral disorders, is a memory-driven disease," said Barbara S. Fox, Ph.D., ATI's founder and Chief Scientific Officer. "Exposure to cues previously associated with drug use triggers memories that drive unhealthy behavior. ATI is developing therapeutics that will, for the first time, help patients overwrite (1) A data entry mode that writes over existing characters on screen when new characters are typed in. Contrast with insert mode. (2) To record new data on top of existing data such as when a disk record or file is updated. those memories and move down the path to recovery." ATI is using effective cognitive enhancers with a unique patient-controlled drug delivery platform, FREEDOM(TM) (Frequent or Episodic Dosing of Medication), to target and overwrite memories that drive unhealthy behavior. ATI has pending patents covering the core concept of active cognitive pharmacotherapy. The current market for addiction and behavioral medications is $4 billion and growing rapidly. Most behavioral disorders have few or no effective pharmacotherapies available, resulting in a significant unmet medical need. ATI currently has 3 products in development for the treatment of addictive disorders Addictive disorders Addictive disease disorders are characterized by the chronic use of a drug (such as heroin, cocaine, or amphetamines), alcohol, or similar substances. . In addition to The Straw(TM), the company is developing Cobrex(TM), a small molecule dopamine reuptake inhibitor Dopamine Reuptake Inhibitors (DARI), Dopamine Uptake Inhibitors, Dopamine Transporter Inhibitors are compounds that inhibit the reuptake of extracellular dopamine back into the presynaptic cell by blocking the cell membrane-spanning dopamine transporter. for the treatment of cocaine addiction. Development through the first two clinical trials for Cobrex(TM) will be funded by a $4.7 million NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. grant. The third product is Albrex(TM), a small molecule therapeutic for alcoholism. Albrex(TM) is a broad-spectrum neurotransmitter neurotransmitter, chemical that transmits information across the junction (synapse) that separates one nerve cell (neuron) from another nerve cell or a muscle. Neurotransmitters are stored in the nerve cell's bulbous end (axon). reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. inhibitor designed to overwrite associative memories of addiction, and to treat the cognitive deficits and depression that are commonly seen in alcoholics. Both Cobrex(TM) and Albrex(TM) are in late pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. and are based on technology in-licensed from the Research Triangle Institute The Research Triangle Institute (RTI) is a non-profit research organization based in the Research Triangle Park (RTP) of North Carolina. RTI is the oldest tenant of this major research park, and the sister organization to the Research Triangle Foundation. . ATI successfully closed a $500,000 angel round of financing in December 2001. The round was led by Alison Taunton-Rigby, Ph.D., a member of ATI's board of directors, and included a number of successful, experienced biotechnology executives. ATI is currently looking to raise an institutional round of financing to fund ongoing clinical and pre-clinical development of the Company's products. Addiction Therapies, Inc. (ATI) is developing novel therapeutics to rescue patients from behavioral disorders such as addiction. ATI's active cognitive pharmacotherapy technology combines cognitive enhancing medications with proprietary patient-controlled drug delivery to overwrite the memories that drive behavioral disorders. The Company has three products in clinical development for tobacco dependence, cocaine addiction and alcoholism. ATI's early-stage programs are focused on different forms of drug addiction drug addiction or chemical dependency Physical and/or psychological dependency on a psychoactive (mind-altering) substance (e.g., alcohol, narcotics, nicotine), defined as continued use despite knowing that the substance causes harm. , anxiety, eating disorders eating disorders, in psychology, disorders in eating patterns that comprise four categories: anorexia nervosa, bulimia, rumination disorder, and pica. Anorexia nervosa is characterized by self-starvation to avoid obesity. and other impulse control disorders Impulse Control Disorders Definition Impulse control disorders are characterized by an inability to resist the impulse to perform an action that is harmful to one's self or others. . For more information about ATI, please visit http://www.addictiontherapies.com. This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the Company's (i) technologies, product candidates, intents and goals, and (ii) research and development plans. Forward-looking statements reflect ATI's current estimates with respect to future events. Actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. |
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