Acclaimed Alcoholism Research Institution to Conduct Study of PROMETA(TM) for Initiating and Maintaining Sustained Abstinence in Alcohol Dependent Subjects.
Hythiam, Inc. (NASDAQ:HYTM) announced today that medical researcher Raymond Anton, MD, and his colleagues Drs. Hugh Myrick and Robert Malcolm, of the Center for Drug and Alcohol Program's (CDAP) Charleston Alcohol Research Center (CARC) at the Medical University of South Carolina (MUSC) will conduct a double-blind, placebo controlled clinical study of the PROMETA(TM) treatment protocol for alcoholism.
"Although PROMETA seeks to address multiple addictions -- to alcohol, cocaine and methamphetamine -- alcoholism still represents the most widespread substance abuse problem in America, with millions of victims," said Terren S. Peizer, Hythiam's Chairman and CEO. "We are gratified that researchers of the caliber of Dr. Anton and his team are interested in studying PROMETA's ability to initiate and sustain abstinence among those who suffer from alcoholism. PROMETA(TM) seeks to define a new class of treatment that may actually induce remission from alcoholism. To date, there are no FDA approved drugs or medical treatments that make this claim.
Peizer continued, "This study is synergistic with -- if not a complement to -- ongoing research on our protocols; and because it is a relatively short study it will allow for the rapid gathering and dissemination of data to interested parties. Dr. Anton's study follows on the heels of the recently announced double-blind, placebo controlled clinical study of PROMETA for methamphetamine dependence conducted by Dr. Walter Ling of UCLA. These two institutions are highly regarded as the top research entities in their respective disciplines -- South Carolina for alcoholism, and UCLA for psychostimulant dependence. We are honored by their interest and we look forward to their results."
MUSC's CDAP has the honor of being chosen by the National Institute on Alcohol Abuse and Alcoholism to be a national Alcohol Research Center. The Center's focus on pharmacotherapy and co-morbidity is based upon the philosophy that there is a biological basis for alcohol use and alcoholism. The Center's philosophy continues to be that alcohol ingestion, compulsive use, withdrawal, and relapse are associated with central nervous system dysfunction and that this dysfunction can be addressed, in part, with medications.
The principal investigator for the study is Scientific Director of the MUSC Alcohol Research Center and Director of CDAP, Dr. Raymond Anton. He is also Director of the Clinical Neurobiology Laboratory in the Institute of Psychiatry. Dr. Anton has a distinguished career in the field of alcohol research, having been involved with the National Institute on Alcohol Abuse and Alcoholism on their scientific boards and research review committees for more than fourteen years. Most recently, Dr. Anton participated in The COMBINE Study, a federally funded multisite clinical trial of using Acamprosate and Naltrexone in combination for alcoholic subjects.
"The unique aspect of the PROMETA(TM) treatment protocol for alcohol dependence is the hypothesized normalization of the altered GABA-A receptor function induced by chronic alcohol abuse and withdrawal. Normalization of the receptor, along with stabilization of glutamate output, a wide spread brain neurotransmitter, may effect a resetting of brain activity that could provide sustained therapeutic benefit over time," said Dr. Anton. "Our goal will be to conduct a robust investigation that will provide data on abstinence, cravings, and improved cognition. We will use state-of-the-art methodologies including brain imaging in order to ascertain what specific improvements are occurring if indeed a resetting/stabilization phenomenon is taking place."
The MUSC study of PROMETA(TM) is a double-blind, prospective six-week clinical trial with an eight-week follow-up period. During the acute phase, subjects will receive treatment on the first two days of either PROMETA(TM) or placebo followed by almost six weeks of continued medication or placebo. Dependent variables will include alcohol withdrawal symptoms, alcohol use, behavioral/sleep assessments, acoustic startle response, and cue-induced brain activation. All patients will receive six weeks of Combined Behavioral Intervention (CBI) therapy, a state-of-the-art behavioral counseling pioneered in The COMBINE Study.
Participants for this study will be 60 alcohol-dependent individuals, age 18-70, who are seeking treatment for their alcoholism at either the MUSC Center for Drug and Alcohol Programs (CDAP) or the VA Medical Center's Substance Abuse Treatment Center (SATC) Intensive Outpatient Program. Participants will meet DSM-IV criteria for primary alcohol dependence, drink on at least 70 percent of days in the last 30 days prior to assessment, and drink at least five drinks per drinking day. In order to focus on studying PROMETA's effects on assisting individuals with the initiation of abstinence, patients will be admitted to the study who have experienced no more than 72 hours since their last drink of alcohol.
Various tools will be used for baseline assessments, including the Alcohol Dependence Scale (ADS), the Structured Clinical Interview for DSM-IV (SCID), and the Obsessive Compulsive Drinking Scale (OCDS), among others. Additionally, three procedures will be employed to assess central nervous system functioning and craving: cognitive testing, acoustic startle and functional Magnetic Resonance Imaging (fMRI).
"This brain imaging technology will allow the direct evaluation of the effects of the PROMETA protocol on brain responsiveness to alcohol cues and craving activation," said Dr. Anton. "As such, it will provide the most proximal information on the brain, the organ that controls alcohol consummatory behavior."
Dr. Anton's work in alcohol research has led to numerous distinctions, including a Fellowship from the American College of Neuropsychopharmacology (ACNP) and service on the NIAAA Task Force on Revision of the Treatment Assessment Manual. He has also served on the board of directors of the Research Society on Alcoholism, and as an associate editor of "Alcoholism: Clinical and Experimental Research." Dr. Anton has published numerous studies and articles on alcoholism and addiction in top tier publications including the Journal of the American Medical Association, American Journal of Psychiatry, Archives of General Psychiatry, Alcohol Clinical and Experimental Research, and Neuropsychopharmacology. He earned his medical degree from Rutgers School of Medicine (currently Robert Wood Johnson School of Medicine) and did his residency in psychiatry at Yale University School of Medicine.
About PROMETA(TM) Studies
Over the past year, numerous studies have been announced regarding Hythiam's PROMETA treatment protocols. These include, but are not limited to:
--An open-label study of the PROMETA treatment protocol for methamphetamine, conducted by Dr. Harold Urschel of Research Across America in Dallas, Texas.
--A randomized controlled study of the PROMETA treatment protocol for alcohol, conducted by Dr. Jeffery Wilkins, at Cedars-Sinai Medical Center in Los Angeles.
--A multi-site, double-blind, placebo-controlled study of the PROMETA treatment protocol for methamphetamine, conducted by Dr. Walter Ling from the Integrated Substance Abuse Program (ISAP) at University of California, Los Angeles (UCLA).
Hythiam's PROMETA(TM) treatment protocols are designed for use by healthcare providers seeking to treat individuals diagnosed with dependencies to alcohol, cocaine or methamphetamines, as well as combinations of these drugs. The PROMETA(TM) protocols include medically supervised procedures designed to address both the neurochemical imbalances in the brain and some of the nutritional deficits caused or worsened by substance dependence. Changes in brain chemistry and function play an important role in the physical and behavioral symptoms of substance dependence, including tolerance, withdrawal symptoms, craving and relapse. The PROMETA(TM) protocols also provide for one-month of prescription medication and nutritional supplements, combined with psychosocial or other recovery-oriented therapy chosen by the patient in conjunction with their treatment provider. As a result, PROMETA(TM) represents an innovative approach to managing alcohol, cocaine or methamphetamine dependence that is designed to address physiological, nutritional and psychosocial aspects of the disease, and is thereby intended to offer patients an opportunity to achieve sustained recovery.
About Hythiam, Inc.
Hythiam(R) is a healthcare services management company, focused on delivering solutions for those suffering from alcoholism and other substance dependencies. Hythiam researches, develops, licenses and commercializes innovative physiological treatment protocols that seek to address substance dependence. Additionally, Hythiam provides proprietary administrative services to assist physicians and facilities with staff education, marketing and sales support, and outcomes tracking for data analysis. For further information, please visit www.hythiam.com.
Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history and lack of statistically significant formal research studies, the risk that treatment protocols might not be effective, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and substantial regulation in the healthcare industry; and additional risks factors as discussed in the reports filed by the company with the Securities and Exchange Commission, which are available on its website at http://www.sec.gov.
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|Date:||Oct 25, 2005|
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