Cypress Bioscience Featured in invivodata Webconference.Business Editors & Health/Medical Writers SAN DIEGO--(BW HealthWire)--June 18, 2002 The invivodata(TM) Web seminar held on Friday, June 14, 2002, featured Cypress Bioscience Inc. (Nasdaq:CYPB) Chief Medical Officer R. Michael Gendreau, M.D., Ph.D. Dr. Gendreau presented Cypress' approach to measuring spontaneous pain in its Fibromyalgia Syndrome fibromyalgia syndrome Fibrositis, tension myalgia Psychiatry A condition characterized by muscular pain, fatigue, sleep disorders, anxiety, depression, headaches, IBS–possibly linked to anxiety and panic disorders Management Exercise, benzodiazepines, SSRIs, (FMS FMS - Flexible Manufacturing System (factory automation). ) clinical research. The seminar, entitled, "Increasing Sensitivity of Patient Self Report Data," included a review of data collected during a pilot study conducted by Cypress at Georgetown University's world-renowned Chronic Pain and Fatigue Research Center. In this study, Cypress and Georgetown measured the patient's real-time pain experiences, sleep quality and overall satisfaction with their treatment via an electronic patient experience diary system. The electronic diary system allows one to collect patient-reported real-time data, as opposed to relying on a traditional paper diary system wherein a patient has to recall and record in a journal pain experienced at some prior time. The analyses of the pilot data showed that the real-time data more accurately reflected patients' experiences than weekly or monthly summaries of their pain. Cypress' experience with the invivodata(TM) system in this pilot trial convinced the company to use it in their current Phase II trial of the drug Milnacipran, an NSRI NSRI National Sea Rescue Institute (South Africa) NSRI National Survey of Religious Identification NSRI Noradrenalin Serotonin Reuptake Inhibitor (norepinephrine norepinephrine (nôr'ĕpīnĕf`rən), a neurotransmitter in the catecholamine family that mediates chemical communication in the sympathetic nervous system, a branch of the autonomic nervous system. and serotonin reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. inhibitor), which is currently being evaluated as a potential treatment for FMS. "The invivodata(TM) system is able to deliver real-time data that provides a less biased view of our patients' pain experiences. This kind of data cannot be collected with paper diaries. Moreover, by uploading data nightly from the diaries and posting compliance reports and feedback in real-time on the Web, our site coordinators have information they can use to manage the trial effectively," said Dr. Gendreau. Cypress' Phase II trial of Milnacipran is distinguished from previous FMS trials not only by the electronic patient experience diary system, but also by other novel assessment tools that have been developed by the company and incorporated into the study design. It is known that people with FMS have a lower threshold for "evoked" pain in response to an unpleasant stimulus. Therefore, evoked pain is being measured throughout the trial via an instrument that was designed and validated by Cypress -- the Automated Pain Threshold Tester (APT2). The APT2 automates and standardizes the testing and measurement of evoked pain. Fifteen physician practices across the United States are participating in the Phase II trial of Milnacipran. The participating sites are a mix of large community-based rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. practices and academic medical centers, including The Cleveland Clinic, and The Hospital for Special Surgery in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of . Patient recruitment into the trial began earlier this year, with a goal of enrolling approximately 200 patients by the end of the year. About FMS Fibromyalgia Syndrome (FMS) is characterized by widespread pain and stiffness throughout the body accompanied by severe fatigue, poor sleep and headache. FMS patients have at least comparable disability, more pain and lower quality of life than patients with rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. . FMS is estimated to affect between 2-4 percent of the world's population and is both chronic and severely debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction . FMS is the second most commonly diagnosed disorder in rheumatology clinics, second only to osteoarthritis. Currently, there is no 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. approved treatment for FMS. As a result, treatments utilized today are mainly palliative and consist of a regimen that includes medication to diminish pain and improve sleep, exercise programs that stretch muscles and improve cardiovascular fitness, and relaxation techniques to ease muscle tension. Antidepressants Antidepressants Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics , such as tricyclic antidepressants (TCAs), are often prescribed for FMS patients, as low doses of these medications appear to relieve pain associated with FMS. In some cases, medications that promote deeper sleep and relax muscles and traditional non-narcotic pain medications also provide some relief. About Cypress Bioscience Inc. Cypress is committed to be the innovator and commercial leader in providing products for the diagnosis and treatment of patients with Functional Somatic Syndromes, such as Fibromyalgia Syndrome, or FMS, and other related chronic pain and central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . In January 2001, the company began a strategic initiative focusing on FMS. In August 2001, Cypress licensed its first product for clinical development, Milnacipran. Milnacipran, the first of a new class of agents known as NSRIs, or Norepinephrine Serotonin Reuptake Inhibitors, shares a pharmacological profile with the tricyclic antidepressants (TCAs), considered the most effective drugs for treatment of FMS, while appearing to lack the side effects associated with the latter. Milnacipran is currently being evaluated as a potential treatment for FMS in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II . For more information about Cypress, please visit the company's Web site at www.cypressbio.com. For more information about FMS, please visit www.FMSresource.com. This press release, as well as Cypress' SEC filings and web site at http://www.cypressbio.com, contain 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. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress Annual Report on Form 10-K and any subsequent SEC filings. In addition, there is the risk that we may not be able to successfully develop or market any products for the treatment of FMS under the Pierre Fabre agreement or at all; that our clinical development plan or timeline for milnacipran may be delayed, including our Phase II clinical trial; that the capital that we raised will not allow us to execute our business plans into 2003; that we may encounter regulatory or other difficulties in the development of milnacipran for FMS; and that milnacipran may not significantly improve the treatment of FMS. Cypress undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law. |
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