Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

Natural Interferon Alpha Boosts Saliva Production In Patients With Sjogren’s Syndrome AMARILLO, TX -- January 5, 2001 -- Amarillo Biosciences, Inc. (ABI) announces the completion of the Company's second phase III clinical trial in primary Sjogren's syndrome. Sjogren's syndrome is an autoimmune connective tissue disorder which affects between one and two million people in the United States and a similar number in Europe. Sjogren's syndrome patients characteristically suffer from dry mouth and eyes. Dry mouth frequently compromises the oral health of these patients and makes it difficult to eat and talk. Increasing natural saliva production is a treatment goal in Sjogren's syndrome patients. The phase III clinical trial was a double-blinded, placebo-controlled study in which 256 patients were treated three times daily with a lozenge containing either 150 International Units of natural interferon alpha (IFN-a) or with a placebo for 24 weeks. An improvement in saliva production was noted in the group given IFN-a. This result was similar to that seen in the initial phase III study which utilized the same protocol. The most robust increases were noted in unstimulated whole saliva (UWS) production, with the IFN-a treated patients who completed the entire 24 weeks demonstrating more than 2 times the increase of the placebo group. Increases in stimulated whole saliva (SWS) and improvement in a number of subjective measures of dry mouth also favored the IFN-a group. There were highly significant correlations between improvements in UWS and SWS at 24 weeks and between increased UWS and improvement in oral symptoms in the IFN-a treated patients, including oral dryness (p=0.001), oral comfort (p=0.03), the ability to swallow dry food (p=0.003), the ability to swallow any food (p=0.001) and throat dryness (p=0.03). Significant correlations between these measures were not found in the placebo group. In study patients (68 percent of those enrolled) who had circulating autoantibodies, a frequent finding in patients with Sjogren's syndrome, there was a significantly greater improvement in UWS in the IFN-a group compared to placebo at the conclusion of the trial (p=0.03). This finding is important in that the presence of one or more autoantibodies is likely to have increased importance in the diagnosis of Sjogren's syndrome in the future. The Company plans to discuss these findings, in addition to the combined results of the phase III clinical studies, with the FDA during an upcoming teleconference. When results from the two identical phase III trials are combined, significant increases in UWS are found at the 24 week time point in the IFN-a treated patients compared to controls (p=0.0134). Moreover increases from baseline in UWS within the IFN-a group were highly significant (p=0.0005). Patients within the IFN-a treated group also had significant (p=0.0001) improvement from baseline in symptoms of oral dryness, oral comfort and throat dryness. The improvement in these and other symptoms was highly correlated with changes in both the UWS and SWS. "The finding of an increase in UWS is particularly important for patients with Sjogren's syndrome, as UWS represents the baseline production of saliva that patients experience throughout the day," said Joseph M. Cummins, President and CEO for Amarillo Biosciences. "The UWS is of paramount importance in maintaining a healthy mouth and oral comfort. We believe that increases in UWS may be the result of improvement in the underlying gland function and salivary pathology of this disorder. This suggests that IFN-a is more than a symptomatic treatment in Sjogren's syndrome; it addresses the underlying secretory dysfunction. If proven, IFN-a will represent a true advance in therapeutic options for this condition." As revealed in news release of April 7, 2000, measurements of stimulated whole saliva and subjective oral dryness were the primary end points of the study. When an intent-to-treat analysis was used to analyze the data, which includes all randomized patients regardless of whether they completed the full trial, the results were not significant. Further clinical trials will focus on examining histopathological improvements in labial minor salivary glands as a result of low dose natural IFN-a treatment. E-mail this page to a friend or colleague! To print, use this version