Normalization in Medical Technology

Human Genome Sciences Reports Positive Data from Long-Term Treatment with LymphoStat-B(R) in Patients with Active Systemic Lupus Erythematosus

... that LymphoStat-B also promoted progressive normalization of autoantibody, immunoglobulin and ... or infectious events over time. -- normalization of IgG in patients with elevated IgG at baseline; ... ACR poster presentation reporting the progressive normalization of autoantibody, immunoglobulin and ...

AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria

... attacks. AMT has demonstrated that its product, AMT-021, results in normalization of the PBGD protein in an animal model of AIP. In this model, the therapy ... that develops in untreated mice. AMT-021 is intended to provide long-term normalization of the PBGD protein in order to prevent acute porphyric attacks and ...

Analysis of Ulcerative Colitis (UC) Time to Symptom Resolution Data from Pivotal Study of LIALDA(TM) (mesalamine) Presented at DDW

... 9 days and 17 days -- Placebo: 14 days and 35 days -- normalization of stool frequency at the first day and first of three days, ... 38 days and 53 days -- Resolution of both rectal bleeding and normalization of stool frequency at the first day and first of three days, ...

Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients

... of the nucleoside class. The primary objective of the studies are to assess the effect of clevudine on reducing levels of virus in the blood and normalization of liver function at 48 weeks after initiating therapy. Conference Call and Webcast Members of Pharmasset's management team will host a ...

Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections

... related to influenza. The primary objective of the study was to evaluate time to clinical stability, which is a composite endpoint comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. This type of endpoint has previously been used in ...

Phase III Trial Results Show Elitek(R) (rasburicase) Significantly Reduced Plasma Uric Acid Levels versus Allopurinol in Adults with Hematologic Cancers at Risk for Tumor Lysis Syndrome

... of PUA concentration and the safety profile in three treatment arms. Among the three treatment arms, plasma uric acid response rate (defined as normalization or maintenance of PUA levels less than or equal to 7.5mg/dl at days 3-7) was 87% of patients treated with Elitek compared to 66% receiving ...

Human Genome Sciences Reports Positive Long-Term Data for LymphoStat-B in Patients With Active Systemic Lupus Erythematosus

... reporting the safety profile of LymphoStat- B through three years, click here. To view the EULAR poster presentation reporting the progressive normalization of autoantibody, immunoglobulin and complement levels over three years of treatment with LymphoStat-B, click here. To view the EULAR poster ...

BARACLUDE(R) (Entecavir) Treatment Resulted In Greater Viral Load Suppression Compared to Adefovir at 96 Weeks In Antiviral-Naive Adult Chronic Hepatitis B E-Antigen Positive Patients

... adefovir-treated patients had viral load greater than or equal to 10^5 copies/mL. -- 97 percent (n=28/29) of BARACLUDE patients achieved ALT normalization (ALT of less than or equal one time the upper limit of normal) compared with 85 percent (n=17/20) of adefovir-treated patients. -- 24 ...

Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting

... of British Columbia (Abstract 2740) -- Sunday, December 9, 2007, 6:00 p.m.-8:00 p.m., Hall B3 and B4 (Poster Board #:930-II) -- Early normalization of Serum Free Light Chain Is Associated with Prolonged Time to Progression Following Bortezomib Pegylated Liposomal Doxorubicin Treatment of ...

Indevus Pharmaceuticals Reports Positive Results of Phase II Octreotide Implant Trial

... Approximately 60% of these implant trial patients achieved a normal age-adjusted IGF-1 concentration. Sandostatin LAR produces a similar age-adjusted normalization of IGF-1 concentrations (51 to 67%). The remaining patients had entered the trial with baseline GH levels >5 ng/mL, and 59% achieved GH suppression ...

New Analyses of Long-Term LIALDA(TM) (mesalamine) Data Presented at ACG

... from the LIALDA 301 and 302 studies examined the treatment time required for patients to experience initial symptom resolution of rectal bleeding and normalization of stool frequency. Patients with active, mild-to-moderate UC were randomized to receive LIALDA 2.4g/day (given once or twice daily) or 4.8g/day ...

Baraclude (entecavir) Therapy Resulted in Undetectable Levels of Hepatitis B Virus in Cohort of Patients Who Re-Started Treatment

... - polymerase chain reaction or PCR) and 83 percent achieved liver enzyme normalization (ALT less than or equal to 1xULN) after 48 weeks of therapy. "This ... of re-treatment with BARACLUDE -- 83 percent (n=79/95) of patients had ALT normalization (ALT less than or equal to 1 times the upper limit of normal) by week 48 ...

Helix BioPharma Corp. Announces Positive Phase II Clinical Results with its Topical Interferon Alpha-2b

... as the proportion of patients with resolution of their abnormal Pap smear LSIL cytology to normal during the 12 week study duration. Pap smear normalization was considered to occur if the patient's Pap smear improved to group II or better from any of Pap smear groups IIW through IIID as per the common ...

Intarcia Therapeutics Announces Final Results From a Phase 2 Study of Injectable Omega Interferon plus Ribavirin for the Treatment of Hepatitis C Genotype-1

... due to adverse events. Results of this Phase 2 study suggest a favorable overall safety profile with no substantial safety issues being identified. normalization of serum ALT, a marker of reduced liver inflammation, occurred in 100% of patients achieving SVR and no patients receiving omega interferon with ...

Intarcia Therapeutics Announces Presentation of Final Results From a Phase 2 Combination Study for the Treatment of Hepatitis C at the Digestive Disease Week Conference

... due to adverse events. Results of this Phase 2 study suggest a favorable overall safety profile with no substantial safety issues being identified. normalization of serum ALT, a marker of reduced liver inflammation, occurred in 100% of patients achieving SVR; and no patients receiving omega interferon with ...

Investigational Drug Cediranib (AZD2171) Shows Promise in Patients With Recurrent Glioblastoma (GBM)

... own debilitating side effects. Based on the first 16 patients a steroid-sparing effect was demonstrated in most patients and was associated with the normalization of tumor vessels. This normalization might help to secure delivery and improve effectiveness of other therapeutic techniques such as ...

Repros' Androxal Shows Highly Statistically Significant Positive Effects in Men with Secondary Hypogonadism

... and 31.9% for 12.5mg, 25mg, Androgel and placebo arms, respectively. The improvement in total testosterone in the Androxal arms was the result of normalization of the pituitary gonadotrophic hormones LH (luteinizing hormone) and FSH (follicle stimulating hormone). Consistent with the diagnosis of secondary ...

Neurologix Announces Publication of Landmark Gene Therapy Study Demonstrating Safety and Statistically Significant Improvement in Patients With Advanced Parkinson's Disease

... brain are impressive. Moreover, the PET results offer an important window into the function of the living brain in these patients, which supports a normalization of brain activity specific to the treated hemisphere." The study used an adeno-associated virus (AAV) vector to deliver an inhibitory gene ...

Generex Biotechnology to Make Presentations At 46th Annual Meeting of the European Society of Pediatric Endocrinology

... Doctors Jaime Guevara-Aguirre, Marco Guevara-Aguirre, and Jeannette Saavedra, all of the Institute of Endocrinology IEMYR, Quito, Ecuador; and Near normalization of Metabolic Control in Type-1 DM Using Conventional Insulin Therapy and a 13-Point Method Designed to Enhance Compliance, by Doctors Jaime ...