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Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

INDIANAPOLIS and EDMONTON, Alberta, July 27 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

- Late-Breaking Data from Pivotal BLOOM Trial Presented at the American Diabetes Association's 69th Scientific Sessions Expand on Previously Announced Positive Top-Line Results - NEW ORLEANS, June 6, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) announced today...

Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms

SAN FRANCISCO, May 18 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY ), the global specialty biopharmaceutical company, today announced new findings on INTUNIV (guanfacine) extended release, a selective alpha-2A-agonist, at a major psychiatric meeting. This randomized placebo con...

Data Presented at American Headache Society's Annual Scientific Meeting Show Primary Endpoint Met as Well as Improvement on Important Secondary Endpoints in Phase IIb Acute Migraine Trial of TorreyPines Therapeutics' Tezampanel

Company's End-of-Phase II Meeting with FDA Set for Sept. 29 LA JOLLA, Calif., June 30 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX ) today announced that data presented at the 50th Annual Scientific Meeting of the American Headache Society showed that, in addition to mee...

Ceragenix Announces Results from Phase IV Study of EpiCeram Meet All Primary and Secondary Endpoints

DENVER--(BUSINESS WIRE)--Apr 24, 2007 - Ceragenix Pharmaceuticals Inc. (OTCBB:CGXP) today announced positive results from its post-clearance marketing study comparing EpiCeram's(TM) efficacy to that of Cutivate(R) cream, a mid-strength topical steroid in the treatment of moderate-to-severe atopic d...

BDSI Announces Positive Key Secondary Efficacy Endpoint Results for Bema Fentanyl

MORRISVILLE, N.C.--(BUSINESS WIRE)--May 14, 2007 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced additional statistically significant results with BEMA Fentanyl in cancer patients with breakthrough pain in its Phase III efficacy clinical trial for the product. Results were base...

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

THE WOODLANDS, Texas--(BUSINESS WIRE)--Jun 5, 2007 - Repros Therapeutics Inc. (NasdaqGM:RPRX) announced topline results of a six month U.S. Phase 3 study of Androxal(TM), an oral drug being developed to restore normal testicular function in men with secondary hypogonadism. Further, Androxal demonst...

YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial

- Company Announces Lead Investigator for U.S. Trial - MISSISSAUGA, ON, July 11, 2007 /PRNewswire-FirstCall/ - YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced results of secondary endpoint data f...

Tiny Cup Attached to Eye Improves Drug Delivery For Retinal Diseases

...achieve a therapeutic concentration in the retina. The chemotherapy destroys the bone marrow and depresses the child's immune system, often leading to secondary infections. Intravitreal injections using a syringe, often used to treat age-related macular degeneration, require frequent out-patient visits ...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

...tibix and FOLFOX4 once every two weeks (Q2W) or FOLFOX4 alone Q2W. The primary endpoint of the study is progression-free survival by KRAS status and secondary endpoints include overall survival, objective response rate, time to progression, duration of response and safety. Long-term follow up for overall sur...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

... 26 weeks of treatment with mipomersen versus 3% for placebo and all of its secondary endpoints in a highly statistically significant manner. We are very please...ent, vs. 3% for placebo (p<0.001). The study also met each of its three secondary endpoints of reduction in apoB, total cholesterol and non-HDL-C. Ge...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...n the trazodone group versus the placebo group. Statistical significance was achieved for the primary endpoint (p value of 0.012). The majority of the secondary efficacy end points, including the HAMD-17 depressed mood item, the Clinical Global Impressions Severity (CGI-S) scale, the Montgomery Asberg Depressi...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies... cancer) or multiple myeloma and bone metastases. secondary endpoints were to evaluate if denosumab is superio...e number of patients developing metastatic disease secondary to a primary cancer is increasing. Bone metastases...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

...enotype 1. The primary objective was to assess the safety, tolerability, and pharmacokinetics of PSI-7851 after once-daily (QD) dosing for 3 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. Patients were randomized to receive either PSI-7851 (8 patients per coh...

British Woman Celebrates a Year of Living Cancer-Free

...m remission," Dr. Kottaridis said. "However, this is a Phase I study that has been designed to assess toxicity as the main end point, efficacy being a secondary one. It is very important for us to be able to recruit more patients and complete the current phase before moving to a multicenter international study...

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

...J Am Acad Child and Adolesc Psychiatry. 2009;48(2):1-11. 3. Connor D, Spencer T, Kratochvil C, et al. Effects of guanfacine extended release on secondary measures in children with attention-deficit/hyperactivity disorder and oppositional symptoms. Presented at the American Psychiatric Association Annual...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

...usal women with an intact uterus aged 40 to 75 years. The primary end point of the SMART-1 trial was incidence of endometrial hyperplasia at one year. secondary end points included bone mineral density (BMD) at two years, menopausal vasomotor symptoms at four and 12 weeks, vaginal maturation index at six month...

Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression

... (CGI-I) and the Quick Inventory of Depressive Symptomatology (QIDS SR-16). secondary endpoints included the CGI-S, IDSC30 and HAMA. The data presented at the NC...istically significant. BCI-952 also demonstrated improvements on the secondary endpoints of the IDSC30, HAMA and CGI-S. These improvements were statistica...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

...y endpoint for the clinical trial was the percent of patients assigned to the R788 100 mg bid dose who were ACR 20 responders at the end of 3 months. secondary efficacy endpoints included other ACR scores and, a comparison of response rates for the R788 100 mg bid dose versus placebo as determined by MRI usin...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

...daily in a variable dose determined by patient blood sugar levels. There was no lead-in or wash-out period. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outc...

First Potential Lupus-Specific Treatment in Sight

...lupus and the first Phase III (late stage) trial of a new biologic immune therapy for lupus to succeed in meeting its primary endpoint and most of its secondary endpoints. Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statem...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

...n for the primary endpoint. -- Results for prespecified major secondary efficacy endpoints were: -- A significantly greater percentage of...ferent among treatment groups. However, although not a major secondary endpoint, improvement in the SF-36 PCS score at Week 52 was s...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

...mg and 600 mg in both single and multiple doses were generally safe and well-tolerated in these trials. Further analyses of the study data, including secondary efficacy endpoints and detailed safety is underway. Additional data will be submitted for presentation at an upcoming medical meeting. "The...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

...dy. The primary efficacy endpoint of the study is the mean change from baseline in viral load (log10 HIV RNA) at week 48 of treatment. A key secondary efficacy endpoint is the proportion of patients with plasma HIV RNA less than 50 copies/mL at week 48 of treatment. Atazanavir boosted by rit...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

...y efficacy endpoint for the study was the percent of patients assigned to the R788 100 mg bid dose who were ACR 20 responders at the end of 6 months. secondary efficacy endpoints included a comparison of response rates for the R788 100 mg bid and R788 150 mg qd doses at the ACR 20, ACR 50 and ACR 70 scores, a...

FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)

...May 2, 2006, and is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

...ts with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compa...the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies...s with advanced breast cancer and bone metastases. secondary endpoints were to evaluate if denosumab was superi...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

... Study in major abdominal surgery patients achieved primary and secondary endpoints REDWOOD CITY, Calif., June 29 /PRNewswire/ -- AcelRx Pharmac...tients who dropped out due to inadequate analgesia, a clinically meaningful secondary endpoint, was also significantly different from placebo (p<0.001) for bo...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

... presented at the IEC further reinforce the efficacy and safety of eslicarbazepine acetate in the treatment of partial-onset seizures, with or without secondary generalisation(3,4). Pooled data from more than 1,000 patients enrolled in the three pivotal phase III studies demonstrated that add-on therapy...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

...a." Only preliminary top-line efficacy and safety data are available at this time. Further analyses are planned, including analyses of additional secondary endpoints. Jazz Pharmaceuticals anticipates submitting a New Drug Application for sodium oxybate to the U.S. Food and Drug Administration (FDA) by the...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

...y. The primary endpoint will be the change in the amount of kidney interstitial capillary GL-3 as measured in kidney biopsies using histology. secondary endpoints will include safety and tolerability, kidney GL-3 as measured in urine, and an assessment of renal function (including glomerular filtration...

HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject for Second Phase II Study

...ling signals will be generated that can support healing of the wound by the patient's own cells. Typically caused by impaired microcirculation secondary to venous hypertension, venous leg ulcers are increasingly common, are costly, and are often a cause of prolonged suffering for patients. Characterize...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

...nited States. The primary composite endpoint for PROTEGE includes both the patient's total daily insulin usage and his/her HbA1c levels at 12 months. secondary endpoints are evaluated at 24 months. Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separ...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

...fidence-interval, 20m to 69m), as compared to 23m (95 percent confidence-interval, -2m to 48m) in patients on background bosentan therapy. Among secondary objectives, patients administered tadalafil 40 mg showed improvement in time to clinical worsening, as compared to placebo (5 percent for tadalafil 40...

Isis Highlights New Data on Antisense Drugs to Treat Type 2 Diabetes and Obesity at ADA Scientific Sessions

... the highest dose accompanied by a significant increase (>100-fold) in glucose excretion in the urine in multiple species including monkeys secondary improvements in glucose tolerance and insulin sensitivity Significant reduction in plasma glucose levels in extremely hyperglycemic animals ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

...failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure o...p-value 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-valu...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

...all lymphocytic lymphoma; all of whom had experienced disease progression despite prior treatment. The primary endpoint of the study is to assess ORR. secondary endpoints include assessment of progression-free survival (PFS), overall survival, time to disease progression and the safety profile of Afinitor(1). ...

Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients

... (n=334) or premixed biaspart 70/30 insulin BID (BPA 70/30) twice-a-day (n=343). The primary endpoint was mean change from baseline to week 52 in A1C. secondary objectives were proportion of subjects reaching specific A1C levels and treatment differences in postprandial plasma glucose (PPG), fasting plasma glu...

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

...ic subjects (n=145). The main study end-point was change from baseline in pre-bronchodilator FEV(1) at 2 years (non inferiority margin of 50 ml/year). secondary endpoints included change from baseline in other PFT parameters (forced vital capacity, total lung capacity, and carbon monoxide diffusion test). ...

Large, Long-Term Study Shows Avandia Has No Increased Overall Cardiovascular Risk Compared to Other Commonly Used Diabetes Medicines

... patients randomized to Avandia, the results for the following prespecified secondary endpoints also showed: Fewer deaths from any cause (136 ... interval=0.49 to 1.06) None of the differences for these secondary endpoints (any cause death, cardiovascular death, MACE, heart attack and st...
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