Clinical Trial News
This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.
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Summit Receives Fast Track Designation From US FDA for Ezutromid in the Treatment of Duchenne Muscular Dystrophy
Posted 4 days ago in Clinical Trials
OXFORD, United Kingdom, Sept. 26, 2016 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, today announces it has received Fast Track designation from the US Food and Drug Administration (‘FDA’) for ezutromid in the treatment of DMD. Ezutromid is a utrophin modu...
Read more...Gilead Terminates Phase 2/3 Study of GS-5745 in Patients With Ulcerative Colitis
Posted 9 days ago in Clinical Trials
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 21, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is stopping its combined Phase 2/3 clinical study of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis. This decision follows a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC)...
Read more...Novel Novartis malaria compound shows potential to be effective against infections resistant to all currently available antimalarial drugs
Posted 9 days ago in Clinical Trials
Basel, September 21, 2016 - Today Novartis published proof of concept study results in the New England Journal of Medicine showing that its new antimalarial compound, KAF156, demonstrated activity against both vivax and falciparum malaria, including artemisinin-resistant parasites. Malaria is a life-threatening disease primarily caused by parasites (Plasmodium falciparum and Plasmodium vivax) transmitted to...
Read more...Vical and Astellas Announce Topline Results from a Phase 2 Study of Investigational Cytomegalovirus (CMV) Vaccine (ASP0113) in Kidney Transplant Patients
Posted 12 days ago in Clinical Trials
SAN DIEGO and TOKYO - September 19, 2016 – Vical Incorporated (Nasdaq: VICL) and Astellas Pharma Inc. (TOKYO: 4503) today announced topline results from a randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety and efficacy of cytomegalovirus (CMV) vaccine, ASP0113, versus placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor. Results from the study d...
Read more...Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clinical Fractures In Postmenopausal Women With Osteoporosis
Posted 12 days ago in Clinical Trials
THOUSAND OAKS, Calif. and BRUSSELS, Sept. 18, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced findings from the FRAME study showing that the investigational agent romosozumab significantly reduced the incidence of new vertebral fractures in postmenopausal women with osteoporosis through 12 and 24 months, meeting the study's co-primary endpoints. The results from the Phase 3...
Read more...Radius Announces Publication of Additional Positive Results from the Phase 3 ACTIVE Trial of Abaloparatide-SC in JBMR
Posted 12 days ago in Clinical Trials
WALTHAM, Mass., Sept. 18, 2016 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced that additional positive results from the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial were published in the Journal of...
Read more...Novartis BAF312 reduces the risk of disability progression in pivotal phase III study in secondary progressive MS patients
Posted 13 days ago in Clinical Trials
Basel, September 17, 2016 - Novartis today announced positive results of the Phase III EXPAND study showing that oral once-daily BAF312 (siponimod) significantly reduced the risk of disability progression compared with placebo in people with secondary progressive multiple sclerosis (SPMS).[1] SPMS is a form of MS characterized by continuous worsening of neurological function over time, independent of relapses.[2]...
Read more...Oral Ozanimod Efficacy and Safety Results at 2 Years from Phase 2 RADIANCE Trial of Patients with Relapsing Multiple Sclerosis Presented at 32nd ECTRIMS
Posted 2 weeks ago in Clinical Trials
BOUDRY, Switzerland--(BUSINESS WIRE) September 16, 2016 -- Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results from the 96-week blinded extension period (for a total of up to 120 weeks of exposure on treatment) of the RADIANCE phase 2 trial of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing ...
Read more...Amgen Presents Positive Data At EHMTIC 2016 Demonstrating Erenumab Significantly Reduces Monthly Migraine Days In Patients With Chronic Migraine
Posted 2 weeks ago in Clinical Trials
THOUSAND OAKS, Calif., Sept. 15, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced detailed global Phase 2 results showing erenumab demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine. The data will be presented in posters #P057 and #P058 at the 5th European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow,...
Read more...Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Sitagliptin and Metformin in People with Type 2 Diabetes
Posted 2 weeks ago in Clinical Trials
KENILWORTH, N.J., and NEW YORK, N.Y., September 15, 2016 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, in partnership with Pfizer Inc. (NYSE: PFE) today announced that a Phase 3 study (VERTIS SITA2) of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint. Both 5 mg and 15 mg daily doses of ertugliflozin showed...
Read more...GSK’s Candidate Shingles Vaccine Shows High Efficacy Against Shingles and its Complications in Adults Aged 70 Years and Over
Posted 2 weeks ago in Clinical Trials
14 September 2016 -- GSK (LSE/NYSE: GSK) today announced the publication of detailed results from a randomised phase III study (ZOE-70) of its investigational shingles vaccine, Shingrix, showing 90% efficacy in adults aged 70 years and older that is maintained for at least four years1. The results were published in the New England Journal of Medicine (NEJM). The study, from which headline results were reported in...
Read more...Aerie Pharmaceuticals Reports Positive Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results
Posted 2 weeks ago in Clinical Trials
IRVINE, Calif.--(BUSINESS WIRE)-- September 14, 2016 -- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today reported the successful 90-day primary efficacy results of its 12-month Phase 3 "Mercury 1" clinical trial for its...
Read more...Phase III Efficacy Results of Investigational Medicine Ocrevus (Ocrelizumab) Reinforced by Exploratory Analyses in Two Forms of Multiple Sclerosis
Posted 2 weeks ago in Clinical Trials
South San Francisco, CA -- September 13, 2016 -- Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY), today announced new analyses from the three Ocrevus (ocrelizumab) Phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) will be presented during the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS),...
Read more...Rexahn Pharmaceuticals Initiates stage 2 of Phase Ib/IIa Clinical Trial of RX-3117 in Relapsed or Refractory Metastatic Pancreatic Cancer
Posted 2 weeks ago in Clinical Trials
ROCKVILLE, Md., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing next generation targeted therapeutics for the treatment of cancer, today announced it has initiated stage 2 of the Phase Ib/IIa clinical trial with the novel oral anti-cancer agent RX-3117 in relapsed or refractory pancreatic cancer patients. The decision to proceed...
Read more...Bioblast Pharma Reports Results of a Clinical Trial of Trehalose in Oculopharyngeal Muscular Dystrophy (OPMD) Patients
Posted 2 weeks ago in Clinical Trials
TEL AVIV, Israel, Sept. 12, 2016 (GLOBE NEWSWIRE) -- Bioblast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company, today announced results of the Extension study for patients who completed HOPEMD, the Company’s initial clinical trial for patients with Oculopharyngeal Muscular Dystrophy (OPMD). This Extension study was a multi-center, randomized, open-label study with a n...
Read more...FDA Approves Investigational New Drug (IND) Application for Cantrixil (TRX-E-002-1) in Ovarian Cancer
Posted 2 weeks ago in Clinical Trials
SYDNEY, Sept. 12, 2016 /PRNewswire/ -- Australian oncology-focused biotechnology company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that it had received confirmation from the United States Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for Cantrixil (TRX-E-002-1) had been successfully opened, and the phase I study of Cantrixil in patients with ovarian cancer may...
Read more...Lexicon Reports Positive Top-Line Results in Pivotal Phase 3 Study for Sotagliflozin in Patients with Type 1 Diabetes
Posted 3 weeks ago in Clinical Trials
The Woodlands, Texas, September 9, 2016 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the pivotal inTandem1 Phase 3 clinical trial of sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin. Top-line results from the Phase 3 study showed that patients treated with s...
Read more...GTx Achieves Stage 1 Milestone in Phase 2 Clinical Trial of Enobosarm in ER+/AR+ Breast Cancer
Posted 3 weeks ago in Clinical Trials
MEMPHIS, Tenn.--(BUSINESS WIRE)--Sep. 8, 2016-- GTx, Inc. (Nasdaq: GTXI) today announced the achievement of the Stage 1 milestone for the 9 mg cohort of its Phase 2 clinical trial of enobosarm (GTx-024) to treat women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. A pre-defined number of patients demonstrated clinical benefit per protocol to allow the clinical trial...
Read more...Takeda Initiates Global Phase 3 Clinical Trial (TIDES) of Dengue Vaccine Candidate (TAK-003)
Posted 3 weeks ago in Clinical Trials
Osaka, Japan, September 7, 2016 – Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that it has vaccinated the first subject in the Tetravalent Immunization against Dengue Efficacy Study (TIDES), a Phase 3 double-blind, randomized and placebo-controlled trial of its live-attenuated tetravalent dengue vaccine candidate (TAK-003). TIDES will enroll approximately 20,000 healthy children be...
Read more...Evoke Pharma Announces Positive Non-Clinical Pre-NDA Meeting with FDA for Gimoti
Posted 3 weeks ago in Clinical Trials
SOLANA BEACH, Calif., Sept. 07, 2016 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (Nasdaq:EVOK) (the "Company"), a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, today announced that it has completed a pre‑New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of met...
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