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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.

Arena Pharmaceuticals Completes Enrollment in Ralinepag Phase 2 Clinical Trial for Pulmonary Arterial Hypertension (PAH)

Posted 3 days ago in Clinical Trials

SAN DIEGO, Dec. 7, 2016 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that it has completed enrollment in the ralinepag phase 2 trial. Ralinepag is an oral, selective IP receptor agonist targeting the prostacyclin pathway for the treatment of pulmonary arterial hypertension (PAH). The study enrolled approximately 60 patients at sites globally. "This marks an important step in the...

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Sage Announces Expedited Development Plan for SAGE-547 in the Treatment of Postpartum Depression based on FDA Breakthrough Therapy Meeting

Posted 4 days ago in Clinical Trials

CAMBRIDGE, Mass. December 6, 2016 --(BUSINESS WIRE)-- Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced its expedited development plan for SAGE-547 following receipt of formal meeting minutes from a breakthrough therapy meeting with the U.S. Food and Drug Administration (FDA). This...

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Theravance Biopharma Receives FDA Fast Track Designation for Velusetrag (TD-5108) for Idiopathic and Diabetic Gastroparesis

Posted 4 days ago in Clinical Trials

DUBLIN, Dec. 6, 2016 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis. Velusetrag is an oral investigational drug in development for the treatment of patients...

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Novartis presents results from first global registration trial of CTL019 in pediatric and young adult patients with r/r B-ALL

Posted 6 days ago in Clinical Trials

Basel, December 4, 2016 - Findings from a Novartis clinical trial (ELIANA) evaluating efficacy and safety of CTL019, an investigational chimeric antigen receptor T cell (CAR T) therapy, in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) will be presented today during an oral session at the 58th American Society of Hematology (ASH) annual meeting (Abstract...

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Acetylon Presents Early Phase 1a/1b Results for Citarinostat (ACY-241) in Combination with Pomalyst and Dexamethasone Showing Promising Treatment Responses in Relapsed or Relapsed-and-Refractory Multiple Myeloma

Posted 6 days ago in Clinical Trials

BOSTON – December 4, 2016 – Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, today announced that it will present initial clinical data from a Phase 1a/1b clinical trial evaluating the safety and preliminary anti-tumor activity of the selective HDAC6 inhibitor citarinostat (ACY-241), in combination with pomalidomide (Po...

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Phase 2 Results Show Investigational Compound Glasdegib Improved Overall Survival in Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

Posted 7 days ago in Clinical Trials

December 3, 2016 - Today, Pfizer Inc. (NYSE:PFE) announced new data from a randomized Phase 2 study of glasdegib (PF-04449913), an oral, smoothened (SMO) inhibitor, showing the addition of glasdegib to low-dose cytarabine (LDAC) significantly increased overall survival (OS) when compared to LDAC alone in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who were ineligible for...

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Novartis SEG101 (crizanlizumab, formerly SelG1) significantly reduces frequency of sickle cell pain crises in Phase II study

Posted 7 days ago in Clinical Trials

Basel, December 3, 2016 - Results from the Phase II SUSTAIN study show that SEG101 (crizanlizumab, formerly SelG1), an anti-P-selectin antibody, reduced the median annual rate of sickle cell-related pain crises (SCPC) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in patients with or without hydroxyurea therapy[1]. "Acute painful episodes, commonly referred to as vaso-occlusive crises, are a substantial...

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U.S. FDA Grants Fast Track Designation for HER2-Targeting Antibody Drug Conjugate DS-8201 for HER2-Positive Metastatic Breast Cancer

Posted 9 days ago in Clinical Trials

Tokyo, Japan, and Parsippany, N.J. – (December 1, 2016) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational HER2-targeting antibody drug conjugate DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior tre...

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Cytokinetics Announces Start Of GALACTIC-HF, a Phase 3 Clinical Trial of Omecamtiv Mecarbil

Posted 9 days ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., Dec. 01, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced the activation of the first clinical site and the start of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil which is being conducted by Amgen, in collaboration with...

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The Lancet Publishes Results From COSMIC-HF Trial Showing Omecamtiv Mecarbil Significantly Improved Cardiac Function In Patients With Chronic Heart Failure

Posted 10 days ago in Clinical Trials

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Nov. 30, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Cytokinetics, Inc. (NASDAQ:CYTK) today announced The Lancet published results from a Phase 2 clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure. The COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) trial met its primary...

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ViiV Healthcare Launches Phase III Program to Evaluate a Long-Acting, Injectable HIV Treatment Regimen

Posted 12 days ago in Clinical Trials

London, 18 November 2016 -- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the start of two phase III studies designed to evaluate an investigational long-acting, injectable regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC) for the treatment of HIV-1 infection. The two studies,...

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GSK Starts Phase III Programme with Daprodustat for Anemia Associated with Chronic Kidney Disease

Posted 2 weeks ago in Clinical Trials

London 24 November 2016 -- GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a phase III development programme investigating daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a treatment for anaemia associated with chronic kidney disease (CKD). The phase III programme includes two studies evaluating the safety and efficacy of daprodustat compared to...

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Lilly Announces Top-Line Results Of Solanezumab Phase 3 Clinical Trial

Posted 2 weeks ago in Clinical Trials

INDIANAPOLIS, Nov. 23, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a phase 3 study of solanezumab in people with mild dementia due to Alzheimer's disease (AD). Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated...

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Juno Therapeutics Places JCAR015 Phase II ROCKET Trial on Clinical Hold

Posted 2 weeks ago in Clinical Trials

SEATTLE--(BUSINESS WIRE)--Nov. 23, 2016-- Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that it has voluntarily placed on hold the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, known as the “ROCKET” trial. The clinical h...

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AstraZeneca Head and Neck Cancer Trials Resume New Patient Enrolment as FDA Lifts Partial Clinical Hold

Posted 2 weeks ago in Clinical Trials

22 November 2016 -- AstraZeneca today announced that the US FDA has lifted the partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. The Phase III KESTREL trial has already re-opened for new patient enrolment at some clinical study sites and the...

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U.S. FDA Grants Fast Track Designation for the Development of Oragenics’ AG013 for Oral Mucositis

Posted 2 weeks ago in Clinical Trials

TAMPA, Fla.--(BUSINESS WIRE) November 21, 2016 -- Oragenics (NYSE:MKT - OGEN.BC), a leader in the development of novel antibiotics against infectious disease and developing effective treatments for oral mucositis (OM), today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AG013, the Company’s lead therapeutic candidate for the treatment of OM. Oragenics expects to file an ...

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Ocular Therapeutix Announces Successful Topline Results for Both Inflammation and Pain Primary Efficacy Endpoints from Phase 3 Clinical Trial of Dextenza

Posted 2 weeks ago in Clinical Trials

BEDFORD, Mass.--(BUSINESS WIRE)--Nov. 14, 2016-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced positive topline results from its phase 3 clinical trial of Dextenza™ (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. D...

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Tetraphase Publishes Phase 3 IGNITE1 Eravacycline Data in JAMA Surgery

Posted 3 weeks ago in Clinical Trials

WATERTOWN, Mass., Nov. 17, 2016 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced the publication of results from IGNITE1, the Company's phase 3 clinical trial which evaluated eravacycline compared to ertapenem for the treatment of complicated...

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GTx Achieves Second 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)--Nov. 16, 2016-- GTx, Inc. (Nasdaq: GTXI) today announced the achievement of the Stage 1 milestone for the 18 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...

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Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In Second Phase 3 Study

Posted 3 weeks ago in Clinical Trials

THOUSAND OAKS, Calif., Nov. 16, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive top-line results for erenumab from a global Phase 3, randomized, double-blind, placebo-controlled STudy to evaluate the efficacy and safety of erenumab in migRaIne preVEntion (STRIVE). These data showed the STRIVE study met the primary endpoint, demonstrating statistically significant reductions from baseline in monthly...

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