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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.

Matinas BioPharma Reports Positive Topline Data from Phase 1 Study of MAT2501

Posted 3 days ago in Clinical Trials

BEDMINSTER, N.J., March 27, 2017 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications, today reported positive topline data from its Phase 1 single-ascending dose study of MAT2501 in healthy volunteers. MAT2501 is Matinas BioPharma’s orally-administered formulation of the broad s...

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Allergan and Paratek Announce Positive Results From Two Phase 3 Trials of Sarecycline for the Treatment of Moderate to Severe Acne

Posted 3 days ago in Clinical Trials

DUBLIN and BOSTON, March 27, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, announced that two (2) Phase 3 trials of sarecycline for the treatment of moderate to severe acne met their 12 week...

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Moleculin Receives Orphan Drug Designation for Annamycin for the Treatment of Acute Myeloid Leukemia

Posted 8 days ago in Clinical Trials

HOUSTON, TX -- (Marketwired) -- 03/22/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced its lead candidate, Annamycin (also known as "Liposomal...

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Novartis Provides Update on Phase III study of RLX030 (serelaxin) in Patients with Acute Heart Failure

Posted 8 days ago in Clinical Trials

Basel, March 22, 2017 - Novartis today announced results from the global Phase III RELAX-AHF-2 study investigating the efficacy, safety and tolerability of RLX030 (serelaxin) in patients with acute heart failure (AHF). RELAX-AHF-2 did not meet its primary endpoints of reduction in cardiovascular death through Day 180 or reduced worsening heart failure through Day five when added to standard therapy in patients...

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Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study Of Abemaciclib Met Primary Endpoint Of Progression-Free Survival

Posted 10 days ago in Clinical Trials

INDIANAPOLIS, March 20, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that its MONARCH 2 trial of abemaciclib met the primary endpoint of progression-free survival (PFS). The Phase 3 study evaluated abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor...

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Immunomedics Announces Publication of Results in Journal of Clinical Oncology, Demonstrating Treatment With Sacituzumab Govitecan (IMMU-132) Produces Early and Durable Responses in Patients With Metastatic Triple-Negative Breast Cancer

Posted 2 weeks ago in Clinical Trials

MORRIS PLAINS, N.J., March 15, 2017 /PRNewswire/ -- Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or "the Company") today announced that sacituzumab govitecan (IMMU-132), the Company's lead antibody-drug conjugate (ADC), was highly active in heavily-pretreated patients with metastatic triple-negative breast cancer (TNBC) who received a median of five lines of therapy since diagnosis. Results from this...

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BriaCell Receives FDA Clearance to Initiate Phase I/IIa Clinical Trial of BriaVax in Patients with Advanced Breast Cancer

Posted 2 weeks ago in Clinical Trials

Berkeley, CA and Vancouver, BC – March 15, 2017 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate an open-label Phase I/IIa clinical trial of BriaVaxTM in patients with advanced breast cancer. B...

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FDA Grants Orphan Drug Designation to Boehringer Ingelheim’s Investigational Anti-CD33 Monoclonal Antibody BI 836858 for Treatment of Myelodysplastic Syndromes

Posted 3 weeks ago in Clinical Trials

Ridgefield, Conn., March 9, 2017 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS). Orphan drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis, or prevention of rare d...

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Servier and Pfizer Announce FDA Clearance of IND Application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia

Posted 3 weeks ago in Clinical Trials

March 9, 2017 - Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq: CLLS), announced today that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational New Drug (IND) clearance to proceed in the U.S. with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory...

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Ocera to Announce Additional Encouraging Results from its Phase 2b STOP-HE Study of IV OCR-002 in Patients with Hepatic Encephalopathy

Posted 3 weeks ago in Clinical Trials

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 08, 2017 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced it will report additional encouraging results from its Phase 2b STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy (HE) at the Cowen and...

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Menlo Therapeutics Announces Successful Pruritus Reduction Results from Phase 2 Serlopitant Trial (TCP-102) in 127 Subjects With Prurigo Nodularis

Posted 3 weeks ago in Clinical Trials

Menlo Park, CA - March 8, 2017 -- Menlo Therapeutics Inc. announced today that the phase 2 trial (TCP-102) evaluating serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis successfully met its primary efficacy endpoint and key secondary endpoints, demonstrating a statistically significant reduction in pruritus (p

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Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent (dupilumab) in Moderate-to-Severe Atopic Dermatitis

Posted 3 weeks ago in Clinical Trials

Paris, France and Tarrytown, N.Y. - March 4, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today presented detailed results from the one-year Phase 3 CHRONOS study, which showed that patients receiving the investigational drug Dupixent® (dupilumab) with topical corticosteroids (TCS) achieved significantly improved measures of overall disease severity compared to TCS alone in adults with uncontrolled ...

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Chugai's Anti-IL-31 Receptor A Humanized Monoclonal Antibody nemolizumab (CIM331) Global Phase II Study Data Published in The New England Journal of Medicine Online

Posted 4 weeks ago in Clinical Trials

TOKYO March 02, 2017 --(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the data from the global phase II study (the XCIMA study) for the planned indication of atopic dermatitis (AD) was published in The New England Journal of Medicine Online on March 2, 2017 (EST). The study was conducted to evaluate the safety and efficacy of nemolizumab in 264 patients with moderate-to-severe AD,...

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Myovant Sciences Initiates Phase 3 Clinical Trial of Relugolix in Men with Advanced Prostate Cancer

Posted 4 weeks ago in Clinical Trials

BASEL, Switzerland, March 1, 2017 /PRNewswire/ -- Myovant Sciences (NYSE: MYOV) today announced it has initiated a Phase 3 clinical trial, HERO, to evaluate the safety and efficacy of relugolix in treating men with advanced prostate cancer. Relugolix is an oral, once-daily, small molecule, gonadotropin-releasing hormone (GnRH) receptor antagonist that lowers testosterone by inhibiting pituitary release of...

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SELLAS Life Sciences Announces Updated Positive Phase 2 Data Reinforcing Meaningful Clinical Benefit of its WT1 Immunotherapeutic Anti-cancer Treatment in Multiple Myeloma Patients

Posted 4 weeks ago in Clinical Trials

HAMILTON, Bermuda, and NEW YORK, NY, March 1, 2017 — SELLAS Life Sciences Group (SELLAS or the Company), a late-stage biopharmaceutical company developing novel cancer immunotherapies for an extensive list of cancer indications, today reported updated positive Phase II data from its WT1 immunotherapeutic anti-cancer treatment, galinpepimut-S, in multiple myeloma (MM) patients. Consistent with preliminary data, the u...

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Neurotrope Bioscience Concludes Patient Dosing and Monitoring in its 148 Patient Phase 2 Clinical Trial of Moderate to Severe Alzheimer's Dementia

Posted 4 weeks ago in Clinical Trials

NEW YORK, February 28, 2017 /PRNewswire/ -- Neurotrope, Inc. (OTCQB: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease, announced the conclusion of dosing and patient monitoring in its Phase 2 double blind, placebo controlled clinical trial of bryostatin-1 in the treatment of moderate to severe Alzheimer's dementia. Patients...

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aTyr Pharma Receives U.S. FDA Orphan Drug Designation for the Treatment of Limb Girdle Muscular Dystrophy with Resolaris

Posted 4 weeks ago in Clinical Trials

SAN DIEGO, Feb. 28, 2017 /PRNewswire/ -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaris™ was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy (LGMD) p...

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Merck’s Letermovir, an Investigational Antiviral Medicine for Prevention of Cytomegalovirus (CMV) Infection in Bone Marrow Transplant Recipients, Highly Effective Through Week 24 Post-Transplant in Pivotal Phase 3 Study

Posted 4 weeks ago in Clinical Trials

KENILWORTH, N.J.--(BUSINESS WIRE) February 26, 2017 -- Merck & Co., Inc. (NYSE:MRK), known as MSD outside the United States and Canada, today announced results of the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of an allogeneic hematopoietic...

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In First Phase 3 Trial, Merck’s Investigational Inactivated Varicella Zoster Virus Vaccine (V212) Reduced the Incidence of Confirmed Herpes Zoster Cases by an Estimated 64 Percent in Immunocompromised Subjects

Posted 5 weeks ago in Clinical Trials

KENILWORTH, N.J.--(BUSINESS WIRE) February 24, 2017 -- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first Phase 3 study results for V212, the company’s investigational inactivated varicella zoster virus vaccine (VZV) for the prevention of herpes zoster or HZ, also known as shingles, in immunocompromised patients. This was a double-blind, randomized, placebo-controlled, m...

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Reata Announces Initiation of Phase 2/3 Study of Bardoxolone Methyl in the Treatment of Chronic Kidney Disease Due to Alport Syndrome

Posted 5 weeks ago in Clinical Trials

IRVING, Texas, Feb. 23, 2017 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) (“Reata” or the “Company”) today announced the initiation of patient screening in a Phase 2/3 trial to evaluate bardoxolone methyl (“bard”) in patients with chronic kidney disease (“CKD”) caused by Alport syndrome. The purpose of this study is to determine the safety and efficacy of bard in Alport syndrome patients, and to det...

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