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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.

The Medicines Company and Alnylam Pharmaceuticals Announce Agreement with FDA on Phase III Clinical Program for Inclisiran

Posted 4 days ago in Clinical Trials

PARSIPPANY, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 26, 2017-- The Medicines Company (NASDAQ:MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) today announced that The Medicines Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program for inclisiran, which is designed to support the submission of a New Drug Application (NDA). The Company has received...

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Shionogi Presents Results of the First Clinical Efficacy Trial and In Vitro Data on Cefiderocol (S-649266), a Siderophore Cephalosporin

Posted 8 days ago in Clinical Trials

OSAKA, Japan, April 22, 2017 /PRNewswire/ -- Shionogi & Co., Ltd. today announced it will present for the first time clinical trial efficacy results, as well as supportive in vitro data, on cefiderocol (S-649266), an investigational siderophore cephalosporin in late stage development with activity against a broad range of Gram-negative pathogens, including those highly resistant to currently available agents such as...

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CytRx Announces FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in Soft Tissue Sarcomas

Posted 11 days ago in Clinical Trials

LOS ANGELES, April 19, 2017 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR) today announced the U.S. Food and Drug Administration (FDA) has reached an agreement with CytRx on preparations for a New Drug Application (NDA) submission for aldoxorubicin in soft tissue sarcomas (STS). STS remains a high unmet medical need. "We are very pleased to have achieved clarity from the FDA regarding CytRx's soft tissue...

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Protalix BioTherapeutics Announces New Preclinical Results Demonstrating a Positive Effect of pegunigalsidase alfa (PRX-102) on Small-fiber Neuropathy in Fabry Disease Models Compared to Commercially Available Enzyme Replacement Therapies

Posted 12 days ago in Clinical Trials

CARMIEL, Israel, April 18, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today new, promising results from a preclinical trial conducted in collaboration with Prof. Raphael Schiffmann, Director, Institute of Metabolic Disease at the Baylor Research Institute, Dallas, Texas. It was demonstrated that treatment of Fabry mice with pegunigalsidase alfa (PRX-102) slows the...

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OncoMed's Phase 2 Trial of Tarextumab in Small Cell Lung Cancer Does Not Meet Endpoints

Posted 13 days ago in Clinical Trials

REDWOOD CITY, Calif., April 17, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today reported top-line results from the company's randomized 145-patient Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with...

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Genentech Announces Positive Interim Results for Emicizumab in Phase III Study of Children with Hemophilia A

Posted 2 weeks ago in Clinical Trials

South San Francisco, CA -- April 16, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced interim results from the Phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with hemophilia A and inhibitors to factor VIII. At this interim analysis after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful...

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FDA Allows NuvOx Pharma to Run a Phase II Clinical Trial in Brain Cancer

Posted 2 weeks ago in Clinical Trials

TUCSON, Ariz.--(BUSINESS WIRE)-- April 13, 2017 Nuvox Pharma announces that the FDA has allowed an Investigational New Drug (IND) application to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor, glioblastoma multiforme (GBM). NVX-108 is an injectable drug that travels through the bloodstream arriving first at the lungs to pick up oxygen and...

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AOBiome Completes Patient Enrollment In Phase 2 Clinical Trial Of Lead Candidate B244 To Treat Elevated Blood Pressure

Posted 2 weeks ago in Clinical Trials

CAMBRIDGE, Mass., April 13, 2017 /PRNewswire/ -- AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, announced today completion of patient enrollment in the Company's Phase 2 clinical trial of its lead product candidate, designated B244, to treat individuals with elevated blood pressure. The multicenter, randomized,...

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Aerie Pharmaceuticals Reports Positive Rocket 4 Six-Month Topline Safety and Efficacy Results for Rhopressa (netarsudil ophthalmic solution) 0.02%

Posted 2 weeks ago in Clinical Trials

IRVINE, Calif.--(BUSINESS WIRE) Apr 12, 2017 -- 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 six-month topline safety and efficacy results of its Rocket 4 Phase 3 clinical trial for product candidate...

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Protalix BioTherapeutics Announces Positive Results from Phase II Clinical Trial of alidornase alfa (AIR DNase™) for the Treatment of Cystic Fibrosis

Posted 2 weeks ago in Clinical Trials

CARMIEL, Israel, April 12, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today positive results from the Company’s phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF). Sixteen patients were enrolled in the study, all of whom completed the study. alidornase alfa is a plant cell-expressed, chemically-modified recombinant DNase enzyme r...

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Ohr Pharmaceutical Provides Update on Ongoing Squalamine Clinical Trial in Wet-AMD

Posted 2 weeks ago in Clinical Trials

NEW YORK, April 10, 2017 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced that it plans to amend the ongoing clinical trial investigating Squalamine in wet-AMD (the MAKO Study) to enable efficacy analyses by the end of calendar 2017 or early 2018. The study remains a multi-center, randomized, double-masked, placebo controlled clinical...

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OncoMed's Phase 2 Demcizumab Pancreatic Cancer Trial Misses Primary Endpoint

Posted 3 weeks ago in Clinical Trials

REDWOOD CITY, Calif., April 10, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today reported top-line results from the company's Phase 2 YOSEMITE clinical trial of demcizumab (anti-DLL4, OMP-21M18) in combination with Abraxane® (paclitaxel ...

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AbbVie Announces Positive Phase 2b Data Demonstrating Investigational Medicine Elagolix Significantly Reduced Heavy Menstrual Bleeding in Women with Uterine Fibroids

Posted 3 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., April 7, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced detailed results from a Phase 2b clinical trial evaluating the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) compared to placebo. The data demonstrated that...

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Kura Oncology Doses First Patient in Phase 1 Trial of ERK Inhibitor KO-947

Posted 3 weeks ago in Clinical Trials

LA JOLLA, Calif., April 07, 2017 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced that the first patient has been dosed in its Phase 1 clinical trial of KO-947, a potent and selective small molecule inhibitor of extracellular-signal-regulated kinases 1 and 2 (ERK1/2). “We are committed ...

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Tolero Pharmaceuticals Presents Preclinical Data on CDK9 Inhibitor Alvocidib and its Prodrug, TP-1287, at AACR 2017

Posted 3 weeks ago in Clinical Trials

SALT LAKE CITY, UT April 5, 2017 --Tolero Pharmaceuticals, Inc., a clinical-stage company developing treatments for serious hematological diseases, presented preclinical data on alvocidib, an investigational inhibitor of cyclin-dependent kinase 9 (CDK9), in Phase II development for relapsed/refractory acute myeloid leukemia (AML) and its prodrug, TP-1287. The findings were presented during the American Association...

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Zavante Therapeutics’ Zolyd Met Primary Endpoint in Pivotal ZEUS Study for Treatment of Complicated Urinary Tract Infections

Posted 3 weeks ago in Clinical Trials

SAN DIEGO, CA – April 5, 2017 – Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that the company’s investigational product candidate, ZOLYD™ (fosfomycin for injection, also known as ZTI-01), met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS™ clinical tria...

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Corbus Pharmaceuticals to Commence Single Phase 3 Study of Anabasum for Treatment of Systemic Sclerosis Following Guidance Received from Successful End-of-Phase 2 Meeting with FDA

Posted 3 weeks ago in Clinical Trials

NORWOOD, MA -- (Marketwired) -- 04/05/17 -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, today announced that the Company will be proceeding with a single Phase 3 study to support a New Drug Application ("NDA") for anabasum for the treatment of diffuse cutaneous systemic...

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Positive Type A Meeting with FDA Confirms Acceptability of Evoke Pharma's Proposed Comparative Exposure PK Trial for Gimoti NDA

Posted 3 weeks ago in Clinical Trials

SOLANA BEACH, Calif., April 04, 2017 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company recently completed a positive Type A meeting with the U.S. Food and Drug Administration (FDA) to finalize the design of the pivotal comparative exposure pharmacokinetic (PK) trial and to reach agreement...

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Oxis International Inc. Announces Approval of FDA Phase 2 Trial with Its Bispecific Antibody OXS-1550

Posted 3 weeks ago in Clinical Trials

LOS ANGELES, CA / ACCESSWIRE / April 4, 2017 / Oxis International Inc. (OTCQB:OXIS and Euronext Paris OXI.PA) announced today that the Food and Drug Administration has cleared the way for the Company's wholly owned subsidiary, Oxis Biotech Inc., to begin a FDA Phase 2 clinical trial for its promising cancer treatment OXS-1550 in the treatment of lymphoma and leukemia. Oxis Biotech, a targeted immuno-oncology...

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Paratek Announces Positive Phase 3 Study of Omadacycline in Community-Acquired Bacterial Pneumonia

Posted 3 weeks ago in Clinical Trials

BOSTON, April 03, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today positive top-line results from a global, pivotal Phase 3 clinical study comparing its once-daily oral and IV, broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). This study represents the second positive Phase 3...

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