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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.

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Tenth Cohort Completed in Cellceutix Clinical Trial of Anti-Cancer Drug Kevetrin, No Adverse Events Reported

Posted 3 days ago in Clinical Trials

BEVERLY, MA–(Marketwired – Mar 24, 2015) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the tenth cohort in the Company’s Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard’s Dana-Farber Cancer...

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Acura Pharmaceuticals Reports Successful Topline Results From Nexafed Extended-Release Clinical Study

Posted 4 days ago in Clinical Trials

PALATINE, IL, March 23, 2015 -- Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), today announced preliminary topline results from a pilot clinical study which demonstrated bioequivalence of one formulation of Nexafed (pseudoephedrine HCl) extended-release tablets to Sudafed® 12-Hour Tablets. Nexafed extended-release tablets utilize Acura's IMPEDE 2.0 enhanced methamphetamine-resistant technology. Acura intends to...

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Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab

Posted 4 days ago in Clinical Trials

Monday, March 23, 2015 -Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) announced today that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200 million upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to lift the partial...

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Boehringer Ingelheim’s Investigational Biologic Cleared Skin Better than Ustekinumab in Head-to-Head Phase II Psoriasis Study

Posted 7 days ago in Clinical Trials

SAN FRANCISCO, Calif., March 20, 2015 – For the first time, Boehringer Ingelheim announced Phase II data from its investigational compound BI 655066*. Nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (described as PASI 90) after 12 weeks of treatment with BI 655066 compared to ustekinumab (77.1% versus 40% of patients). The study (NCT02054481)...

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Biogen Idec Presents Positive Interim Results From Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab

Posted 7 days ago in Clinical Trials

CAMBRIDGE, Mass., Friday, March 20, 2015 – Today Biogen Idec (NASDAQ:BIIB) announced data from a pre-specified interim analysis of PRIME, the Phase 1b study of aducanumab (BIIB037), in which aducanumab demonstrated an acceptable safety profile and positive results on radiologic and clinical measurements in patients with prodromal or mild Alzheimer’s disease (AD). These data are being presented today at the 12th...

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Pfizer Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials

Posted 7 days ago in Clinical Trials

Friday, March 20, 2015 - Pfizer Inc. (NYSE:PFE) announced today the presentation of detailed pooled results from two pivotal Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program at the 73rd American Academy of Dermatology (AAD) Annual Meeting. These results, evaluating the efficacy and safety of tofacitinib citrate for the treatment of adults with moderate to severe chronic plaque psoriasis who are...

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Phase II Data for Celgene's Investigational Oral GED-0301 for Patients with Active Crohn's Disease Published in NEJM

Posted 9 days ago in Clinical Trials

SUMMIT, N.J., Mar 18, 2015 --(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that results from a double-blind, placebo-controlled, multicenter phase II trial of three doses of GED-0301 (mongersen) in patients with active Crohn's disease were published in the March 19 issue of The New England Journal of Medicine. "GED-0301 offers a unique approach to treating Crohn's, using antisense technology...

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Results of Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) Published in NEJM

Posted 9 days ago in Clinical Trials

Wednesday, March 18, 2015 - Pfizer Inc. (NYSE:PFE) today announced the publication of findings from its Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) in the March 19 issue of The New England Journal of Medicine. The study, conducted in collaboration with Julius Clinical and the University Medical Centre Utrecht in the Netherlands, investigated the efficacy of immunization with Prevenar 13*...

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AstraZeneca announces positive Phase III top-line results for PT003 from the PINNACLE 1 and PINNACLE 2 studies in COPD

Posted 9 days ago in Clinical Trials

Wednesday, 18 March 2015 -- AstraZeneca today announced positive top-line results from the Phase III PINNACLE program, which included two pivotal 24-week studies (PINNACLE 1 and PINNACLE 2) to investigate the potential of PT003 to improve lung function in patients with Chronic Obstructive Pulmonary Disease (COPD). PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist...

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GSK Announces Start of Phase III Programme to Evaluate Retosiban for Spontaneous Preterm Labour

Posted 10 days ago in Clinical Trials

London, UK, 17 March 2015 -- GSK today announced the start of a phase III programme to evaluate the efficacy and safety of retosiban, an investigational oxytocin antagonist. Retosiban is being developed as a potential treatment to improve neonatal outcomes of babies born to women in spontaneous preterm labour by prolonging the time to delivery. A preterm (or premature) birth is when a baby is born at least three...

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New Data from Boehringer Ingelheim’s GLORIATM-AF Registry Show Non-Valvular Atrial Fibrillation (NVAF) Patients at High Risk of Stroke May Be Undertreated

Posted 11 days ago in Clinical Trials

Ridgefield, CT, March 16, 2015 –Boehringer Ingelheim Pharmaceuticals, Inc. today will present results from two analyses of the GLORIATM-AF Registry Program examining the use of antithrombotic treatment to reduce the risk of stroke for patients with non-valvular atrial fibrillation (NVAF). The new findings are the first reported prescribing patterns data from Phase II of the GLORIA-AF Registry Program and were...

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Acadia Pharmaceuticals Updates Planned Timing of Nuplazid NDA Submission

Posted 2 weeks ago in Clinical Trials

SAN DIEGO--(BUSINESS WIRE)--Mar. 11, 2015-- Acadia Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in neurological and related central nervous system disorders, today provided an update on the planned timing of its Nuplazid (pimavanserin) New Drug Application (NDA) submission. Acadia plans to...

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Lpath to Submit Additional Data for Lpathomab Investigational New Drug Application

Posted 2 weeks ago in Clinical Trials

SAN DIEGO, March 11, 2015 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), a leader in the discovery and development of lipid-targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has requested additional analysis of certain data submitted as part of Lpath's recently submitted Investigational New Drug (IND) application for Lpathomab™. Lpathomab is a novel antibody targeting Lysophosphatidic...

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AGTC Files IND for the Treatment of X-Linked Retinoschisis

Posted 2 weeks ago in Clinical Trials

GAINESVILLE, Fla., March 10, 2015 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq:AGTC), a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical trial...

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Puma Biotechnology Initiates Phase II Trial of PB272 in Early Stage HER2-Positive Breast Cancer

Posted 2 weeks ago in Clinical Trials

LOS ANGELES, Calif., Mar. 10, 2015 - Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced the initiation of a Phase II trial of Puma's investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer. The 70 patient study will be an open label single arm Phase II trial of PB272 monotherapy administered to patients with HER2-positive early stage...

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Lexicon Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Clinical Trial of Telotristat Etiprate

Posted 2 weeks ago in Clinical Trials

The Woodlands, Texas, March 9, 2015 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on developing breakthrough treatments for human disease, today announced that it has completed enrollment in TELESTAR, its pivotal Phase 3 clinical trial of telotristat etiprate for patients with carcinoid syndrome. The company expects to announce top-line data from the TELESTAR trial in the...

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Corbus Pharmaceuticals' IND Receives Clearance From FDA to Initiate Phase 2 Trials with Resunab in Scleroderma

Posted 2 weeks ago in Clinical Trials

NORWOOD, MA -- (Marketwired) -- 03/09/15 -- Corbus Pharmaceuticals Holdings, Inc. (OTCQB: CRBP) (the Company), announced today that company's Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) is now open and it is authorized to initiate a Phase 2 clinical study with Resunab™ for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). Scleroderma is a chronic,...

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Capricor Announces Enrollment of Its Phase II Clinical Trial for Cenderitide to Treat Heart Failure

Posted 3 weeks ago in Clinical Trials

LOS ANGELES, March 5, 2015 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it is currently enrolling a Phase II clinical trial with Cenderitide, a dual receptor natriuretic peptide agonist that has previously been used in approximately 270 patients including those...

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FDA Grants Breakthrough Therapy Designation to Epstein-Barr Virus (EBV) Targeted T-Cells for Treatment of EBV-Associated Lymphoproliferative Disease

Posted 3 weeks ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., March 2, 2015 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq:ATRA) today announced that its collaborative partner, Memorial Sloan Kettering Cancer Center (MSK) has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for Atara's optioned cytotoxic T lymphocytes activated against Epstein-Barr Virus (EBV-CTL) in the treatment of patients with...

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Study of Next-Generation Investigational HIV-1 Maturation Inhibitor Shows Positive Results in Preventing Viral Replication

Posted 4 weeks ago in Clinical Trials

PRINCETON, N.J.. February 26, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced data supporting the clinical development of BMS-955176, an investigational component designed to prevent the maturation of HIV-1. Presented yesterday in a late-breaking oral presentation and a poster presentation at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, the Phase...

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