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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Merck Initiates Phase 3 Study of Letermovir for Prevention of Cytomegalovirus (CMV) Infection

Posted 3 days ago in Clinical Trials

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- July 24, 2014 -- Merck, known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in a global Phase 3 clinical study of letermovir (MK-8228), an investigational antiviral agent. The multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of letermovir for the prevention of...

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Kinex Pharmaceuticals Announces Allowance of the IND application for KX2-391 Ointment by the FDA

Posted 3 days ago in Clinical Trials

July 24, 2014 -- Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months. KX2-391 is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization....

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Galectin Therapeutics Announces First Patient Dosed in Cohort 1 of Phase 1B Clinical Trial of GR-MD-02

Posted 6 days ago in Clinical Trials

NORCROSS, Ga., July 22, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the first patient has been dosed in cohort 1 of the Company's Phase 1B clinical trial evaluating GR-MD-02 in combination with ipilimumab (Yervoy®) in patients with metastatic melanoma. Providence Portland...

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Advaxis and MedImmune Partner on Immuno-Oncology Combination Clinical Trial

Posted 6 days ago in Clinical Trials

PRINCETON, N.J., July 22, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca. The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint...

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Ignyta Announces Initiation of STARTRK-1 Global Phase I/II Clinical Trial of RXDX-101

Posted 6 days ago in Clinical Trials

SAN DIEGO--(BUSINESS WIRE) July 21, 2014 -- Ignyta, Inc., an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company's global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a...

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Titan Pharmaceuticals Announces First Patient Enrollment In Clinical Study Of Probuphine for Opioid Dependence

Posted 6 days ago in Clinical Trials

South San Francisco, CA - July 21, 2014 - Titan Pharmaceuticals, Inc. (TTNP.OB) today announced enrollment of the first patients in the Phase 3 clinical study to support resubmission of the New Drug Application (NDA) for Probuphine, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence. The study, which is expected to be completed by the middle of 2015, is designed to...

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Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for Major Depressive Disorder

Posted 6 days ago in Clinical Trials

ALISO VIEJO, Calif., July 21, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for a Phase II study assessing the safety and efficacy of AVP-786, Avanir's next generation compound. The company plans to initiate this study evaluating AVP-786 for the adjunctive treatment of...

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Rexahn Pharmaceuticals Provides Update on Phase I Supinoxin Trial in Cancer Patients with Solid Tumors

Posted 9 days ago in Clinical Trials

ROCKVILLE, Md.--July 18, 2014 -- (BUSINESS WIRE)-- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced an update in its Phase I multi-center dose-escalation study to evaluate the safety, tolerability, dose-limiting toxicities and maximum tolerated dose (MTD) of Supinoxin™ (RX-5902) in cancer...

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Cynapsus Therapeutics Commences Phase 2 Clinical Trials in the United States

Posted 10 days ago in Clinical Trials

TORONTO, CANADA – (Marketwired) – July 17, 2014 - Cynapsus Therapeutics Inc. (CTH: TSX-V) (CYNAF: OTCQX), a specialty pharmaceutical company focused on Parkinson’s disease, today announced that following communication from the United States Food and Drug Administration (“the FDA”) on July 16, 2014, Phase 2 clinical studies for APL-130277 will commence immediately. Specifically, clinical study CTH-105 will...

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Alkermes Announces Initiation of Phase 1 Clinical Study of ALKS 8700 for Treatment of Multiple Sclerosis

Posted 11 days ago in Clinical Trials

DUBLIN--(BUSINESS WIRE)--Jul. 17, 2014-- Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of ALKS 8700, a novel monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). The randomized, double-blind study will evaluate the safety, tolerability and pharmacokinetics of several oral formulations of ALKS 8700 compared to both placebo and active...

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Dipexium Pharmaceuticals Initiates Pivotal Phase 3 Clinical Trial of Locilex

Posted 11 days ago in Clinical Trials

NEW YORK, July 17, 2014 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) today announced it has initiated patient enrollment in the first of two pivotal Phase 3 clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex (pexiganan cream 0.8%), the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild...

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Auspex Pharmaceuticals Initiates Pivotal Phase 2/3 Clinical Trial for SD-809 in Tardive Dyskinesia

Posted 11 days ago in Clinical Trials

LA JOLLA, Calif., July 17, 2014 (GLOBE NEWSWIRE) -- Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, today announced the enrollment of the first two patients in a multi-center pivotal Phase 2/3 clinical trial of its investigational drug, SD-809 (deutetrabenazine), for the...

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OncoMed Pharmaceuticals Initiates Randomized Phase 2 "ALPINE" Clinical Trial of Tarextumab

Posted 12 days ago in Clinical Trials

REDWOOD CITY, Calif., July 16, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE" (Antibody therapy in first-Line Pancreatic cancer Investigating...

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Targacept Phase 2b Clinical Trial in Alzheimer’s Disease Does Not Show Superiority of TC-1734 Over Donepezil

Posted 2 weeks ago in Clinical Trials

Winston-Salem, NC – July 14, 2014 - Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced top-line results from a Phase 2b monotherapy clinical trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease. In the trial, TC-1734 did not meet the objective of showing superiority to donepezil, the marketed medication most often...

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Alcobra Completes Patient Recruitment in Phase III Clinical Trial of MDX in Adult ADHD

Posted 2 weeks ago in Clinical Trials

TEL AVIV, Israel, July 14, 2014 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that recruitment of patients has been completed in the Company's Phase III clinical trial of Metadoxine Extended...

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Novartis announces NEJM publication of two pivotal Phase III secukinumab studies

Posted 2 weeks ago in Clinical Trials

EAST HANOVER, N.J., July 9, 2014 Novartis today announced that The New England Journal of Medicine (NEJM) published the results from two pivotal Phase III studies evaluating the interleukin-17A (IL-17A) inhibitor secukinumab (AIN457). Secukinumab met all primary and key secondary endpoints in the ERASURE and FIXTURE studies, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator's Global...

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Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab for Atopic Dermatitis

Posted 2 weeks ago in Clinical Trials

TARRYTOWN, N.Y. and PARIS, July 9, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi (EURONEXT:SAN and NYSE:SNY) today announced positive results from a Phase 2b dose-ranging study of dupilumab, an investigational therapy, in adult patients with moderate-to- severe atopic dermatitis (AD), a serious, chronic form of eczema. All doses of dupilumab met the primary endpoint of a greater...

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Lexicon and JDRF Collaborate for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes

Posted 2 weeks ago in Clinical Trials

The Woodlands, Texas, July 9, 2014 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that JDRF, the world’s largest non-profit supporter of type 1 diabetes (T1D) research, will provide funding to support a Phase 2, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of LX4211 in a younger population with T1D. Up to 76 individuals with T1D, younger than 30...

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Boehringer Ingelheim’s Volasertib Phase II data Published

Posted 2 weeks ago in Clinical Trials

Ridgefield, CT, July 08, 2014 – Results from a Phase II study that compared volasertib plus low-dose cytarabine (LDAC), a form of chemotherapy, versus LDAC alone in older patients with untreated acute myeloid leukemia (AML) were published today in the American Society of Hematology journal Blood. Volasertib has not been approved by the FDA; its safety and efficacy have not been established. The study’s...

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Endo and Biodelivery Sciences Announce Positive Top-Line Results From The Phase III Clinical Trial Of BEMA Buprenorphine

Posted 2 weeks ago in Clinical Trials

DUBLIN, Ireland and RALEIGH, N.C., – July 7, 2014 – Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), and BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced today positive top-line results from its pivotal Phase III efficacy study of BEMA buprenorphine in opioid-experienced patients. BEMA buprenorphine is being developed for the management of pain severe...

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