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Benitec Biopharma initiates new site for ongoing Phase 1/2a TT-034 trial for hepatitis C

Benitec Biopharma Limited, a clinical-stage biotechnology company developing innovative therapeutics based on its gene-silencing technology, DNA-directed RNA interference (ddRNAi), is pleased to announce it has initiated a new site for its ongoing Phase 1/2a TT-034 trial at the Methodist Health System Clinical Research Institute in Dallas, Texas.

16 Sep 2015

Bionomics’ BNC210 Phase 1 trial for anxiety and depression meets primary endpoint

Bionomics Limited, a biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer, today reported positive data from the completed Phase 1 multiple ascending dose, placebo controlled clinical trial of BNC210, an orally administered negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor (alpha-7 receptor) being developed for the treatment of anxiety and depression.

16 Sep 2015

AstraZeneca presents safety and efficacy data for ExQW at 51st Annual Meeting of EASD

AstraZeneca today announced new analyses of exenatide once weekly (ExQW) demonstrating a favorable gastrointestinal (GI) tolerability profile, including less frequent upper and lower GI adverse events (AE), compared to shorter-acting glucagon-like peptide-1 receptor agonists (GLP-1RA), exenatide twice daily (ExBID) and liraglutide once daily (LiraQD).

16 Sep 2015

Avillion enrolls patients in BFORE Phase III trial to treat chronic myelogenous leukemia

Avillion LLP, a co-developer of late-stage pharmaceutical assets, announces the completion of enrolment in a global Phase III clinical trial called "BFORE," which is designed to assess the effectiveness and safety of BOSULIF (bosutinib) as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

15 Sep 2015

AgeneBio's HOPE4MCI Phase 3 trial receives support from NIH

AgeneBio, a biopharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, announced today that its HOPE4MCI Phase 3 clinical trial has received support from the National Institutes of Health.

15 Sep 2015

UT Southwestern evaluates allopurinol drug to prevent nephropathy in Type I diabetes patients

UT Southwestern Medical Center has joined an international clinical trial studying whether a drug traditionally used to treat gout can help prevent kidney damage in patients with Type 1 diabetes.

15 Sep 2015

EORTC trial evaluates effectiveness of pembrolizumab in patients with high-risk stage III melanoma

A recently opened double- blind phase III EORTC trial 1325 will prospectively assess whether post-operative adjuvant therapy with pembrolizumab, an anti-PD-1 monoclonal antibody, improves recurrence-free survival as compared to placebo in patients with high-risk stage III melanoma.

15 Sep 2015

BfArM approves Greenovation’s moss-aGal phase I clinical trial for Fabry disease

Greenovation Biotech GmbH announced today that it has received approval to begin a phase I clinical trial in Europe for its first drug candidate moss-aGal (agalsidase) from Germany's regulatory authority, the Federal Institute for Drugs and Medical Devices (BfArM).

15 Sep 2015

Sun Biomedical begins DMX-200 Phase II trial for treatment of chronic kidney disease

Sun Biomedical Limited today announced the first patient had been enrolled in a Phase II study of DMX-200, an innovative new treatment that combines two different drugs to treat chronic kidney disease.

15 Sep 2015

FDA grants Orphan Drug Designation to TxCell's Col-Treg for treatment of autoimmune uveitis

TxCell SA, a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to TxCell's Col-Treg, a personalized T cell immunotherapy using collagen-II specific regulatory T-cells, for the treatment of chronic non-infectious uveitis.

15 Sep 2015

Antidepressants can increase depression, mood cycling in rapid-cycling bipolar disorder patients

In patients with rapid-cycling bipolar disorder, antidepressants can increase incidents of depression and mood cycling. Rif S. El-Mallakh, M.D., director of the Mood Disorders Clinical and Research Program at the University of Louisville, along with Nassir Ghaemi, M.D., of Tufts University and other researchers, conducted the first randomized clinical trial that analyzes how modern antidepressants affect patients with rapid-cycling (RC) bipolar disorder (BD).

15 Sep 2015

Mirati to present data on tyrosine kinase inhibitor at ESMO 2015 European Cancer Congress

Mirati Therapeutics, Inc., an oncology company focusing on genetic and epigenetic drivers of cancer, today announced it will present data on its tyrosine kinase inhibitor, MGCD516, at the ESMO 2015 European Cancer Congress being held in Vienna, Austria from September 25-29, 2015.

11 Sep 2015

First patient dosed in long term-safety extension study of Resolaris for adult patients with FSHD

aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe rare diseases, today announced that the first patient has been dosed in a newly initiated long term-safety extension study of Resolaris for adult patients with facioscapulohumeral muscular dystrophy (FSHD), a rare and severe genetic myopathy for which there are currently no approved treatments.

10 Sep 2015

DelMar presents updated VAL-083 Phase I/II trial data at GBM2015 meeting

DelMar Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today presented updated clinical data from its Phase I/II study of lead product candidate VAL-083 (dianhydrogalactitol), in patients with refractory glioblastoma multiforme (GBM), at GBM2015: 2nd International Symposium on Clinical and Basic Investigation in Glioblastoma in Toledo, Spain.

10 Sep 2015

Innovative vaccine therapy shows promise against glioblastoma brain tumors

An innovative vaccine therapy developed at Roswell Park Cancer Institute is being tested in a multisite clinical trial involving 50 patients with newly diagnosed glioblastoma brain tumors. The phase II study, now accruing patients at both Roswell Park and the Cleveland Clinic, will assess the effectiveness of the SurVaxM vaccine in combination with standard chemotherapy as treatment for this often-fatal cancer.

10 Sep 2015

AcelRx's ARX-04 meets primary and secondary endpoints in Phase 3 trial

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that ARX-04 (sufentanil sublingual tablet, 30 mcg) met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial (SAP301) designed to study the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery.

9 Sep 2015

Children's Cancer Institute awarded NCI grant to fast-track new drugs into clinical trials for childhood cancer

Children's Cancer Institute welcomes its inclusion, by the US National Cancer Institute (NCI), in a systematic program of drug evaluation in childhood cancer.

9 Sep 2015

DNDi announces successful completion of SCYX-7158 Phase I study for treatment of sleeping sickness

The Drugs for Neglected Diseases initiative (DNDi) has announced today at the 9th European Congress on Tropical Medicine and International Health in Basel, Switzerland, the successful completion of Phase I human clinical trials for SCYX-7158 (AN5568), the first oral drug candidate specifically developed from the earliest drug discovery stage to combat human African trypanosomiasis, or sleeping sickness, a deadly parasitic disease transmitted by the tsetse fly.

9 Sep 2015

AstraZeneca presents lung cancer research data at WCLC 2015

Data will be reported from across AstraZeneca’s industry-leading lung cancer portfolio at the World Conference on Lung Cancer 2015, beginning this weekend in Denver, Colorado.

8 Sep 2015

Hutchison MediPharma achieves primary endpoint in POC Phase II study to treat NSCLC patients

Hutchison China MediTech Limited today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, successfully achieved the primary endpoint in the second proof-of-concept ("POC") trial of fruquintinib in patients with advanced non-squamous non-small cell lung cancer ("NSCLC") in China.

4 Sep 2015

Drug Trial News

Benitec Biopharma initiates new site for ongoing Phase 1/2a TT-034 trial for hepatitis C

Bionomics’ BNC210 Phase 1 trial for anxiety and depression meets primary endpoint

AstraZeneca presents safety and efficacy data for ExQW at 51st Annual Meeting of EASD

Avillion enrolls patients in BFORE Phase III trial to treat chronic myelogenous leukemia

AgeneBio's HOPE4MCI Phase 3 trial receives support from NIH

UT Southwestern evaluates allopurinol drug to prevent nephropathy in Type I diabetes patients

EORTC trial evaluates effectiveness of pembrolizumab in patients with high-risk stage III melanoma

BfArM approves Greenovation’s moss-aGal phase I clinical trial for Fabry disease

Sun Biomedical begins DMX-200 Phase II trial for treatment of chronic kidney disease

FDA grants Orphan Drug Designation to TxCell's Col-Treg for treatment of autoimmune uveitis

Antidepressants can increase depression, mood cycling in rapid-cycling bipolar disorder patients

Mirati to present data on tyrosine kinase inhibitor at ESMO 2015 European Cancer Congress

First patient dosed in long term-safety extension study of Resolaris for adult patients with FSHD

DelMar presents updated VAL-083 Phase I/II trial data at GBM2015 meeting

Innovative vaccine therapy shows promise against glioblastoma brain tumors

AcelRx's ARX-04 meets primary and secondary endpoints in Phase 3 trial

Children's Cancer Institute awarded NCI grant to fast-track new drugs into clinical trials for childhood cancer

DNDi announces successful completion of SCYX-7158 Phase I study for treatment of sleeping sickness

AstraZeneca presents lung cancer research data at WCLC 2015

Hutchison MediPharma achieves primary endpoint in POC Phase II study to treat NSCLC patients

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Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

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