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Ascendis Pharma initiates TransCon Treprostinil Phase 1 study in healthy volunteers

Ascendis Pharma initiates TransCon Treprostinil Phase 1 study in healthy volunteers

Ascendis Pharma A/S, a clinical stage biotechnology company that applies its innovative TransCon technology to address significant unmet medical needs, today announced that it has initiated a Phase 1 single ascending dose study of TransCon Treprostinil in healthy volunteers. [More]
Aptose begins APTO-253 clinical study in patients with relapsed or refractory hematologic malignancies

Aptose begins APTO-253 clinical study in patients with relapsed or refractory hematologic malignancies

Aptose Biosciences Inc., a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced dosing of the first patient in its Phase 1b clinical study of APTO-253 in patients with relapsed or refractory hematologic malignancies. [More]
U-M researchers identify how amlexanox drug improves metabolism of sugar

U-M researchers identify how amlexanox drug improves metabolism of sugar

Researchers at the University of Michigan have identified how a promising drug in clinical trials for the treatment of obesity and related metabolic disorders improves the metabolism of sugar by generating a new signal between fat cells and the liver. [More]
Sheffield breast cancer patient takes part in new drug research trial

Sheffield breast cancer patient takes part in new drug research trial

A SHEFFIELD patient has become the first in the world to take part in a new drug research trial aiming to better control secondary breast cancer, or cancer which has spread to other parts of the body including the bones, liver and lungs for longer. [More]
Two new ODYSSEY trials meet primary efficacy endpoints

Two new ODYSSEY trials meet primary efficacy endpoints

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that two new ODYSSEY trials, which are the first Phase 3 trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints. [More]
CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of aldoxorubicin for the treatment of Kaposi's Sarcoma (KS) in HIV-infected patients. [More]
ProNAi enrolls first patient in PNT2258 Phase II study for treatment of refractory or relapsed DLBCL

ProNAi enrolls first patient in PNT2258 Phase II study for treatment of refractory or relapsed DLBCL

ProNAi Therapeutics Inc., a private hematology/oncology company dedicated to developing and commercializing a new class of therapeutics based on its proprietary DNAi platform, today reported that the first patient with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) has enrolled in the "Wolverine" Phase II study and been treated with PNT2258. [More]
Combination therapy can reduce recurrence of small, HER2-positive breast tumors

Combination therapy can reduce recurrence of small, HER2-positive breast tumors

In a phase 2 clinical trial, women with small (stage 1), HER2-positive breast tumors who received a combination of lower-intensity chemotherapy and a targeted drug following surgery were highly unlikely to have the cancer recur within three years of treatment, investigators at Dana-Farber Cancer Institute and other institutions report in a paper published today by the New England Journal of Medicine. [More]
ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has been granted a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposal for the design of a Phase 3 trial of ContraVir's lead antiviral candidate, FV-100. [More]
CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. [More]
Johnson & Johnson begins Phase 1 trial of preventive Ebola vaccine program

Johnson & Johnson begins Phase 1 trial of preventive Ebola vaccine program

Johnson & Johnson today announced the start of a Phase 1, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. [More]
LEO Pharma submits NDA for aerosol foam formulation to treat patients with plaque psoriasis

LEO Pharma submits NDA for aerosol foam formulation to treat patients with plaque psoriasis

LEO Pharma announces it has submitted a New Drug Application (NDA) for calcipotriene and betamethasone dipropionate aerosol foam, 0.005%/0.064%, to the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis. [More]
BrainStorm's phase 2a ALS study meets primary endpoint

BrainStorm's phase 2a ALS study meets primary endpoint

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced positive final results from its phase 2a clinical trial of NurOwn™ in amyotrophic lateral sclerosis (ALS) patients, which enrolled 14 subjects at Hadassah Medical Center in Jerusalem. [More]
FDA receives Actavis' NDA resubmission for cariprazine

FDA receives Actavis' NDA resubmission for cariprazine

Actavis plc (NYSE: ACT) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application (NDA) resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. [More]
Final Phase 1 data of zoptarelin doxorubicin Phase 1/2 trial published in Clinical Cancer Research

Final Phase 1 data of zoptarelin doxorubicin Phase 1/2 trial published in Clinical Cancer Research

Aeterna Zentaris Inc. today announced that an article on final data for the Phase 1 portion of the ongoing Phase 1/2 trial in prostate cancer with zoptarelin doxorubicin (formerly AEZS-108), a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin, has been published in the December issue of Clinical Cancer Research. [More]
Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1b clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy. [More]
Can-Fite BioPharma completes RA Phase III study of lead drug candidate CF101

Can-Fite BioPharma completes RA Phase III study of lead drug candidate CF101

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it completed the design of the Rheumatoid Arthritis (RA) Phase III study of its lead drug candidate CF101. [More]

G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. announced that its strategic partner, G-treeBNT Co. Ltd., has filed an IND with the Korean Ministry of Food and Drug Safety for a Phase IIB/III clinical trial with RGN-259 (designated GBT-201 in Korea and the licensed Pan Asia territory) for the treatment of patients with dry eye syndrome. [More]
Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, today announced that it has started its bremelanotide pivotal registration program. [More]
Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

Kinex Pharmaceuticals announced today that the first patient has been dosed with KX2-361 at Roswell Park Cancer Institute. [More]