Clinical Trials

Amgen’s Repatha reduces risk of cardiovascular events in FOURIER Outcomes study

Amgen announced that the FOURIER trial assessing whether Repatha (evolocumab) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke).

Abeona enrolls first high dose subject in phase 1/2 gene therapy trial for ABO-102

Abeona Therapeutics has enrolled the first high-dose subject in the ongoing Phase 1/2 trial for ABO-102 (AAV-SGSH) in Sanfilippo Syndrome Type A.

Kainos Medicine starts phase 1 trials of Parkinson’s Disease drug candidate

Kainos Medicine has started phase 1 clinical trials of its Parkinson's Disease drug candidate code-named KM-819.

Aurinia selects Worldwide Clinical Trials as CRO for phase 3 lupus nephritis study

Worldwide Clinical Trials has been selected as Aurinia Pharmaceuticals' clinical research organization (CRO) for the AURORA phase 3 study of volcosporin to treat active lupus nephritis (LN).

Eisai’s liver cancer drug Lenvima succeeds in phase 3 trial

Eisai has announced positive topline results from the randomized, multicenter Phase 3 trial (Study 304) evaluating the company's multiple receptor tyrosine kinase inhibitor, lenvatinib (marketed as Lenvima), for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

FDA authorizes NantKwest’s IND application for first-in-human haNK cell therapy phase I study

The US Food and Drug Administration (FDA) has authorized NantKwest’s Investigational New Drug Application (IND) for its first-in-human, high-affinity natural killer (haNK) cell therapy phase I clinical study.

Otonomy starts patient enrollment in phase 2 trial of OTO-104

Otonomy has started the enrollment of the first patients in a phase 2 clinical trial assessing OTO-104 for the prevention of hearing loss in cancer patients undergoing chemotherapy with platinum-based agents.

Clinigen begins US Managed Access program for TESARO’s niraparib in ovarian cancer patients

Clinigen Group's Idis Managed Access (MA) division has partnered with TESARO to launch a Managed Access program for the investigational PARP 1/2 inhibitor, niraparib.

Chi-Med starts phase II study of sulfatinib in second-line biliary tract cancer in China

Hutchison China MediTech (Chi-Med) has started a Phase II study of sulfatinib in second-line biliary tract cancer (“BTC”) patients in China.