Company

Product

Description

Indication

Status

Date

Phase II

Imugene Ltd., of Sydney

IMU-131 (HER-Vaxx)

3-peptide virosome-based vaccine against HER2/neu

HER2-positive gastric cancer

First patient dosed in open-label study expected to enroll 68 participants across sites in Asia, Eastern Europe and India, randomized to HER-Vaxx plus standard-of-care (SOC) chemotherapy or SOC alone; primary endpoint is overall survival, with secondary endpoint of progression-free survival; safety, tolerability and immune response also will be measured

3/14/19

Taiwan Liposome Co. Ltd., of Taipei, Taiwan

TLC-590

Bioseizer liposomal formulation of ropivacaine

Postsurgical pain relief

Dosed first patient in study following bunionectomy; randomized, double-blind, comparator- and placebo-controlled trial will test safety, pharmacokinetics and efficacy in about 200 patients; primary endpoint is area under the curve of the numerical pain rating scale

3/18/19

Phase III

Akebia Therapeutics Inc., of Cambridge, Mass.

Vadadustat

Oral hypoxia-inducible factor prolyl hydroxylase inhibitor

Anemia due to chronic kidney disease

Top-line results from 2 pivotal studies in Japanese subjects showed each study, 1 in nondialysis-dependent patients and 1 in hemodialysis-dependent subjects, met the primary endpoint; results from 2 single-arm studies in peritoneal dialysis subjects and hemodialysis subjects further support use on those indications; partner Mitsubishi Tanabe Pharma Corp. expects to submit an NDA in Japan in 2019

3/12/19


Notes

The date indicated refers to the BioWorld Clinical data table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.

 

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