Policy & Regulation
Moleculin passes FDA approval to study WP1066 in the treatment of paediatric brain cancer
13 November 2019 -

Pharmaceutical company Moleculin Biotech Inc (Nasdaq:MBRX) said on Tuesday that it will now commence a Phase 1 clinical trial of Investigational New Drug (IND) of its drug candidate WP1066 for treating children with recurrent or refractory malignant brain tumours.

The US FDA has approved the request made by Dr Tobey MacDonald, professor of the Department of Pediatrics at Emory University School of Medicine, director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center, who is the trial's principle investigator.

Following the US FDA approval, the trial will be conducted at the Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta.

According to the company, WP1066 is an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while stimulating a natural immune response, targeting brain tumours, pancreatic cancer and haematologic malignancies.

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