FDA clears Moleculin's IND application to Conduct Phase 1 Study of WP1066 for Recurrent Malignant Glioma

Moleculin Biotech, Inc. (MBRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application of the drug candidate WP1066 for Recurrent Malignant Glioma

The company plans to evaluate strategic partnerships and collaborations to conduct a Phase 1 open label clinical study of oral WP1066 in adult patients.

Commenting on the trial, Walter Klemp, Chairman and CEO, said, “WP1066 has demonstrated significant anti-tumor activity in a wide range of tumor cell lines and increased survival in a number of animal models to-date. Additionally, the preliminary results demonstrated in the ongoing trial of WP1066 for pediatric brain tumors bolster our confidence and this IND clearance provides further momentum for its continued research and development”

Additionally, WP1066 in combination with radiation is being evaluated in the pre-clinical study, for the treatment of Glioblastoma Multiforme (GBM).

Moleculin Biotech is currently trading high 2.6 percent at $ 1.96