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April 22, 2022

Moleculin obtains FDA clearance for Phase I glioma treatment trial

The trial will analyse the safety, pharmacokinetics and efficacy of oral WP1066 in adult recurrent malignant glioma patients.

Moleculin Biotech is all set to commence Phase I clinical trial of WP1066 to treat recurrent malignant glioma, a type of brain tumour, after receipt of the US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application. 

An Immune/Transcription Modulator, WP1066 is intended to induce the immune response to tumours by hindering the errant activity of Regulatory T-Cells (TRegs).

It can also hinder crucial oncogenic transcription factors, such as phosphorylated signal transducer and activator of transcription 3 (p-STAT3), c-Myc and hypoxia inducible factor 1α (HIF-1α). 

The company intends to seek strategic collaborations to carry out the trial.

The open-label, single-arm, dose-escalation trial will analyse the safety, pharmacokinetics and efficacy of oral WP1066 to treat adult recurrent malignant glioma patients.

Moleculin Biotech chairman and CEO Walter Klemp said: “WP1066 has demonstrated significant anti-tumour activity in a wide range of tumour 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 paediatric brain tumours bolster our confidence and this IND clearance provides further momentum for its continued research and development.” 

At present, WP1066 is being assessed in partnership with Emory University to treat paediatric brain tumours, including diffuse interstitial pontine glioma (DIPG). 

Till date, the trial treated three participants in the first two cohorts of the Phase I dose-escalation segment of the physician-sponsored clinical trial. 

One of the participants with DIPG in the first cohort of the trial demonstrated response to the treatment with WP1066 showing clinical improvement as well as radiologic reduction of tumour size. 

Currently, WP1066 is being analysed pre-clinically along with radiation to treat glioblastoma multiforme.

In February last year, the company entered an agreement with contract research organisation Catalyst Clinical Research to conduct clinical trial of Annamycin, a next generation anthracycline.

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