StockMarketWire.com - Clinical stage drug development company Evgen Pharma released two positive updates on its cancer drug candidate.

Preclinical data which shows SFX-01 may be of benefit to metastatic breast cancer patients who have developed CDK4/6 resistance patient.

'An increasing body of in vitro data from there showed that in these models SFX-01 may suppress tumour growth and metastasis in patients who have become resistant to CDK4/6 inhibitors,' the company said.

Should these data be reinforced with in vivo work, the company will pursue a phase II placebo-controlled study to evaluate SFX-01 as a treatment for patients who have failed on CDK4/6 inhibitors that could commence in 2022.

In a separate announcement, the company said the University of Auckland had produced 'very similar' results to data generated by Dr Claudio Festuccia at University L'Aquila showing the efficacy of SFX-01 as a treatment for Glioma, a type of brain cancer.

Festuccia had previously reported results that shows that with in vivo pre-clinical subcutaneous and orthotopic models, SFX-01 produced tumour shrinkage and significantly extended survival times.

SFX-01 was also found to potentiate (i.e. substantially increase) the therapeutic effect of radiotherapy in these models.

Plans for a phase 2 GBM clinical trial with an adaptive design are progressing with a scheduled start in the first half of 2022, company said.

In tandem work has started with regulatory advisers on preparation of an investigational new drug application for submission to the US Food and Drug Administration in Q4/2021.




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