Clinical stage oncology company Prescient Therapeutics (ASX:PTX) has demonstrated the strength of its portfolio with a new government approval setting up new treatment trials.
The company has secured U.S. Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application for the forthcoming Phase Ib and Phase II clinical trial and program in acute myeloid leukemia (AML).
The study will combine Prescient’s lead drug candidate, the novel Akt inhibitor PTX-200, together with the chemotherapeutic agent cytarabine, in refractory or relapsed patients with AML.
In an earlier AML clinical trial, 17 out of 32 patients treated with PTX-200 exhibited stable disease, and three patients with AML had significant responses, with bone marrow blast reductions of over 50%.
These promising results demonstrate that PTX-200 may have significant efficacy in AML, especially in patients with aberrantly hyper-activated Akt.
The latest approval represents further validation of Prescient assets, especially considering that for most U.S. investors and pharmaceutical companies, an FDA IND is the “gold standard” pathway for developing a drug.
Prescient now has four open INDs with the FDA, which represents a particularly valuable pipeline with increasingly promising commercial potential especially compared with other ASX biotech companies.
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