Prescient Therapeutics (ASX:PTX) has advised that the U.S. Food and Drug Administration has reactivated the Investigational New Drug (IND) for its PTX-100 drug candidate in a Phase Ib trial for the treatment of metastatic breast cancer.
This follows a submission to the FDA of a detailed and complete protocol for the proposed study in patients with Stage IV metastatic breast cancer.
The objective of the study will be to determine the optimal dosing schedule and dose of PTX-100 in combination with chemotherapy drug docetaxel, which is approved for the treatment of patients with metastatic breast cancer.
Metastatic breast cancer is one of the leading causes of cancer mortality, accounting for more than 400,000 deaths annually worldwide.
PTX-100 is a potent and selective inhibitor of an important cancer growth enzyme called geranylgeranyltransferase-1 (GGT=1), part of the well validated Ras signalling pathway known to contribute to many forms of cancer.
In preclinical studies, PTX-100 has been shown to synergize with standard chemotherapeutic regimes, making them more effective.
Furthermore, in a first-in-human single-agent, dose ranging clinical study, PTX-100 was shown to be well tolerated in patients with refractory solid tumours.
In the study carried out at University of Pennsylvania and Indiana University, four of 13 evaluable patients experienced stabilisation of their disease, in spite of the fact that their cancers were late stage and resistant to prior treatments of chemotherapy.
The proposed PTX-100 study is on track to commence early 2016. This will be conducted as a Phase Ib open label dose escalation safety study to select an optimal dose and treatment regimen of PTX-100 in combination with docetaxel.
It is expected that follow on studies will be conducted in order to precisely target and determine the cancers, combinations of drugs, and patients that will most clearly benefit from this drug.
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