IND reactivated for Prescient breast cancer drug

The US FDA has reactivated the Investigational New Drug (IND) for the novel drug candidate PTX-100 (formerly known as GGTI-2418) in a phase Ib trial for the treatment of metastatic breast cancer. This follows a submission to the FDA by the drug’s owner, Prescient Therapeutics (ASX:PTX), of a detailed and complete protocol for a proposed study in patients with Stage IV metastatic breast cancer.

The proposed study will 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. The proposed study is currently on track to commence in early 2016.

PTX-100 is a potent and selective inhibitor of a cancer growth enzyme called geranylgeranyltransferase-1 (GGT-1), part of the Ras signalling pathway known to contribute to many forms of cancer. In preclinical studies, PTX-100 has been shown to synergise with standard chemotherapeutic regimes, making them more effective.

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. 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 reactivation of the IND for PTX-100 is an important development for Prescient and opens the way to commence additional clinical trials at some of the world’s leading cancer centres,” said Prescient Managing Director Dr Rob Crombie.

The news follows Prescient’s appointment last month of Professor Said M Sebti as its chief scientific officer (CSO). Dr Crombie has described Professor Sebti’s experience in drug discovery and cancer research as “exemplary”, stating, “He will bring a wealth of experience to Prescient, assisting the company’s clinical-stage drug candidates through the clinical trial process towards commercialisation.”

Professor Sebti has said he is “excited about seeing drug candidates that I helped generate at the bench advance through further clinical development in humans”.

Prescient Therapeutics (ASX:PTX) shares were trading 3.66% higher at $0.085 as of around 12.30 pm on Wednesday.