IND For Phase 1b/2 Ovarian Cancer Trial Transferred To Prescient

Prescient Therapeutics,  a clinical stage oncology company, has notified the US Food and Drug Administration (FDA) of the transfer of the Investigational New Drug (IND) for its novel drug candidate PTX-200 (formerly known as TCN-P) in a Phase 1b/2 trial for the treatment of metastatic ovarian cancer. The IND was previously held by an Investigator at the Moffitt Cancer Center. This follows the acquisition of the drug from AKTivate Therapeutics in late 2014.

A Phase 1b/2 trial of the compound in combination with current standard of care is already underway in patients with recurrent or persistent platinum resistant ovarian cancer at Florida’s Lee Moffitt Cancer Center, one of the largest cancer centres in the US. Six patients have now been enrolled to take part in the trial, which is examining TCN-P in combination with standard of care therapy cisplatin.

This trial was previously funded by a grant from the U.S. Department of Defense. In addition, Prescient is planning a Phase 1b/2 trial evaluating PTX-200 as a new therapy for acute myeloid leukaemia in late 2015.

Early studies suggest that the PTX-200 compound, which targets a key tumour survival pathway known as AKT, may help to minimise the problem of chemotherapy resistance – a major problem in the treatment of ovarian cancer globally and linked to extremely poor survival rates.

Ovarian cancer is the fifth leading cause of cancer deaths in women in the United States. Approximately half of those diagnosed will die from metastatic disease.

Chemotherapy has been a general standard of care, typically consisting of platins, a group of platinum-based drugs. However, ovarian cancer often recurs, presenting as platinum-resistant.

Prescient Managing Director Dr Robert Crombie, said “Despite decades of research focused on the role of surgery and cytotoxic chemotherapy for epithelial ovarian cancer, current treatments make little substantive impact on cure rates for the disease.”

“There is a vital need for new therapies that may be used in conjunction with current standards of care and we are committed to unlocking the value of this highly promising drug candidate that has great potential as a new treatment for this difficult to treat cancer.”

About Prescient Therapeutics
Prescient Therapeutics is a clinical stage oncology company developing novel compounds that show great promise as potential new therapies to treat a range of cancers that have become resistant to front line chemotherapy.

Lead drug candidate PTX-200 inhibits an important tumour survival pathway known as AKT, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukaemia. This highly promising compound is now the focus of two current clinical trials. The first is a Phase 1b/2 study examining PTX-200 in breast cancer patients at the prestigious Montefiore Cancer Center in New York.

Prescient’s second novel drug candidate, PTX-100, is a first in class compound with the ability to block an important cancer growth enzyme known as geranylgeranyl transferase (GGT). It also blocks the Ral and Rho circuits in cancer cells which act as key oncogenic survival pathways, leading to apoptosis (death) of cancer cells. PTX-100 was well tolerated and achieved stable disease in a Phase 1 trial in advanced solid tumours. Prescient expects to commence Phase 1b/2 clinical trials in breast cancer and multiple myeloma in late 2015. At the same time, Prescient plans to develop its novel p27 cancer biomarker as a companion diagnostic that will potentially identify those patients that are most likely to respond to PTX-100 therapy.

Prescient has licensed access to its Co-X-Gene™ platform technology to French biotechnology company Transgene for use in two immunotherapeutic products.