Prescient’s PTX-100 Phase 1b study shows encouraging responses on a patient population that is notoriously difficult to treat.

Clinical stage oncology company Prescient Therapeutics (ASX:PTX) has revealed that its PTX-100 Phase 1b clinical trial continues to exhibit safety and encourages clinical activity.

The trial is being conducted on an expansion cohort of patients with relapsed and refractory T cell lymphomas (TCL).

It’s being led by globally renowned haematologist, Professor H. Miles Prince at the Epworth Hospital in Melbourne.

Results showed that PTX-100 continues to exhibit an excellent safety profile at the highest dose of 2000 mg/m2.

Moreover, the drug continues to show encouraging clinical activity in a difficult to treat patient population, including a striking response in a patient with refractory cutaneous TCL (CTCL).

This particular patient had failed four therapies, and had VGPR (very good partial response) on PTX-100, and is currently still on treatment.

PATIENT 121-010. Image: Supplied

“It is very exciting to see PTX-100 show clinical activity in a patient population that is notoriously difficult to treat, and where these patients have failed several lines of prior therapies,” said Prescient CEO, Steven Yatomi-Clarke.

“Furthermore, PTX-100 continues to exhibit an excellent safety profile, which is uncharacteristic of available TCL therapies.”

Safety and efficacy

Eight patients have been screened and seven have been dosed with PTX-100 in the expansion cohort where PTX-100 continues to exhibit an excellent safety profile.

There have been very few adverse events in the expansion cohort so far, and no serious adverse events related to PTX-100.

Two PTCL patients that had commenced therapy withdrew from the study for reasons unrelated to the trial.

Another PTCL patient passed away due to reasons not associated with the study, as frequently occurs in studies of advanced malignancies.

In each of these cases, subjects were not on the study long enough to observe responses, however, relevant pharmacokinetic and safety data were still collected, which are to the primary objectives of the study.

PTX-100 also continues to exhibit encouraging clinical activity in the difficult-to-treat patient population.

Apart from the encouraging progress of patient 121-010 above, patient 121-003 also had a partial response with PTX-100 that endured for over 32 months before the disease progressed.

This patient had aggressive PTCL and had failed five prior treatments.

Another two patients with CTCL that failed three prior therapies have experienced stable disease that have endured for 3-4 months so far, and currently remain on therapy.

“It is exciting to see encouraging responses in CTCL patients, alongside PTCL patients, and we will aim to recruit more CTCL patients to the study. We look forward to sharing these updates with the market,” said Yatomi-Clarke.

Next steps

In light of these encouraging responses in CTCL in particular, Prescient has now amended the study protocol to accommodate the recruitment of additional CTCL patients.

This recruitment remains on schedule which may commensurately extend the study period.

Prescient says the study will remain open while patients continue to derive clinical benefit from PTX-100.

Principle Investigator of the study, Professor H. Miles Prince, said: “We continue to see impressive responses in both systemic and cutaneous T cell lymphomas on this study.”

“Furthermore, PTX-100 continues to be extremely well tolerated by patients. We look forward to continuing accruing patients to the trial who otherwise have limited treatment options.”

Join a briefing

Join Prescient CEO and MD Steven Yatomi-Clarke for an investor briefing next Wednesday, 2nd November at 12pm (AEDT), where he will discuss these results in more detail and provide a company update. Click here to book in.

This article was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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