On a morning steeped in red, Prescient Therapeutics (ASX: PTX) and Antisense Therapeutics (ASX:ANP) were two of the few companies to offer investors hope, after releasing modest news around drug trial dosing and a US Food and Drug Administration (FDA) orphan drug application.

Prescient gained 11 per cent while Antisense advanced over 6 per cent this morning.

PTX and ANP share price chart


Prescient’s news covered the results from the first cohort of three acute myeloid leukemia (AML) patients in the phase 1b study of PTX-200 and cytarabine completed dosing at 25 mg/m2.

No dose limiting toxicities were observed, and therapy was better tolerated than under the previous dosing schedule, which used a higher volume of the chemotherapy treatment cytarabine and more days of PTX-200 dosing.

The study has now progressed to the next dose level of 35 mg/m2.

The company has already said that under the previous dosing scheme three of 15 patients experienced complete responses in relapsed or refractory AML.

Prescient has opened the next cohort for enrolment at 35 mg/m2 PTX-200.

“It is pleasing to see the AML study continue to advance despite the COVID-19 pandemic,” Prescient chief medical officer Dr Terrence Chew said.

He said the company was seeking “to expand on the encouraging responses previously observed in this study, in a patient population that is difficult to treat and has limited treatment options”.


Orphan application in the US

Antisense has submitted an application for Orphan Drug designation for its drug ATL1102 for the treatment of Duchenne muscular dystrophy (DMD) to the FDA.

The company recently announced positive phase II results with ATL1102 in DMD.

“This is an important regulatory and commercial milestone in the further development of ATL1102 for DMD and represents another key step forward towards bringing this potentially transformative therapy to patients with a significant unmet need,” Antisense managing director and chief Mark Diamond said.

Orphan drug designation can be granted for drugs intended to treat rare diseases that affect fewer than 200,000 people in the US.

Incentives to accelerate the development of these treatments include tax credits towards the cost of clinical trials, waiver of US prescription drug filing fees and orphan product exclusivity for seven years upon marketing authorisation.


In other ASX health news:

Medlab Clinical (ASX:MDC) says an ongoing observational study of medical cannabis drug NanaBis, which is being developed as a non-opioid alternative for the treatment of chronic and cancer-induced bone pain, has now enrolled 432 of a target 2000 patients and data shows a 59.5 per cent reported reduction in pain.

Cogstate (ASX:CGS) partner Eisai in Japan has begun building the brain performance application “Easiit”, a base element of a digital platform for dementia, and will incorporate Cogstate’s NouKNOW assessment by the end of September.