PharmAust recruits first canine to phase 2 monepantel trial centre in US
美国试验将涉及用 PharmAust 的莫奈太尔治疗 10 只患有 B 细胞淋巴瘤的犬科动物，以评估其疗效。
Clinical-stage biotechnology company PharmAust (ASX: PAA) has recruited the first canine with B-cell lymphoma to its phase 2 trial centre in the US to assess the efficacy of treatment using lead drug monepantel (MPL).
The medical oncology team at US-based Pathway Vet Alliance (trading as Thrive Pet Healthcare and Heart of Texas Veterinary Specialty Centre) will treat up to 10 dogs with MPL, according to pilot program guidelines set by the Food and Drug Administration.
In the past week, the first canine patient has been put through a physical exam and standardised staging tests and sent home to commence treatment with MPL tablets.
The patient will be required to return to the clinic for appraisal on days 14 and 28.
Progressing to plan
PharmAust principal investigator Dr Kim Agnew said the trial was progressing to plan.
“It is very exciting to start our first enrolments in the US,” he said.
“The team at Heart of Texas provides very compassionate patient-focused treatment … the clinic experiences a high oncological caseload so we are hopeful the enrolment rate will be expedited.”
Canine trials
PharmAust’s canine trials to date have indicated that a combination of MPL and standard-of-care therapy can more than double the life expectancy of sick dogs.
MPL is already approved for veterinary use for a different indication in food chain animals.
The company is aiming to repurpose the drug as a safe and effective cancer treatment without the associated side effects of chemotherapy.
Veterinary trial centres have been set up in Australia, New Zealand and the US to evaluate the anti-cancer benefit of MPL in dogs with untreated B-cell lymphoma to finalise phase 2 evaluation of the drug.
To date, 29 canines have been treated using MPL monotherapy.
PharmAust requires positive clinical benefits for 18 or more patients from a total 46 canines to in order to meet its statistical endpoint.
The company said continued positive outcomes would enable it to prepare for a phase 3 registration trial.