Biotech drug developer Noxopharm (ASX: NOX) has reported positive end-of-study results from its DARRT-1 phase 1b trial treating men with late-stage prostate cancer.
In an update yesterday, the oncology-focused company announced that clinical responses had pointed to the NOX66 DARRT treatment regimen as a “potentially major new treatment option”, with two-thirds of study participants having responded to treatment with stable disease or better at six months following the start of treatment and with significantly lower pain levels.
“NOX66 DARRT has delivered a very meaningful anti-cancer effect in a high proportion of men, halting progression of their disease and providing an average 80% reduction in their pain levels, including some men becoming pain-free,” Noxopharm executive chairman and chief executive officer Dr Graham Kelly said.
He said the results put NOX66 DARRT “right at the top end of response rates in late-stage cancer”.
“This is exciting data that validates our confidence in the future of the NOX66 DARRT treatment regimen,” Dr Kelly added.
According to Noxopharm, this treatment represents a “global unmet need and multi-billion-dollar market opportunity” given that 360,000 men globally are estimated to die from prostate cancer each year.
Noxopharm’s NOX66 DARRT clinical program tested the ability of its drug Veyonda (NOX66) to augment an immunological response to palliative dosages of radiotherapy.
The study treated 25 men with late-stage metastatic castration-resistant prostate cancer with a combination of low-dose palliative radiotherapy and Veyonda, which is designed to boost local inflammatory and immune responses in tumours in the body.
Three cohorts of patients were treated with either 400 milligrams, 800mg or 1200mg of Veyonda in combination with the radiotherapy to determine the optimal dose.
By the end of the study at six months, 16 men had completed the trial with 15 being measurable radiographically.
Across all three Veyonda dosage groups, one patient had a partial response, nine had stable disease and five out of the 15 had progressive disease, giving an overall tumour response rate of 66%.
In addition, 62% of patients had a pain response with falls from the baseline ranging from 43% to 100% (pain free).
“The combination of Veyonda and low-dose radiotherapy has proven to be very well tolerated and minimally intrusive – important factors for patients with advanced cancer and generally poor health when considering their future,” Dr Kelly said.
“Another positive is that NOX66 DARRT uses external beam radiotherapy, a relatively inexpensive and readily-available source of radiotherapy around the world, supporting wide uptake,” he added.
According to Noxopharm, planning for the next stage of testing is already underway in collaboration with the company’s medical advisory boards.
This next stage will be a double-blind, control-arm, multi-national phase 2/phase 3 adaptive study which Noxopharm said it hopes will be the “final step to obtaining marketing approval”.
Last week, Noxopharm unveiled the prospectus of its majority-owned subsidiary Nyrada, which plans to start trading on the ASX before Christmas.
Nyrada is seeking to raise up to $8.5 million at $0.20 per share, which would imply a $22 million market capitalisation at completion of the initial public offering.
The subsidiary was originally established by Noxopharm in 2017 to house the company’s non-oncology drug assets.
It has three leading research and development programs and an option to acquire a fourth drug development candidate. The programs involve developing drugs to lower cholesterol or treat neurological and chronic inflammatory diseases.
In its prospectus, Nyrada said the IPO funds would be used to accelerate these programs, aiming to have at least one drug candidate ready to enter a first-in-human phase I safety, tolerability and pharmacokinetic study by the end of 2021.