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  • Noxopharm (NOX) has received positive interim results from its clinical trial for end-stage prostate cancer
  • The trial is being conducted by St Vincent’s Hospital in Sydney
  • It will evaluate Noxopharm’s lead product candidate, Veyonda, in 56 patients
  • Veyonda switches on the body’s first-line defence mechanism and destroys cancerous cells
  • The trial produced an over-17 month median overall survival rate, which is significantly longer than originally expected
  • Noxopharm is up a slight 2.22 per cent on the ASX, with shares currently trading for 23 cents apiece

Noxopharm (NOX) has received positive interim results from its LuPIN clinical trial in end-stage prostate cancer.

The LuPIN study is being conducted by St Vincent’s Hospital in Sydney and will be evaluating Noxopharm’s lead product candidate, Veyonda, in combination with Lu-PSMA-617 in 56 patients with late stage metastatic castration-resistant prostate cancer (mCRPC).

Prostate cancer is very common. One in nine American men will be diagnosed in their lifetime, while it is the most common cancer amongst males in Australia. According to the Cancer Council, prostate cancer is among the top five most commonly diagnosed cancers in the nation.

Despite significant advances in the treatment, many men still succumb to cancer. 3500 men lost their lives to prostate cancer in Australia in 2018.

Veyonda works with chemotherapy and radiotherapy to increase the number of cancer cells killed by those treatments.

It then acts as an immune-oncology drug by switching on the body’s first-line defence mechanism, which is the main system responsible for fighting cancer.

The data presented at the ASCO Genitourinary Cancers (GU) Symposium today has reported the interim results for the first 32 patients receiving the medication.

Out of these 32 patients, eight received a dosage of 400mg while the remaining 24 received 800mg.

“The combination treatment of Veyonda and Lu-PSMA-617 has delivered a clinically meaningful and strong anti-cancer effect in a high proportion of men and importantly continues to have an excellent safety profile,” Noxopharm Chief Medical Officer Dr Gisela Mautner said.

“The data boosts our confidence that Veyonda will prove to be of major benefit for a high proportion of patients with late-stage prostate cancer,” she added.

All recruited patients has received and failed two prior lines of therapy, (chemo and androgen-signalling inhibitors) and most patients (29 out of 32) has failed a third therapy prior to entering the trial.

According to Noxopharm, the combined treatment of Veyonda and Lu-PSMA-617 continues to have a good safety profile with only half of the patients experiencing mild adverse events.

Of these people 17 out of 32 experienced dry mouth, 15 out of 32 were fatigued and 14 out of 32 had anaemia.

Minimal higher-grade side effects were also reported but all were manageable.

The median overall survival was 17.1 months which indicates a significantly longer survival duration than clinically expected.

A total of 47 patients, 15 out of 32, were well enough to receive all six cycles of therapy, 87 per cent, 28 out of 32, had a fall in PSA (an important marker for anti-cancer activity), and 62.5 per cent, 20 out of 32, had a strong PSA response of over 50 per cent.

Half of the patients with severe pain at the start of the study had a significant reduction of their pain due to the secondary tumours

“Being able to deliver a meaningful anti-cancer response for at least 50 per cent of patients with Stage four of any form of cancer would be a remarkable outcome,” Executive Chairman and CEO Dr Graham Kelly commented.

“A median overall survival of 17.1 months, plus the ability to offer at least a 50 per cent chance of achieving a meaningful response, should be seen as highly positive outcomes,” he added.

The final 24 patients are now receiving higher doses of Veyonda.

Noxopharm is up a slight 2.22 per cent on the market with shares trading for 23 cents apiece at 2:19 pm AEDT.

NOX by the numbers
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