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Regeneus receives positive early results from cancer vaccine trial, shares rise

Published: 04:13 30 Jul 2018 BST

syringe taking sample from beaker
Shares were up 6.3% this morning trading at 25 cents

Regeneus Ltd (ASX:RGS) has met the primary endpoint of safety and tolerability for its phase I, 12-person safety trial for its cancer vaccine.

The study known as the ACTIVATE trial, is the first clinical trial of RGSH4K, the company’s autologous tumour vaccine product for the treatment of solid tumours.

Immune response detected at all dose levels

Notably, RGSH4K also showed encouraging signs of immune stimulation in some patients, as demonstrated by changes in cancer markers, immune cells and cytokines.

This immune stimulation was seen in one or more patients at all three of the dose levels.

Preliminary indications of anti-tumour activity were seen in some patients however long term follow up on 50% of the patients continues.

READ: Regeneus welcomes positive step forward for Progenza’s US patent

Regeneus’s CEO John Martin said: “Data obtained from this first-in-human clinical study, including the preliminary evidence of clinical activity, is encouraging and highlights the clinical potential of RGSH4K.

“We are pleased with these results and we will use them to advance further studies and our partnering discussions with interested parties.”

Results support advancing clinical evaluation

The immune response, including favourable changes in biomarkers, coupled with the benign safety profile for RGSH4K encourages proceeding to further clinical evaluation.

This could be either as a single agent or in combination with other therapies.

Three vaccines given at three week intervals

The single centre, open label, first-in-human phase I study was designed to evaluate the safety and tolerability of RGSH4K and to identify the biologically active doses to take into future trials.

12 patients heavily pre-treated with chemotherapy or radiotherapy, with various advanced solid tumours received RGSH4K in three dose cohorts.

A total of three vaccines were administered in the treatment phase, given at three week intervals, and patients had the option to continue dosing in an extension phase.

There were no dose limiting toxicities and no serious adverse events related to the vaccine.

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