Regeneus : NSLHD: Clinical Trials Approved For Personalised Human Cancer Treatment

Man's best friend is proving his worth to cancer patients in Northern Sydney, in what is hoped to be an important innovation in cancer treatment.

Building on previous research with dogs undertaken at the Kolling Institute of Medical Research, based at Royal North Shore Hospital, a new phase of in-human trials has been approved. The research will use the cancer patient's own tumour as the starting point for developing a personalised vaccine.

The Phase 1 trial, to be funded by Sydney-based regenerative medicine company, Regeneus, will involve 21 patients from whom tumour samples have been taken. The trials will be conducted under the supervision of Royal North Shore Hospital oncologists, Professor Stephen Clarke and Associate Professor Nick Pavlakis.

The trial of a human cancer vaccine is the next step in research. It follows on from encouraging results in the use of personalised cancer vaccines to treat dogs diagnosed with advanced cancers. Nearly all of the dogs treated exceeded their expected survival time, with many owners reporting an improved quality of life.

Professor Clarke, Director of the Northern Sydney Cancer Centre, said he was pleased to be able to begin trials of the technology in human patients.

"Despite new advances, there are cancers that do not respond well to existing therapies."

"Manipulation of the immune system to allow the body to better fight the cancer has become a popular treatment target and because of that reality, using the patient's primary tumour as the source for a vaccine offers the hope of an improved immune response to tumour-associated proteins called antigens," Professor Clarke said.

Regeneus CEO, John Martin, says the company is pleased to help fund the development of a therapy for humans that has already shown encouraging results with canines.

"This is the next step in building on the ground-breaking vaccine development, undertaken at the Kolling Institute, which led to the successful canine cancer vaccine".

In this trial, adult patients with a variety of advanced cancer types will be treated using this revolutionary technology.

The process will work as follows:

1. Suitable patients will have their tumour removed and stored (known as tumour banking) prior to commencing first-line treatment;
2. If the patient relapses, and there are no other useful treatment options available, they will move into the next stage of the trial and have a personalised vaccine produced from their tumour;
3. The personalised, or autologous vaccine, will be injected into the patient at staged intervals, and monitored for a response.

Professor Clarke said the aim would be for the cancer to be stabilised and the tumour to shrink. Ideally this would then lead to an extended life expectancy for the patient, similar to the results obtained in the canine research.

"The upcoming clinical trials are exciting, and oncologists are viewing autologous vaccines as a promising therapy. We hope the trials will show that this personalised treatment is relevant to primary and secondary tumours and will reduce the risk of tumour recurrence. We're also hoping it will prove to be generally applicable and that, eventually, we can create a large number of vaccines from a single tumour sample."

Further detail in relation to the trial and the tumour bank can be found on the Australian New Zealand Clinical Trials Registry website

People interested in participating should consult their oncologist about their suitability. Oncologists can contact the study leaders for more information.

The vaccine, known as RGSH4K, is produced from a patient's own cancer cells and, combined with a proprietary immunostimulant, is designed to activate the immune system against the cancer cells to initiate a body-wide response. The immune system's memory should recognise and respond to existing and new tumours.

Cancer immunotherapies represent a treatment option without many of the side effects of standard chemotherapy. Cancer vaccines interfere minimally with most chemotherapeutic drugs making them likely helping agents to traditional therapies. The RGSH4K vaccine contains no live cancer cells.

The study known as the ACTIVATE trial, is a single centre, open label, first-in-human, Phase 1 dose escalating study to evaluate the safety, tolerability and preliminary efficacy of RGSH4K, administered in 21 patients with advanced cancers.