Dear Shareholders,
Following yesterday’s update on Novogen’s GDC-0084 trial, our CEO, Dr James Garner was interviewed by Sarah-Jane Tasker of
The Australian. Please
click here to read the article from today’s edition (for subscribers). Please find the article reproduced with permission below.
Thanks to all those shareholders who attended last night’s information session in Melbourne. We look forward to tomorrow night’s session in Sydney and invite final RSVPs by COB today. To RSVP, please contact Donna Cross via
[email protected] or +612 9472 4101. To view the invitation, please
click here.
Kind regards,
The Novogen team
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Novogen to test brain cancer drug
The Australian
BY SARAH-JANE TASKER
April 11, 2017
Australian biotech Novogen has confirmed plans to start a phase-two clinical trial to test what it says is one of the most keenly watched drugs globally for brain cancer.
Novogen has been progressing development plans for a new drug to treat glioblastoma (GBM), the most common and aggressive form of brain cancer.
The company said yesterday that a phase-one clinical trial had shown promising results with tumour growth stopped in 40 per cent of patients.
GBM affects about 130,000 patients worldwide annually and has one of the poorest outcomes of any cancer, with only 3-5 per cent of patients alive five years after diagnosis.
The drug Novogen is developing, which it licensed from Genentech, is designed to inhibit tumour growth by targeting a biochemical control mechanism that is thought to be critical to growth of the tumour.
Novogen chief executive James Garner said there had been little progress in the management of GBM over the past decade.
“We know that clinicians and oncologists are frustrated with the treatment currently available and all eyes will be on the results of this trial,” Dr Garner said.
“Genentech is a well respected name in the industry and it is part of Swiss pharmaceutical company Roche, which does about $32 billion a year in cancer drug sales.”
Novogen expects to start recruiting patients in the second half of this year and the trial is expected to run in Australia, the US and parts of Europe, with about 200 participants. It is expected to take 18 months to recruit the patients and then another 12 months to assess the outcome.
“We are looking for a clear answer to the question — does the drug work,” Dr Garner said.
He said most drugs did not get into the brain, as the brain pumped drugs out, which he said made it difficult when trying to treat any type of brain disease.
“Most cancer drugs don’t get into the brain, but our drug is interesting because it was designed by Genentech specifically as a brain cancer drug,” he said.
“Because it was designed from the start to treat brain cancer, they tried to optimise its properties so that it is as good as it can be as a cancer drug and we can show it does get into the brain.”
Dr Garner added that for diseases like brain cancers, where there was an unmet medical need, the US regulator would consider an accelerated approval path, which meant making the drug available without a final phase-three trial.
“We are trying to optimise our phase-two study to increase the odds of accelerated approval after it is completed,” Dr Garner said.
“There is a possibility that this is a study that could result in a commercial launch of the drug.”
