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FDA Grants IND Approval to Promising Anti-Cancer Agent Veyonda®

User
Posted 12 Jun 2021 at 08:10

Noxopharm’s Graham Kelly - the cancer researcher who saved his own life

8:42AM JUNE 11, 2021

Graham Kelly will never forget the year 2014. Some of the top cancer specialists in Australia told him that the treatments on his prostate cancer had failed and that the cancer had spread around his body.

He might live another month, maybe two. To make matters worse, if that was possible, earlier results from the cancer treatment he had developed, using material obtained from plant legumes, had been disappointing.

But since that disappointment, and despite his illness, Kelly had been frantically checking his research and now believed there was nothing wrong with his drug. Rather the fault was in the way it had been administered.

He then made a decision that has the potential to be a fateful global moment in late stage cancer treatment. He tested his conclusions by injecting himself with the drug using his revised delivery methods. He had nothing to lose. It worked -- and he is still alive. A miracle.

It has taken another seven years but after further refinement the Australian drug (now called Veyonda) and its delivery method are now about to start phase two clinical trials.

Australia has rarely been at the global forefront of cancer drugs and the listed company Kelly formed to develop and test his discoveries, Noxopharm, is not claiming a cure but rather an extension of life for critically ill prostate, lung, breast and other late stage cancer patients.

It’s rare to find such a dramatic story among listed companies so it is worth recording the story of Veyonda, Noxopharm and its executive chairman.

Back in the early 1970s Kelly was working in Sydney University’s department of transplant surgery, with particular emphasis on kidneys. A large number of those receiving the early transplants later suffered skin cancers as a result of the anti-rejection drugs.

Kelly did a lot of work to determine what was actually causing these cancers, which led him to link into the research being conducted on why people in Japan and parts of China suffered much lower cancer rates than those in western societies.

At the time the fashionable answer was that meat eating in western societies was the reason for the difference, but that turned out to be wrong. What prevented the Japanese and many Chinese from getting cancer was the large amount of legumes and the so-called “isoflavones” that dominated their diet.

Kelly discovered that in the 1960s massive plantings of a special clover substantially increased dietary isoflavones in sheep, which reduced their birthrates. For Kelly the lesson from the sheep experience was that isoflavones from legumes were powerful materials that could alter bodily functions.

He developed a theory that isoflavones from legumes were actually metabolised within the body to produce novel chemicals. These chemicals possessed important hormone-like functions, which made important contributions to human health.

Excited, he left academia and founded the company, Norvet Ltd, which listed on the ASX in 1994 - the same day as CSL. It later changed its name to Novogen.

It was that company that had been hit with the disappointing results.

By 2015 Kelly had an unbreakable conviction that he had made a groundbreaking cancer discovery. Indeed, every day that he lived was “the proof”. But, of course, there was still a lot of work to be done.

At the risk of oversimplification, cancers are usually caused when particular cell production is not stopped by the body’s systems.

Kelly was convinced that the isoflavones from legumes (idronoxil was the active ingredient), could help reverse that excess cell production process by triggering a whole of body immune response that shrinks the abnormal tissues.

Accordingly the drug produced needed to be used in combination with conventional cancer treatments, including drugs and radiotherapy.

No-one else was researching in this area. All researchers have doubts but Kelly had a confidence rare in research -- he had tried the drug out on himself when he was close to death.

In 2015 Kelly established private biotechnology company Noxopharm Pty Ltd and floated it a year later.

Phase one trials have been successful and now the next step, the much larger phase two trials, are about to start and the company has the cash to complete them.

The trials will be conducted in Australia, US, France and Hungary at 15 sites. The international contract research organisation, Parexel will oversee the study, which will involve approximately 100 patients with cancers that have failed standard treatment options.

The main focus will be late-stage prostate cancer where, as happened with Kelly, the cancer has spread from the prostate to other parts of the body. Kelly has expanded the trial to include late-stage breast and lung cancer patients.

If the trial is successful (and despite the “Kelly trial” there are no certainties) in theory Noxopharm could raise the large sums required to conduct a stage three trial.

But if Veyonda and its delivery methods are successful in the treatment of cancers that move out of their origins it will impact a very large number of people. Veyonda would become a major global drug requiring extensive distribution systems.

Accordingly, it is almost certain that Noxopharm will link with a pharmaceutical giant if Veyonda goes to phase three. Australia’s only company with the resources able to conduct phase three trials is CSL, but a late-stage cancer treatment is way out of its ambit.

GenesisCare is pleased to announce a clinical alliance with Noxopharm to offer a compassionate access program with Noxopharm’s novel lead product candidate, Veyonda®, for patients with advanced, treatment-resistant, metastatic prostate cancer (mCRPC) being treated with theranostics.

 

 

The alliance formalises a program under which Noxopharm has been making Veyonda® available through GenesisCare for compassionate use in combination with 177Lu-PSMA therapy for mCRPC patients in Australia.

 

 

Veyonda® (Idronoxil) is an experimental oncology drug that may enhance the effects of theranostic treatment with 177Lutetium-PSMA (Lu-PSMA) in men with advanced prostate cancer. Theranostics with LuPSMA combines diagnostic imaging, drug delivery and response monitoring

 

 

User
Posted 14 Jun 2021 at 03:49

Thanks for posting Roy.  Let's hope it passes through all phases an becomes a recoognised trratment.

Barry
User
Posted 14 Jun 2021 at 06:40

Very good read
Thanks Roy

User
Posted 14 Jun 2021 at 08:18
Very interesting, just ordered some Miso and tamari to boost the isoflavones. interesting the reduced rates of cancer in Japan was linked to isoflavone use rather than reduced dairy consumption.

User
Posted 15 Jun 2021 at 16:42

Thanks for posting this Roy. It makes for interesting reading.

Ido4

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User
Posted 14 Jun 2021 at 03:49

Thanks for posting Roy.  Let's hope it passes through all phases an becomes a recoognised trratment.

Barry
User
Posted 14 Jun 2021 at 06:40

Very good read
Thanks Roy

User
Posted 14 Jun 2021 at 08:18
Very interesting, just ordered some Miso and tamari to boost the isoflavones. interesting the reduced rates of cancer in Japan was linked to isoflavone use rather than reduced dairy consumption.

User
Posted 15 Jun 2021 at 16:42

Thanks for posting this Roy. It makes for interesting reading.

Ido4

User
Posted 15 Jun 2021 at 19:14
Optimism should be tempered with caution; the majority of drugs trials unfortunately prove unsuccessful.

 
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