Special Report: Regeneus won’t be able to grow patients a new knee with its stem cells, but it might be able to stop osteoarthritis causing so much grief.

That’s a big deal because there isn’t much on the market right now that can help with the debilitating pain and reduced quality of life caused by osteoarthritis.

Regeneus (ASX:RGS) — a pioneer in regenerative health — just finished a Phase 1 osteoarthritis trial with Progenza, an anti-inflammatory drug that can be made en masse from a person’s stem cells.

Regeneus CEO John Martin.
Regeneus CEO John Martin.

“The Phase 1 data dealt with safety and tolerability, but it also showed that the group that got the Progenza cells had sustained reduction of pain in their knees and an increase in the volume of cartilage,” chief John Martin told Stockhead.

The process for patients involves only a single injection and a 12-month follow-up period.

The current alternatives for patients are surgical (knee replacement); symptomatic relief such as weight loss and pain killers; or regular injections with hyaluronic acid, according to write-up of the study in the Journal of Translational Medicine.

Mr Martin says there’s not much evidence yet to suggest the hyaluronic acid option actually works, and it is rarely used outside of Japan.

Big opportunity in Japan

While the trial was conducted in Sydney, Japan is where Regeneus will be building a product and an initial market.

A Japan patent, a manufacturing partnership with Japanese biopharmaceutical maker AGC, and an ageing population who prefer injections over surgery make that market particularly interesting.

Japan is also attractive because of a conditional approval process — designed in 2014 to give it an edge in the regenerative medicine field — that enables drugmakers like Regeneus to bring its treatment to market faster.

Once Regeneus has a complete set of Phase 2 osteoarthritis data, it will be able to introduce Progenza to the Japanese market in a five-to-seven year conditional phase to prove that it works consistently, instead of running a Phase 3 trial.

The kicker is the Japanese government will chip in 70 per cent of the market price of the drug while Regeneus is selling the drug to Japanese taxpayers during that conditional period.

The new kind of stem cells

Regeneus encapsulates the new field of stem cell therapeutics: repair versus recreation.

Mr Martin says stem cells were originally viewed through the prism of embryonic cells and the science was centered around using an individual’s own cells — ‘autologous’ treatment — and went so far as to imagine regrowing a spinal cord or other body parts.

Since then — and since the ethical storm that surrounded the embryonic cell issue — scientists have discovered that adult stem cells not only exist but are excellent for repairing damage.

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Mr Martin calls adult stem cells “medicinal signalling cells” as they pump out therapeutic agent “signals”.

“They’re like a group of first responders turning up to an accident site and telling the other people on the scene — the other cells — how they can help to fix the situation,” he said.

“Their purpose is largely to reduce inflammation, and once you get that under control it provides an opportunity for healing and repair to start.”

Many doses from a single donor

Most importantly, they’ve discovered that drugs can be made from stem cells that don’t belong to the patient — an ‘allogeneic’ treatment.

This has enabled a huge market opportunity to open up: instead of offering stem cell treatment as an expensive bespoke service — stem-cells-as-a-service if you will — Regeneus can produce millions of doses from a single donor.

Mr Martin says this has big pharma interested.

“Everyone really wants the simplicity and the standardisation of a product that is made in a lab, so it’s both made at scale and safe,” he said.

“It’s a Good Manufacturing Process-approved product so there’s a lot of testing, data collection, and manufacturing sign off that goes with the approval of a cell based product.

“We can also compare results between patients because it’s a standardised dose rather than a bespoke product made from each individual’s cells.”

Trials in dogs and horses

Regeneus started, back in 2007, with autologous stem cell solutions for orthopedic conditions in dogs and horses, and it was from those trials that they figured out a mass market allogeneic version for people might work.

The shift happened in 2010 but they’re still working to help the family Labrador with its creaky joints.

They’re two-thirds through a pre-pivotal study — a Phase 2 trial in human terms — with the University of Pennsylvania treating dogs.

It that works they’ll be the first company in the world to create a mass market stem cell arthritis treatment for dogs.

From dogs to diabetes

And from dogs, there’s a whole new world of disease they can set their focus on.

“The one thing about stem cells is that they have incredibly broad application to disease type,” Mr Martin says.

“Osteoarthritis was just the first area, because we had to pick one and we picked that because we started in dogs.

“But pain is an area we are looking at as stem cells can play an interesting role in pain reduction due to their anti-inflammatory properties.

“Our IP covers heart failure and runs right through to inflammatory conditions like diabetes — we call it a platform technology for that reason, because it has so many applications.”

And from there, perhaps stem cells can begin to repay the faith placed in them in the early days of the 1990s.


This special report is brought to you by Regeneus.

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