Zyoxel

While these headlines represent truly significant milestones along the road to a new drug, not to mention equally significant man hours and expenditure, journey’s end is almost certainly a long way in the future.

With rare exceptions, studies are unlikely to have progressed beyond laboratory experiments, known as in vitro testing.

What lies ahead is a tortuous, difficult and increasingly expensive process to prove that theory and reality are truly one and the same.

It is estimated that for every 100 ideas or projects for a new treatment, only one will ever feature on a prescription. Weeding out the other 99 takes considerable time and money, especially for clinical trials.

Regulatory authorities have a strict regimen to ensure drugs are not just effective, but above all, safe.

Even after a new medicine goes on sale, it is carefully monitored for any adverse events or AEs. It takes very few AEs before a drug must be withdrawn for further tests.

The first hurdles for any new drug candidate are efficacy and toxicity or ‘tox’, and three out of every five stumble, usually for tox.

The key tox areas are cardiac and liver, with liver heading the list.

Drugs can cause liver damage and liver failure. Researchers want to eliminate the non-runners quickly and reserve their time and resources for possible winners. ‘Fail fast, fail early’ is their mantra.

At present, the early tests are conducted on single cells placed in the multiple wells of test plates, but these 2D cells behave very differently to real cells in the body.

Zyoxel, based at Begbroke Science Park, has developed ways of growing 3D cells that mimic the body’s function.

By very slowly injecting candidate compounds into these cells they can accurately forecast potential failures, then swiftly and precisely pinpoint the failures.

Chief executive Dr Tim Hart explained: “The gel in which we grow the cells is a biological material, much like the body’s environment.

“When the cells are grown in 3D, they behave as normal, talking and interacting with one another. That does not happen in 2D. Also, we are mimicking the extracellular matrix, the natural space between cells, and that is important too.

“It means the cells act as they do in live tissue, not just as cells.”

Zyoxel uses different cells to those normally found in laboratories. The usual lab cells are cultured, which means they grow well, but do not exhibit the true characteristics of real cells.

The company cultivates human primary cells, taken from donor organs such as livers. This complements their technology in imitating the human body.

There is also a developing interest in stem cells. What Zyoxel does is to take human skin cells and transform them into induced pluripotent stem cells — those capable of developing in one of several ways — known as IPS.

The aim is to be able to conduct clinical trials in the test tube.

By taking the IPS cells, the company can produce a tissue cell bank. Using this, they can check a drug for toxicity.

Clinical trials may involve perhaps 5,000 patients. But that sample may not be wide enough and there are patients who will suffer an AE in the liver that clinical trials did not foresee. Zyoxel’s technology will allow them to test a far wider sample against such problems.

The expertise is a platform technology. It can be used in safety testing cell therapies for neuronal diseases, tracking the new stem cells into the neurons.

A Government-funded collaboration is using a 3D model of the central nervous system. When the stem cells are introduced, they are followed and their repairs to neurons observed. This gives a far greater insight at tissue-level interactions.

The Zyoxel methodology can be applied to diabetes drug efficacy, looking at what are called islets, which are formed by the pancreas.

IVF is yet one more key area. Success levels of IVF implants are still too low.

Key to success is knowing which embryos to re-implant. Those are the ‘quiet’ embryos, with low metabolic rates. Using perfusion, metabolic rates can be accurately measured.

Zyoxel sells both hardware and services. TissueFlex is its patented hardware, a box that allows cells to be placed in gel and perfused.

Currently sold as empty units, the next step is sell them with biological product, the actual type of cells to be researched. The service element is producing systems for drug companies such as Pfizer.

A spinout from Oxford University and the work of Professor Zhanfen Cui, Zyoxel is funded mainly by a Chinese technology fund, with other investment from local backers. A second £2m funding round is underway.

Dr Hart said: “We believe we are the closest you can get to mimicking real-life in a test tube and we are continuing to develop the platform across a whole range of scenarios.”

Name: Zyoxel Established: 2009 Chief executive: Dr Tim Hart Number of staff: Nine

Contact: 01865 309600 Web: www.zyoxel.com