positive biomarker results in world-first stem

Positive Biomarker Results in World-First Stem Cell
Knee Osteoarthritis Trial
Sydney, Australia – 8 October 2013
• MRI shows HiQCell therapy has potential disease modifying effect by slowing
cartilage degradation
• Cartilage breakdown marker (CTX-II) stabilises in HiQCell treatment group and
increases significantly in placebo group
• Inflammation and osteoarthritis biomarker (macrophage inhibitory factor (MIF))
decreases significantly in HiQCell treatment group and increases in placebo
group
• Discovery that biomarker MIF can be used to accurately measure the antiinflammatory
effects of stem cell treatments

Regenerative medicine company, Regeneus (ASX: RGS) announced today important findings from the
biomarker analysis of its landmark double-blind placebo-controlled clinical study of HiQCell® for knee
osteoarthritis. The results demonstrate a molecular basis that explains how HiQCell may slow cartilage
degradation.
The study results show two statistically significant findings:
- Treatment with HiQCell stabilised levels of CTX-II in urine, an important cartilage breakdown molecule
that increases in patients with osteoarthritis as the disease progresses. Patients that received the
placebo showed an increase in CTX-II over the course of the study whereas patients that received the
HiQCell treatment showed no increase.
- A second important biomarker of inflammation and osteoarthritis, Macrophage migration inhibitory
factor (MIF) increased in the serum of the placebo group and decreased in the treatment group. MIF
induces the production of enzymes that degrade cartilage and the reduction of MIF levels in the
treatment group is likely to have reduced cartilage degradation via decreased enzyme levels.
Regeneus CEO, Professor Graham Vesey, said: “These biomarker results are important as they provide
medical specialists with a molecular basis that explains how HiQCell slows cartilage degradation. CTX-II is
well recognized as a key measurement in trials to determine whether a treatment is slowing the progression
of osteoarthritis. While MIF is recognized as an important inflammatory marker, to our knowledge this is the
first time that it has been demonstrated that you can use MIF to measure the anti-inflammatory effects of
cell therapy. Due to the significance of these findings, we have sought patent protection on the use of
biomarker measurements, including MIF, for determining when to administer stem cell therapies.”
Dr Diana Robinson from Sydney Sportsmed Specialists, who has treated 117 joints across a cohort of 54
HiQCell patients, said: “The lack of disease progression and the biomarker results indicate that HiQCell
treatment may have a disease modifying effect. This correlates well with the post-treatment MRI results I