Study Confirming Zolpidem Effect in Brain Damage Accepted for
Presentation at Clinical Conference.

9/11/09

ReGen Therapeutics Plc "ReGen" or "the Company" is pleased to
announce further positive news concerning its 'Zolpidem Project'.

Final results of a study using SPECT scanning have shown that
zolpidem significantly improves the cognitive and motor performance
of subjects with brain damage. The results of this study, conducted
in Pretoria, South Africa will be presented by Dr. Ralf Clauss* at
the 4th International Congress on Brain and Behaviour, 3-6 December
2009 in Thessaloniki, Greece. A manuscript of this study has also
been accepted for publication in a peer-reviewed specialist journal
and will appear in print over the next few months.

Commenting on the study Dr.Clauss said, "This prospective study adds
further evidence to the numerous previous reports that zolpidem is
clinically effective in patients with established brain damage. The
fact that around 50% of subjects receiving a 10mg zolpidem tablet
daily experienced sedation confirms that a lower, flexible
formulation is required to optimise efficacy in individual subjects".
The Company estimates  that the market for products exploiting this
new use could be worth at least $4.3bn. Further studies are being
planned for 2010, currently, ReGen is seeking to find a
co-development/licensing partner or grant assistance to bring this
new patented use and appropriate novel formulations to market.
A detailed abstract of the study appears below.

Abstract:
23 of 41 consecutive adult patients, at least 6 months after brain
damage were selected as neurologically disabled patients after
scoring less than 100/100 on the Barthel Index. Causes of brain
damage included stroke (12 subjects), traumatic brain injury (7
subjects), anaphylaxis (2 subjects), drug overdose (1 subject) and
birth injury (1 subject). The selected 23 patients had a baseline
SPECT scan before starting daily zolpidem therapy and a second within
two weeks of therapy, performed 1 hour after receiving 10 mg oral
zolpidem. Scans were designated as improved when at least two of
three independent assessors detected improvement after zolpidem. The
rest were designated non-improved.

After four months of daily zolpidem therapy, the clinical condition
of subjects was rated on the Tinetti Falls Efficacy Scale (TFES)
before and after zolpidem. The TFES ratings of all subjects and scan
improvers and non-improvers were compared statistically.

Mean overall improvement after zolpidem on TFES was 11.3%, from
73.4/100 (SD 25.4) to 62.1/100 (SD 28.8) (p=0.0006). 10/ 23 (43%)
improved on SPECT scan after zolpidem. Their mean TFES improvement
was 19.4% (SD 16.75) compared with 5.08% (SD 5.17) in 13/23 non
improvers (p=0.0081).
* Dr. Clauss is a Nuclear Medicine specialist at the Royal Surrey
County Hospital, Guildford, UK and is scientific consultant to ReGen.
Notes to Editors:
In June 2008, ReGen Therapeutics Plc announced that collaborators at
Aston University, Birmingham UK had discovered new evidence of
zolpidem's unique mode of action using
pharmaco-magneto-encephalography (MEG) brain imaging. They found that
non-functioning areas of the brain within the stroke damage area of a
patient were being kept in a dormant state by excessive slow wave
activity that zolpidem reversed. This effect could not be reproduced
with placebo or another sedative with a similar pharmacological
action called zopiclone. ReGen has filed a new patent application
around this important discovery.
Analysis of data from a previous clinical study conducted in patients
with long-standing brain damage by ReGen established that the
sublingual route of dosing is more consistent, faster in onset and
more potent than existing tablets, characteristics that will greatly
help patients to control the effect of dosing when they need to avoid
sedation. More importantly, the trial also demonstrated that 2.5 mg
sublingually was non-sedative even when repeated, and since published
reports have shown 2.5mg to be an effective dose in this new
indication, it established a clear demarcation between ReGen's new
indication and generic sedative formulations.
For further information, please contact:
Percy Lomax
ReGen Therapeutics Plc
Tel: 020 7153 4920

Roland Cornish/Felicity Geidt
Beaumont Cornish Limited
Tel: 020 7628 3396
David Scott/Nick Bealer
Alexander David Securities Limited
Tel: 020 7448 9820


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