TopoTarget reports Phase II trial results with Avugane™ in acne vulgaris


TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen 
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com

- New Avugane™ data in the two groups of patients receiving 3% and 6% doses
support further clinical development - 

Copenhagen, Denmark - 13 March 2009 - TopoTarget A/S (OMX: TOPO) has announced
that treatment with topical Avugane™ gel (valproic acid) 3% and 6% gave
encouraging results in patients with acne vulgaris. Although the changes in the
counts of the acne lesions did not reach statistically significant differences
between the three treatment groups (0.5%, 3%, and 6%) in this small study, the
overall assessment both by the investigators and the patients did demonstrate a
trend towards more favourable effect in the 3% group. 
The original protocol had the 6% Avugane™ treatment as the target treatment and
it was unfortunate that stability problems prevented a study of this probably
optimal concentration. However the short treatment provided to six patients
with the 6% Avugane™ did show promising results particularly of the
inflammatory lesions. All three grades of the Avugane™ gels were very well
tolerated. 
The trend in the efficacy assessment report supports a trial of a new and more
stable formulation of 6% Avugane™. 
TopoTarget intends to outlicense the drug to a partner with expertise in the
dermatological field. 

“Although this study supports our previous positive valproic acid results in
acne there are still a formulation tasks to solve with this product. We are
focusing on belinostat and have stopped our dermatology activities and we hope
to outlisence the use of valproic acid for skin diseases,” says professor Peter
Buhl Jensen, CEO of TopoTarget. “In addition to the opportunity of using
valproic acid in dermatology it is exciting to see that there are 17
investigators initiatiated clinical trials ongoing in cancer using valproic
acid. These trials are not sponsored by TopoTarget but we do have a strong
patent protection in the use of valproic acid in cancer and we look forward to
seeing the results of these studies”, Peter Buhl Jensen further comments. 

TopoTarget A/S

For further information, please contact:

Peter Buhl Jensen	Telephone	 +45 39 17 94 99
CEO		Mobile	 +45 21 60 89 22

Attachments

announcement no.  06-09 topotarget reports phase ii trial results with avugane.pdf