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March 2008

Zymenex gets FDA approval for the Metazym trial in the US

Zymenex has received approval from the American FDA (Food and Drug Administration) for the clinical trial testing enzyme replacement therapy using Metazym on metachromatic leukodystrophy (MLD) in the US.

Ten patients with late-infantile MLD will be enrolled in the Phase 2 trial under the responsibility of Dr. Maria L. Escolar at the University of North Carolina, Chapel Hill (NC), USA. Patients will be recruited after the inclusion/exclusion criteria for the trial will be defined.

The FDA approval is the first prerequisite before the actual Metazym clinical trial could begin. Now, the trial protocol must be approved by the Ethical Committee at the University of North Carolina. Last but not least, the administrative and logistical issues must be resolved between the University of North Carolina and Zymenex. These processes are expected to take at least 6 months, therefore it is anticipated the trial to begin early fall 2008.

In February 2008, a Natural History Study on MLD with the goal of determining the evolution of the disease was also approved by the FDA and the Ethics Committee of the University of North Carolina. The patients with late-infantile MLD, up to 10 and currently being recruited, will not receive Metazym. The data collected from the study performed by Dr. Escolar with the support of Zymenex will serve as references to judge Metazym effectiveness in treated patients.

In Europe, Metazym is being evaluated in a clinical trial for already a year under the responsibility of. Drs Allan M. Lund and Christine i Dali from Rigshospitalet, Copenhagen in Denmark. Jens Fogh, CEO of Zymenex, and Christine i Dali will be attending the ELA Families/Scientists Meeting in Paris, France on March 29 & 30, 2008 to inform the patients and their families about the progress made on the European Metazym clinical trial.