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Phase II trial for Zymenex lethal disease treatment candidate

Zymenex has initiated the Phase II part of the clinical trial in seriously ill children with MLD. The trial will hopefully show the way to a cure for the rare and until now incurable disease, Metachromatic Leukodystrophy (MLD), which is diagnosed in children between the ages of 2-5 years and paralyses the nervous system in such a way that the children die.

"We have covered a good part of the ground, but we still have a way to go before we can say we have a breakthrough," says CEO Jens Fogh, Zymenex A/S. "He sees 2007 as a challenging year, with crucial phases for the development of the company's lead project, the enzyme Metazym. If good progress is made in the experimental treatment of the children, it is already planned to start a parallel clinical trial with the enzyme in the United States.

Chief physician Dr. Allan M. Lund, University Hospital Copenhagen, Denmark, coordinates the clinical trial, which takes place at the Danish private clinical trial unit PhaseOneTrials A/S. Dr. Christine i Dali, who is a specialist in paediatrics, employed at the University Hospital Copenhagen, is responsible for testing the enzyme in the patients. "The patient families and specialists from around the world are following this field very closely. The disease is due to a gene-defect and the disease is lethal and no therapy exists today," says Dr. Christine i Dali.

Supplemental information:

Metachromatic Leukodystrophy (MLD), is one of 45 diseases within the family of Lysosomal Storage Diseases.

MLD is caused by an increased concentration of sulphatide in cells and an ensuing breakdown of "myelin", a substance that protects the nerves in the brain and the rest of the body. The disease occurs due to a lack of the enzyme Arylsulfatase A (ASA), which causes irreparable neurological damage. The disease is lethal and no therapy exists today. Children with MLD are often diagnosed at the age of two years and are quickly bound to a wheelchair and become bedridden until they die within three to four years. The disease is rare and therefore unknown to the general public. The disease can in some ways be compared to Multiple Sclerosis, which also exists in several forms and can have a very quick and lethal progression.

Experimental treatment of subjects in Denmark must, in each case be approved by the authorities. In order to give permission to treat subjects in clinical trials, the authorities require that the trial product be developed using strict quality requirements cGMP and that it has been demonstrated in animal studies that the trial product is safe. Permission must be obtained from the Danish Medicines Agency and the Independent Ethics Committee who, secure that the trial is performed according to applicable regulations and guidelines and ethics requirements.

Zymenex A/S has developed Metazym. The company is a Scandinavian biopharmaceutical company, founded in 1998, with headquarters in Hillerød north of Copenhagen, Denmark and research laboratories in Stockholm, Sweden. The company is focused on research and development of pharmaceutical products for the treatment of rare, genetic diseases, for which there is no treatment today and which, due to the small patient populations, fall within "Orphan Diseases" and the Orphan Drug Acts. Zymenex is supported financially by the Danish venture capital investors BankInvest and Sunstone Capital.

Further information:

President, CEO, Jens Fogh, DVM, Zymenex A/S, Hillerød, Denmark, telephone: + 45 48 25 00 54, www.zymenex.com

Specialist in Pediatrics, Christine i. Dali, MD, University Hospital Copenhagen, Copenhagen, Denmark, telephone: + 45 25 22 91 55

Chief Physician, Allan Lund, MD, PhD, University Hospital Copenhagen, Copenhagen, Denmark, telephone: + 45 35 45 38 87