Biohit Oyj Stock Exchange Release April 29, 2014 at 4:30 pm local time (EEST)
Biohit Oyj initiates two clinical trials for prevention of migraine-type headache attacks, testing the efficacy of Acetium® capsule in novel clinical indications. The purpose of the trial is to assess the effect of Acetium® capsule in prevention of headache attacks among patients suffering from migraine or cluster/Horton headache. Both studies will be conducted as multi-center clinical trials in collaboration with Terveystalo Oy and Aava Medical Center altogether in six cities in Finland.
The study hypothesis is based on the fact that acetaldehyde liberates histamine from the mast cells which are ubiquitous in all human tissues. Histamine in turn is a well-known trigger of the acute attacks of vascular-type headaches (migraine, cluster). By preventing the local effects of acetaldehyde with Acetium ® capsules, it might be possible to prevent the headache attacks in these two categories of patients.
Both studies will be conducted as placebo-controlled, double-blind clinical trials, where half of the subjects will receive the active compound and the other half will receive a placebo.
- Acetium® capsule in prevention of headache attacks among patients with cluster headache: altogether, 100 subjects with clinically diagnosed cluster headache will be enrolled in the study.
- Acetium® capsule in prevention of headache attacks among migraine patients: a cohort of 200 patients with clinically diagnosed aural or non-aural migraine will be enrolled.
Both studies will be initiated in May, and then also publicly announced at Biohit website. Enrollment in either study takes place via medical centers, which include Terveystalo Helsinki Kamppi, Tampere, Turku, Jyväskylä, Oulu and Aava Medical Center, Helsinki.
The principal investigator in both trials is docent Mikko Kallela, specialist in neurology (Helsinki University Central Hospital, Department of Neurology), and the investigator-in-charge in each center is a neurology specialist.
The principal investigator, Mikko Kallela: ´The study hypothesis is entirely new and represents a previously unexplored innovation. The role of histamine and mast cells of the meningeal matrix as a trigger of acute attacks of cluster and migraine headache can be very important. These two trials enable us to evaluate the validity of this novel concept in a clinical setting.´
CEO Semi Korpela, Biohit Oyj: ´Over 10% of the population suffer migraine-type headaches and it is a major cause of sickness leaves. Acetium® capsules have no reported adverse effects, which makes long-term use safe. According to a spontaneous feedback from the field, many Acetium® users (taking one capsule in the morning, one in the evening) have obtained relief for their headache attacks. Acetium ® capsules are available in pharmacies without doctor’s prescription.´
Study protocols:
- Efficacy of Acetium® Capsule in Prevention of Headache Attacks in Migraine Patients. Randomized Intervention Trial with a Medical Device (Acetium® Capsules). (Acetium® in Migraine Prevention Study) http://www.biohithealthcare.com/resource/file...graine.pdf
- The Efficacy of Acetium® Capsule in Prevention of Cluster Headache. Randomized Intervention Trial with a Medical Device (Acetium® Capsules). (Acetium® in Prevention of Cluster Headache Study) http://www.biohithealthcare.com/resource/file...luster.pdf
Additional information:
Chief Medical Director of Biohit Oyj, Professor Kari Syrjänen, MD, PhD tel. +358 9 773 861 kari.syrjanen@biohit.fi
CEO Semi Korpela, Biohit Oyj tel. +358 9 773 861 investor.relations@biohit.fi www.biohithealthcare.com
Biohit in brief
Biohit Oyj is a globally operating Finnish biotechnology company. Biohit’s mission is “Innovating for Health” – we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit's Series B share (BIOBV) is quoted on NASDAQ OMX Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com
