All new medicines are put through a series of clinical trials (4 phases) to test whether they are safe and if they work. The medicines will usually be tested against another treatment called a control. This will either be a substance containing no active treatment (a placebo) or a standard treatment that is already in use.
Daval have undertaken two Phase 2 clinical trials and have treated individual cases under its specials licence.
In the double-blind, placebo-controlled, Phase 2 clinical trial of the effects of HICSD in dSSc involving 20 patients which was undertaken in the UK (Study DISS01/EudraCT: 2007-003122-24), the safety, tolerability and efficacy of HICSD in patients with dSSc was assessed. Injections of HICSD (1mL) were given subcutaneously twice weekly. The safety and tolerability of HICSD has been confirmed for a treatment period of up to 52 weeks of continuous usage. There were no safety concerns during this study. The frequency of adverse events was not different between active and placebo treated patients.
In addition, a single centre, randomised, double-blind, placebo-controlled Phase 2 clinical trial of HICSD in 20 patients with SPMS was conducted in the UK to measure the effect of regular HICSD injections on the symptoms of overactive bladder in patients with MS (Study DIMS04/EudraCT: 2006-006872-39). Injections of HICSD were given subcutaneously (1 mL every 3 to 4 days) for 4 weeks. The treatment period was 14 weeks in total (including a 6‑week washout period between the treatments), with an extension to 52 weeks. Treatment-emergent AEs (TEAEs) were reported by 75% of the patients during the blinded phase and by 50% of the patients during the extension phase. The majority of TEAEs were reported as mild; no AE was severe. There was only 1 SAE reported which was assessed as unrelated to the investigational medicinal product (IMP). There were no serious safety issues during the blinded or extended phases of the trial