Coramsine(Tm) Successfully Completes Phase I Trial
SOLBEC'S CORAMSINE(tm) SUCCESSFULLY COMPLETES PHASE I TRIAL IN PSORIASIS
* Solbec's Phase I/IIa trial of Coramsine(tm) for the treatment of psoriasis has finished treating patients with no adverse events reported by the investigators.
* The data gathered during the final stage of the trial will be un-blinded and analysis of efficacy undertaken.
Perth, Australia. 9th February 2005. Solbec Pharmaceuticals Ltd (ASX:SBP) today announced that its Phase I (safety) trial of Coramsine(tm) in the treatment of psoriasis has reached its primary endpoint successfully and ahead of schedule. Phase I trials are primarily intended to demonstrate the safety of the compound under test and in reports to date, the investigating physicians did not note treatment-related adverse events during any stage of the trial.
This clinical trial was conducted in three stages, the first two of which were concerned only with investigation of safety, tolerability and pharmacokinetics (time required for absorption, duration of action, distribution in the body, and excretion) in healthy individuals. The third stage recruited ten psoriasis patients and looked additionally at efficacy for 56 days.
The efficacy element of the trial was conducted as a double-blind, within-patients design in which Coramsine(tm) cream was compared to placebo and a standard topical treatment for psoriasis. Patients applied each of the three creams to different areas of psoriasis without knowing which cream was which (patient "blinding"). The investigators were also not informed of which cream was used on which rash when they assessed response (investigator "blinding").
Following completion of the patient treatment, the investigators can be "unblinded" and compare efficacy between the creams. This means analysis of the findings of the trial's third stage and reporting on the results. Solbec expects to receive the report early in the second quarter of 2005.
In accordance with ASX and Ausbiotech Draft Code of Practice on Reporting for Biotechnology, Medical Device and Other Life Science Companies, Solbec offers the following information.
Phase I Psoriasis Study:
The trial is titled: A Phase I, safety and tolerability study of topical Coramsine(tm) in healthy subjects, followed by subjects with mild to moderate psoriasis. The trial was carried out at the Royal Adelaide Hospital in South Australia with Dr Patrick Walker as principal investigator.
This study intended to evaluate the safety and tolerability of Solbec's Cream Formulation containing 0.01% Coramsine(tm) (formerly SBP002) in healthy volunteers and patients with psoriasis. Patients with psoriasis are also evaluated for evidence of efficacy (activity of the cream against psoriasis). Blood samples are taken at regular intervals to investigate the pharmacokinetics of the drug, when administered topically.
The trial was divided into three stages:
1) To determine the safety and tolerability of a single topical administration of Coramsine(tm) on the skin of three healthy subjects.
2) To determine the safety and tolerability of repeated topical administration of Coramsine(tm), twice daily for four days, on the skin of three healthy subjects.
3) To determine the safety and tolerability of topically administered Coramsine(tm) twice daily for 56 days, to a target lesion of ten subjects with psoriasis. To determine the extent of absorption of solasonine and solamargine following topical application and to ascertain whether there is accumulation following repeated dosing for 15 days.
After each Stage of the trial, the Hospital Ethics committee reviewed the trial for any adverse events or side effects which may have been seen, and gave approval for the trial to proceed to the next stage.
In the trial, Solbec's Coramsine(tm) cream is compared against a placebo (identical cream formulation to the Coramsine(tm) cream, but lacking the active ingredient) and against an active comparator Calcipotriol cream, a commonly used treatment for psoriasis. The trial is double blinded, that is, the three creams are each allocated a code, and neither the patients nor the trial staff knowing which cream is being used until the end of the trial.
All study procedures are carried out according to Good Clinical Practice (GCP), and monitored according to the ICH (International Conference on Harmonization) principles of GCP. Patients give informed consent before commencing any study procedures.
The treatment phase of this trial has been completed successfully with no significant adverse events noted in any of the three trial phases.
Unblinding and analysis of the data is underway, which will allow meaningful interpretation of any efficacy seen during the study.
A full report is expected on completion of sample and data analysis.
Solbec Pharmaceuticals Ltd identifies naturally-occurring compounds with potential in the development of better therapies for debilitating conditions and life-threatening diseases. The company is currently progressing its key project, Coramsine(tm), through Phase I/IIA clinical trials for the treatment of mesothelioma and malignant melanoma, and as a topical treatment for psoriasis. Solbec's two proprietary ingredients in Coramsine(tm) were isolated from the fruit of a weed known as the Devil's Apple (Solanum linnaeanum). They show activity against some cancers and cause potentially therapeutic changes to the immune system. In addition to human health, Coramsine(tm) has potential application in the areas of animal health and diagnostics. Solbec's business strategy is to partner or out-license Coramsine(tm) for the final stages of pre-commercial development and marketing.