January 2012: Regenera Pharma Ltd. initiates dual-centre, Phase I/IIa study in healthy volunteers and patients with Alzheimer’s Disease to investigate the safety, tolerability, cognitive, and behavioural effects of RPh20121/01/12
Regenera Pharma Ltd. has received approval from Health Canada to initiate a Phase I study in healthy volunteers followed by Phase I/IIa study in patients with moderate-to-severe Alzheimer’s disease.
This is a dual-center, double-blind, placebo-control study in healthy volunteers and patients with Alzheimer’s disease to investigate the safety, tolerability, cognitive, and behavioral effects of RPh201. Phase I will assess the safety and tolerability of subcutaneous RPh201 administration in healthy volunteers following single and multiple ascending doses. Thirty-six subjects will be enrolled in the study, which will take place at INC Research’s Early Phase unit in Toronto Phase I/IIa will enroll 20 patients and will explore the safety, tolerability, and potential efficacy of RPh201 in patients with moderate-to-severe Alzheimer’s disease, receiving twice-weekly subcutaneous doses of RPh201 for three months. Patients will be monitored for a follow-up period of an additional three months. The Phase I/IIa study will take place at the Toronto Memory Program, Toronto, Canada.
This study is currently recruiting participants. For more information about the study, please visit ClinicalTrials.gov.
Initiation of this trial represents an important milestone in the clinical development of RPh201. The company is expecting to reinforce the encouraging pre-clinical efficacy results as well as the safety profile that was clearly demonstrated for this drug. The Company believes that this clinical trial will offer a very safe and effective advantage over existing treatments.