US-based biotechnology company Neurotrope has completed enrolment for its Phase II study of bryostatin to treat moderate-to-severe Alzheimer's disease (AD).
Bryostatin is a macrocyclic lactone isolated from the bryozoan Bugula neritina with anti-neoplastic activity.
Bryostatin-1 fuses and prevents the cell-signalling enzyme protein kinas C, thereby inhibiting tumour cell proliferation, tumour cell differentiation and the induction of tumour cell apoptosis.
The Phase II, randomised, double-blinded, placebo-controlled study will be primarily focused on measuring the severe impairment battery (SIB) induced by the administration of bryostatin.
Its secondary endpoint is to determine the effect of bryostatin measured on the basis of Mini Mental State Exam (MMSE), Activity of Daily Living (ADL) and Neuropsychiatric Inventory scale (NPI).
The study has enrolled a total of 18 patients who will receive two doses of bryostatin at 20mcg and 40mcg along with placebo for a period of 12 weeks.
Neurotrope CEO Dr Susanne Wilke said: "Bryostatin's multi-modal mechanism of action not only targets the neuronal deficits of AD but also synaptic deficits.
“This combined mechanism of action through PKC epsilon activation gave the company the confidence to commit to these trials in moderate-to-severe patients.
"We believe that we may have a breakthrough in Alzheimer's disease and other neurological disorders. With the recently completed financing, we believe that we are in a strong position to negotiate terms with pharmaceutical partners."