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news.Neurotrope Bioscience has selected Worldwide Clinical Trials (WCT), a clinical research organization (CRO) to start pre-patient enrollment activities to conduct a Phase IIb trial of its compound bryostatin-1 to treat Alzheimer's disease (AD).
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As part of the deal, Neurotrope will pay WCT about $300,000 for the services and related third-party costs.
In early second quarter of 2015, Neurotrope plans to submit its protocol to the FDA for this clinical trial in about 150 patients with moderately severe to severe AD.
Patient enrollment for the six month study is expected to be initiated sometime during the third quarter pending the FDA’s review of the protocol.
The company also plans to enter into a definitive agreement with WCT for services related to the study at the appropriate time subject to available resources.
Neurotrope president and chief executive officer Charles Ramat said: "WCT has strong relationships with numerous clinical sites with experience in Alzheimer’s disease and possesses a great expertise in conducting Alzheimer’s clinical trials which is critical to Neurotrope as we move through this important process.
"We are confident that they will play a key role for us throughout bryostatin’s clinical development as we continue to move towards its eventual commercialization for the treatment of this debilitating disease."
Neurotrope has an exclusive license to develop and commercialize bryostatin, a potent modulator of an enzyme called protein kinase C epsilon (PKCe).
PKCe has been examined extensively by the Blanchette Rockefeller Neurosciences Institute (BRNI) as a possible treatment of cognitive disorders.