Roskamp Institute Articles Better Science. Real Discovery.

February 14, 2012

News:KEY CLINICAL TRIAL OF ALZHEIMER’S DISEASE DRUG BEGINS IN EUROPE DRUG DISCOVERED BY ROSKAMP INSTITUTE RESEARCH

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Contact: Steve Klindt
Tel: Tel:941-752-2949 x 390
Email: Sklindt@roskampinstitute.net

KEY CLINICAL TRIAL OF ALZHEIMER’S DISEASE DRUG BEGINS IN EUROPE DRUG DISCOVERED BY ROSKAMP INSTITUTE RESEARCH
SARASOTA, FL (Feb. 14) –

A research team today announced the launch of a European large-scale clinical trial of Nilvadipine, an Alzheimer’s disease drug developed at the Roskamp Institute (www.rfdn.org) in Sarasota. More than 500 Alzheimer’s patients in nine European countries will participate in the phase III trial designed to study the effectiveness of the medication.

“We believe that Nilvadipine blocks the production of amyloid proteins linked to Alzheimer’s disease,” said Roskamp Institute President and CEO Michael Mullan, M.D., Ph.D., who along with Associate Director Fiona Crawford, Ph.D., and Daniel Paris Ph.D. led the team that developed the drug. “That means Nilvadipine is aimed at addressing the actual disease, and not just the symptoms.”

A consortium of medical teams from nine European countries is meeting in Ireland this week to plan the US$10 million multicenter study. Phase III studies are usually the last step in the regulatory process before a drug can move into clinical practice. The consortium, called NILVAD for Nilvadipine/Alzheimer’s Disease, will involve participants from Ireland, England, Hungary, Greece, France, Sweden, Germany, Italy and the Netherlands.

The 500 participants, who have mild to moderate cognitive impairments, will begin the double-blind study this fall. Each participant will be followed for 18 months to see if the drug produces a change in cognitive abilities.

“We won’t cure Alzheimer’ disease without clinical trials,” said Crawford, who added that major pharmaceutical companies have not been able to come up with an effective drug. “Currently, there are only eight interventions underway in phase III trial, and it’s a tremendous achievement for a small research institute like ours to be part of the process.”

February 17, 2011

A grant from Pfizer to study the effect of two antidepressant medications for Roskamp Institute Scientist

1-13-2011

Dr. Corbin Bachmeier of the Roskamp Institute in collaboration with Dr. Gary Levin of the University of Southern Nevada recently received a grant from Pfizer to study the effect of two antidepressant medications currently on the market, venlafaxine (Effexor) and desvenlafaxine (Pristiq), on the expression of the drug efflux transport proteins P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in vivo.  This work is a continuation of their previous efforts, supported through a grant from Wyeth Pharmaceuticals, which determined that venlafaxine induces drug efflux protein expression in brain endothelial cells, an in vitro model of the blood-brain barrier (BBB), in a dose dependant manner.  Moreover, these effects were functionally significant as treatment with venlafaxine reduced the permeability of a known drug efflux probe, rhodamine 123, across the BBB model and Caco-2 cell monolayers, a model of intestinal absorption.  Conversely, treatment with desvenlafaxine in the BBB model did not result in a statistically significant change in the expression of either P-gp or BCRP nor did desvenlafaxine impact the permeability of R123 across the BBB model or Caco-2 monolayers.  As it is difficult to predict clinical outcomes based solely on in vitro observations, the current in vivo studies will examine the impact of these compounds on drug efflux protein expression in a live animal.  In doing so, these studies will provide a better understanding of the potential for drug-drug interactions and the relevance of these effects to a clinical setting.

The Roskamp Institute is devoted to understanding causes and finding cures for neuropsychiatric and neurodegenerative disorders and addictions. The Institute utilizes a broad range of scientific approaches to understanding the causes of and potential therapies for these disorders with an emphasis on Alzheimer’s disease. For more information, please call (941)752-2949

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