Cassava Affaire: Pharmaceutical manufacturer defends phase III Alzheimer’s studies
The biotechnology company Cassava Sciencesproducer of simufilaman anti-Alzheimer’s drug currently in phase III clinical trials, was accused of scientific misconduct and fraud by a shareholder rights law firm. Cassava Sciences ‘stock tumbled when the company, Labaton Sucharow LLP, raised concerns through a citizens’ petition – a public request made by individuals and community organizations to change or alter a health policy – asking to suspend the clinical trial.
In a statement, the company said it would uphold the integrity of its scientists and their drug data simufilam, which targets a protein called filamin A to cure the Alzheimer’s disease.
However, the citizens’ petition from the FDA puts it the results of the leading scientists involved in the research are questioned, most notably Scientific Advisor Hoau-Yan Wang, PhD, Associate Medical Professor at the City College of New York School of Medicine, and Lindsay Burns, Cassava Vice President. According to the report, the initial analysis “suggests a pattern of clear errors and anomalies that are consistent with the manipulation and misrepresentation of data” and that these findings “undermine the fundamental science on which simufilam therapy is based.”
The report continues describing three main areas of concern and six minor concerns, referred to as “suspicious claims”. Cassava Sciences CEO Remi Barbier said the the company’s claims are startling and unfounded. Additionally, Barbier said these concerns were not brought to the attention of the company prior to filing the FDA citizens’ petition. “I have never heard of a city petition for a pre-Phase 3 drug. We see this filing as a technique intended to add to the pile of fear and doubt generated by their initial paper,” she wrote.
The FDA has announced that it has received the petition.