Cassava Sciences, a biotech company whose work on the experimental Alzheimer’s drug simufilam has been heavily criticized and is the subject of ongoing federal probes, has suffered another blow. A much-anticipated investigation by the City University of New York has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime Cassava collaborator, of scientific misconduct involving 20 research papers.
The CUNY investigation into Wang began in the fall of 2021, in response to allegations from other investigators that were forwarded by the Office of Research Integrity , the federal entity that oversees work funded by the National Institutes of Health. NIH provided millions of dollars for work by Wang and Burns, including about $1.2 million to Wang since December 2020. The investigation was not completed until this year, in May, according to emails obtained by.
It appears likely that no primary data and no research notebooks pertaining to the 31 allegations exist. together since the mid-2000s. Their studies of the brain’s opioid receptors were applied to developing a pain drug that reached clinical trials but never won Food and Drug Administration approval. The collaborators shifted their efforts to the possible influence on Alzheimer’s of filamin-A, a protein that provides cellular scaffolding for neurons and other cells.
Cassava conducted relatively small phase 2 trials of the drug. Based on what it said were promising results, it launched the phase 3 trials needed to win FDA approval. One of Cassava’s phase 3 trials to treat mild-to-moderate Alzheimer’s has enrolled more than 800 volunteers. The company says that by December it will complete enrollment of nearly 1100 more patients for a second phase 3 trial. After the petition, FDA declined to pause those trials, but reserved the right to do so.
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