AUSTIN, Texas, November 04, 2021 (GLOBE NEWSWIRE) - Cassava Sciences, Inc. (Nasdaq: SAVA) has been informed by the Journal of Neuroscience that there is no evidence of data manipulation in an article published in July 2012 describing a new approach to the treatment of Alzheimer's disease1. The peer-reviewed article was co-authored by scientists and academic collaborators from Cassava Sciences and is the basis of simufilam, the Company's leading drug candidate for the proposed treatment of Alzheimer's disease.
"I have never doubted the integrity of our people or of science," said Rémi Barbier, President and CEO. "We remain focused on conducting a Phase 3 clinical program of simufilam in people with Alzheimer's disease. It's a big business, despite the experts who can be louder than they've learned. We will stay the course until our work is done.
In August 2021, a law firm2 representing anonymous short sellers submitted a citizen petition to the United States Food and Drug Administration (FDA) which alleges, among other things, the manipulation of data in Western transfers in an article scientific published by the Journal of Neuroscience in July 2012 (Western blotting is a complex laboratory technique used to separate and measure proteins). In response to this claim online and others like it, the Journal of Neuroscience requested raw data for the article, including uncropped original Western blot images. After receiving this data and completing its review, the Journal of Neuroscience states, "No evidence of data manipulation was found for the Western blot data. "A human error that does not impact the data conclusions has been identified (a duplicate panel in Figure 8B of the article), and the publisher should print a correction.
The Journal of Neuroscience has given Cassava Sciences permission to share a statement on this matter, fully reprinted below:
"The Journal of Neuroscience follows COPE [CommitteeonPublicationEthics] directives and takes all allegations of misconduct very seriously. In response to the data manipulation allegations in JNeurosci 2012; 32: 9773-9784, the Journal requested raw data, including uncropped original Western blot images. The Journal has determined that there is a duplicate panel in Figure 8 and a corrigendum has been requested and will be printed. No evidence of data manipulation was found for the Western blot data.
In October 2021, a second citizen petition was submitted to the FDA by someone unknown to Cassava Sciences. This second petitioner "calls on the FDA for the approval of simufilam and the immediate launch of phase 4 trials for further evaluation of efficacy, safety and, more importantly, to address one of the most great needs of modern medicine ".
The FDA did not engage with the Company regarding any of the citizen petitions.
About Cassava Sciences, Inc. Cassava Sciences' mission is to discover and develop innovations for chronic neurodegenerative diseases. Over the past 10 years, Cassava Sciences has combined cutting edge technology with new knowledge in neurobiology to develop new solutions for Alzheimer's disease. For more information, please visit: https://www.CassavaSciences.com.
For more information, please contact: Eric Schoen, Chief Financial Officer [email protected] or (512) 501-2450
Caution Regarding Forward-Looking Statements: This press release contains forward-looking statements, including, but not limited to, those regarding the conduct of a Phase 3 program with simufilam in Alzheimer's disease, the claims and action requests made in citizen petitions submitted to the FDA, and oral or written comments made by our employees regarding simufilam and its clinical development.
Drug development involves a high degree of risk, and historically only a small number of research and development programs result in a product being commercialized.
These statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, risks associated with the launch, conducting or completing our clinical studies on time, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our business operations, including those described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended 31 December 2020 and future reports to be filed with the SEC. The foregoing sets out many factors, but not all, that could cause actual results to differ from the expectations of any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and the events discussed in this press release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the statements. prospective. Therefore, you should not rely on forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility to update or revise any forward-looking statements contained in this press release.
For more information on these and other risks related to our business, investors should see our SEC filings, which are available on the SEC's website at.
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1JNeurosci2012; 32: 9773-9784, "Reduction of Alzheimer's disease pathogenesis linked to amyloid by a small molecule targeting filamin A"
2LabatronSucharowLLP. Two days after issuing its petition, the law firm issued a press release revealing that it represents anonymous clients who have a short position in shares of Cassava Sciences (a short position allows an investor to draw a financial gain from a drop in the share price).