No Evidence of Data Manipulation in Science Publication on Simufilam
18 August 2022 - 11:15PM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, was recently
informed by the Journal of Prevention of Alzheimer's Disease (JPAD)
that there is no convincing evidence to support allegations of data
manipulation in a 2020 paper on simufilam co-authored by the
Company’s personnel and its science collaborators.
JPAD communicated the following statement to the
Company on Monday, August 15th after the close of market, which is
reprinted in full below:
“We have completed
our review of your article “PTI-125 Reduces Biomarkers of
Alzheimer’s Disease in Patients” (JPAD 2020;7(4):256-264). We
do not find convincing evidence of manipulation of data or intent
to mislead, and therefore take no action regarding the published
paper.”
“From the onset, I have said that allegations of
research misconduct are false, and for good reason – I see no
supporting evidence for the allegations,” said Remi Barbier,
President & CEO. “I’m hopeful that written pronouncements from
neutral and independent science experts will help close the chapter
of baseless attacks against our science. At some point it becomes
irrational for our detractors to repeat over and over again the
same old tired mantra of data manipulation.”
- In May 2022, Neurobiology of Aging
investigated and found no evidence of data manipulation in a paper
on simufilam published in that journal in 2017. The journal’s
Editor-in-Chief stated: “A reader has made the editors aware of
concerns regarding the above-referenced report published at
Neurobiology of Aging [i.e., “PTI-125 binds and reverses an altered
conformation of filamin A to reduce Alzheimer's disease
pathogenesis.” Neurobiol. Aging, 55:99-114]. These issues were
conveyed to the authors, who provided a detailed response,
including images of relevant uncropped western blots and
photomicrographs, as the editor requested. The material was
evaluated by an independent expert with relevant methodological
expertise, the manuscript was scanned by AI-based figure proofing
software (i.e., Proofig), and all available input was considered by
the handling editor and Editor-in-Chief. Overall, the editors did
not find compelling evidence of data manipulation intended to
misrepresent the results.” The journal’s full notice is available
on-line:https://www.sciencedirect.com/science/article/pii/S0197458022000562?via%3Dihub
- In December 2021, Cassava Sciences
announced that Neuroscience investigated and found no evidence of
data manipulation in a paper published in that journal in 2005. The
Editor-in-Chief stated: “After careful examination of these
original material, Neuroscience found no evidence of manipulation
of the western blot data or other figures of this publication.” The
journal’s full editorial note is available on-line:
https://www.sciencedirect.com/science/article/pii/S0306452221005789?via%3Dihub
- In November 2021, Cassava Sciences
announced that The Journal of Neuroscience investigated and found
no evidence of data manipulation in a paper on simufilam published
in that journal in July 2012. The Editor-in-Chief previously
authorized Cassava Sciences to share a statement on this matter,
including: “No evidence of data manipulation was found for Western
blot data.” The full statement provided to the Company and the
journal’s full notice are both available
on-line:https://www.cassavasciences.com/news-releases/news-release-details/review-journal-neuroscience-shows-no-evidence-data-manipulationhttps://www.jneurosci.org/content/42/3/529
A related investigation by academic authorities
at The City University of New York (CUNY) is ongoing. Pending a
public response from CUNY, both Neurobiology of Aging and Journal
of Neuroscience previously issued an outstanding “expression of
concern”, which is a non-standardized type of editorial notice used
by academic publishers to raise awareness to a possible problem,
according to the Council of Science Editors (2012).
About SimufilamSimufilam is
Cassava Sciences’ proprietary, small molecule (oral) drug that
restores the normal shape and function of altered filamin A (FLNA)
protein in the brain. Cassava Sciences owns worldwide development
and commercial rights to its research programs in Alzheimer’s
disease, and related technologies, without royalty obligations to
any third party.
About Cassava Sciences,
Inc.Cassava Sciences, Inc. is a clinical-stage
biotechnology company based in Austin, Texas. Our mission is to
detect and treat neurodegenerative diseases, such as Alzheimer’s
disease. Our novel science is based on stabilizing – but not
removing – a critical protein in the brain. For more information,
please visit: https://www.CassavaSciences.com.
For More Information Contact:
Eric Schoen, Chief Financial Officer, (512) 501-2450,
or eschoen@CassavaSciences.com.
Cautionary Note Regarding
Forward-Looking Statements: This news release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, relating to: our expectations regarding CUNY’s
on-going investigative activities; our viewpoints regarding lack of
supporting evidence for allegations of research misconduct; our
expectations regarding the role of written pronouncements from
science experts; the potential cessation of attacks against the
Company; comments made by our employees regarding allegations of
data manipulation; the treatment of Alzheimer’s disease; and
potential benefits, if any, of our product candidates. These
statements may be identified by words such as “may,” “anticipate,”
“believe,” “could,” “expect,” “would”, “forecast,” “intend,”
“plan,” “possible,” “potential,” and other words and terms of
similar meaning. Drug development and commercialization involve a
high degree of risk, and only a small number of research and
development programs result in commercialization of a product. Our
clinical results from earlier-stage clinical trials may not be
indicative of full results or results from later-stage or larger
scale clinical trials and do not ensure regulatory approval. You
should not place undue reliance on these statements or any
scientific data we present or publish.
Such statements are based largely on our current
expectations and projections about future events. Such statements
speak only as of the date of this news release and are subject to a
number of risks, uncertainties and assumptions, including, but not
limited to, those risks relating to the ability to conduct or
complete clinical studies on expected timelines, to demonstrate the
specificity, safety, efficacy or potential health benefits of our
product candidates, the severity and duration of health care
precautions given the COVID-19 pandemic, any unanticipated impacts
of the pandemic on our business operations, and including those
described in the section entitled “Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2021, and
future reports to be filed with the SEC. The foregoing sets forth
many, but not all, of the factors that could cause actual results
to differ from expectations in any forward-looking statement. In
light of these risks, uncertainties and assumptions, the
forward-looking statements and events discussed in this news
release are inherently uncertain and may not occur, and actual
results could differ materially and adversely from those
anticipated or implied in the forward-looking statements.
Accordingly, you should not rely upon forward-looking statements as
predictions of future events. Except as required by law, we
disclaim any intention or responsibility for updating or revising
any forward-looking statements contained in this news release. For
further information regarding these and other risks related to our
business, investors should consult our filings with the SEC, which
are available on the SEC's website at www.sec.gov.
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