Cassava Sciences, Inc. (Nasdaq: SAVA) a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced the appointment of James Kupiec, MD, to the newly created
position of Chief Clinical Development Officer. Dr. Kupiec will
lead the Phase 3 clinical development strategy for simufilam,
Cassava Sciences’ investigational drug for the treatment of
dementia in Alzheimer’s disease. Dr. Kupiec will also serve as a
member of the executive management team, reporting to the President
& CEO.
“We are delighted to have Dr. Kupiec join our
team,” said Remi Barbier, Chairman, President & CEO of Cassava
Sciences. “Jim’s extensive experience as a leader in the clinical
development of investigational drugs for Alzheimer’s disease and
other neurodegenerative disorders represents a significant
advantage for Cassava Sciences as we prepare for Phase 3 clinical
trials of simufilam. I believe Jim will play a critical role
collaborating with key neuroscience research leaders, regulatory
authorities and potential pharmaceutical research partners.”
“I am quite excited to join the Cassava
leadership team at this pivotal stage,” said Dr. Kupiec. “The
dramatic biomarker response generated by simufilam in clinical
trial subjects with Alzheimer’s disease suggests that a
transformative, novel therapeutic in the future is a real
possibility. I am gratified to have this extraordinary opportunity
to engage with investigators and their patients and to advance the
clinical pipeline at Cassava Sciences.”
Dr. Kupiec previously served as VP, Global
Clinical Leader for Parkinson’s Disease and Clinical Head of the
Neuroscience Research Unit for Pfizer, Inc., in Cambridge, MA. He
joined Pfizer in 2000 after seven years with Sanofi, and two years
with Ciba-Geigy Pharmaceuticals. During his 17-year career at
Pfizer, Dr. Kupiec had extensive governance, business development,
alliance and leadership responsibilities. He and his team focused
on developing potential disease-modifying and symptomatic therapies
for Alzheimer’s disease and other neurodegenerative disorders. As a
Global Project Leader and Clinical Head, Dr. Kupiec created and
implemented global drug development strategies, met with worldwide
regulatory authorities, and co-chaired numerous joint development
committees with other pharmaceutical companies. After leaving
Pfizer in 2017, Dr. Kupiec was an independent consultant to
biotechnology companies and, most recently, served as Chief Medical
Officer for ProMIS Neurosciences Inc., a biotechnology company
focused on antibody therapeutics for neurodegenerative disorders,
where he had responsibility for clinical and biomarker
strategies.
Dr. Kupiec earned his BS with Honors in
Biochemistry at Stony Brook University and his MD from the Albert
Einstein College of Medicine. He completed his residency training
at the Strong Memorial Hospital, University of Rochester School of
Medicine, and is certified by the American Board of Internal
Medicine. He served as an investigator on many clinical trials
before transitioning to the pharmaceutical industry.
About Alzheimer's Disease
Alzheimer’s disease is a progressive brain disorder that destroys
memory and thinking skills. Currently, there are no drug therapies
to halt Alzheimer’s disease, much less reverse its course. In the
U.S. alone, approximately 5.8 million people are currently living
with Alzheimer’s disease, and approximately 487,000 people age 65
or older developed Alzheimer’s in 2019.1 The number of people
living with Alzheimer’s disease is expected to grow dramatically in
the years ahead, resulting in a growing social and economic
burden.2
About SimufilamSimufilam is a
proprietary, small molecule (oral) drug that restores the normal
shape and function of altered filamin A (FLNA), a scaffolding
protein, in the brain. Altered FLNA in the brain disrupts the
normal function of neurons, leading to Alzheimer’s pathology,
neurodegeneration and neuroinflammation. The underlying science for
simufilam is published in peer-reviewed journals, including Journal
of Neuroscience, Neurobiology of Aging, Journal of Biological
Chemistry, Neuroimmunology and Neuroinflammation and Journal of
Prevention of Alzheimer’s Disease.
Cassava Sciences is also developing an
investigational diagnostic, called SavaDx, to detect Alzheimer’s
disease with a simple blood test.
Simufilam and SavaDx were both developed
in-house. Both product candidates are substantially funded by
peer-review research grant awards from the National Institutes of
Health (NIH). 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’ mission is to discover and develop
innovations for chronic, neurodegenerative conditions. Over the
past 10 years, Cassava Sciences has combined state-of-the-art
technology with new insights in neurobiology to develop novel
solutions for Alzheimer’s disease. For more information, please
visit: https://www.CassavaSciences.com
For More Information
Contact:Eric Schoen, Chief Financial OfficerCassava
Sciences, Inc.eschoen@CassavaSciences.com(512) 501-2450
Cassava Sciences Safe
HarborThis 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 strategy and plans; the treatment of Alzheimer’s
disease; the status of current and future clinical studies with
simufilam, including our intention to conduct a Phase 3 clinical
program; risks and uncertainties associated with drug development;
verbal commentaries made by our employees; and potential benefits,
if any, of the our product candidates. These statements may be
identified by words such as “may,” “anticipate,” “believe,”
“could,” “expect,” “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, 2019 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.
1,2 Source: Alzheimer’s Association. 2019 Alzheimer’s Disease
Facts and Figures. Available online at:
https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
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