Anavex Life Sciences Appoints Former FDA Lead Neurology Statistician as Vice President Head of Biostatistics
09 March 2023 - 11:00PM
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:
AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of neurodegenerative
and neurodevelopmental disorders including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today announced the appointment of Kun Jin, Ph.D.,
as Vice President, Head of Biostatistics.
Dr. Jin will draw on his extensive experience,
including recently as the Statistical Team Leader at the U.S. Food
and Drug Administration (FDA). Dr. Jin provided statistical review
coverage and expertise for neurological drug products for the
Center for Drug Evaluation and Research (CDER), and performed
timely and quality reviews of marketing applications, including New
Drug Applications (NDA), Biologic License Applications (BLA), and
Investigational New Drug (IND) applications. Under the leadership
of Dr. Jin, the neuropharmacological statistical team has completed
several hundred statistical reviews of NDAs, BLAs, and efficacy
supplements.
"I'm excited to welcome Dr. Jin to Anavex at
this pivotal time. Dr. Jin has significant experience that will be
instrumental as we continue our efforts to maximize value for
patients and shareholders," said Christopher U Missling, Ph.D.,
President and Chief Executive Officer of Anavex. "Dr. Jin's deep
and extensive biostatistics experience within clinical development
and regulatory process will be invaluable as we advance key mid-
and late-stage programs, to provide clinical and regulatory
biostatistics leadership in support of Anavex’s goal to bring
transformational medicines to the market."
“I’m honored to be joining Anavex and I am very
much looking forward to helping guide the Company to secure access
to better healthcare outcomes for families around the world,” said
Dr. Jin. “There is such a significant unmet medical need around the
globe caused by Alzheimer’s disease, Parkinson’s disease, and
neurodevelopmental diseases like Rett syndrome and Fragile X
syndrome. Anavex has a cutting-edge technology that can make a
great deal of difference to those patients. I believe I can make a
substantial contribution at this very important time in the
Company’s transition towards commercialization.”
Prior to joining Anavex, Dr. Jin had a
distinguished career of more than 27 years at the FDA. During his
tenure at the agency, Dr. Jin has contributed extensively to
statistical review issues and trial designs surrounding the
regulatory approval of drugs for the treatment of neurological
diseases including Alzheimer’s disease, Parkinson’s disease,
migraine, epilepsy, and multiple sclerosis, as well as rare
diseases, such as ALS and DMD. Dr. Jin was the lead author in top
theoretical statistics, biostatistics, and molecular genetics
journals. He was also a winner in a worldwide innovation
competition on clinical cardiology data processing (Predicting
Acute Hypotensive Episodes).
Dr. Jin has extensive research experience in
Alzheimer’s clinical trials. He has been an invited speaker and has
authored publications on topics in Alzheimer’s disease endpoints
and trial designs. He conducted FDA/CDER The Oak Ridge Institute
for Science and Education (ORISE) Summer Fellowship projects, built
the Integrative Alzheimer’s Trial Database, FDA/CDER Regulatory
Science and Review (RSR) Project and the results have been
communicated at Accelerate Cures/Treatments for All Dementias
(ACT-AD), Drug Information Association (DIA), and Joint Statistical
Meetings (JSM). Before joining the FDA, Dr. Jin was Assistant
Professor at the Division of Biostatistics, University of
Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Dr. Jin
received his Ph.D. in Statistics from the University of California
at Berkeley, California.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of novel therapeutics for the treatment of
neurodegenerative and neurodevelopmental disorders, including
Alzheimer's disease, Parkinson's disease, Rett syndrome, and other
central nervous system (CNS) diseases, pain, and various types of
cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine),
has successfully completed a Phase 2a and recently a Phase 2b/3
clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept
study in Parkinson's disease dementia, and both a Phase 2 and a
Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is
an orally available drug candidate that restores cellular
homeostasis by targeting sigma-1 and muscarinic receptors.
Preclinical studies demonstrated its potential to halt and/or
reverse the course of Alzheimer's disease. ANAVEX®2-73 also
exhibited anticonvulsant, anti-amnesic, neuroprotective, and
anti-depressant properties in animal models, indicating its
potential to treat additional CNS disorders, including epilepsy.
The Michael J. Fox Foundation for Parkinson's Research previously
awarded Anavex a research grant, which fully funded a preclinical
study to develop ANAVEX®2-73 for the treatment of Parkinson's
disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic
receptors, is a promising clinical stage drug candidate
demonstrating disease-modifying activity against the major
hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice,
including cognitive deficits, amyloid, and tau pathologies. In
preclinical trials, ANAVEX®3-71 has shown beneficial effects on
mitochondrial dysfunction and neuroinflammation. Further
information is available at www.anavex.com. You can also connect
with the company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not
strictly historical in nature are forward-looking statements. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. All forward-looking statements are qualified in
their entirety by this cautionary statement and Anavex Life
Sciences Corp. undertakes no obligation to revise or update this
press release to reflect events or circumstances after the date
hereof.
For Further Information:Anavex
Life Sciences Corp.Research & Business DevelopmentToll-free:
1-844-689-3939Email: info@anavex.com
Investors:Andrew J.
BarwickiInvestor RelationsTel: 516-662-9461Email:
andrew@barwicki.com
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