Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”),
a molecular genetics diagnostic company specializing in the early
detection of cancer, announced today the appointment of Jane
Edwards, CCRA, RAC, as VP of Clinical Affairs.
As an integral part of her role, Ms. Edwards will manage the
design and logistical operations of the Company’s multifaceted
clinical trials - to include subjects in the US and EU - which
support key stages of the FDA submission process for ColoAlert, the
Company’s highly efficacious, and easy-to-use detection test for
colorectal cancer (CRC). She will also develop and liaise closely
with Key Opinion Leaders responsible for carrying out, or
contributing to, both the European and US clinical studies and
supporting related publications.
“The strength of the design and execution of our clinical trials
in Europe and the US is integral to the efficiency and
effectiveness of our FDA submission and approval process for
ColoAlert,” commented Guido Baechler, Chief Executive Officer of
Mainz Biomed. “We’re thrilled to welcome Jane to our team and know
that having such a highly respected and proven leader in the field
of clinical trial strategies in diagnostics and medical devices in
charge of our initiatives in this area will ensure that our FDA
approval process is as seamless as it can be.”
Ms. Edwards has over 20 years of senior level experience in
clinical program strategies including global clinical research and
operations, regulatory, technical services and clinical training.
She has successfully led clinical operations, and authored and
executed studies involving various disease areas including
cardiovascular, diabetes, nephrology, toxicology and coagulation.
She joins Mainz Biomed from L3 Healthcare, a full-service contract
research organization, where, as VP of Clinical Research, she led
clinical research and operations.
Prior to joining L3 Healthcare, she held the role of Senior
Director, Clinical Research at Beaufort CRO, a global contract
research organization that partners with IVD, medical device and
biopharmaceutical developers. While at Beaufort CRO she led the
clinical team executing many large, multi-center trials for various
indications. She also held the position of Associate Director,
Clinical Operations at Alere, a global leader in point of care
diagnostics which was acquired by Abbott in 2016. At Alere, she
successfully led the active U.S. and global clinical operations
teams, helping to devise optimal strategies for FDA pre-submissions
of new diagnostic products and managing the department’s
multi-million dollar global trial budgets.
“I’ve been highly impressed by the sophistication of the
ColoAlert test in its current form and am also keenly aware of the
immense future potential that comes with the integration of the
portfolio of novel gene expression (mRNA) biomarkers,” said Jane
Edwards. “ColoAlert is an impressive solution with the potential to
positively impact an enormous number of lives and I’m very excited
to be playing a role in ensuring it’s able to meet its full
potential.”
About ColoAlertColoAlert detects colorectal
cancer (CRC) via a simple-to-administer test with a sensitivity and
specificity nearly as high as the invasive colonoscopy*. The test
utilizes proprietary methods to analyze cell DNA for specific tumor
markers combined with the fecal immunochemical test (FIT) and is
designed to detect tumor DNA and CRC cases in their earliest
stages. The product is CE-IVD marked (complying with EU safety,
health and environmental requirements) and is transitioning to
compliance with IVDR. The product is commercially available in a
selection of countries in the European Union. Mainz Biomed
currently distributes ColoAlert through a number of clinical
affiliates. Once approved in the U.S., the Company’s commercial
strategy is to establish scalable distribution through a
collaborative partner program with regional and national laboratory
service providers across the country.*Dollinger MM et al.
(2018)
About the ColoFuture StudyThe ColoFuture study
is an international clinical trial evaluating over 600 patients
(women or men) in the age range of 40-85 at two participating
centers in Norway and two in Germany. Subjects are invited to
potentially participate in the trial when referred for a
colonoscopy (pre-inclusion) to screen for CRC or an overall
diagnostic analysis. Those who agree to provide a stool sample in
advance of the procedure will be eligible for participation.
Inclusion criteria are based on one of the following diagnostic
outcomes: CRC, advanced precancerous lesions in colon, or normal
colon. Then, each patient outcome will compare the observations
recorded from the colonoscopy to the results from the ColoAlert
test that incorporates the novel biomarkers. The primary endpoints
of the study are to determine sensitivity and specificity rates for
CRC with ColoAlert plus the new mRNA biomarkers. There are multiple
secondary endpoints for evaluating the modified ColoAlert test,
including, determining sensitivity for AA lesions in colon,
specificity for advanced precancerous lesions in colon and,
specificity for no colorectal finding (normal colon). The Company
is expecting to complete enrollment during the second half of 2022
and is targeting reporting study results in early 2023.
About Colorectal CancerColorectal cancer (CRC)
is the second most lethal cancer in the U.S. and Europe, but also
the most preventable with early detection providing survival rates
above 90%. Annual testing costs per patient are minimal, especially
when compared to late-stage treatments of CRC which cost patients
an average of $38,469 per year. The American Cancer Society
estimates that in 2021 there will be approximately 149,500 new
cases of colon and rectal cancer in the U.S. with 52,980 resulting
in death. Recent FDA decisions suggest that screening with stool
DNA tests such as ColoAlert in the US should be conducted once
every three years starting at age 45. Currently there are 112
million Americans aged 50+, a total that is expected to increase to
157 million within 10 years. Appropriately testing these US-based
50+ populations every three years as prescribed equates to a US
market opportunity of approximately $3.7 Billion per year.
About Mainz Biomed N.V.Mainz Biomed develops
market-ready molecular genetic diagnostic solutions for
life-threatening conditions. The Company’s flagship product is
ColoAlert, an accurate, non-invasive, and easy-to-use early
detection diagnostic test for colorectal cancer. ColoAlert is
currently marketed across Europe with FDA clinical study and
submission process intended to be launched in the first half of
2022 for U.S. regulatory approval. Mainz Biomed’s product candidate
portfolio includes PancAlert, an early-stage pancreatic cancer
screening test based on Real-Time Polymerase Chain Reaction-based
(PCR) multiplex detection of molecular-genetic biomarkers in stool
samples, and the GenoStick technology, a platform being developed
to detect pathogens on a molecular genetic basis.
For more information, please
visit www.mainzbiomed.com
For media enquiries, please contact
press@mainzbiomed.com
For investor enquiries, please contact
ir@mainzbiomed.com
Forward-Looking StatementsCertain statements
made in this press release are “forward-looking statements” within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by the use of words such as
“anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”,
and “project” and other similar expressions that predict or
indicate future events or trends or that are not statements of
historical matters. These forward-looking statements reflect the
current analysis of existing information and are subject to various
risks and uncertainties. As a result, caution must be exercised in
relying on forward-looking statements. Due to known and unknown
risks, actual results may differ materially from the Company’s
expectations or projections. The following factors, among others,
could cause actual results to differ materially from those
described in these forward-looking statements: (i) the failure to
meet projected development and related targets; (ii) changes in
applicable laws or regulations; (iii) the effect of the COVID-19
pandemic on the Company and its current or intended markets; and
(iv) other risks and uncertainties described herein, as well as
those risks and uncertainties discussed from time to time in other
reports and other public filings with the Securities and Exchange
Commission (the “SEC”) by the Company. Additional information
concerning these and other factors that may impact the Company’s
expectations and projections can be found in its initial filings
with the SEC, including its registration statement on Form F-1
filed on January 21, 2022. The Company’s SEC filings are available
publicly on the SEC’s website at www.sec.gov. Any forward-looking
statement made by us in this press release is based only on
information currently available to Mainz Biomed and speaks only as
of the date on which it is made. Mainz Biomed undertakes no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise, except as required by law.
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