Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study
December 06 2022 - 3:01AM
Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a
molecular genetics diagnostic company specializing in the early
detection of cancer, announced today that it has received approval
from an independent Institutional Review Board (IRB) for the
protocol ReconAAsense, the Company’s U.S. pivotal study to evaluate
the clinical performance of its highly efficacious and easy-to-use
detection test for colorectal cancer (CRC). Mainz Biomed will now
initiate the study, which will form the basis of the data package
to be submitted for review by the U.S. Food and Drug Administration
(FDA) to achieve marketing authorization.
ReconAAsense is a prospective clinical study that will include
approximately 15,000 subjects from 150 sites across the United
States. The study objectives include calculating sensitivity,
specificity, positive predictive value (PPV) and negative
predictive value (NPV) in average-risk subjects for CRC and
advanced adenomas (AA).
Integral to the Company’s development strategy concerning the
evolution of the product’s specifications is the potential to
upgrade its technical profile to achieve a transformational
advancement in self-administered CRC screening. To this end, Mainz
Biomed recently initiated eAArly DETECT, its U.S. extension of
ColoFuture, the Company’s European feasibility study evaluating the
integration of a portfolio of novel gene expression (mRNA)
biomarkers into its next-generation product. These biomarkers have
demonstrated a unique ability to identify precancerous colonic
polyps and early-stage CRC (Herring et al., 2021). The eAArly
DETECT study was initiated in November of 2022 and is evaluating
the effectiveness of these biomarkers to enhance product
specifications to extend its capability to include the detection of
advanced adenomas while increasing rates of diagnostic sensitivity
and specificity for colorectal cancer. Mainz Biomed expects to
complete eAArly DETECT enrollment in Q1 2023 and targets reporting
topline results in 1H 2023. Based on the study’s outcome, Mainz
Biomed will decide on the integration of the biomarkers evaluated
in ColoFuture’s eAArly DETECT into the ReconAAsense study.
“Given that colorectal cancer continues to be one of the
deadliest forms of cancer, early detection plays a critical role in
disease prevention and treatment,” commented Guido Baechler, Chief
Executive Officer of Mainz Biomed. “We look forward to commencing
the U.S. regulatory approval process for our next-generation
product and are passionate about bringing this easy-to-administer
test to the U.S. In addition, we eagerly await results from the
ColoFuture feasibility study, as the potential to include novel
biomarkers to detect advanced adenomas will be a game changer for
at-home CRC screenings.”
Once enrollment commences, ReconAAsense will continue until at
least 73 evaluable subjects are diagnosed with colorectal cancer,
and at least 138 evaluable subjects are diagnosed with advanced
adenoma. Details about the ReconAAsense study will soon be online
at clinicaltrials.gov. The Company anticipates reporting results in
2025.
About Colorectal Cancer According to the
Centers for Disease Control and Prevention (CDC), colorectal 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 estimated that in 2021 there were approximately 149,500 new
cases of colon and rectal cancer in the US, with 52,980 resulting
in death. Recent decisions by the US Food and Drug Administration
(FDA) 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
and a US market opportunity of approximately $3.7 billion per
year.
About Mainz Biomed NV 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 and the United Arab Emirates with
the intention of beginning its pivotal FDA clinical study in 2022
for US regulatory approval. Mainz Biomed’s product candidate
portfolio also 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. To learn more, visit mainzbiomed.com or follow us on
LinkedIn, Twitter and Facebook.
For media inquiries -In Europe: MC
Services AG Anne Hennecke/Caroline Bergmann +49 211
529252 20 mainzbiomed@mc-services.eu
In the US: Spectrum Science Melissa Laverty/Valerie
Enes +1 540 272 6465 mainz@spectrumscience.com
For investor inquiries, please
contact
ir@mainzbiomed.com
Forward-Looking Statements Certain
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 annual report on Form 20-F filed on May
5, 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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