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Results from METRICs Study Informs Expansion of StageZero's New Care Oncology Protocol

Newsfile - Wed Feb 15, 2023

Launch of New Protocol will now make the connection between patients' metabolic health and cancer outcomes using advanced biomarker testing and interactive digital health platform to actively track patient progress.

Toronto, Ontario--(Newsfile Corp. - February 15, 2023) - StageZero Life Sciences, Ltd. (TSX: SZLS) (OTCQB: SZLSF) ("StageZero" or the "Company"), a global healthcare company providing solutions to help improve patient outcomes through early cancer detection and adjunctive metabolic cancer therapies, today announced significant enhancements to the company's proprietary Care Oncology Protocol ("COC Protocol").

Metabolically targeted drugs show promise as adjunctive therapy to make cancer cells more sensitive to chemotherapy, radiation and other standard of care treatments. By coupling the COC Protocol with specific blood biomarker data, this will enable our clinical team to objectively assess the degree of metabolic control which may be being exercised by the COC Protocol and to further refine the dosing and treatment over time.

"By adding biomarker testing, a proprietary algorithm and new digital health platform to track patient progress while on the protocol, it will enable us to better evaluate the connection between metabolic status and cancer outcomes. As we connect outcomes to improved metabolic and inflammatory health, it could change the way cancer is treated," said James Howard-Tripp, Chairman and CEO of StageZero Life Sciences. "This new protocol is intended to benefit patients, but will also serve as the foundation for METRICS II, a novel approach to generate additional clinical data of sufficient quality to support changes in clinical practice," he added.

A Case Study in Glioblastoma:

The METRICS study was conducted by the London, UK, Care Oncology Clinic between 2013 - 2016 using a perspective analysis comprising 95 patients with a biopsy confirmed Glioblastoma IV brain tumor ("GBM"). Patients could be enrolled into the adjunctive COC Protocol at any time i.e., from presentation of their GBM or at any future time-point if deemed eligible to receive treatment by the consulting COC oncologist. All patients continued to receive their standard of care therapy (surgery, radiation, chemotherapy) and follow up.

The primary endpoint was median overall survival (defined as time from diagnosis until death from any cause):

  • Patients receiving the adjunctive COC Protocol had a median overall survival of 26.3 months and a two-year survival of 55.8%.
  • Comparative data from Public Health England (Brodbelt et al., 2015), patients receiving standard of care therapy alone had a median overall survival of 14.8 months and a two-year survival of 28.7%; and data from the European Organisation for Research and Treatment of Cancer, a median overall survival of 15.8 months and a two-year survival of 26.5% (Stupp et al., 2005).
  • The full study can be read here: https://www.frontiersin.org/articles/10.3389/fphar.2019.00681/full.

Plans for METRICS II Are Underway

StageZero and Care Oncology are in discussions with leading cancer centers in London, UK and Toronto, Canada to expand the original METRICS study using the new tools available in the next generation COC Protocol. Early discussion includes looking at glioblastoma patients earlier in the course of their disease, tracking metabolic syndrome and inflammation through blood biomarker tests, and introducing neuroimaging to track progress in tumors while on the protocol.

History of The COC Protocol

Since 2013 Care Oncology has been treating cancer patients, with multiple, different cancer types, using their patented COC Protocol™. The COC Protocol is a metabolic therapy that uses a combination of conventional pharmaceuticals which may work together to restrict the overall ability of cancer cells to take up and use (i.e., 'metabolize') energy.

The Role of Metabolic Dysfunction and Inflammation in Cancer

Current cancer treatments are designed to target cancer cells in the here and now, rather than dealing with the root causes that facilitated their development in the first place. Two of these root causes are metabolic dysfunction and chronic inflammation and paradoxically, some of the very treatments used to treat cancer may actually make these issues worse.

Care Oncology's COC Protocol seeks to measure and track these root causes and other key biomarkers, which if optimized, may improve cancer outcomes. COC oncologists carefully review blood test results and other patient data and make recommendations to help drive improvements. This can include advice around nutrition, stress, sleep, exercise, as well as the recommendation or prescription of a specific set of medications. By coupling the COC Protocol with specific blood biomarker data, this will enable our clinical team to objectively assess the degree of metabolic control which may be being exercised by the COC Protocol and to further refine the dosing and treatment over time.

About StageZero Life Sciences, Ltd.

StageZero Life Sciences, Ltd. is a vertically integrated healthcare company dedicated to improving the early detection and management of cancer and other chronic diseases through next-generation diagnostics and a unique telehealth program that provides clinical interventions to help patients reduce the risk of developing late-stage disease (AVRT™).

The Company's next generation test, ARISTOTLE®, is the first ever mRNA multi-cancer panel for simultaneously screening for multiple cancers from a single sample of blood with high sensitivity and specificity for each cancer. ARISTOTLE® uses mRNA technology to identify the molecular signatures of multiple cancer types and is built on the Company's patented technology platform, the Sentinel Principle. This underlying technology has been validated in more than 9,000 patients and used by more than 100,000 patients in North America.

ARISTOTLE®, is processed at the Company's clinical laboratory, StageZero Life Sciences, Inc., a CAP accredited and CLIA certified high-complexity reference laboratory in Richmond, Virginia.

StageZero Life Sciences trades on the Toronto Stock exchange under the symbol SZLS and on the OTCQB under the symbol SZLSF.

Care Oncology Inc. is a StageZero Life Sciences company.

Forward-Looking Statements

This press release contains forward-looking statements identified by words such as "expects", "will" and similar expressions, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties that could cause the Company's actual events to differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements, except as required by law.

For further information please contact:
Investor Relations
Rebecca Greco
1-855-420-7140 ext. 1838
rgreco@stagezerols.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/154933

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