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To date
Sernova reports 7 patients in its Phase I/II type 1 diabetes clinical trial achieved freedom from insulin injections and demonstrate blood sugar control in the non-diabeticrange (HbA1c 6.5%);6 patients have reached between 5.5 and 50 months of sustained insulin independence and freedom from severe hypoglycemic episodes;
Completion of enrollment in Cohort 2
At baseline, all patients in the study were dependent on multiple daily insulin injections with average HbA1c levels (a measure of glucose control over the prior 2 to 3 months) greater than 6.5% across the study population. In addition, prior to enrollment in the study, patients had a history of severe hypoglycemic events (a potentially life-threatening drop in blood sugar leading to impaired cognition and consciousness) and undetectable plasma levels of C-peptide (a marker of natural insulin production). Insulin independence in these first 7 patients has been accompanied by freedom from severe hypoglycemic events, sustained HbA1c levels in the non-diabetic range (HbA1c <6.5%), and persistent transplant-mediated insulin production measured by plasma C-peptide.
The trial, which focuses on Sernova’s Cell Pouch technology, demonstrates thatinsulin independence and additional clinically meaningful patient outcomes were achieved with lower than traditional islet masses infused intra-portally, indicating an important contribution of the islet grafts in Cell Pouch to the observed favorable blood glucose control.
in Cohort 2, later in the year.
About
About Sernova’s Cell Pouch for use with Cell Therapeutics
On implantation, The Cell Pouch forms a natural, vascularized tissue environment in the body allowing long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the
For further information, please contact:
VP, Investor Relations
Tel: +1 519-902-7923
Email:christopher.barnes@sernova.com
Website:www.sernova.com
Forward Looking Information:
This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available onwww.sedarplus.cafor additional information on risks and uncertainties relating to the forward-lookingstatements.
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