IRW-News: Sernova Corp. : Sernova’s Principal Investigator Presents at the 81st Session of the American Diabetes Association …

IRW-PRESS: Sernova Corp. : Sernova’s Principal Investigator Presents at the 81st Session of the American Diabetes Association …

Sernova’s Principal Investigator to Present Positive Patient and Interim Results from Phase I / II Study of Type 1 Diabetes at the American Diabetes Association’s 81st Session

The first patient successfully completes the clinical study and reports on his study experience and effects

LONDON, ONTARIO, June 28, 2021 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FWB / XETRA: PSH), a leader in regenerative medicine therapeutics, announced today that its lead investigator, Dr. Piotr Witkowski and the clinical study team involved in Sernova’s phase I / II clinical trial in type 1 diabetes (T1D) in the USA, preliminary data and patient observations from the ongoing study as part of the 25-29 American Diabetes Association (ADA) held the 81st Scientific Meeting on June 6, 2021.

The data obtained by Sernova were presented in a poster presentation entitled Persistent graft function after allotransplantation into pre-vascularized Sernova Cell Pouch device: Preliminary results from the University of Chicago.

The overall goal of Sernova’s Phase I / II clinical trial is to evaluate the safety, tolerability and effectiveness of the company’s Cell Pouch, which is transplanted with the insulin-producing islet cells. Patients eligible to participate in the clinical trial must meet strict entry criteria. For example, they must have been suffering from type 1 diabetes for a long time with severe episodes of hypoglycaemia cognitive disorder and no glucose-stimulated C-peptide can be detected in their blood.

In his poster presentation, Dr. Witkowski reported the continued safety and tolerability in all six patients participating in the study. In addition, the two longest-treated patients continue to show a defined and meaningful clinical benefit, consistent with the main previously established indicators of effectiveness in type 1 diabetes.

These include lowering the HbA1c value, reducing or eliminating serious hypoglycemic events, reducing or stopping the daily amount of insulin to be injected, detecting C-peptides in the patient’s blood and improving glucose control, which is measured as part of ongoing glucose monitoring he follows. The remaining patients are currently in different study phases and their progress is continuously being evaluated. The study plans to enroll a total of seven patients. Active screening is currently taking place to recruit the last patient.

It is important that the most advanced patient who was found to have a positive clinical benefit from the cell pouch and the transplanted islet cells and who subsequently received an additional single infusion of islet cells (via the portal vein) successfully completed the study protocol. This patient’s data supports the long-term safety of Sernova’s Cell Pouch.

Above all, it is important that the patient has been insulin-independent for 14 months (i.e. no insulin injections are required) and that their blood sugar is optimally adjusted. The patient has recently given Sernova permission to share the effects and personal experiences as the first recipient of the Cell Pouch in Sernova’s Phase I / II clinical trial in type 1 diabetes as follows:

After completing the safety, tolerability and effectiveness study of Sernova’s Cell Pouch for clinical islet cell transplantation and being the first transplant candidate, I can easily say that life is wonderful when you don’t have to constantly think about how to manage your diabetes. After suffering from type 1 diabetes for 47 years and having to endure around 21,535 injections of various types of insulin – cow / pig insulin or synthetic insulin -, 34,310 finger pricks and 1,460 urine tests, I was constantly on the insulin pump for 15 years I had to calculate bread units and do blood tests, had hypoglycemia and was a permanent guest at doctors, I haven’t had to inject insulin for 14 months. My Sernova team, consisting of scientists, doctors and technicians, whose efforts I cannot appreciate highly enough, as well as Dr. Witkowski and the University of Chicago supervisors did this truly amazing feat in the middle of a global pandemic! My only wish is that it would have been possible sooner. “

The lead investigator Dr. Witkowski said: As a clinical scientist and surgeon, for me, success is usually based on measuring objective results. Often the patient’s point of view and the impact on their lives from their own narratives are given too little attention, although this would be so important. I am delighted with the transformative and meaningful impact our clinical trial has had and continues to have on the life of our first patient. I would like to extend my sincere congratulations to this person who successfully completed our Sernova study with the positive result of insulin independence. We are busy optimizing the framework of the clinical protocol we have developed, and I am excited and proud to be involved in the development of Sernova’s novel cell therapy approach to the treatment of type 1 diabetes.

Sernova’s stated goal is to achieve a functional cure based on our Cell Pouch technologies for all people with type 1 diabetes, says Dr. Philip Toleikis, President & CEO of Sernova. In the course of the further development of our clinical program, we would like to thank our patients and doctors as well as the pharmaceutical and medical technology cooperation partners who were also involved, who supported us in achieving this goal of going beyond established but inadequate therapies. Successful science is a gradual process, and every advance brings us closer to our goal. It is very timely that we can celebrate the success of our first study patient right now as the world marks the 100th anniversary of the discovery of insulin.

ABOUT SERNOVA’S CLINICAL STUDY

Sernova is currently conducting a non-randomized, open-label, single-arm, and company-sponsored Phase I / II study to evaluate the safety and tolerability of islet cell transplantation in the patented Cell Pouch in diabetics with hypoglycemic cognitive disorders. The primary aim of the study is to evaluate the safety of the Cell Pouch following implantation and islet cell transplantation. As a secondary goal, the effectiveness is to be assessed on the basis of a series of defined measures. Patients who participated in Sernova’s clinical study before the Cell Pouch with the islet cells was transplanted are unable to produce C-peptide (a biomarker for the insulin produced by the islet cells).

A tissue pouch (the cell pouch) is implanted in the test subjects in question. After chambers of vascularized tissue have formed in the Cell Pouch, the test subjects are stabilized with immunosuppressants and an initial dose of purified islet cells is introduced into the Cell Pouch according to strict administration criteria.

A so-called guard pouch is removed for an early assessment of the islet cell transplant. During a follow-up period of around six months, the safety and effectiveness of the treatment for the subjects is verified. At this point, a decision will be made to transplant a second islet cell dose with a further follow-up examination to demonstrate safety and effectiveness. Patients are then followed for a year to assess long-term safety and effectiveness.

For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939.

You can find more information about the requirements for inclusion in the study on the website www.pwitkowski.org/sernova.

ABOUT SERNOVA

Sernova deals with the development of regenerative technologies for medicine and therapeutics, in which with the help of a medical device and immune-protected therapy cells (i.e. human donor cells, corrected human cells and cells obtained from stem cells) the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood diseases How hemophilia, as well as other diseases, can be improved by replacing proteins or hormones that are missing or insufficiently available in the body. You can find more information at www.sernova.com.

For more information, please contact:

Investor Relations

Sernova Corp.

Tel: (519) 858-5126

inves[email protected]

www.sernova.com

FORWARD LOOKING INFORMATION

This release contains statements that, unless they are historical facts, constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, but not limited to, statements regarding the company’s prospects, plans, and objectives. Wherever possible, but not always, words such as “expected”, “plans”, “anticipated”, “believes”, “intends”, “estimates”, “projected”, “potentially for” and similar expressions, or that events are used or terms “will occur,” “would,” “could,” or “should” are used to identify forward-looking statements. These statements reflect management’s views with respect to future events, including the results of clinical studies, and are based on information available to management at the time these statements were made. It should also be noted that patient views and results within the clinical trial may vary in each patient depending on several factors. Many factors could cause actual results, performance or achievements of Sernova not to be as expected, estimated or intended or to differ materially from the forward-looking statements contained in this press release. Many of these factors are beyond our control, including those caused, linked to, or influenced by the novel coronavirus pandemic. Investors should refer to the company’s quarterly and annual reports available at www.sedar.com for additional information about the risks and uncertainties associated with the forward-looking statements. Sernova has neither the intention nor the obligation to correct or update forward-looking statements, neither as a result of new information or future events nor for any other reason.

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