Sernova Corp T.SVA

Alternate Symbol(s): SEOVF

Healthcare Biotechnology

Sernova Corp. is a Canada-based clinical-stage biotechnology company, which is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. The Company is focused on developing a functional cure for insulin-dependent diabetes with its therapeutic cell technology, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. The Cell Pouch is a scalable, implantable medical device. The Cell Pouch is designed to create a vascularized organ-like environment for the transplantation and engraftment of therapeutic cells. Its regenerative medicine therapeutic approach is to provide cell therapies where the cells, transplanted within an organ-like vascularized implantable device, the Cell Pouch, generates proteins, hormones or factors released into the bloodstream for treatment of diseases requiring replacement of these molecules in the body.

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Sernova Corp

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Post by jwalliscaon Mar 30, 2020 12:55pm

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Post# 30860513

Rb2211 Isolation: "si senor" :)

Rb2211:

My understanding about cohort isolation is like yours.

The original protocol for the FDA trial made isolation mandatory.

It would appear that this serendipity avoidance of the COVID-19 Black Swan is paying off as the latest 24 March 2020 news shows the FDA trial continues better than AOK.

jwall

Excerpt from 24 March News (note trial is ongoing AOK):

Diabetes

We are currently conducting a US Phase I/II clinical trial in type 1 diabetic patients with severe hypoglycemia unawareness - entitled "Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch(TM) for Clinical Islet Transplantation" - at the University of Chicago ("US Phase I/II Cell Pouch Clinical Trial").

Key requirements for a successful diabetes regenerative medicine approach have been our focus, more specifically, these include first ensuring robust survival of insulin-producing cells within our Cell Pouch and proof of insulin release into the bloodstream in subjects with no ability to produce insulin prior to Cell Pouch transplant.

The following represents significant achievements for the US Phase I/II Cell Pouch Clinical Trial:

- Increased number of patients enrolled and transplanted in our clinical trial. In the most advanced patient treated with the Cell Pouch and insulin-producing islets, abundant and surviving vascularized insulin-producing islets were confirmed in the sentinel Cell Pouch by independent pathologist assessment following 90 days transplant.

- - Why is this important? This early efficacy endpoint within the sentinel Cell Pouch is an indicator of transplanted islet health in the therapeutic Cell Pouches remaining in the patient, including the islets ability to read blood sugar and produce insulin into the bloodstream.
- Enduring bloodstream levels of insulin from the Cell Pouch transplanted islet cells in the fasting patient was shown through detection of C-peptide, a biomarker of insulin produced by the islet cells.
- - Why is this important? This finding, combined with glucose-stimulated C-peptide and other early efficacy indicators observed, is an indication of a normalizing response by the Cell Pouch therapeutic cells to the body's varied need for insulin production, i.e. an indicator and evidence of ongoing islet survival within the vascularized environment of the Cell Pouch.
- The independent Data Safety Monitoring Board (DSMB) completed its first review of our US Phase I/II Cell Pouch Clinical Trial. No safety concerns were raised, and continuation of the clinical study was recommended.
- - Why is this important? Independent DSMB review of the trial on a yearly basis in compliance with FDA guidelines and confirmation of favorable safety profile of the Cell Pouch and islets.