(TheNewswire)
Sernova’s CellPouch System shows sustained clinical benefit in study patients withtype 1 diabetes through multiple efficacy indicators and ongoingsafety and tolerability
LONDON, ONTARIO – TheNewswire - January 15,2021 – Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a leadingclinical-stage regenerative medicine therapeutics company todayannounced that its principal clinical investigator, Dr. PiotrWitkowski, presented additional positive preliminary safety andefficacy data at the 2021 American Society of Transplant SurgeonsWinter Symposium. Sernova’s Cell Pouch™ transplanted with insulinproducing cells in patients with type 1 diabetes continues to showpersistent islet function and clinically meaningful improvement inmeasures of glucose control.
Dr. Witkowski highlighted the following key points in hispresentation:
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- 5 of 7 patients are currently enrolled in the study.
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- 5 of 7 patients have been implanted with the Cell Pouch
- 3 of 7 patients have received their first/one islet transplant
- 2 of 7 patients have received their first and second islettransplant
- The remaining 2 patients are actively being pre-screened to completetrial enrolment
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The overall objective of the study is to assess the safety,tolerability, and efficacy of the Cell Pouch with insulin-producingislets. In addition to other criteria, prior to entry into the study,the patients must demonstrate long-standing type 1 diabetes withsevere hypoglycemic unawareness episodes and no glucose-stimulatedC-peptide circulating in their bloodstream.
In his presentation, aside from confirming ongoing safety andtolerability in all currently enrolled patients, Dr. Witkowski focusedon the first transplanted patients who are furthest in the study andwho have received a second islet transplant. Importantly, thesepatients are showing defined clinical benefit with a clinicallymeaningful reduction in daily injectable insulin requirement, alongwith the following additional ongoing efficacy indicators:
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- Absence of life threatening severe hypoglycemic events;
- Sustained blood levels of C-peptide (a biomarker for insulinproduced by cells in the Cell Pouch);
- Reduction in HbA1c (a measure of long-term glucose control); and,
- Improvement in overall Continuous Glucose Monitoring (CGM) measuredglucose control parameters (e.g., blood glucose ‘Time in Range’).
With the positive clinical benefit achieved in patients with CellPouch islets, one patient was later provided a single infusion ofislets (portal vein). This top-up to the islets already received inthe Cell Pouch contributed to this patient achieving and sustaininginsulin independence. This patient has now been insulin free(requiring no injectable insulin) for nine months with optimal glucosecontrol.
“I am pleased with the invitation to presentadditional positive preliminary clinical trial results to my esteemedpeers at the 2021 ASTS meeting,” said Dr. Witkowski. “While wecontinue to validate the therapeutic potential of Sernova’s CellPouch with islets for type 1 diabetes, we also continue to optimize conditions within the designed clinicalprotocol towards a therapy to provide to diabetic patients, as weobserve ongoing safety and efficacy measures in our trial patients. Iam excited to be part of this evolution in patient treatment as weadvance the Cell Pouch cell therapy approach towards a functional curefor diabetes.”
ABOUT SERNOVA’S CLINICALTRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, singlearm, company-sponsored trial, to assess the safety and tolerability ofislet transplantation into the company’s patented Cell Pouch indiabetic subjects with hypoglycemia unawareness and an inability toproduce their own insulin. The secondary objective is to assessefficacy through a series of defined measures.
Eligible subjects are implanted with Cell Pouches. Followingdevelopment of vascularized tissue chambers within the Cell Pouch,subjects are then stabilized on immunosuppression and a dose ofpurified islets, under strict release criteria, transplanted into theCell Pouch.
A sentinel pouch is removed for an early assessment of the islettransplant. Subjects are followed for additional safety and efficacymeasures for approximately six months. At this point, a decision willbe made with regards to the transplant of a second islet dose withsubsequent safety and efficacy follow up. Following this period,eligible patients may be administered a single dose of islets throughthe portal vein. Patients will be then further followed for one yearto assess longer-term safety and efficacy.
This study is supported in part by funding from JDRF, the leadingglobal organization funding type 1 diabetes (T1D) research.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939 . Formore information on enrollment and recruitment details please visit www.pwitkowski.org/sernova .
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutictechnologies using a medical device and immune protected therapeuticcells (i.e. human donor cells, corrected human cells and stem-cellderived cells) to improve the treatment and quality of life of peoplewith chronic metabolic diseases such as insulin-dependent diabetes,blood disorders including hemophilia, and other diseases treatedthrough replacement of proteins or hormones missing or in short supplywithin the body. For more information, please visit www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-lookingstatements are statements that are not historical facts and aregenerally, but not always, identified by the words “expects”,“plans”, “anticipates”, “believes”, “intends”,“estimates”, “projects”, “potential” and similarexpressions, or that events or conditions “will”, “would”,“may”, “could” or “should” occur. Although Sernovabelieves the expectations expressed in such forward-looking statementsare based on reasonable assumptions, such statements are notguarantees of future performance, and actual results may differmaterially from those in forward-looking statements. Forward-lookingstatements are based on the beliefs, estimates, and opinions ofSernova’s management on the date such statements were made, whichinclude our beliefs about the conduct and outcome of clinical trials.Sernova expressly disclaims any intention or obligation to update orrevise any forward-looking statements whether as a result of newinformation, future events or otherwise.
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