SVA Sernova Corp

Sernova Corp. (TSX VENTURE:SVA), a clinical stage company developing medical
technologies for the long-term treatment of chronic metabolic diseases including
diabetes, blood disorders such as haemophilia and other diseases, today
announced interim results in an ongoing type 1 diabetes human clinical trial
with the Company's Cell Pouch(TM). 


Sernova's human clinical trial is designed to assess the safety and efficacy of
the Cell Pouch in subjects with unstable diabetes receiving an islet transplant.
Interim study results in the first group of patients support that the implanted
Cell Pouch, transplanted with insulin-producing islets is showing longer-term
safety and biocompatibility with one of the patients beyond the 180 day time
point. 


Encouraging early results up to 30 days post-islet transplant were presented at
the International Pancreas and Islet Transplantation Congress in September,
2013. These results showed after implantation under the skin, the Cell Pouch is
safe and biocompatible. Following islet transplantation, the islets living
within a natural tissue matrix were supported with a rich supply of blood
vessels, similar to the pancreas. Of further importance, the islets were shown
to make insulin, somatostatin and glucagon - key hormones in the control of
blood sugar levels. The ongoing study is being conducted with Dr. James Shapiro
as principal investigator at the University of Alberta Health Sciences Centre in
Edmonton, Alberta. 


"The fact that the Cell Pouch continues to exhibit both safety and
biocompatibility in longer term follow-up is an important milestone in the early
clinical testing of this device, and provides encouragement that human islets
transplanted within the device may provide the opportunity to change the
standard of care of patients with diabetes," said Dr. James Shapiro. "I look
forward to the ongoing results of the investigation as the study progresses." 


The study, entitled "A Phase I/II Study of the Safety and Efficacy of Sernova's
Cell Pouch for Therapeutic Islet Transplantation," is an open label, non-
randomized, Phase I/II safety and efficacy study of up to 20 patients with type
1 diabetes undergoing allograft pancreatic islet transplantation. Patients who
have met the enrolment criteria and provided informed consent are implanted with
the Cell Pouch approximately 2-24 weeks prior to transplantation of donor human
islets. To prevent islet graft rejection, the standard of care immunosuppressive
regimen is provided.


The primary endpoint of the study is to assess the safety of the Sernova Cell
Pouch in these patients just prior to islet transplantation, following islet
transplantation and at various points during follow up. The secondary endpoint
of the study, efficacy, is to determine the proportion of subjects implanted
with the Cell Pouch and transplanted with islets who achieve and maintain
insulin independence. Patient follow up occurs for a minimum of three years to
assess long-term safety and efficacy. 


"In the second half of 2014, we expect to provide further preliminary safety and
efficacy data", remarked Dr. James Shapiro.


"This interim update by Dr. Shapiro suggests we are making positive strides
forward. The Cell Pouch could potentially be a game changer for patients
suffering from this debilitating disease. Indeed, this is the result of years of
hard work and dedication from our company's staff and collaborators," said Dr.
Philip Toleikis, President and CEO of Sernova Corp. "We have developed the
subcutaneous Cell Pouch for Sernova's first clinical application, insulin-
dependent diabetes, as an alternative site for islet transplantation that may
allow for safer, more efficient engraftment of islets and potential improved
long-term insulin independence using a marginal islet mass. What adds further
credence to the Cell Pouch's mechanism of action is the application of the Cell
Pouch for other clinical indications which Sernova is undertaking", added Dr.
Toleikis."


About the Cell Pouch

The Cell Pouch is a proprietary, scalable, biocompatible medical device, that
once implanted subcutaneously, incorporates with the patient's tissue and
microvessels. The Cell Pouch is contract manufactured (ISO13485) to meet
international regulatory standards. Sernova's research has demonstrated that
when the Cell Pouch is inserted under the skin, it forms an ideal environment,
rich in microvessels and tissue matrix for the placement and function of
therapeutic cells. The Cell Pouch is currently being evaluated in clinical
trials at the University of Alberta with Dr. James Shapiro as principal
investigator in patients with type 1 diabetes receiving an islet transplant. 


It has been shown in multiple preclinical studies to provide a safe environment
for transplantation, as well as for the long-term survival and efficacy of
therapeutic cells. Sernova's goals for the diabetes indication include making
the Cell Pouch available to a wider group of patients than currently possible
with intraportal delivery of islets. Sernova also plans to make the Cell Pouch
available as a natural, improved site for non-primary-derived, insulin-secreting
cells. This may enable long-term treatment in large numbers of patients with
insulin-dependent diabetes without limitation to availability of donor-derived
cells. 


About Sernova 

Sernova Corp is a clinical stage regenerative medicine company developing
medical technologies for the treatment of chronic debilitating metabolic
diseases such as diabetes, blood disorders including haemophilia and other
diseases treated through replacement of proteins or hormones missing or in short
supply within the body. Sernova is developing the Cell Pouch, an implantable
medical device for therapeutic cells (donor, xenogeneic or stem cells) which
then release proteins and/or hormones as required. 


About Clinical Islet Transplantation Program

Please view www.islet@ca for more information on the Clinical Islet
Transplantation Program at the University of Alberta.


Forward Looking Information 

This release may contain forward-looking statements. Forward-looking statements
are statements that are not historical facts and are generally, but not always,
identified by the words "expects", "plans", "anticipates", "believes",
"intends", "estimates", "projects", "potential" and similar expressions, or that
events or conditions "will", "would", "may", "could" or "should" occur. Although
Sernova believes the expectations expressed in such forward-looking statements
are based on reasonable assumptions, such statements are not guarantees of
future performance and actual results may differ materially from those in
forward looking statements. Forward-looking statements are based on the beliefs,
estimates and opinions of Sernova's management on the date such statements were
made. Sernova expressly disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new information,
future events or otherwise. 


Neither the TSX Venture Exchange nor its Regulation Services Provider (as that
term is defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release.


FOR FURTHER INFORMATION PLEASE CONTACT: 
Sernova Corp.
Philip Toleikis, Ph.D.
President and CEO
(604) 961-2939
philip.toleikis@sernova.com  / info@sernova.com
www.sernova.com


Ray Matthews & Associates
Suite 601-128 West Cordova Street,
Vancouver, BC V6B 0E6
(604) 818-7778
www.raymatthews.ca

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