- Outcomes present statistically vital decreases in insulin necessities, will increase in c-peptide ranges and enhancements in glucose tolerance in comparison with baseline
- Disruptive gene remedy method developed by College of Pittsburgh researchers could also be a promising therapy for Sort 1 and Sort 2 diabetes
Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene remedy firm centered on growing life-changing therapies for sufferers with most cancers and diabetes, in the present day introduced that knowledge highlighting the potential of Genprex’s gene remedy for Sort 1 diabetes is being offered by its analysis collaborators on the College of Pittsburgh (Pitt) on the sixteenth Worldwide Convention on Superior Applied sciences & Remedies for Diabetes (ATTD 2023) going down February 22-25, 2023 in Berlin, Germany.
The summary knowledge have been launched, and the presentation will likely be delivered on February twenty fifth at 2:25 pm CET by Ranjeet S. Kalsi, DO, a member of the laboratory of George Gittes, MD, from Pitt’s Division of Pediatric Surgical procedure, Pittsburgh, Pennsylvania. The entire presentation will likely be out there on the Firm’s web site right here following the shut of Dr. Kalsi’s presentation.
The presentation titled, “Pancreatic Intraductal Infusion of Adeno-Related Virus (AAV) to Deal with Non-Human Primates in a Toxin-Induced Diabetes Mannequin,” will report outcomes from eight non-human primates (NHPs) with toxin-induced diabetes after streptozocin administration. They obtained a novel infusion course of that used an AAV vector to ship Pdx1 and MafA genes on to the pancreas.
“These outcomes are compelling as they exhibit the potential for this gene remedy to create newly fashioned beta-like cells that may produce insulin. Additionally they validate earlier research of this method in diabetic mouse fashions that confirmed restoration of regular blood glucose ranges for a number of months,” acknowledged Mark Berger, MD, Chief Medical Officer of Genprex. “We’re desirous to proceed working to advance this gene remedy into human medical trials with a purpose to replicate these outcomes in individuals and probably present long-term alternative of beta-cells.”
The statistically vital examine outcomes present that post-infusion of the AAV engineered assemble, the eight NHPs had “decreased insulin necessities (p<0.001); elevated c-peptide ranges (p<0.05); and improved glucose tolerance in comparison with baseline (p<0.05) with one demonstrating reestablished normoglycemia. Immunohistochemistry revealed insulin and glucagon staining, which counsel the formation of insulin-producing cells.”
The diabetes applied sciences licensed from Pitt by Genprex have been developed within the laboratory of George Gittes, MD, Professor of Surgical procedure and Pediatrics and Chief of the Division of Pediatric Surgical procedure on the College of Pittsburgh College of Medication. “We’re delighted with the statistically vital outcomes from this NHP examine in Sort-1 diabetes because it additional helps our thesis on the potential of our gene remedy method in diabetes. Importantly, it exhibits a constructive knowledge development from our earlier mouse mannequin knowledge to those NHP knowledge,” famous Dr. Gittes.
“These promising knowledge are very encouraging and additional help our perception that this gene remedy method to treating diabetes has the potential to vary the course of the illness in each Sort 1 and Sort 2 diabetes,” mentioned Rodney Varner, President and Chief Government Officer of Genprex. “Based mostly on knowledge from quite a few preclinical in vivo research, we’re inspired that our novel gene remedy method might present long-term efficacy in people probably making exogenous insulin pointless, which might be a gamechanger for the 537 million individuals all over the world dwelling with diabetes.”
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene remedy firm centered on growing life-changing therapies for sufferers with most cancers and diabetes. Genprex’s applied sciences are designed to manage disease-fighting genes to supply new therapies for big affected person populations with most cancers and diabetes who presently have restricted therapy choices. Genprex works with world-class establishments and collaborators to develop drug candidates to additional its pipeline of gene therapies with a purpose to present novel therapy approaches. Genprex’s oncology program makes use of its proprietary, non-viral ONCOPREX® Nanoparticle Supply System, which the Firm believes is the primary systemic gene remedy supply platform used for most cancers in people. ONCOPREX encapsulates the gene-expressing plasmids utilizing lipid nanoparticles. The resultant product is run intravenously, the place it’s then taken up by tumor cells that categorical tumor suppressor proteins which are poor within the physique. The Firm’s lead product candidate, REQORSA® (quaratusugene ozeplasmid), is being evaluated in three medical trials as a therapy for non-small cell lung most cancers (NSCLC) and small cell lung most cancers (SCLC). Each NSCLC medical applications obtained a Quick Monitor Designation from the Meals and Drug Administration. Genprex’s diabetes gene remedy method is comprised of a novel infusion course of that makes use of an endoscope and an adeno-associated virus (AAV) vector to ship Pdx1 and MafA genes on to the pancreas. In fashions of Sort 1 diabetes, GPX-002 transforms alpha cells within the pancreas into practical beta-like cells, which might produce insulin however are distinct sufficient from beta cells to evade the physique’s immune system. In an analogous method, GPX-003 for Sort 2 diabetes, the place autoimmunity will not be at play, is believed to rejuvenate and replenish exhausted beta cells.
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Statements contained on this press launch relating to issues that aren’t historic info are “forward-looking statements” throughout the that means of the Non-public Securities Litigation Reform Act of 1995. These forward-looking statements are made on the idea of the present beliefs, expectations and assumptions of administration, usually are not ensures of efficiency and are topic to vital dangers and uncertainty. These forward-looking statements ought to, subsequently, be thought of in gentle of varied necessary elements, together with these set forth in Genprex’s studies that it recordsdata every so often with the Securities and Change Fee and which it’s best to assessment, together with these statements below “Merchandise 1A – Danger Components” in Genprex’s Annual Report on Kind 10-Ok for the 12 months ended December 31, 2021.
As a result of forward-looking statements are topic to dangers and uncertainties, precise outcomes could differ materially from these expressed or implied by such forward-looking statements. Such statements embrace, however usually are not restricted to, statements relating to: the timing and success of Genprex’s pre-clinical improvement applications, medical trials and regulatory approvals, together with the extent and impression of the COVID-19 pandemic; the impact of Genprex’s product candidates, alone and together with different therapies, on most cancers and diabetes; Genprex’s future progress and monetary standing; Genprex’s industrial and strategic partnerships, together with these with its third social gathering producers and their skill to efficiently carry out and scale up the manufacture of its product candidates; and Genprex’s mental property and licenses.
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