PITTSBURGH, Pa.--(BUSINESS WIRE)-- Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the publication of preclinical results for Amnion-derived Multipotent Progenitor Cells (AMP cells) in the journal Neurotherapeutics. These new, peer-reviewed results demonstrate, for the first time, the neuroprotective properties of systemically delivered AMP cells in mice with experimental autoimmune encephalomyelitis (EAE)-induced experimental optic neuritis (ON) and myelitis. The studies were conducted in the laboratory of Kenneth S. Shindler, MD, PhD, an associate professor of Ophthalmology and Neurology at the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA.

The publication, entitled “Amnion-derived Multipotent Progenitor Cells Suppress Experimental Optic Neuritis and Myelitis,” details the neuroprotective effects of intravenous (IV) or intraperitoneal (IP) injected AMP cells, a novel population of cells produced by the proprietary culturing of cells selected from the amnion of a placenta, using different treatment regimens in the ON and myelitis mouse model. In these studies, AMP cell dosing was either a 1X dose of 2 x 10⁶ cells/200µl vehicle on day 9 post-immunization or a 3X dose 1 x 10⁶ cells/200µl vehicle on days 9, 12 and 15 post-immunization. Controls received 200µL vehicle on the same dosing schedule. All mice were sacrificed on day 42 post-immunization, and optic nerves and spinal cords were collected for analyses.

“Noveome’s previous studies have shown that a single daily dose of ST266, the secretome which is produced by the AMP cell during culturing, administered through the nose, attenuated visual dysfunction, prevented retinal ganglion cell loss, and reduced both inflammation and demyelination 6 weeks after induction of EAE,” said Larry Brown, Sc.D., Noveome’s Chief Scientific Officer. “In this study, we wanted to see if systemically administered AMP cells could have a similar effect. The hypothesis was that the cells would continue to secrete the secretome in vivo, thus acting like a delivery system.”

IV and IP administration of AMP cells significantly reduced ascending paralysis and attenuated visual dysfunction in EAE mice. Histological analysis revealed a statistically significant decrease in spinal cord demyelination and a trend towards decreased inflammation scores. In the optic nerves, all AMP cell treatments demonstrated a statistically significant decrease in inflammation and reduced demyelination. Both the IV and IP 3X dose significantly attenuated visual dysfunction. The 1X IP dose showed a trend in attenuating visual dysfunction, but it was not statistically significant. Protective effects of systemically administered AMP cells suggest they may serve as a potential novel treatment for multiple sclerosis.

“We are pleased to see these preclinical results for the treatment of damaged optic nerves and spinal cord myelitis using systemically administered AMP cells. These results further demonstrate the potential of our novel cell-free platform biologic ST266, the AMP cell secretome containing multiple growth factors and anti-inflammatory cytokines, to achieve neuroprotective benefits in systemically delivered treatment regimens,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome.

Disclosure: Dr. Shindler serves as a consultant for Noveome and as such has received consulting fees and honoraria payments.

About Noveome Biotherapeutics, Inc.

Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is a complex, non-cellular product containing hundreds of biologically active proteins and other biologic factors. ST266 is currently being evaluated in multiple indications across ophthalmic, CNS and systemic inflammatory conditions. Topline data from an ongoing Phase 1 trial using a novel intranasal delivery method to deliver ST266 to the optic nerve and brain are expected later in 2020. A Phase 2 trial in persistent corneal epithelial defects (PEDs) is completed and results demonstrate ST266’s benefit in healing PEDs. Noveome is currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs and a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit Noveome.com.

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