PITTSBURGH – January 31, 2017 – Noveome Biotherapeutics, Inc., a clinical-stage company and leader in the field of paracrine signaling, today announced the publication of groundbreaking preclinical data in a multiple sclerosis (MS) model with ST266, the company’s novel secretome. Intranasally delivered ST266 demonstrated anti-inflammatory activity and prevented retinal ganglion cell (RGC) loss in the optic nerve, showing its therapeutic potential for treating optic neuritis, the most common presenting sign of MS. The research was conducted in the laboratory of Kenneth S. Shindler, M.D., Ph.D., a professor of Ophthalmology in the Perelman School of Medicine at the University of Pennsylvania, with funding support provided by Noveome, and was published today in Nature Scientific Reports in an article titled, “Intranasal Delivery of a Novel Amnion Cell Secretome Prevents Neuronal Damage and Preserves Function in a Mouse Multiple Sclerosis Model.”
Results showed that intranasally administered ST266 in a preclinical model reached the central nervous system within 30 minutes and was detected at higher concentrations in the vitreous and optic nerve than the brain, demonstrating that intranasal delivery can target tissues of the eye. In a preclinical model of optic neuritis, early treatment with ST266 prevented neuronal damage and dysfunction by significantly reducing the loss of RGCs, suppressing inflammatory cell infiltration into the optic nerve, and limiting the degree of demyelination induced by optic neuritis. Treatment of later-stage optic neuritis showed similar results, with ST266 administration leading to a reduction in neuronal damage and demyelination, resulting in improved visual function compared to untreated groups. These data suggest that ST266 helps promote RGC survival by potentially activating multiple pathways, including the stimulation of SIRT1-mediated mitochondrial function and AKT phosphorylation to prevent cell death. Intranasal drug delivery is not currently used to treat any ophthalmic conditions, including optic nerve diseases, and the current results support further exploration of this novel treatment strategy.
“Current therapies reduce inflammation but fail to prevent RGC loss; thus, there is a need for combination treatment options that are able to prevent RGC axon loss for patients with optic neuritis. The unique and diverse biologic molecules present in ST266 were seen to help promote anti-inflammatory and neuroprotective activity in this preclinical model and suggest that ST266 has the potential to mediate neuroprotection through activation of multiple intracellular signaling pathways,” said Dr. Shindler. “These results are particularly important as the preservation of RGCs has been recognized as a significant factor when treating optic neuritis due to potential permanent visual dysfunction.”
“We believe this is the first demonstration of a potentially successful therapeutic treatment of the optic nerve using intranasal delivery of large molecular weight biomolecules,” commented Larry Brown, Sc.D., Chief Scientific Officer of Noveome. “These promising results reinforce the multifaceted potential of ST266 in multiple disease areas, including disorders in the back of the eye. The study also reconfirmed the safety profile and potent nature of ST266 in a preclinical model, which provides encouragement and support for continued research.”
Editor’s Note: Dr. Shindler has served as a scientific advisory board member and consultant to, and has received consulting fees from, Noveome (formerly Stemnion, Inc.). In addition, Noveome has provided unrestricted funds to Penn to support research in Dr. Shindler’s laboratory.
ST266 is a novel secretome – a rich, complex solution of biologically active molecules secreted from proprietary cells. Instead of a single drug and target, the ST266 secretome utilizes paracrine signaling to induce changes in nearby cells, including modulating inflammation, speeding impaired wound healing, promoting bone restoration, restoring nerve function, regenerating cells, and restoring cellular homeostasis. ST266 has demonstrated these unique attributes in multiple preclinical studies, indicating that it can be applied across a wide range of disease indications to improve patient outcomes. In addition, Phase I clinical trials have demonstrated the robust safety of ST266 when administered in ophthalmic, dermal, and oral formulations.
Noveome is a Pittsburgh, PA-based, clinical-stage biotherapeutics company leveraging the science of paracrine signaling to restore cellular communication in impaired tissue and disease processes. Our paracrine therapeutic approach has the potential to create safe and effective products across a wide range of disease indications to improve patient outcomes. For more information on Noveome visit www.noveome.com.
Gail Kempler, Ph.D.
Director, Investor Relations
Noveome Biotherapeutics, Inc.
MacDougall Biomedical Communications