We develop first-in-class transformational therapeutics for neurological disorders
Gloriana Therapeutics is a Rhode Island-based biotechnology company developing proprietary Encapsulated Cell (EC) products for the treatment of neurological disorders. The Company was founded as NsGene from a spin-off from NeuroSearch, a Danish pharmaceutical company. The US subsidiary became a stand-alone company in 2017, and changed its name to Gloriana Therapeutics. Gloriana wholly owns the rights, data, and resources surrounding the EC platform technology. The Company focuses on developing advanced therapies for neurological disorders with great medical need such as neurodegenerative disorders, nerve injury pain, epilepsy, and sensorineural hearing loss.
Gloriana's proprietary Encapsulated Cell technology platform targets the brain directly with powerful protein therapeutics. Using minimally invasive surgery, slender EC devices can be introduced into diseased areas of the brain where the permeable distal tip secretes therapeutic protein(s) synthesized by an encapsulated engineered cell line. The cells have been shown to survive and secrete for a year or longer, a sufficient amount of time for diseased brain cells to recover function. EC devices can produce biologics such as neurotransmitters, small peptides, enzymes, growth factors, and antibodies. They are also capable of secreting multiple protein therapeutics simultaneously, opening the door for novel disease targeting.
The EC technology combines the targeting of gene therapy with the safety and clinical consonance of an implantable and retrievable device. Direct targeting of the Central Nervous System (CNS) allows for the use of novel biologics and combinations that cannot be given systemically or by means of direct gene therapy or pump technologies. Unlike direct gene therapy, the EC technology does not modify the cells or DNA of the host. In addition, the ability to end the EC therapy, by removing the device and associated modified cells, alleviates many safety and regulatory concerns. Unlike pump and catheter technologies, the EC devices are minimally invasive and do not require formulated drugs or refilling.
Gloriana is a clinical stage R&D Company and has tested its EC-NGF product in patients with AD in an open label Phase Ib trial in a total of 10 patients in collaboration with the Karolinska University Hospitals in Stockholm, Sweden. In this trial, up to four EC-NGF devices per patient were placed in the basal forebrain where NGF targets cholinergic neuron degeneration associated with mental decline in AD. The data from the human trial showed positive effects and the treatment was both safe and long lasting (6-12 months). Based on encouraging results, the Company is developing a next generation product that optimizes dosing and disease target mechanisms involved in AD.
In a development program sponsored in part by the Michael J. Fox Foundation for Parkinson's Research (MJFF), the Company develops a regenerative product based on EC devices secreting Glial cell line-Derived Neurotrophic Factor (GDNF). GDNF has been shown to have strong neuroprotective and regenerative effects when applied to the putamen, a brain region where the dopaminergic brain cell nerve endings degenerate and cause symptoms of Parkinson's disease (PD). The EC-GDNF program is in late preclinical development and clinical trials are anticipated to start in the near future. The EC-GDNF program is paving the way for a follow-on multigenic EC device which secretes more than one therapeutic targeting several disease processes in PD simultaneously.
Epilepsy affects tens of millions of individuals worldwide and is characterized by debilitating seizures, cognitive decline, and psychiatric disorders. A significant portion of epilepsies in adults originate focally from temporal lobe structures. These TLEs cannot be cured and one third of all patients do not respond to pharmacological treatment. Even when effective at reducing seizures, the currently available drugs typically cause significant unwanted side effects. Because of the focal nature of TLE, EC devices can target the anatomical structures and secrete potent antiepileptic biologics. Gloriana's EC-GDNF devices have shown strong antiepileptic effects in animal models of TLE and are associated with cognitive improvements and no evidence of side effects.
Currently the Company's internal programs are focusing on Parkinson's disease, funded in part by the Michael J. Fox Foundation,
orphan disorders with Alzecure Biologics, and sensorineural hearing loss with MED-EL.
Supporting in vitro and in vivo data are available for other early pipeline products and Gloriana is actively seeking partners and funding to support parallel development activities. An overview of product opportunities can be requested by contacting us.
Dr. Wahlberg is a neurosurgeon, translational scientist, and entrepreneur with more than 20 years of biotechnology R&D experience in developing biologics-based therapies for neurological disorders. As a researcher and co-founder and COO of NsGene and founder and CEO of Gloriana Therapeutics, he has established a successful track record in inventing and patenting new technologies, raising grant funding and venture capital, and establishing academic and commercial partnerships to move products from R&D into clinical therapeutic product opportunities. He holds a B.S. in Biophysics, an M.D. with Neurosurgery specialization, and a Ph.D. in neuroscience.
Mr. Clorite is an experienced financial expert, real estate developer and entrepreneur with more than 25 years in management positions. As the head of a global financial trading business, he was responsible for all aspects of risk management, operations, and systems development of a $100 million+ annual revenue global business with a multibillion dollar balance sheet. He also has extensive small business creation experience over a diverse spectrum of industries. He holds a B.A. from Union College.
Dr. Emerich is a neuroscientist with extensive industrial experience in developing drug and cell and gene-based therapies for neurological disorders. He manages the R&D efforts at Gloriana, including the in vivo research and preclinical translation. He is an author of more than 200 peer-reviewed articles and an inventor on 40 patents. He holds a PhD in Neuroscience from Rutger's University.