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Principal Investigator: Nikolai Anton Sopko
Organization: EVINCIS BIO, INC.
Fiscal Year: 2021
Award: $314,913
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
Abstract
Erectile dysfunction (ED) affects about 18 million men in the U.S. and is estimated to affect 322 million men
worldwide by 2025. ED can have a profound negative impact on quality of life and well-being and is often
associated with anxiety and depression. ED also represents a significant economic burden, with over $4 billion
spent in 2017 in the U.S. ED is a common consequence of diseases that affect the microvasculature and nervous
tissue, including common chronic diseases such as hypertension, dyslipidemia, and diabetes, and a frequent
side effect of prostate cancer treatment. Currently available ED treatments are moderately effective at best, have
high discontinuation rates, and address only the symptoms, not the underlying causes. To address the need
for novel treatments for ED, Evincis Bio is developing a regenerative gene therapy based on stromal
cell‐derived factor‐1 (SDF-1) mRNA. SDF-1 is a highly conserved chemokine that regulates an endogenous
repair pathway used by many tissues throughout the body, such as the heart, brain, muscle, and vasculature.
Often upregulated following injury, SDF-1 signaling leads to stem cell migration to the injury site. SDF-1 binds to
its receptor CXCR4 on resident tissues, including nerves, muscle, and vasculature, inducing angiogenesis,
neurogenesis, anti-apoptotic pathways, and upregulating the expression of growth factors. Evincis has
demonstrated that SDF-1 penile injections improve erectile function in a rat model of ED. This
improvement was associated with increased major pelvic ganglion (MPG) neurons, decreased penile fibrosis,
and increased growth factor expression in penile tissues. SDF-1 penile injections were shown to upregulate the
expression of stem cell-associated genes in the MPG and erectile tissue. Evincis has also demonstrated the
feasibility of targeted mRNA-based gene expression in penile tissues. In fact, mRNA technology is being
utilized by several current COVID-19 vaccines. In this Phase I project, Evincis will conduct in vitro and in vivo
dosing, efficacy, and safety studies to support further clinical research. This will be accomplished through the
following specific aims: 1) Screen engineered mRNA candidates in vitro for expression efficiency and cytotoxicity;
2) Determine EVI-200 dosage, expression duration, and safety in vivo; and 3) Perform efficacy and cancer safety
studies in vivo. These studies will support further Phase II work, in which Evincis will expand the preclinical
testing to additional disease states, investigate different nucleic acid carriers, perform pharmacokinetic and
toxicology studies, and initiate the GMP setup necessary to support an IND application and start a Phase I clinical
trial. Evincis will pursue approval as a biologic, resulting in a product J-code and stand-alone reimbursement for
the in-office procedure. If successful, EVI-200 will be the first therapy specifically designed to treat the
underlying causes of ED due to injury of nerve, muscle, and vascular tissue, and potentially provide a
cure for millions of individuals. This project will also serve as a proof-of-concept for EVI-200 as an mRNA-
based regenerative therapy for other conditions, such as urinary incontinence.
Terms: <2019-nCoV vaccine><Address><Adipose tissue><Adrenergic alpha-Antagonists><Adrenergic alpha-Blockers><Adrenergic alpha-Receptor Blockaders><Adrenergic α-Antagonists><Adrenergic α-Blockers><Affect><American><Anxiety><Apoptotic><Artificial Penis><Binding><Biological><Blood Plasma><Blood Platelets><Blood Vessels><Body Tissues><Brain><Brain Nervous System><C-X-C Chemokine Receptor Type 4><CD184 Antigen><COVID-19 vaccine><COVID19 vaccine><CXCL12 protein><CXCR4 Receptors><Cancers><Cardiac Diseases><Cardiac Disorders><Cardiovascular Agents><Cardiovascular Drugs><Cell Communication and Signaling><Cell Signaling><Chemokine (C-X-C Motif) Ligand 12><Chemokine (C-X-C Motif) Receptor 4><Chemokine, CXC Motif, Receptor 4><Chemotactic Cytokines><Chronic Disease><Chronic Illness><Cialis><Clinic><Clinical Research><Clinical Study><Code><Coding System><Common Rat Strains><DNA Therapy><Data><Devices><Diabetes Mellitus><Disease><Disorder><Dose><Drug Interactions><Drug Kinetics><Drugs><Dyslipidemias><Early-Stage Clinical Trials><Economic Burden><Encephalon><Engineering><Erectile dysfunction><Fatty Tissue><Fibrosis><Fusin><Ganglia><Gene Expression><Gene Transfer Clinical><Genes><Genetic Intervention><Growth Agents><Growth Factor><Growth Substances><Heart><Heart Diseases><Homologous Chemotactic Cytokines><Hypertension><In Vitro><Individual><Injection of therapeutic agent><Injections><Injury><Insurance><Intercrines><Intracellular Communication and Signaling><Investigational Drugs><Investigational New Drug Application><Investigational New Drugs><LESTR Receptor><LPS-Associated Protein 3><Leukocyte-Derived Seven-Transmembrane Domain Receptor><Levitra><Lipopolysaccharide-Associated Protein 3><Lytotoxicity><Maintenance><Malignant Neoplasms><Malignant Tumor><Marrow platelet><Medication><Mental Depression><Messenger RNA><Modality><Modeling><Molecular Interaction><Muscle><Muscle Tissue><NO3-><Nerve><Nerve Cells><Nerve Tissue><Nerve Unit><Nervous Tissue><Neural Cell><Neural Ganglion><Neurocyte><Neurons><Neuropeptide Y Receptor Y3><Nitrates><Nucleic Acids><Oral><Pathway interactions><Patients><Pelvic><Pelvic Region><Pelvis><Penile Implant><Penile Prosthesis><Penis Prosthesis><Performance><Personal Satisfaction><Pharmaceutic Preparations><Pharmaceutical Preparations><Pharmacokinetics><Pharmacology><Phase><Phase 1 Clinical Trials><Phase I Clinical Trials><Phosphodiesterases><Plasma><Plasma Serum><Platelets><Porifera><Pre-B Cell Growth Stimulating Factor><Preclinical Testing><Procedures><Progenitor Cells><Prostate CA therapy><Prostate Cancer therapy><Proteins><Proteins Growth Factors><Public Health><QOL><Quality of life><Randomized Controlled Trials><Rat><Rats Mammals><Rattus><Reticuloendothelial System, Serum, Plasma><SARS-CoV-2 vaccine><SARS-CoV2 vaccine><SARS-coronavirus-2 vaccine><SBIR><SDF-1><SDF-1 Receptor><SDF-1alpha><SDF1/PBSF Receptor CXCR4><SIS cytokines><Safety><Sdf1 protein><Series><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 vaccine><Signal Transduction><Signal Transduction Systems><Signaling><Site><Small Business Innovation Research><Small Business Innovation Research Grant><Spleen Seven-Transmembrane-Segment Receptor><Sponges><Standardization><Stromal Cell-Derived Factor 1><Stromal Cell-Derived Factor 1 Receptor><Symptoms><Technology><Thrombocytes><Tissues><Toxicology><Translating><Treatment Protocols><Treatment Regimen><Treatment Schedule><Urinary Incontinence><Vacuum><Vascular Hypertensive Disease><Vascular Hypertensive Disorder><Vasodilating Agent><Vasodilator Agents><Vasodilator Drugs><Vasodilators><Viagra><Work><adipose><alpha adrenergic blockade><alpha antiadrenergic agent><alpha blocker><alpha-Adrenergic Blocking Agents><angiogenesis><base><biological signal transduction><chemoattractant cytokine><chemokine><chronic disorder><clinical infrastructure><corona virus disease 2019 vaccine><coronavirus disease 2019 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