PRONEUROGEN IN THE NEWS & PUBLICATIONS
June 2024 FDA INVESTIGATOR NEW DRUG APPROVAL to begin Phase 1 Single Ascending Dose (SAD) safety studies with PNA5 in healthy adults.
April 2024 Conference Presentation at the 18th Annual Biomarkers and Personalized Medicine in Cardiovascular Disease Symposium. “Biomarkers for the Identification of Vascular Cognitive Impairment in Patients with Heart Failure: A Pilot Study”
March 2024 Submission of Investigator New Drug application to the FDA to begin clinical trials with PNA5 in humans.
October 2023 PRONEUROGEN FOUNDER, DR. MEREDITH HAY AWARDED $7.9MM GRANT FROM NIH NATIONAL INSTITUE ON AGING FOR LONG-TERM TOXICOLOGY STUDIES WITH PNA5 IN 2 SPECIES. ““PNA5: A Novel Mas Receptor Agonist for Treatment of Cognitive Impairment in Patients at Risk for Vascular Dementia and Alzheimer's Disease Related Dementia: an FDA required Toxicology Study”. Support for project period,”
Hoyer-Kimura C, Hay M, Konhilas JP, Morrison HW, Methajit M, Strom J, Polt R, Salcedo V, Fricks JP, Kalya A, Pires PW. PNA5, A Novel Mas Receptor Agonist, Improves Neurovascular and Blood-Brain-Barrier Function in a Mouse Model of Vascular Cognitive Impairment and Dementia. Aging Dis. 2023 Sep 29. doi: 10.14336/AD.2023.0928.
Sulaiman MI, Alabsi W, Szabo L, Hay M, Polt R, Largent-Milnes TM, Vanderah TW. PNA6, a Lactosyl Analogue of Angiotensin-(1-7), Reverses Pain Induced in Murine Models of Inflammation, Chemotherapy-Induced Peripheral Neuropathy, and Metastatic Bone Disease. Int J Mol Sci. 2023 Oct 9;24(19):15007. doi: 10.3390/ijms24191500
BruhnsR., Sulaiman, M., Gaub, M., Bae1, E.L., Davidson Knapp, R. B., Larson, A.R., Smith, A., Coleman, D.L., Staatz, W.D., Sandweiss, A.J., Joseph, B., Hay, M., Largent-Milnes, T.M. and Vanderah, T. Angiotensin-(1-7) improves cognitive function and reduces inflammation in mice following mild traumatic brain injury. Frontiers in Beh. Neuroscience, Aug 4, 2022., doi.org/10.3389/fnbeh.2022.903980.
AAIC Conference Poster Presentation- San Diego, CA- 2022
Angiotensin-(1-7)/Mas Receptor Agonist: A Disease Modifying Therapeutic for Vascular Dementia (VCID) Protects Cognitive Function and Inhibits Serum Neurofilament Light Protein, July 31, 2022.
Circulating Neurodegeneration Biomarkers Neurofilament Light Protein And P-tau181 Are Increased in Individuals with Heart Failure At Risk For Vascular Cognitive Impairment, August 1, 2022.
JULY 2022 - PRONEUROGEN AWARDED $500,000 PHASE 1 SBIR FROM NIH NATIONAL INSTITUTE ON AGING TO DEVELOP EXTENDED RELEASE FORMULATION OF PNA1 AND FOR TREATING VASCULAR DEMENTIA & ALZEIMER’S DISEASE RELATED DEMENTIAS. Project Title: “Scale-up Manufacturing and IND Enabling Studies of Extended-Release Formulation of Mas Receptor Agonist for Treating Vascular Cognitive Impairment and Alzheimer's Disease-Related Dementias”
MARCH 2022 - PUBLICATION. Encinas-Basurto, D., Konhilas, J.P., Polt, R., Hay, M., and Heidi M. Mansour Glycosylated Ang-(1-7) MasR Agonist Peptide Poly Lactic-co-Glycolic Acid (PLGA) Nanoparticles and Microparticles in Cognitive Impairment: Design, Particle Preparation, Physicochemical Characterization, and In Vitro Release., Pharmaceutics. 2022 Mar; 14(3): 587.
OCT 2021 - PUBLICATION. Hoyer-Kimura C, Konhilas JP, Mansour HM, Polt R, Doyle KP, Billheimer D, Hay M. Neurofilament light: a possible prognostic biomarker for treatment of vascular contributions to cognitive impairment and dementia. 2021 Oct 15;18(1):236. doi: 10.1186/s12974-021-02281-1
OCT 2021 - PUBLICATION. Collins KL, Younis US, Tanyaratsrisakul S, Polt R, Hay M, Mansour HM, Ledford JG. Angiotensin-(1-7) Peptide Hormone Reduces Inflammation and Pathogen Burden during Mycoplasma pneumoniae Infection in Mice. Pharmaceutics. 2021 Oct 4;13(10):1614. doi: 10.3390/pharmaceutics13101614
AUG 2021 - PUBLICATION. Alabsi W, Acosta MF, Al-Obeidi FA, Hay M, Polt R, Mansour HM. Synthesis, Physicochemical Characterization, In Vitro 2D/3D Human Cell Culture, and In Vitro Aerosol Dispersion Performance of Advanced Spray Dried and Co-Spray Dried Angiotensin (1-7) Peptide and PNA5 with Trehalose as Microparticles/Nanoparticles for Targeted Respiratory Delivery as Dry Powder Inhalers. Pharmaceutics. 2021 Aug 17;13(8):1278. doi: 10.3390/pharmaceutics13081278.
AUG 2020
PRONEUROGEN AWARDED $500,000 PHASE 1 SBIR FROM NIH NATIONAL INSTITUTE ON AGING TO DEVELOP EXTENDED RELEASE FORMULATION OF PNA1 AND PNA5 FOR TREATING VASCULAR DEMENTIA & ALZEIMER’S DISEASE RELATED DEMENTIAS. “Formulation of a Novel Therapeutic for Treating Cognitive Impairment in Patients at-risk for Alzheimer's Disease-Related Dementias and Vascular Contributions to Cognitive Impairment”
JULY 2020 - PUBLICATION. Christopher R. Apostol, Meredith Hay, and Robin Polt. “Glycopeptide Drugs: A Pharmacological Dimension Between “Small Molecules” and “Biologics”. Peptides. 2020 Jul 13:170369. doi: 10.1016/j.peptides.2020.170369.
APRIL 2020
PRONEUROGEN FOUNDER, DR. MEREDITH HAY AWARDED $5.7 MM GRANT FROM NIH NATIONAL INSTITUE ON AGING TO ADVANCE PNA5 TO CLINICAL TRIALS FOR VASCULAR DEMENTIA AND ALZEIMER’S DISEASE RELATED DEMENTIAS - “IND Enabling Studies for a Novel Mas Receptor Agonist for Treatment of Cognitive Impairment in Patients at Risk for Alzheimer's Disease Related Dementia”
SEPT 2019
PRONEUROGEN AWARDED PHASE 1 SBIR FROM NIH NATIONAL INSTITUTE ON AGING TO ADVANCE NOVEL ALZHEIMER’S THERPAY WITH DR. ROBERTA BRINTON “Novel formulations of Allopregnanolone to treat Alzheimer's Disease”.
JUNE 2019
PRONEUROGEN AWARDED PHASE 1 SBIR FROM NIH NATIONAL INSTITUTE ON AGING TO WORK WITH THE 3M COMPANY TO DEVELOP NOVEL DELIVERY FORMULATION “Microneedle Formulation for Treating Cognitive Impairment in Patients at-risk for Alzheimer's Disease Related Dementia (ADRD) and Vascular Contributions to Cognitive Impairment and Dementia (VCID)”
MAY 2019
PRONEUROGEN FOUNDER, DR. MEREDITH HAY, AND COLLEAGUES PUBLISH NEW REPORT IN THE JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS SHOWING PNA5 AS A NOVEL TREATMENT FOR VASCULAR COGNITIVE IMPAIRMENT.(http://jpet.aspetjournals.org/content/369/1/9).
FEB 2019
PATENT PROTECTION: PRONEUROGEN has been awarded five new patents since January 1, 2019. This brings our total number of US patents to 5 and completes protection of ProNeurogen’s core intellectual property in the US. We presently have a total of 9 patents internationally.
JAN 2019
PRONEUROGEN FOUNDER, DR. MEREDIT HAY, AND COLLEAGUES AWARDED NEW USPTO PATENT 10,72,908. THE INVENTION PROVIDES A METHOD FOR USING A COMPOSITION COMPRISING AN ANGTIOTENSIN-(1-7) RECEPTOR AGONIST TO TREAT COGNITIVE DSYFUNCTION OR IMPAIRMENT DUE TO INCREASES IN INFLAMMATION, CYTOKINE PRODUCTION AND BRAIN INFLAMMATION.
NOV 2018, SOCEITY FOR NEUROSCIENCE PRESENTATION
Streicher, J., Falk, T., Hay, M., Apostol, C.R., Bartlett, M.J., Heien, M. L., Molnar, G., Liu, C., Smith, C. L, Szabo, L., and R. Polt. Glycopeptides as Systemically Delivered CNS Active Drugs from Endogenous Peptide Hormones., Soc. for Neuroscience, 2018.
JULY 2018, BOULDER PEPTIDE CONFERENCE PRESENTATION
Hay, M. Novel Ang-(1-7) Derivatives for Treating Cognitive Impairment and Pain, Boulder Peptide Conference, 2018.
MAR 2018
UNIVERSITY OF ARIZONA PHARMACOLOGY HEAD DR. TODD VANDERAH AND PRONEUROGEN FOUNDER DR. MEREDITH HAY AWARDED $730 THOUSAND, 3-YEAR GRANT FROM ARIZONA DEPARTMENT OF HEALTH TO ADVANCE PRONEUROGEN PEPTIDES PNA5 AND PNA6 TO TREAT NEUROPATHIC AND CANCER PAIN.
DEC 2017
THE JAPAN PATENT OFFICE AWARDS NEW PATENT TO DRS. HAY, KONHILAS AND BARNES FOR THE USE OF ANG-(1-7) TO TREAT COGNITIVE IMPAIRMENT CAUSED BY INFLAMMATORY DISEASE, JAPAN 6254692. THE PATENT IS LICENSED EXCLUSIVELY TO PRONEUROGEN.
OCT 2017
THE U.S. PATENT AND TRADEMARK OFFICE HAS AWARDED TWO PATENTS TO THE UA BASED ON THE TEAM’S NOVEL APPROACH TO TREATING DISEASES CAUSING MEMORY LOSS AND COGNITIVE IMPAIRMENT. U.S. PATENT 9,670,251 WAS AWARDED JUNE 6 AND U.S. PATENT 9,796,759 WAS AWARDED OCT. 24. THE PATENTS, BOTH LICENSED TO PRONEUROGEN, SERVE AS THE CORNERSTONE FOR PRONEUROGEN’S DRUG DEVELOPMENT PROGRAM.
http://deptmedicine.arizona.edu/news/2017/ua-startup-proneurogen-advances-new-therapies-vascular-dementia-announces-award-patents
SEP 2017
PRONEUROGEN FOUNDER, DR MEREDITH HAY, AND UNIVERSITY OF ARIZONA RESEARCHERS BEGIN ENROLLMENT IN PHASE 2 TRIAL FOR PATIENTS AT RISK FOR COGNITIVE IMPAIRMENT FOLLOWING CARDIAC BYPASS SURGERY. https://uanews.arizona.edu/story/ua-team-tackles-better-brain-health
https://www.youtube.com/watch?v=zR7Vn9nECps&feature=youtu.be
MAR 2017
UNIVERSITY OF ARIZONA AWARDED $2.8 MILLION, 4-YEAR GRANT FROM NIH FOR PHASE 2a CLINICAL TRAIL FOR COGNITION. ProNeurogen president, Dr Meredith Hay, University of Arizona Sarver Heart Center Director, Dr Nancy Sweitzer, and University of Arizona Head of Department of Psychology, Dr Lee Ryan, awarded a $2.8 million NHLBI grant to studyefficacy of PNA1 to treat cognitive impairment in cardiac bypass patients.
JAN 2017
PRONEROGEN PRESIDENT, DR MEREDITH HAY AND UA TEAM PUBLISHES MEMORY ENHANCING EFFECTS OF ANG-(1-7) IN PRECLINICAL MODEL OF VASCULAR DEMENTIA https://www.ncbi.nlm.nih.gov/pubmed/28054808 Patients with congestive heart failure (CHF) have increased hospital readmission rates and mortality if they are concomitantly diagnosed with cognitive decline and memory loss. Results of the work demonstrate that CHF-induced cognitive impairment is attenuated by treatment with systemic Ang-(1-7).
DEC 2016
PRONEUROGEN ADVISORY BOARD MEMBER, DR TODD VANDERAH PUBLISHES PAPER ON THE NOVEL EFFECTS OF ANG-(1-7) TO INHIBIT BONE-CANCER PAIN. http://journals.lww.com/pain/Fulltext/2016/12000/Angiotensin__1_7__Mas_receptor_as_an.11.aspx. Cancer-induced bone pain is often severe because of enhanced inflammation, rapid bone degradation, and rapid disease progression. Data from this study suggest that Ang-(1-7)/MasR activation significantly attenuates CIBP, while lacking many side effects seen with opioids. Thus, Ang-(1-7) may be an alternative therapeutic strategy for the nearly 90% of patients with advanced-stage cancer who experience excruciating pain.
APRIL 2016
PRONEUROGEN AND UA SCIENTISTS BEGIN PHASE IIA ENROLLMNET FOR TREATMENT OF HEART FAILURE INDUCED COGNITIVE IMPAIRMENT
FEB 2016
PRONEUROGEN NAMES GILLIAN THACKRAY AND ELIZABETH HOCKING TO BOARD OF DIRECTORS
DEC 2015
PRONEUROGEN AND UA SCIENTISTS COMPLETE PRECLINICAL TESTING OF SECOND GENERATION NOVEL NEUROPEPTIDE. In an article published in Spectroscopy Conference, 2016, ProNeurogen’s second generation peptides show significantly improved serum half-lives and improved blood-brain-barrier penetration. The second generation peptides show improved efficacy in reversing inflammation/heart failure induced cognitive impairment in animal models of heart failure. In addition, these peptides are shown to reduce reactive oxygen formation and improves inflammatory profile in heart failure model.
SEPT 2015
PRONEUROGEN NEUROPROTECTIVE PEPTIDE IND APPLICATION FOR PNA1 GETS GO-AHEAD FROM FDA FOR PHASE II STUDY IN CARDIAC BYPASS PATIENTS.
AUG 2015
PRONEUROGEN SIGNS EXCLUSIVE LICENSE WITH THE UNIVERSITY OF ARIZONA FOR PROPRIETARY TECHNOLOGY RELATING TO THE USE OF ANG (1-7) AND NOVEL DERIVATIVES DOR TREATMENT OF INFLAMMATION RELATED BRAIN DISORDERS.
JUN 2015
PRONEUROGEN AND UA SCIENTISTS AWARDED ARIZONA ALZHEIMER’S CONSORTIUM AWARD
NOV 2014
PRONEUROGEN OBTAINS PRECLINICAL DATA ON NOVEL NEUROPROTECTIVE PEPTIDES
Patients with congestive heart failure (CHF) have a much higher probability of mortality if they are concomitantly diagnosed with cognitive decline and memory loss. Furthermore, these patients have hospital readmission rates ranging from 40 to 50% within 6 months that are due, in part, to patient non- compliance with therapy as a result of cognitive impairment. Dr. Hay and colleagues have developed a small peptide that reversed cognitive impairment in an animal model of congestive heart failure.
OCT 2013
NATIONAL HEART LUNG AND BLOOD- SMARTT PROGRAM AWARD TO PRONEUROGEN FOUNDER
Dr. Meredith Hay has been awarded support from the NHLBI SMARTT program for IND development of a novel peptide therapeutic to treat cognitive impairment in cardiac bypass surgery patients.