SALWA A. ELGEBALY, M.Sc., Ph.D.
Curriculum Vitae

Current Position:
2006 - Present

Founder & CEO
Nour Heart, Inc.
Established in Hartford, Connecticut
United States of America
Cell: 860-680-8860
E-mail: selgebaly@nourheart.com

Personal Statement:

My research focus is on myocardial ischemia defined as reduction of blood flow to heart muscle (myocardium) due to a partial or complete blockage of one or more coronary arteries. Ischemic heart disease (IHD) is characterized by the presence of myocardial ischemia in patients with coronary artery disease (CAD), unstable angina (UA), acute myocardial infarction (AMI) (heart attack), and heart failure (HF).

Nour Heart is developing and commercializing diagnostic and therapeutic products for the early detection, prevention, and treatment of myocardial ischemia in patients with ischemic heart disease. Currently we are developing and commercializing for human use our innovative and patented technologies related to:


1. Novel Diagnostic Blood-Based Test:

Nourin®miRNAs: Novel Molecular Biomarkers for Early Identification or Exclusion of Myocardial Ischemia in Women Suspected of Having Coronary Artery Disease (CAD)

Heart disease is the number one cause of death worldwide, and women, at all ages, have higher disease mortality rates than that of men. Nour Heart’s blood-based biomarkers, Nourin protein and its regulatory miRNAs are elevated in the setting of myocardial ischemia before it progresses to infarction. Assessment of Nourin® miRNAs enables the rapid identification of a population of patients with ischemia, but without injury or infarction, and exclusion of myocardial ischemia, thus potentially improving the treatment algorithms for women.


2. Novel Bioenergetic Preventive Therapy:

Cyclocreatine Phosphate (CCrP): A Novel Therapy to Protect Hearts Against Ischemic Injury and Retore Cardiac Function.

The cardioprotective drug, Cyclocreatine Phosphate (CCrP) (Nourexal™) is an FDA Orphan Designated Drug for heart transplantation (DRU-2015-4951). It is a New Paradigm that restores cellular energy (adenosine triphosphate (ATP)) despite hypoxia/ischemia. As a bioenergetic drug, CCrP protects hearts against ischemic injury and restores cardiac function during reperfusion. Clinical applications include, end-stage heart failure patients scheduled for heart transplantation procedure, patients undergoing high-risk cardiac surgery and high-risk intervention cardiology.

Professional Expertise:
A. Overall Summary:
  • Dr. Elgebaly’s unique experience in academia, clinical trials in investigative sites, and pharmaceutical industry includes: 1) academic drug discovery and development at the University of Connecticut School of Medicine, 2) established two new Clinical Trials and Research Centers in Connecticut (Grove Hill Medical Center and Connecticut Multispecialty Group) and functioned as the Director of the Centers to oversee all FDA-regulated Phase II and Phase III clinical trials in local and international investigative sites, 3) established one new Clinical Trials and Research Center at University of Alexandria Faculty of Medicine, Alexandria, Egypt, and 4) functioned as the Director of Clinical Affairs in a Maryland-based pharmaceutical Company, AnGes Inc. which included FDA filing for drug registration for human use.
  • Wrote a Review Article: Elgebaly SA, et al.: Cyclocreatine Protects Against Ischemic Injury and Enhances Cardiac Recovery During Early Reperfusion. Expert Review of Cardiovascular Therapy, Volume 17(9), 683-697, 2019.
  • Presented three abstracts about Nourin & Cyclocreatine Phosphate in the 2020 American Heart Association: https://www.ahajournals.org/doi/10.1161/circ.142.suppl_3.13103, https://www.ahajournals.org/doi/10.1161/circ.142.suppl_3.13051 , https://www.ahajournals.org/doi/10.1161/circ.142.suppl_3.13311
  • Dr. Elgebaly is also a frequent lecturer in international conferences on the subject of Nourin, Cyclosporin H, and Cyclocreatine Phosphate. Specifically, Dr. Elgebaly was invited to present her work by:
    • Nobel Prize Winner in Medicine, Professor Sir John Vane, London, UK,
    • Nobel Prize Winner in Medicine, Professor R. Levi Montalcini, Rome, Italy,
    • Professor Sir Magdy Yacoub in London, United Kingdom.
B. Academic & Industrial Experience:
  • Research & Development for heart-related diagnostic and therapeutic products.
  • Dr. Elgebaly’s research resulted in the discovery of the potent tissue-derived inflammatory mediator, Nourin and its antagonists Cyclosporin H (anti-inflammatory) and the cardioprotective Cyclocreatine (anti-inflammatory & anti-apoptotic). Cyclosporine H (Nourexin) is a potent anti-inflammatory drug against influenza flu-induced acute and chronic inflammation.
  • Clinical trials in pharmaceutical setup and investigative sites (patients).
  • FDA requirements for product submission for approval.
  • Participant, FDA-Sponsored Cardiac Safety Research Consortium
  • Dr. Elgebaly has been awarded millions of dollars to support her research from such organizations as the National Institute of Health (NIH), academic institution such the University of Connecticut School of Medicine, as well as the Maryland Technology Development Cooperation, several pharmaceutical companies, corporate competitive awards and private funding.
C. Product Commercialization:
  • Cyclocreatine Phosphate and FDA Orphan Drug Designation
  • Nour Heart was granted the Orphan Drug Designation (ODD) by U.S. Food and Drug Administration for its new patented drug Cyclocreatine Phosphate for the unique designation of: prevention of ischemic injury to enhance cardiac graft recovery and survival in heart transplantation (DRU-2015-4951) (also see attachment A below).

  • Cardiac Nourin Blood Test
  • Nourin is a potent inflammatory mediator rapidly released within minutes by ischemic and necrotic myocardium. Nourin can diagnose unstable angina (UA) patients presenting with chest pain to Emergency Department (ED). Currently, Nour Heart is developing the Nourin test to quickly rule in or out symptomatic patients with unstable angina at presentation to emergency department (EDs), as well as patients suspected of having coronary artery disease.

D. Clinical Research and Clinical Trial Expertise:

Dr. Elgebaly has extensive experience in conducting FDA-regulated drug tested Phase II and Phase III clinical trials (also see details in attachment B below), pharmaceutical industry (Director of Clinical Affairs), as well as FDA filing for drug registration for human use. Dr. Elgebaly previously held the position of Director of Clinical Affairs in the pharmaceutical company, AnGes Inc. in Maryland, and she established in Connecticut and functioned as the Director of the two new Clinical Trials and Research Centers at the Investigative Sites; Grove Hill Medical Center and Connecticut Multispecialty Group. She successfully managed over 26 clinical studies and worked closely with over 80 physicians and surgeons. Furthermore, because of Dr. Elgebaly’s Nourin technology as a novel early biomarker for cardiac patients, she is an active participant with the FDA-sponsored Cardiac Safety Research Consortium-CSRC. Currently, Dr. Elgebaly functions as a Volunteer Official Consultant/Expert for the Egyptian Parliament for their efforts to establish the new Clinical Trials Law and the new Law to Govern Animal Facilities and Animal Use in Research.

Education:

1979
Ph.D. in Medicinal Chemistry (Oncology) University of North Carolina, Chapel Hill School of Pharmacy Department of Medicinal Chemistry Chapel Hill, North Carolina, USA

1975
MS in Oncology University of Wisconsin, Madison School of Medicine, Oncology Department Madison, Wisconsin, USA

1973
B.Sc. in Pharmacy with Honors University of Alexandria, Alexandria School of Pharmacy, Alexandria, Egypt.

Postgraduate Training:

2006
Completed an extensive course on “Study Monitoring & Auditing According to FDA and International Guidelines”. Society of Clinical Research Associates (SOCRA).

1998
Completed an extensive course on “Drug Development & FDA Regulations” Society of Clinical Research Associates (SOCRA).

1979-1981
Postdoctoral Fellow Department of Pathology University of Connecticut School of Medicine Farmington, CT 06030

Appointments:

2006 - Present
Founder & CEO Nour Heart, Inc. Nour Heart is a Biomedical Company that holds the US-issued patents and pending patent applications for the tissue-derived inflammatory mediator Nourin and its antagonists Cyclosporin H (anti-inflammatory) and Cyclocreatine Phosphate (anti-apoptotic). Nour Heart is developing diagnostic and therapeutic products for patients with ischemic heart disease.

2019 – 2021
Visiting Prof., University of Alexandria Faculty of Pharmacy, Alexandria, Egypt.

2007 - 2012
Adjunct Assistant Professor United States Naval Academy Annapolis, Maryland

2003-2006
Director, Nourin Preclinical and Clinical Development Program Inverness Medical Innovations Boston, MA

2002 – 2003
Director, Clinical Affairs AnGes, Inc. 9210 Corporate Boulevard, Suite 130 Gaithersburg, MD 20850

2000 – 2002
Director, Clinical Trials & Research Connecticut Multispecialty Group Hartford, CT

1998-2000
Founder and Director, Clinical Trials & Research Grove Hill Medical Center 300 Kensington Ave, New Britain, CT

1992-1997
Associate Professor Department of Surgery, University of Connecticut School of Medicine and Hartford Hospital and Farmington, CT 06030

1985-1992
Assistant Professor Department of Surgery, University of Connecticut School of Medicine, Farmington, CT 06030

1987-1988
Director, Surgical Research Center Department of Surgery, University of Connecticut School of Medicine Farmington, CT 06030

1980-1985
Instructor Department of Surgery, University of Connecticut School of Medicine, Farmington, CT 06030

1979-1980
Postdoc Department of Pathology, University of Connecticut School of Medicine, Farmington, CT 06030

Teaching Activities:

1986 – 1992
Assistant and Associate Professor Department of Surgery University of Connecticut School of Medicine, Farmington, CT Medical Students and Post-Doctoral Fellows Topic: Inflammation and Tissue Injury

Management & Research Funding:

Dr. Elgebaly managed her own laboratory as a Principal Investigator at the University of Connecticut School of Medicine. During that period, Dr. Elgebaly, supervised over 40 employees, including surgical residents, cardiology fellows, postdoctoral fellows, medical and graduate students, college and high school students, and a number of technicians.

Dr. Elgebaly responsibilities involved supervising the overall directions of various projects, writing grants and scientific articles, presenting scientific results in various conferences, and managing various funds. As a Director of Clinical Trials & Research at Grove Hill Medical Center and Connecticut Multispecialty, Dr. Elgebaly established the two Clinical Trials & Research departments and successfully managed over 26 clinical studies and worked closely with over 80 physicians and surgeons.

Dr. Elgebaly has been awarded millions of dollars to support her research from such organizations as the National Institute of Health (NIH), academic institution such the University of Connecticut School of Medicine, as well as the Maryland Technology Development Cooperation, several pharmaceutical companies, corporate competitive awards and private funding. For the past 7 years, Nour Heart funded all R&D work.

Honors and Awards:

2019
Marquis Who’s Who

2007-2010
Received an Award from Women in Bio, Maryland

1998
Selected for inclusion in Who’s Who in American Inventors

1985
Selected for inclusion in World Who’s Who of Women

1979-1980
Postdoctoral Fellowship, Farmington, CT

1976-1979
Predoctoral Fellowship, Chapel Hill, NC

1973-1975
Predoctoral Fellowship, Madison, Wisconsin

1973
B.Sc. in Pharmacy with Honors from University of Alexandria, Egypt

Memberships

1992-present
Member, American Heart Association (AHA)

2012-present
Member/Participant FDA-Sponsored Cardiac Safety Research Consortium, Duke, NC.

2021-present
Member, Women in Bio-Founders

Professional Accomplishments

2021-present
FDA Orphan Drug Designation-Cyclocreatine Phosphate (Cardioprotective) (DRU-2015-4951)

2005 – Present
Established a new Clinical Trials Center at the University of Alexandria, Faculty of Medicine, Alexandria, Egypt. Currently, I am a volunteer consultant.

2006 - Present
Scientific Reviewer - Bibliotheca Alexandrina Research Grants and Special Projects Alexandria, Egypt.

2012 – 2016
Governor’s Commission on Middle Eastern American Affairs, Maryland. Conference Chair, Middle Eastern American Women: Realities & Perceptions - May 5, 2013.

2010 – 2012
Commissioner for Women, Anne Arundel County, Maryland. Conference Chair, Unveiling the Mystique about the American Muslim Women - October 22, 2011.

2004 – 2007
Vice Chair, the Baltimore-Luxor-Alexandria Sister City Committee (BLASCC), Baltimore, Maryland.

2003
Received the 2002 - 2003 Award from the National Council for Jewish Women entitled “Women Who Dare To Make A Difference” in Hartford, Connecticut. Only 12 women were selected from the entire State of Connecticut.

2000
Nominated for the “Walter Cronkite Faith and Freedom Award” By Congressman Rob Simmons of Connecticut.

2000 – 2002
Founding President, ANSAR’s For Kids (non-profit organization for Bosnian Children) Hartford, Connecticut.

2000 – 2001
Co-Chair, Hartford Prayer Breakfast.

Patents Issued from U.S. Patent Office, Washington DC:

1. Elgebaly SA: Nourin Molecular Biomarkers Diagnose Angina Patients with Negative Troponin (# 16719723).

2. Elgebaly Salwa Ahmed and Marwa Matboli Sayed: A Novel Autophagy-Related Nourin Gene- Based RNA Network as Early Biomarkers for Cardiac Patients (# 10895572).

3. Elgebaly SA, Elliott Schiffmann & Tamer Elbayoumi: Nourexin-4 Nano-Lipid Emulsions (US #8,333,987).

4. Elgebaly SA and Elliott Schiffmann: Methods to Prevent & Treat Diseases (# 8,288,350).

5. Farghaly A and Elgebaly SA: Phosphagen Synthesis (# 7,964,736).

6. Elgebaly SA and Elliott Schiffmann: Mitochondrial Marker of Ischemia – (#7,662,571).

7. Elgebaly SA: Diagnostic Marker (#7,659,091).

8. Elgebaly SA: Antibodies to a Neutrophil Chemotactic Protein (#5,606,027).

9. Elgebaly SA: Diagnostic Test Procedure for Urinary Tract Inflammatory Condition (US #5,318,891).

10. Elgebaly SA: Methods for Restoring Functionality in Muscle Tissue (#5,091,404).

11. Elgebaly SA: Biological Mediators of Immune Function (#5,403,914).

Trademark Accepted and Pending Application from USPTO, Washington DC:

Accepted Application:
NOTICE OF ACCEPTANCE OF STATEMENT OF USE U.S. Serial Number: 88-768,088 Mark: NOURIN Owner: Nour Heart, Inc. Docket/Reference Number: TTA54611


Pending Application:
Nourexal: Cyclocreatine Phosphate


Selected Publications:
PEER REVIEWED JOURNAL ARTICLES

Dr. Elgebaly’s publications appeared in prestigious journals such as:

  • Science
  • J Thorac and Cardiovascular Surgery
  • Ann Thorac Surg
  • J Transplantation
  • J Urology
  • J Pathology
  • J Molecular and Cellular Cardiology
  • J Pharmacology Experimental Therapy
  • J Pharmaceutical Science
  • J Expert Review of Cardiovascular Therapy
  • J National Cancer Institute
  • Current Eye Research
  • Oncology
  • Biomolecules
  • Diagnostics
  • Int. J. of Molecular Science.

  1. Elgebaly, S.A.; Todd, R.; Kreutzer, D.; Christenson, R.; El-Khazragy, N.; Arafa, R.; Rabie, M.; Mohamed, A.; Ahmed, L.; El Sayed, N. Nourin-Associated miRNAs: Novel Inflammatory Monitoring Markers for Cyclocreatine Phosphate Therapy in Heart Failure. Int J Mol Sci. 2021 Apr; 22(7): 3575.
  2. Elgebaly, S.A.; Christenson, R.; Kandil, H.; El-Khazragy, N.; Rashed, L.; Yacoub, B.; Eldeeb, H.; Ali, M.; Sharafieh, R.; Klueh, U.; and Kreutzer DL. Nourin-Dependent miR-137 and miR-106b: Novel Early Inflammatory Diagnostic Biomarkers for Unstable Angina Patients. “Special Issue: Molecular Biomarkers in Cardiology”, Biomolecules. 2021 Mar; 11(3): 368.
  3. Elgebaly, S.A.; Christenson, R.; Kandil, H.; Rizk, H; El-Khazragy, N.; Rashed, L.; and Kreutzer DL. Nourin-Dependent miR-137 and miR-106b: Novel Biomarkers for Early Diagnosis of Myocardial Ischemia in Coronary Artery Disease Patients. Diagnostics. 2021 Apr; 11(4): 703.
  4. Ibrahim F. Abo-Elmagd, Amr M. Mahmoud, Medhat A. Al-Ghobashy, Marianne Nebsen, Nesrine S. El Sayed, Shahira Nofal, Sameh H. Soror, Todd R., Elgebaly, S.A. Impedimetric Sensor for Cyclocreatine Phosphate Determination in plasma Based on Electropolymerized Poly(o-phenylenediamine) Molecularly Imprinted Polymer. ACS Omega. 2021 Nov 23; 6(46): 31282–31291.
  5. Elgebaly SA, Poston R, Todd R, Helmy T, Almaghraby A, Elbayoumi T, Kreutzer DL. 2019: Cyclocreatine Protects Against Ischemic Injury and Enhances Cardiac Recovery During Early Reperfusion. Expert Review of Cardiovascular Therapy, 17:9, 683-697, (

    REVIEW

    ).
  6. Elgebaly SA, Elbayoumi T and Kreutzer DL. Cyclosporin H: A Novel Anti-inflammatory Therapy for Influenza Flu Patients. Journal of the Egypt. Soc. of Parasitol.: 2017 Apr;47(1):25-33.
  7. Christenson R, Elgebaly SA: Nourin-1: The "Holy Grail" for Assessing Myocardial Ischemia. ADVANCE 16 (1), 19-21, 2004.
  8. Houser SL, El-Kerm AF, Wei A, Doyle K, Houser D, Tyles E, Kaddurah-Daouk R and Elgebaly SA: Enhancement of cardiac function by cyclocreatine in models of cardiopulmonary bypass. J Mol Cell Cardiol. Volume 27, Issue 4, April 1995, Pages 1065-1073.
  9. Elgebaly SA, Houser SL, El-Kerm AF, Doyle K, Gillies C and Dalecki K: Evidence of cardiac inflammation after open heart surgery. Ann Thorac Surg. 1994 Feb;57(2):391-6.
  10. Elgebaly SA, Wei Z, Tyles E, El-Kerm AF, Houser SL, Gillies C and Kaddurah-Daouk R: Enhancement of the recovery of rat hearts after prolonged cold storage by cyclocreatine phosphate. J. Transplantation. 1994 Mar 27;57(6):803-6.
  11. Elgebaly SA, Miano D, Ehler W, Rahhal F and El-Kerm A: The induction of anterior chamber inflammation by factors releaseed from hydrogen peroxide-injured corneas: effect of dexamethasone and indomethacin. Ocular Pharmacol. Spring 1994;10(1):295-306.
  12. Shames NBK, Reddy DV, Watanabe K, Elgebaly SA, Hanninen LA and Kenyon KR: Increased Interleukin-1 activity in the injured Vitamin A-deficient cornea. Cornea. 1994;13(2):156-166.
  13. Elgebaly SA, Hashmi F, Houser S, Allam ME, Doyle K. Cardiac-derived neutrophil chemotactic factors: detection in coronary sinus effluents of patients undergoing myocardial revascularization. J Thorac Cardiovasc Surg. 1992;103(5): 952–959.
  14. Elgebaly SA, Allam ME, Houser S, Hashmi F, Forouhar F and Miano D: Cyclocretaine inhibits neutrophil accumulation in the myocardium of a canine model of coronary artery occlusion and reperfusion. J Pharmacol Exp Therap. 1993; 266(3):1670-1677.
  15. Elgebaly SA, Gillies C, Shimizu RW, Anger CB, Spencer JA, Buchen SY: Effects of visoelastic solutions on neutrophil function and the release of neutrophil chemotactic factors from isolated bovine corneas. Cornea. 1993;3(2):28-34.
  16. Elgebaly SA, Allam ME, Walzak MP and Oselinksy D: Urinary neutrophil chemotactic factors in interstitial cystitis patients and a rabbit model of bladder inflammation. J Urol. 1991;147:206-211.
  17. Elgebaly SA, Donshik P, Rahhal F and Williams W: The detection of neutrophil chemotactic factors in tears of giant papillary conjunctivitis patients: role of conjunctival tissue. Invest Ophthalmol Vis Sci. 1991;32:208-213.
  18. Ehlers W, Williams W and *Elgebaly SA: Conjunctiva-derived neutrophil chemotactic factors: preliminary biochemical characterization. CLAO J. 1991;17:65-68.
  19. Elgebaly SA, Allam ME, Rossomando EF, Forouhar F, Farghaly A and Kreutzer DL: Cyclocreatine inhibits the production of neutrophil chemotactic factors from isolated hearts. Am J Pathol. 1990;137: 1233-1241.
  20. Kozol RA, Punzo A, Ribaudo R, Rossomando EF and Elgebaly SA: Neutrophil chemotactic activity in gastric secretions. Arch Surg. 1990;125(4):454-456.
  21. Ruby ST, Allam M, Gallo M, Barth S and Elgebaly SA: Release of chemotactic factors by veins during preparation for arterial bypass. Arch Surg. 1990;125(4):481-485.
  22. Riley M and Elgebaly SA: Release of a neutrophil chemotactic factor from UV-irradiated rabbit corneas. Curr Eye Res. 1990;9(7):677-682.
  23. Elgebaly SA, Miano D, Fishman J and Kreutzer DL: Cornea-derived neutrophil chemotactic factors: intracellular synthesis and release. Curr Eye Res. 1990;9(9):839-845.
  24. Elgebaly SA, Masetti P, Allam M and Forouhar F: Cardiac-derived neutrophil chemotactic factors: preliminary biochemical characterization. J Mol Cell Cardiol. 1989;21:585-593.
  25. Kozol RA, Downes RA, Kreutzer DL, Wentzel S, Rossomando FF and Elgebaly SA: Release of neutrophil chemotactic factors from gastric tissue: initial biochemical characterization. Dig Dis Sci. 1989;34:68-687.
  26. Elgebaly SA, Herkert N, O’Rourke J and Kreutzer DL: Characterization of neutrophil and monocyte-specific chemotactic factors derived from isolated corneas in response to immunologic injury. Am J Pathol. 126:22-32, 1987.
  27. Kozol RA, Gillies C, Elgebaly SA: Effects of Sodium Hypochlorite (Dakin's Solution) on Cells of the Wound Module. Arch Surg. 1988;123(4):420-423.
  28. Elgebaly SA, Downes R, O’Rourke J and Kreutzer DL: Characterization of inflammatory mediators such as leukocyte chemotactic factors produced by isolated corneas in response to alkali injury. Curr Eye Res. 1987; 6:1263-1274.
  29. Elgebaly SA, Barton R and Forouhar F: Reversal of radiation-induced leukemogenesis in mice by immunomodulation with thiabendazole and dinitrofluourbenzene. J Natl Cancer Inst. 1985;74(4):811-815.
  30. Elgebaly SA, Gillies C, Forouhar F, Hashem M, Baddour M, O’Rourke J and Kreutzer DL: An in vitro model of leukocyte-mediated injury to the corneal epithelium. Curr Eye Res. 1985,4(1):31-41.
  31. Elgebaly SA, Herkert N, Gillies CC, Picciano PT, Donaldson MC, Kreutzer DL. Influence of anti-endothelial cell antibodies on the interactions of leukocytes with vascular endothelial cells in vitro. J Exp Pathol. Spring1985;2(1):59-73.
  32. Elgebaly SA, Forouhar F and Dore-Duffy P: Thiabendazole-induced suppression of renal damage in a murine model of autoimmune disease. Am J Pathol. 1984;115:204-211.
  33. Elgebaly SA, Forouhar F, Gillies C, O’Rourke J and Kreutzer DL: Leukocyte-mediated injury to corneal endothelial cells: a model of tissue injury. Am J Pathol. 1984;116(3):407-416.
  34. Elgebaly SA, Varani J, Kunkel SL and Ward PA: Cyclic AMP levels in subpopulations of tumor cells: correlation with in vitro and in vivo behavior. Oncology. 1982;39:163-166.
  35. Varani J, Lovett EJ III, Elgebaly SA and Lundy J: In vitro and in vivo adherence of tumor variants correlated with malignant potential. Am J Pathol. 1980;111:345-353.
  36. Elgebaly SA, Hall IH, Lee KH, Sumida Y, Imakura Y and Wu RY: Antitumor agent XXVI: effect of brutasol, bruceoside A and bruceantin on P-388 lymphocytic leukemia cell respiration. J Pharm Sci. 1979; 68(7):888-890.
  37. Lee KH, Hall IH, Mar EC, Starnes CO, Elgebaly SA, Waddel TG, Hadgraft RI, Ruffner EG and Weidner I: Sesquiterpene anti-tumor agents: inhibitors of cellular metabolism. Science. 1977;196:533-536.


BOOK CHAPTERS

1. Elgebaly SA, Kozol RA and Kreutzer DL: Alcohol and immune system: role of gastric tissue. In: Alcohol Immunomodulation and AIDS Proceedings (Pawlowski A, Seminara D, Watson R, eds). Symposium on indirect mechanisms of immune modulation. AR Liss, Inc.: New York, Vol.325, 1989.pp 75-78.

2. Kozol RA and Elgebaly SA: Ethanol and its effect on mucosal immunity. In: Drugs of Abuse and Immune Function (Watson R, ed). CRC Press: Colorado, 1989.pp 165-173.


ORAL PRESENTATIONS - PEER-REVIEWED SUBMISSIONS
Scientific Conferences Include:
  • American Heart Association (Circulation J)
  • American Association of Immunologists (J. Immunology)
  • American College of Surgeons (Surgical Forum)
  • Society for Cardiovascular Angiography & Intervenions (Catheterization & Cardiovascular Interventions)
  • American Society of Transplant Surgeons
  • Association for Research in Vision and Ophthalmology (Invest Ophthalmology Visual Science)
  • International Society for Heart Research (J Mol Cell Cardiol.)
  • World Congress of the International College of Surgeons
  • European Cardiology Conference (J Clin. Exp. Cardiology)
  • Global Summit on Heart Diseases and Therapeutics (J Clin. Exp. Cardiology).

  1. Elgebaly, S.A.; Christenson, R.H.; Kandil, H.; El-Khazragy, N.; Rashed, L.; Yacoub, B.; Sharafieh, R.;  Klueh, U.; Kreutzer, D.L. Abstract 13051: Nourin-dependent Mirna-137: A Novel Early Diagnostic Biomarker for Unstable Angina Patients. Circulation. Virtual Meeting – 17 Nov 2020.142:A13051.
  2. Elgebaly, S.A.; Christenson, R.H.; Kandil, H.; ElKhazragy, N.; Rashed, L.; Yacoub, B.; Sharafieh, R.;Klueh, U.; Kreutzer, D.L. Abstract 13103: Nourin-dependent Mirna-106b: A Novel Early Inflammatory Diagnostic Biomarker for Cardiac Injury. Circulation. Virtual Meeting – 17 Nov 2020.142:A13103.
  3. Elgebaly, S.A.; Van Buren, C.; Todd, R.; Poston, R.; Rabie, M.A.; Mohamed, A.F.; Ahmed, L.A.; El Sayed, N.S. Cyclocreatine Phosphate: A Novel Mechanism for Preventing Development of Heart Failure. Circulation. Virtual Meeting – 17 Nov 2020.142:A13311.
  4. Elgebaly SA. Nourexal: A Novel Anti-inflammatory / Antiapoptotic Therapy Against Reperfusion Injury. Heart Diseases and Therapeutics. J Clin. Exp. Cardiology. Chicago, IL. October 2016. Vol. 7(9),33.
  5. Elgebaly SA. Nourexal (Cyclocreatine Phosphate): A New Cardioprotective Therapy Against Reperfusion Injury. Heart Diseases and Therapeutics. J Clin. Exp. Cardiology. Madrid, Spain. December 2016.Vol. 7(11),19-20.
  6. Elgebaly SA, Elliott Schiffmann, Ahmed Farghaly, Tamer Elbayoumi, Donald Kreutzer, Cyclocreatine Phosphate is an Effective Cardioprotective Agent against Ischemic Injury. Catheterization & Cardiovascular Interventions. Los Vegas, Nevada. May 2014.84:S1-S2.
  7. Elgebaly SA, Christenson R, Schiffmann E, Qiao Yi. and Kreutzer DL. Early Identification of Cardiac Ischemia Patients in the Emergency Department. Catheterization & Cardiovascular Interventions. Orlando, Florida. May 2013.81:S2-S3.
  8. Elgebaly SA, Daniel Perez, Kathleen Sullivan, Craig Whitaker, Stephanie Caspe, Qiao Yi, and Donald L. Kreutzer. Nourexin-4: A Novel Anti-inflammatory Therapy for Influenza Flu. of Immunology. Baltimore, Maryland. April 2010.184 (1 Supplement) 52.1.
  9. Elgebaly SA and Kreutzer DL: Release of a potent inflammatory mediator from ischemic brain. 27th International Stroke Conference. American Heart Association, San Antonio, Texas, February 2002.
  10. Tyles E, Houser SL, Shams NK, Consoli KA and Elgebaly SA: Nourin-1 stimulates the secretion of cytokines by neutrophils:  Inhibition by Anti-Nourin-1 Antibody. Circulation. Chicago, IL. November 1995.92(8).
  11. Tyles E, Houser SL, Shams N, Consoli K and Elgebaly SA: Coronary sinus effluents from cardiopulmonary bypass patients stimulate the secretion of cytokines and adhesion molecules by vascular endothelial cells.  Circulation. Miami Beach, FL. November 1994,90(4).
  12. Elgebaly SA, Tyles E and Kulkarni P: Endotoxin-stimulated release of Nourin-1:  A novel 3 kDa cornea-derived chemotactic factor for neutrophils and monocytes.  Invest Ophthalmology Visual Science. Sarasota, FL. May 1994.
  13. Tyles E, Kulkarni P and Elgebaly SA: Release of neutrophil chemotactic factors from ischemic-injured retinal tissue independent of dexamethasone treatment.  Invest Ophthalmology Visual Science. Sarasota, FL. May 1994.
  14. Elgebaly SA, Wei J, El-Kerm AF, Tyles E and Gillies C: Cyclocreatine phosphate significantly improves rat heart function after long-term hypothermic storage.  American Society of Transplant Surgeons. Houston, TX. May 1993.
  15. Elgebaly SA, Tyles E, Houser SL, El-Kerm AF and Mauri F: Partial purification of a novel cardiac-derived neutrophil chemotactic factor:  Nourin-1. Circulation. New Orleans, Louisiana. November 1993.88(4).
  16. Elgebaly SA, House SL, Tyles E, El-Kerm AF, Mauri F and Kreutzer DL: Characterization of a novel small molecular weight neutrophil chemotactic factor human hearts.  Circulation. San Francisco, CA. 86(4).
  17. Elgebaly SA, Houser S, El-Kerm AF, Doyel K and Perlman K: Evidence of cardiac inflammation after open heart surgery.  Surg Forum. Chicago, IL. 1991.41:274-278.
  18. Allam ME, Houser S, Hashmi F, Liu X, Cordis G and Elgebaly SA: Myocardial preservation by cyclocreatine: restoration of post-ischemic myocardial contractility. Surg Forum. San Francisco, CA.  246-249.
  19. Elgebaly SA, Cohen A, Allam M, Yekta N. Cardiac Derived Inflammatory Mediators. J Mol Cell Cardiol. Ann Arbor, Michigan. May 1989. 21(11),S 171.
  20. Elgebaly SA, Masetti P, Forouhar F, Rossomando EF, Cohen A. Ibuprofen fails to inhibit the release of the tissue-derived neutrophil chemotactic factors “Nourin” from ischemic hearts.  XXVI World congress of the International College of Surgeons.  July 3-9, Milan, Italy, 1988.
  21. Elgebaly SA, Kozol RA, Masetti P, Bohr M and Lennan C: Release of neutrophil chemotactic factors from ischemic myocardial tissues. Surg Forum. San Francisco, CA. 38:276-279.
  22. Elgebaly SA, Masetti P and Bohr M: The release of neutrophil chemotactic activity from ischemic coronary artery.  Eleventh International Reticuloendothelial Society Meeting. Kawai, Hawaii, 1987.
  23. Elgebaly SA, O’Rourke J and Kreutzer DL: Characterization of leukocyte chemotactic factors released by isolated corneas in response to injury (chemical vs. mechanical).  In Vitro Toxicology Symposium, Johns Hopkins University, Center for Alternatives to Animal Testing, Baltimore, MD, 1986 (invited abstract).
  24. Elgebaly SA, Donovan M, Forouhar F, Gillies C, O’Rourke J and Kreutzer DL: Morphologic study of leukocyte-mediated injury to corneal endothelium.  Invest Ophthalmology Visual Science. Sarasota, FL, May 1983.

INVITED PRESENTATIONS
  • At professional conferences
  • At another college or university or scholarly institution.

  1. Elgebaly SA, Cyclosporine H:  A Novel Anti-Inflammatory Therapy with Applications for COVID-19 Patients. Reshaping Pharma Sustainability and Innovation for Better Pandemic Response. University of Cairo, Faculty of Pharmacy, Cairo, Egypt, July, 2021 (Virtual).
  2. Elgebaly SA, Cyclocreatine Phosphate: A Novel Mechanism for Preventing Development of Heart Failure. Global Virtual Summit on Cardiology and Cardiovascular Medicine. July, 2021. (Virtual).
  3. Elgebaly SA, Cyclocreatine phosphate: A novel mechanism for preventing development of heart failure. 20th CardioAlex Scientific Conference, University of Alexandria, Alexandria, Egypt, June, 2021. (Virtual).
  4. Elgebaly SA. Nourin molecular biomarkers detect early myocardial ischemia. CardioAlex Conference, Alexandria, Egypt, June, 2020. (Virtual).
  5. Elgebaly SA. Innovative Medicines in Africa: Our Own Experience with Cyclocreatine as a Novel FDA-Designated Cardioprotective Drug. 1st International Conference on African Studies Sustainable development for Africa, Cairo, Egypt, December, 2019.
  6. Elgebaly SA. Innovative Medicines in Egypt: Our Own Experience with Cyclocreatine as a Novel FDA-Designated Cardioprotective Drug. International Conference on Pharmaceutical and HealthCare Sciences, Alexandria, Egypt, November, 2019.
  7. Elgebaly SA. Innovative Medicines in Egypt: Our Own Experience with Cyclocreatine as a Novel FDA-Designated Cardioprotective Drug. Saina University, Faculty of Pharmacy, Saina, Egypt, November, 2019.
  8. Elgebaly SA. Innovative Medicines in Egypt: Our Own Experience with Cyclocreatine as a Novel FDA-Designated Cardioprotective Drug. University of Cairo, Faculty of Pharmacy, Cairo, Egypt, October 2019.
  9. Elgebaly SA. Innovative Medicines in Egypt: Our Own Experience with Cyclocreatine as a Novel FDA-Designated Cardioprotective Drug. Zewail City of Science and Technology (Laureate Ahmed Zewail), Cairo, Egypt, October 2019.
  10. Elgebaly SA. A novel autophagy related Nourin gene-based RNA network as early biomarkers for cardiac patients. CardioAlex Conference, Alexandria, Egypt, June 2019.
  11. Elgebaly SA. Nourin: A Novel Cardiac Biomarker. Egyptian Society of Cardiology, Cairo, Egypt, February, 2019.
  12. Elgebaly SA. Drug Manufacturing in Egypt: Opportunities, Challenges and Strategies for Success - Workshop #4, University of Ain Shams, Faculty of Pharmacy, Cairo, Egypt, December, 2018.
  13. Elgebaly SA. Keynote Speaker: Translational Science from Bench to Patients: Our Own Experience with Cyclocreatine as a Novel FDA-Designated Drug. Association of Egyptian American Scholars (AEAS), Cairo, Egypt, December, 2018.
  14. Elgebaly SA. Keynote Speaker: Innovative Medicines in Egypt. Association of Egyptian American Scholars (AEAS), Cairo, Egypt, December, 2018.
  15. Elgebaly SA. Drug Manufacturing in Egypt: Opportunities, Challenges and Strategies for Success - Workshop #4, University of Helwan, Faculty of Pharmacy, Cairo, Egypt, September, 2018.
  16. Elgebaly SA. Clinical Trials and FDA Filing for Product Approval - Workshop #3, University of Helwan, Faculty of Pharmacy, Cairo, Egypt, May, 2018.
  17. Elgebaly SA. Keynote Speaker: Drug Manufacturing in Egypt: Opportunities and Challenges. The Academy of Scientific Research and Technology (ASRT), “Promoting Egyptian Potentials”, Cairo, Egypt, March 2018.
  18. Elgebaly SA. Cyclocreatine: A Novel Cardioprotective Therapy for Ischemic Heart Disease (IHD) Patients. University of Alexandria, Faculty of Pharmacy, Alexandria, Egypt, January, 2018.
  19. Elgebaly SA. Keynote Speaker: Development and Commercialization of ‘Branded’ Medicines in Egypt. Association of Egyptian American Scholars (AEAS), Cairo, Egypt, December, 2017.
  20. Elgebaly SA. Keynote Speaker: “From Drug Discovery to Commercialization: Sharing Best Practices from International Perspective”. The Academy of Scientific Research and Technology (ASRT), Arab-German Young Academy of Sciences and Humanities (AGYA). Mapping and Strengthening the Regenerative Medicine Landscape in Egypt. Sahl Hasheesh, Sharm Elsheikh, Egypt, October 2017.
  21. Elgebaly SA. Intellectual Property (IP) of Nourexal™ and Product Funding - Workshop #2, University of Helwan, Faculty of Pharmacy, Cairo, Egypt, October, 2017.
  22. Elgebaly SA. Nourexal™: A Novel Anti-inflammatory / Anti-apoptotic Therapy Against Reperfusion Injury. University of Cairo, Faculty of Pharmacy, Cairo, Egypt, November, 2016.
  23. Elgebaly SA. Nourexal™: A Novel Anti-inflammatory / Anti-apoptotic Therapy Against Reperfusion Injury. University of Alexandria, Faculty of Medicine, Alexandria, Egypt, November, 2016.
  24. Elgebaly SA. Entrepreneurship in Pharmaceutical Drug Development (Nourexal™) - Workshop #1, University of Helwan, Faculty of Pharmacy, Cairo, Egypt, April, 2016.
  25. Elgebaly SA. Nourexin-4: A Novel anti-inflammatory therapy for cardiac inflammation and MRSA infection after cardiac catheterization and surgery. Egyptian Cardiology meeting, Sharm Elsheikh, Egypt, February, 2009.
  26. Elgebaly SA. Myocardial protection by the anti-apoptotic drug Nourexal. Egyptian Society of Cardiology, Sharm Elsheikh, Egypt, February, 2009.
  27. Elgebaly SA. Nourin Family: A Novel Therapeutic Target for the Development of Tissue-Specific Anti-Inflammatory Drugs. University of Alexandria Faculty of Pharmacy, Alexandria, Egypt – March, 2006.
  28. Elgebaly SA. Conducting Clinical Research in Egypt: How & FDA Requirements. University of Alexandria Faculty of Medicine, Alexandria, Egypt – March, 2006.
  29. Elgebaly SA. Responsibilities of Clinical Investigators. Cardio Alex 2006, Alexandria, Egypt – June 28, 2006.
  30. Elgebaly SA. Recruiting and maintaining study patients. Cardio Alex 2006, Alexandria, Egypt – June 29, 2006.
  31. Elgebaly SA. New therapeutic pharmacologic approaches for the treatment of diabetic retinopathy. Retinal Aspen Institute, Aspen Colorado, August 2005 (Invited Speaker by Dr. Bert Glaser).
  32. Elgebaly SA, Kreutzer DL, Mauri F, Azrin M, Fuller R, Christenson R: Nourin-1: an early diagnostic marker for myocardial ischemia and infarction to distinguish cardiac patients from non-cardiac patients presenting in emergency room with chest pain. International Egyptian Society of Cardiology, Alexandria, Egypt, February, 2002.
  33. Elgebaly SA. Hypertension and Stroke: Pathogenesis, Diagnosis & Treatment. 15th Annual Conference of the Egyptian Society of Hypertension, Cairo, Egypt, January, 2001.
  34. Elgebaly SA. Hypertension: Pathogenesis & Treatment, Lecture #I. 14th Annual Conference of the Egyptian Society of Hypertension, Cairo, Egypt, January 2000.
  35. Elgebaly SA. Hypertension: Pathogenesis & Treatment, Lecture #II. 14th Annual Conference of the Egyptian Society of Hypertension, Cairo, Egypt, January 2000.
  36. Elgebaly SA. The role of infections and inflammation in the pathogenesis of coronary heart disease. 26th annual conference of the Egyptian Society of Cardiology, Cairo, Egypt, February 1999.
  37. Elgebaly SA. Hypertension, Inflammation and coronary heart disease. 26th annual conference of the Egyptian Society of Cardiology, Cairo, Egypt, February 1999.
  38. Elgebaly SA. The cardiac-derived cytokine Nourin-1: Diagnostic and therapeutic applications.  International Symposium on Heart Disease, Cairo, Egypt, May 1998.
  39. Elgebaly SA, Houser SL, El-Kerm A, Houser D, Kaddurah-Daouk R and Tyles E: Myocardial protection by cyclocreatine. Twenty-fourth Cardiac Surgery Meeting, London, England, May 1994.
  40. Elgebaly SA Tyles E, Houser SL and El-Kerm AF: Cardiac-derived inflammatory mediators. Interscience World Conference on Inflammation, Antirheumatics, Analgesics, Immunomodulators, Geneva, Switzerland, April 1993.
  41. Elgebaly SA. Cyclocreatine: A Potent Cardioprotective Drug. Invited by Professor Sir Magdy Yacoub, London, UK. July, 1994.
  42. Elgebaly SA. Nourin: A Novel Tissue-Derived Inflammatory Mediator. Invited by the Nobel Prize Winner in Medicine, Professor Sir John Vane,

    London, UK,

    July, 1993.
  43. Elgebaly SA. Nourin: A Novel Tissue-Derived Inflammatory Mediator. Invited by the Nobel Prize Winner in Medicine, Professor R. Levi Montalcini,

    Rome, Italy,

    July, 1993.

Manuscript in Preparation:

    Elgebaly, S.A.; Van Buren, C.; Todd, R.; Poston, R.; Rabie, M.A.; Mohamed, A.F.; Ahmed, L.A.; El Sayed, N.S. Cyclocreatine Phosphate: A Novel Mechanism for Preventing Development of Heart Failure.

Invited Review Article Under Preparation:

     Elgebaly, S.A., The Story of Nourin and Cyclocreatine Phosphate.



Attachment A
Product Commercialization:
    A) Cyclocreatine Phosphate and FDA Orphan Drug Designation

Nour Heart was Granted the Orphan Drug Designation (ODD) by U.S. Food and Drug Administration for its new patented drug Cyclocreatine Phosphate for the unique designation of:  prevention of ischemic injury to enhance cardiac graft recovery and survival in heart transplantation (DRU-2015-4951).

The administration of the potent bioenergetic agent, Cyclocreatine and its salt Cyclocreatine Phosphate preserved high levels of myocardial adenosine triphosphate (ATP) in several models of myocardial ischemia resulting in immediate recovery of strong cardiac contractibility during post-ischemic reperfusion. Dogs and rats were used in models of: acute myocardial infarction, global cardiac arrest, heart transplantation, cardiopulmonary bypass surgery for coronary revascularization, and heart failure. Our research also indicates that Cyclocreatine treatment reduced myocardial tissue injury, acidosis, edema, inflammation and apoptosis.

Nour Heart is currently preparing the required New Investigational Drug (IND) application to file it to the FDA for approval to initiate Phase I clinical studies in the U.S.

    B) Cardiac Nourin Blood Test

Nourin is a potent inflammatory mediator rapidly released within minutes by ischemic and necrotic myocardium.  Nourin can diagnose AMI patients earlier than Troponins and it can also diagnose ACS patients (UA and AMI) presenting to Emergency Departments with chest pain. Currently, Nour Heart is developing the Nourin test to complement and enhance the usefulness of the Troponin tests to quickly rule in or out AMI patients presenting with chest pain in Emergency Departments.

Nour Heart is also developing Nourin® miRNAs as novel blood biomarkers for early identification or exclusion of myocardial Ischemia in Women suspected of having coronary artery disease. As a non-invasive and less-expensive blood-based test, Nourin miRNAs might be used as a routine screening test to rule out the majority of negative myocardial ischemia in chest pain patients (86%) and allow CAD-diagnosed patients (14%) to receive critical therapy, while they are still in the stable state. Initiating early therapy can potentially improve patients’ outcomes, quality of life, and saving lives, and reducing the high healthcare costs.



Attachment B
Clinical Trial & Research Expertise:

    Expertise in National and International Biomedical Industrial Field, includes:

  • Industrial Drug Development (R&D);
  • Industrial Clinical Research and FDA submissions;
  • FDA regulations & guidelines;
  • Clinical Trials conducted in Investigative Sites; and
  • International Clinical Trials including:
    • Europe (United Kingdom)
    • Europe (Holland)
    • Japan
    • China
    • Egypt

 

    Industrial R&D & Clinical Research Experience:

  • Director of Clinical Research in Nour Heart with the goal to develop diagnostic and therapeutic products for patients with ischemic heart disease.  
  • Director of Clinical Affairs in the Pharmaceutical Company AnGes, Gaithersburg, MD.
  •  Consultant Director of the Nourin project in the company Unipath, Bedford, UK, with focus on also     
  • developing diagnostic and therapeutic products in the field of cardiovascular diseases. 

 

    Clinical Research Activities Included:
  • Designing and writing study protocols;
  • Supervising preclinical efficacy studies in U.S., Europe and China;
  • Evaluating study results;
  • Filing IND to FDA;
  • Responding to FDA questions;
  • Selecting CROs and assuring timely completion of clinical studies within budget;
  • Selecting Investigative Sites and conducting Investigators Meetings.

 

    Clinical Trials Experience to Include Over 26 Clinical Studies (Phase II, Phase III, and Phase IV) in the field of Oncology, Cardiovascular, Infections, Psychiatry, Pulmonary, Rheumatoid Arthritis, Diabetes, Erectile Dysfunction, Surgery, Gene Analysis:
  • Established two new Clinical Trials & Research Centers in Connecticut:
    • Connecticut Multispecialty Group
    • Grove Hill Medical Center
  • As a Director of these Clinical Trials & Research Centers, the following activities were conducted:
    • Reviewed study protocols and selected clinical studies for our centers;
    • Reviewed confidentiality agreements;
    • Discussed study protocols and Investigative Brochures with Investigators and study Coordinators;
    • Completed FDA regulatory documents;
    • Completed local & central Institutional Review Board (IRB) submissions;
    • Functioned as a sub-Investigator in all clinical studies;
    • Attended all study Investigators Meetings for studies conducted in our sites;
    • Negotiated study budgets with Sponsors;
    • Reviewed and finalized contracts with Sponsors;
    • Supervised Clinical Research Coordinators;
    • Assured that the Investigators and study Coordinators comply with study protocol, GCP guidelines, and FDA regulations;
    • Assured that patients’ safety and confidentiality were met;
    • Communicated with Investigators, study Coordinators, and Sponsors regarding adverse events and patients’ progress;
    • Assured timely patients’ recruitments and that all visits’ requirements were conducted timely and properly;
    • Conducted internally monitored of over 26 clinical studies (Phase II, Phase III, and Phase IV) in the field of Oncology, Cardiovascular, Infections, Psychiatry, Pulmonary, Rheumatoid Arthritis, Diabetes, Erectile Dysfunction, Surgery, Gene Analysis, etc.

     

      International Clinical Research Experience:
  • United Kingdom and China: As a Consultant Director of the Nourin project in Unipath, Bedford, UK, Dr. Elgebaly worked closely with the R&D Department in Bedford, UK, as well as its branch in China.
  • Holland and Japan:As a Director of Clinical Affairs in AnGes, Dr. Elgebaly worked closely with the R&D Department in Japan and established Preclinical efficacy studies in Holland.
  • Egypt: Elgebaly established a new Clinical Trials & Research Center at the University of Alexandria School of Medicine and she currently functions as a volunteer Consultant in aspect related to Drug Testing and Clinical Trials.
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