CRITICAL PIPELINE PROJECT
A new antibiotic project that has shown significant activity against both Gram-ve and Gram +ve bacteria is in pre-clinical development, and T.A.Z. Corporation has licensed rights to this project from NAEJA-RGM Pharmaceuticals.
The NAEJA scientists have designed this new antibiotic project to be effective against the ESKAPE organisms. These organisms are on the W.H.O.’s priority pathogen list, consisting of both gram-positive and gram-negative bacteria, and international programs are designed to tackle these bacteria.
“There is a critical need for new therapies to treat deadly infections caused by Gram-ve ESKAPE pathogens. Only a handful of new treatments with the potential to address these serious threats are currently in development.”
The Pew Charitable Trust
(July 2016)
These compounds have been designed using 30+ years of success to incorporate elements that:
- have been well studied and are well understood;
- are known to limit toxic effects;
- are known to facilitate binding to bacteria;
- are stable;
- translate well from in vitro to in vivo;
- overcome specific competitors’ challenges;
- result in patentable compounds.
This project, built on years of successful learnings, is believed to be superior to competitors currently known to be in development.
CEO’S MESSAGE
As a physician, I am continuously confronted with the challenge of treating infections that over time are developing resistance to antibiotics. Although vigilance is still critical to prevent the overuse of antibiotics, the world is well past the time when this danger can be quickly contained. Public and private organizations, doctors, and scientists from all corners of the globe are forming coalitions to tackle a crisis that has the potential to plunge the world into a new era of untreatable diseases. The situation is really as dire as it sounds. Even the melting of the polar ice caps threatens to expose ancient bacteria for which there may be no known treatments.
The World Health Organization (W.H.O.) released a “priority pathogens” list highlighting in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics. (February 2017) In the United States, the Centers for Disease Control (CDC) has invested +$200 million to help the states respond to infectious disease threats from gram negative pathogens. (August 4, 2017) There are initiatives in place to address the challenges, but are they enough and will they provide timely results?
Many big pharma companies divested themselves of their antibiotic programs years ago. Creative discovery work was outsourced to smaller pharma companies to limit big pharmas’ risks associated with this kind of work. Additionally, the focus of current government initiatives is to identify and develop novel projects, but this inherently suggests a longer timeline to market. With no precedent to follow, no roadmap exists to ensure these projects will be successful in providing solutions when we need them. Simultaneous to these “novel” approaches, fundamental discovery research work must continue to address antibiotic resistance.
My father, Dr. Ronald G. Micetich, spent his career tackling global health issues. As an internationally recognized medicinal chemist and the CEO and founder of SynPhar Laboratories and then NAEJA Pharmaceutical Inc., he was successful in providing the world with several drugs that continue to be used today to treat challenging medical conditions, including Tazobactam, a beta-lactam inhibitor (BLI) used with Pipericilin in ICUs around the world. Although he is no longer with us, his team of scientists were trained and mentored by him to tackle the most challenging medicinal chemistry problems and their work has resulted recently in a new BLI that is currently being developed by a major pharmaceutical company.
T.A.Z. Corporation has licensed, for the world market excluding the USA, the latest patented antibiotic project to be developed by the NAEJA scientists through NAEJA-RGM Pharmaceuticals (www.naeja-rgm.com.) The lead compounds in this new antibiotic project exhibit broad spectrum antibacterial activity against highly resistant strains of clinically important bacteria responsible for both hospital acquired infections and community acquired infections. T.A.Z. Corporation will continue to develop this project on an expedited timeline, with the goal of taking the final candidate compound into clinical trials in 2019… and if we are successful, T.A.Z. Corporation will contribute to the battle against antibiotic resistance.
Keith A. Micetich, MD, CEO, T.A.Z. Corporation
TEAM
William Hope, PhD
Chief Scientific Advisor
William Hope (BMBS, FRACP, FRCPA, PhD), is Professor of Therapeutics and Infectious Diseases at the University of Liverpool in the UK. Professor Hope is a Fellow of the Royal Australasian College of Physicians and a Fellow of the Royal College of Pathologists of Australasia. Professor Hope qualified in Medicine in 1991, before undertaking specialist training in infectious diseases and clinical microbiology. He completed his PhD in antimicrobial pharmacology in 2006, while undertaking fellowships at the University of Manchester, UK, and the National Institutes of Health, Bethesda, USA. He was an NIHR Clinician Scientist and this award focussed on individualised antimicrobial therapy. Professor Hope leads the newly formed Centre for Antimicrobial Pharmacodynamics, which provides the pharmacodynamic packages for new antibiotics.
Areas of special interest and research are antimicrobial pharmacokinetics and pharmacodynamics, antimicrobial drug development and individualisation of antimicrobial therapy. He is a Fellow of the American Academy of Microbiology and European Society of Clinical Microbiology and Infectious Diseases.
David Livermore, PhD
Scientific Advisor
Prof. David Livermore gained his BSc in 1978 and PhD in 1983. He worked at the London Hospital Medical College from 1980 to ‘97 then joined the Public Health Laboratory Service (now Public Health England), becoming Director of its Antibiotic Resistance Monitoring and Reference Laboratory, where he remained until October 2011. He then became Professor of Medical Microbiology at the University of East Anglia, still with sessions supplied to Public Health England as its Lead on Antibiotic Resistance. Prof Livermore has a long track record of research and publication on the evolution and epidemiology of antibiotic resistance, particularly β-lactamases. At PHE he tracked and endeavored to counter the rise of many emerging resistance types, from MRSA to carbapenemase producers. At UEA his work centres upon the rapid detection of antibiotic resistance as a means to refining antibiotic stewardship. Prof Livermore has edited for several journals and serves on the Government’s Antimicrobial Resistance & Healthcare Associated Infection Advisory Committee. Outside work he walks: including, over 20 years, the entire 3000-mile perimeter of England.
David M. Aronoff, MD
Scientific Advisor
David Aronoff, MD is Professor and Addison B Scoville, Jr Chair in Medicine and Director of the Division of Infectious Diseases at the Vanderbilt University School of Medicine. He is a Fellow in the Infectious Diseases Society of America and a Fellow in the American Academy of Microbiology. With a Bachelor of Science degree in Microbiology and a Medical Degree from Tufts University in Boston, he completed his internship and residency training in Internal Medicine at Vanderbilt University, a clinical fellowship in Infectious Diseases, and a research fellowship in Clinical Pharmacology. As a faculty member in Infectious Diseases at the University of Michigan, he completed a research postdoctoral fellowship in Immunology and later rose to the rank of Associate Professor with tenure in the Departments of Internal Medicine and Microbiology & Immunology. He returned to Vanderbilt in October, 2013.
The Aronoff Lab studies serious bacterial infections, particularly those involving the reproductive tract and gastrointestinal system. Dr. Aronoff has been awarded numerous governmental and non-governmental research grants, and has published more than 160 peer-reviewed manuscripts and several book chapters and invited commentaries.
Paul G. Ambrose, PharmD, FIDSA
Scientific Advisor
Dr. Ambrose has worked in the anti-infective drug development area for nearly 20 years at large pharmaceutical companies, contract research organizations and small research institutes. During this time, he has been involved with analyses and data generation for over 100 agents, spanning from small molecule to large molecule antimicrobial agents. Dr. Ambrose’s areas of scientific inquiry primarily involve anti-infective translational science, with the goal of improving patient care through the application of pharmacokinetic-pharmacodynamic (PK-PD) principles. Knowledge gained through the use of non-clinical (in vitro and animal) PK-PD infection models have be leveraged with human pharmacokinetic data in order to discriminate between potential dosing regimens and thereby increase the probability of positive clinical outcomes while minimizing the potential for drug-related toxicities. He is the author or coauthor of over 130 peer-reviewed scientific publications and approximately 300 scientific abstracts, and has served as an Editor for four textbooks, most notably the 1st and 2nd Editions of Antimicrobial Pharmacodynamics in Theory and Clinical Practice and serve as Editor of Antimicrobial Agents and Chemotherapy.
Keith A. Rodvold, PharmD
Scientific Advisor
Dr. Keith A. Rodvold received his Bachelor of Science in Pharmacy (1978) and Doctor of Pharmacy (1980) degrees from the University of Minnesota. He completed his research fellowship in clinical pharmacokinetics and pharmacology at St. Paul-Ramsey Medical Center and the University of Minnesota (1980-1981).
Dr. Rodvold is a Professor of Pharmacy Practice and Professor of Pharmacy in Medicine in the Colleges of Pharmacy and Medicine at the University of Illinois at Chicago. He conducts research in the area of clinical pharmacokinetics and pharmacodynamics of anti-infective agents, with a focus on drug penetration and disposition in special populations. Dr. Rodvold has authored more than 175 original research and review publications, 50 book chapters, and co-editor of the textbooks, Drug Interactions in Infectious Diseases (currently in its fourth edition) and Antibiotic Pharmacodynamics. The American College of Clinical Pharmacy presented Dr. Rodvold with the 2003 Russell R. Miller Award in recognition of his sustained and outstanding contributions to the literature of clinical pharmacy. Dr. Rodvold is a former member of the Anti-Infective Drug Advisory Committee and Pediatric Drug Advisory Subcommittee for the Food and Drug Administration. He is an active member of numerous professional societies and has been elected Fellow of the Infectious Diseases Society of America, American College of Clinical Pharmacology, and American College of Clinical Pharmacy.
Jon B. Bruss, MD, MBA, FAAP, FIDSA
Scientific Consultant
Dr. Jon B. Bruss has therapeutic expertise in guiding global clinical trials in infectious disease. His clinical and academic research experience has included infectious disease research, vaccine research, public health management and tuberculosis control. Dr. Bruss has spent 20 years in drug development with global, clinical and regulatory expertise, managing clinical trials in the area of infectious diseases, including leading drug development in the US, Europe and Asia. Dr. Bruss has held positions of increasing responsibility, including Chief Medical Officer in both large and small pharmaceutical companies. He has a broad understanding of the principles of scientific research and the commercialization of medicines across multiple therapeutic areas. He has extensive international experience, including the building of the Shanghai Children’s Medical Center. He has held academic appointments at Harvard Medical School and the University of Washington, and he is a Board Certified Pediatrician and Specialist in infectious disease with experience in clinical pediatrics, public health management and drug and biologics development (Phases I-IV). Dr. Bruss obtained a Master of Science in Public Health (MSPH) from Tulane University, School of Public Health and Tropical Medicine; and MBA from Kellogg School of Business Management at Northwestern University. Dr. Bruss received his Doctor of Medicine degree from the University of New Mexico, School of Medicine and his undergraduate degree in Biology from the University of Utah.
Keith A. Micetich, MD
CEO & Director
A graduate of the University of Alberta, Edmonton, Alberta, with a BSc., and Doctorate of Medicine, Dr. Micetich is a Fellow of the Royal College of Physicians and Surgeons of Canada, Obstetrics and Gynecology, and a Fellow of the American College of Obstetricians and Gynecologists. Dr. Micetich practiced as an Obstetrician/ Gynecologist in Edmonton, Alberta, Canada, from 1988 until 1995. In 1995 he relocated to the United States where he has practiced medicine in Jackson, Tennessee and is the founder, president and managing partner of Jackson Regional Women’s Center.
For more than twenty years, Dr. Micetich has served as an Executive representing doctors and other medical staff on Advisory Boards, committees, and Boards of Directors. At Tennova Healthcare-Regional Jackson, Dr. Micetich serves as Department Head/ Medical Director of Obstetrics/Gynecology and Pediatrics, as a member of the hospital’s Board of Trustees, its Physician Leadership Group, its Medical Executive Committee and current CEO Search Committee. He has served as the Chief of Staff of Regional Hospital of Jackson and was a member of the National Physician Advisory Board of Community Health Systems (CHS Hospitals) in Franklin, Tennessee. Dr, Micetich is a member of the Bylaws Committee and Medical Executive Committee of Jackson-Madison County General Hospital and has recently served on its CEO Search Committee. He sits on the Physician Advisory Committee for Blue Cross Blue Shield of Tennessee, and he is President of the West Tennessee Independent Physicians Association and a member of the Technical Advisory Group, Gynecological Surgery, for the Tennessee Healthcare Innovation Initiative. Keith Micetich was a board member of NAEJA Pharmaceuticals Inc. of Edmonton, Alberta, Canada from 2002 to 2012, and he is currently a board member of NAEJA-RGM Pharmaceutical Inc.
Brenda M. Weiermair, MBA
Director
Brenda Weiermair is a co-founder of NAEJA-RGM Pharmaceuticals Inc. and has spent the past year serving as interim CEO of NAEJA-RGM for the purpose of re-establishing and restructuring operations of NAEJA Pharmaceutical Inc. During the past year, NAEJA-RGM filed and then quickly secured the patent for an exciting new antibiotic program. She began her career working in the pharmaceutical industry at SynPhar Laboratories Inc. (the precursor to NAEJA Pharmaceutical Inc.) for eight years in a variety of finance and business development roles, and later served on the Board of Directors of NAEJA Pharmaceutical Inc. (2004-2012). For the past twenty years, Ms. Weiermair’s diverse work experience has included senior finance and management positions in software, entertainment, alternative energy and electric vehicle automation, including serving as Treasurer on the Board of the California Hydrogen Business Council. Most recently she has served as the President of Earth Energy Fuels and the CFO of Land Systems Corp. Ms. Weiermair is a turn-around specialist, working for the past ten years with young companies pursuing cutting edge technologies. Her focus is on restructuring, strategy, debt and equity raises, addressing corporate compliance issues, refocusing long-term planning, and launching existing and new ventures. She holds a B.Comm. degree in Accounting & General Management, and an MBA in Finance.
Deborah M. Helfrich, JD
Director
Deborah Helfrich is a co-founder of NAEJA-RGM Pharmaceuticals Inc and currently serves as President and COO. Her 30-year career has been singularly in pharmaceuticals, holding various positions with SynPhar Laboratories Inc. and NAEJA Pharmaceutical Inc., including Director, Legal Affairs (SynPhar Laboratories Inc., 1990-1999), Senior Director, Legal and Administrative Affairs (NAEJA Pharmaceutical Inc., 1999-2005), and Vice President (NAEJA Pharmaceutical Inc., 2005-2015). Mrs. Helfrich also served on the board of NAEJA Pharmaceutical Inc. from 2002 until 2015. She retired in March 2015 from NAEJA but has returned to the workforce to oversee the establishment of operations and legal affairs of NAEJA-RGM Pharmaceuticals. Mrs. Helfrich holds a B.A. and a J.D.