Press Releases

Sideromics Announces Formation of Scientific Advisory Board

 

 

IRVINE, CA, (October 7, 2015) – Sideromics LLC, a pharmaceutical company developing novel antimicrobial compounds to treat and prevent infectious diseases, announced today the formation of a Scientific Advisory Board (SAB) comprised of internationally renowned physicians and scientists. The mission of the SAB will be to provide scientific, strategic, and clinical advice on the advancement of their antimicrobial candidates for infectious diseases.


Sideromics’ Siderocillin is a first-in-class antibiotic group of compounds employing a completely new and novel antimicrobial approach. Recent preclinical studies show antimicrobial activity in a broad range of pathogenic microorganisms, many of which are the leading cause of serious infection and often death, posing some of the greatest healthcare challenges on a global basis. Sideromics is pursuing multiple indications in humans and animal infectious diseases.


Research and development of antibiotics has declined in recent years and the pipeline for antibiotics today is significantly smaller than in the past. In 1990, there were 18 major pharmaceutical companies engaged in antibiotics research, today there are a handful. Given the speed at which microbes have become resistant in recent years, the innovation in antibiotics research has not been successful in addressing this growing problem.


The initial appointments to Sideromics’ Scientific Advisory Board include:


David Andes, M.D. - Professor Medicine and of Medical Microbiology and Immunology at the University of Wisconsin School of Medicine and Public Health in Madison, WI. Head of the Division of Infectious Disease and Director of the Infectious Disease Fellowship Program. The focus of Dr. Andes' research programs involves identification of strategies to combat antimicrobial (especially antifungal) drug resistance. Study approaches include defining the molecular basis for drug resistance, drug target development, pharmacodynamic investigation, and clinical trial study of resistance epidemiology. Dr Andes has authored many publications, serves as editor of Antimicrobial Agents and Chemotherapy, and is an editorial board member for a number of other prestigious journals. He is past president of the International Society of Antimicrobial Pharmacology. After receiving a bachelor of arts in biology from St. Louis University, Missouri, Dr. Andes completed his medical degree at the University of Missouri, in Columbia. His postgraduate training included a residency in internal medicine, chief residency, and clinical fellowship in infectious disease at the University of Wisconsin, Madison. He has research training in antimicrobial pharmacodynamics, molecular biology, and molecular mycology. A principal investigator, co-investigator, and collaborator on a number of research projects on infectious diseases and their treatment, Dr. Andes' publications include co-authoring book chapters, abstracts, and articles in such journals as Antimicrobial Agents and Chemotherapy, Current Opinion in Infectious Disease, and Clinical Infectious Diseases. He serves on the Editorial Board on Antimicrobial Agents and
Chemotherapy and as an ad hoc reviewer for many journals including Clinical Pharmacokinetics, Clinical Microbiology and Infection, Mayo Clinic Proceedings, Medical Mycology, and Clinical Infectious Diseases. Dr. Andes has been an invited lecturer at grand rounds, and local and regional medical education seminars and has made numerous presentations at national and international symposia and conferences. Honored for both his academic and research contributions to medicine, Dr. Andes is active on hospital and research committees as well as in professional medical associations. He is treasurer of the International Society of Anti-infective Pharmacology. His professional affiliations also include the International Society of Antimicrobial Pharmacology, American Society of Microbiology, American College of Physicians, and European Society of Clinical Microbiology and Infectious Diseases.


David S. Perlin, PhD - Executive Director of the Rutgers-New Jersey Medical School’s Public Health Research Institute (PHRI), a 73-year-old specialized center for global infectious diseases research. He is also Director of the new Rutgers Regional Biocontainment Laboratory, one of thirteen NIH-designated national centers, and a Professor of Microbiology and Molecular Genetics. Dr. Perlin helped establish PHRI as a leading center for tuberculosis and opportunistic infections research. He has published more than 215 papers and book chapters and has co-authored two books. His laboratory is supported by grants from the NIH, pharma and biotech sectors. He is on the editorial board of several scientific journals and serves on the Board of Directors of the Aaron Diamond AIDS Research Center, and Scientific/Medical Advisory Boards for the CLSI, LIFE, pharma and biotech companies, and PinnacleCare. Dr. Perlin earned an AB degree from Brandeis University in 1976 and a Ph.D. from Cornell University in 1980. He pursued postdoctoral studies at the Yale University School of Medicine and the University of Rochester School of Medicine and Dentistry. Dr. Perlin joined PHRI in 1985; he was named Scientific Director in 1992, President in 2005, and Director of the new UMDNJ Center in 2006. He was appointed Professor of Microbiology and Molecular Genetics in 2003 and Executive Director of PHRI and the Rutgers Regional Biocontainment Laboratory in 2010. Dr. Perlin was named a Fellow of the New York Academy of Sciences in 2005, and a Visiting Professor at the University of Manchester, UK in 2009.


Jeffrey Parker Henderson, M.D., PhD - Assistant Professor Departments of Internal Medicine, Infectious Disease, Molecular Microbiology and Center for Women’s Infectious Diseases (cWIDR) at the Washington University School of Medicine, in St. Louis, MO. Dr. Henderson holds leadership roles with the Biochemistry Program and Molecular Microbiology and Microbial Pathogenesis Programs. His research area of interest includes pathophysiology of enteric Gram negative infections with a special focus on pathogenic interactions with transition metals. Dr. Henderson holds board certifications in Infectious Disease and Internal Medicine. He received a bachelor of science, with honors, in Chemistry from the University of Wisconsin, his medical degree and a PhD in Molecular Biophysics from the Washington University School of Medicine, St. Louis, MO. His postgraduate training included Internal Medicine residency and Infectious Diseases fellowship at Barnes-Jewish Hospital/Washington University. He is an NIH principal investigator, co-investigator, and collaborator on multiple infectious diseases research projects involving translation between basic and clinical research. He has published over forty peer-reviewed studies and served as a reviewer for multiple journals including the Proceedings of the National Academy of Sciences, U.S.A., PLoS Pathogens, ACS Infectious Diseases, Infection and Immunity, and Journal of Bacteriology. Dr. Henderson has been an invited lecturer at the National Institutes of Health, Gordon Research Conferences, and medical grand rounds. His professional affiliations include the Infectious Diseases Society of America, American Society for Microbiology, and the American Society for Biochemistry and Molecular Biology.


Natan Keller, M.D., PhD - Director of the Clinical Microbiology Department at the Chaim Sheba Medical Center, Tel Hashomer, Israel. He also serves as the chairperson of the Israeli Society for Infectious Disease and has held this position since 2012. Dr. Keller has served in the Israeli military and received his Doctor of Medicine degree from Hebrew University in Jerusalem. Dr. Keller holds an executive MBA degree and a PhD in medical microbiology. He continues to be a lecturer and associate professor in medical epidemiology at the Ariel University Center of Samaria, Ariel, Israel. Dr. Keller’s primary focus in research is microbiology and has presented at scientific meetings around the world. Dr. Keller has co-authored and published over 100 articles. Dr. Keller’s professional affiliations include the American Society of Microbiology, the Israel Society of Infectious Disease, the Israel Medical Association, and the Immuno Compromised Society.


Dr. Daniel Perl, a co-founder of Sideromics, said “I am excited about working with the distinguished and experienced scientists on our Scientific Advisory Board and look forward to their help in developing our new antimicrobial compounds and bringing them to the bedside.”


About Sideromics
Sideromics is a pharmaceutical company developing novel compounds and methods to treat or prevent diseases and disorders caused by pathogenic microorganisms, such as bacteria, fungi, and parasites. Sideromics has developed a pipeline of products with possible indications in humans and domestic animals, as well as for use in food-animal growth & processing. Sideromics’ pipeline of products range from early proof-of-concept through advance stages of development. Current and pending patents and IP cover a broad range of applications in the U.S. and on a global basis.


CONTACT: Sideromics LLC
www.sideromics.com
Investor & Public Relations:
Stacey Lense – Email: stacey.lense@sideromics.com
Rachel Stone – Email: rachel.stone@sideromics.com
(800) 552-1680

Sideromics Announces Formation of Scientific Advisory Board
(October 7, 2015)

Sideromics Completes Pre-IND Meeting with FDA on

Siderocillin for Two Indications: MRSA Bacteremia and ABSSSI

 

 

IRVINE, CA, (April 8, 2014) – Sideromics LLC, a pharmaceutical company specializing in the development of novel antimicrobial compounds, announced today that the company has successfully completed a Type B pre-investigational new drug (PIND) meeting with the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products (DAIP). The purpose of the meeting was to obtain FDA concurrence on the nonclinical, clinical, and regulatory pathway for the development of Siderocillin, a novel first-in-class antimicrobial agent.

 

Sideromics’ Siderocillin, is a first-in-class antibiotic within the Sideromycin group. Siderocillin employs a completely new and novel antimicrobial approach. Sideromics is pursuing multiple indications under this IND program:

 

   1) Treatment of patients with hospital-acquired bacteremia due to

        methicillin-resistant Staphylococcus aureus (MRSA)

   2) Treatment of hospitalized patients with acute bacterial skin and

        skin structure  tissue infections (ABSSSI)

 

Sideromics is currently preparing a GMP batch of Siderocillin, which will undergo a microbiological testing program discussed with the FDA. The PIND meeting with the FDA confirmed that the initial IND for Siderocillin will not require additional nonclinical safety data to support our first phase I single dose trial in humans. This enables Sideromics to enter the clinic promptly.

 

As part of the PIND meeting program, the FDA asked Sideromics to consider requesting designation of Siderocillin as a “Qualified Infectious Disease Product” (QIDP), as well as requesting fast track designation at the time of QIDP designation.

 

QIDP designation is part of the Generating Antibiotic Incentives Now (GAIN) statute, created by Congress to encourage the development of therapies for drug-resistant organisms known to cause serious or life-threatening infections. The GAIN provisions are included in the FDA Safety and Innovation Act (FDASIA) that was signed into law in July 2012. The GAIN act is a legislative effort to incentivize the development of new antibiotic agents that target serious life-threatening infections. Siderocillin is clearly the type of novel compound needed in medicine’s current losing battle with multiresistant organisms.

 

By expediting and fast tracking the FDA review process, the QIDP designation will allow Sideromics to bring Siderocillin to patients with serious infections much more quickly. QIDP status will also complement Sideromics’ patent portfolio with an additional total of 10 years exclusivity in the U.S.Research and development of antibiotics has declined in recent years and the pipeline for antibiotics today is significantly smaller than in the past. In 1990, there were 18 major pharmaceutical companies engaged in antibiotics research, today there are only four. Given the speed at which microbes have become resistant in recent years, the innovation in antibiotics research has not been successful in addressing this growing problem.

 

“This is a serious problem for physicians and health care workers,” says Sharon Moalem MD, PhD, Sideromics cofounder and director of research, “It’s like trying to fight a fire with one hand tied behind your back.” As the number of new antibiotics approved by the FDA has been declining over the last few decades, the number of individuals in the U.S. dying from infections caused by multiresistant microbes, such as MRSA has been on a steep rise.

 

In the latest reports (March 2014) from Centers for Disease Control and Prevention (CDC), the agency found that on any given day, approximately one in 25 patients has at least one infection contracted during the course of their hospital care. In 2011 alone, 722,000 infections were recorded according to new data from CDC.

 

“Our companies mandate was to aggressively screen compounds that target bacteria that are the so called ‘superbugs’ or multiresistant microbes. We discovered Siderocillin by studying how rare human conditions evolved to protect us from microbial infections,” says Moalem.

 

Using their first-in-class intellectual property compounds, with clinical trials set to begin by the end of 2014, Sideromics is poised to make dramatic changes to the antimicrobial landscape.

 

About Sideromics

 

Sideromics is a pharmaceutical company developing novel compounds and methods to treat or prevent diseases and disorders caused by pathogenic microorganisms, such as bacteria, fungi, and parasites. Sideromics has developed a pipeline of products with possible indications in humans and domestic animals, as well as for use in food-animal growth & processing. Sideromics’ pipeline of products range from early proof of concept through advance stages of development. Current and pending patents and IP cover a broad range of applications in the U.S. and on a global basis.

 

CONTACT: Sideromics LLC

                     Investor & Public Relations:

                     Stacey Lense – Email: stacey.lense@sideromics.com

                     Rachel Stone – Email: rachel.stone@sideromics.com

                    (800) 552-1680

 

Released April 8, 2014

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