Welcome!

News Feed Item

Sideromics Completes Pre-IND Meeting with FDA on Siderocillin for Two Indications: MRSA Bacteremia and ABSSSI

IRVINE, Calif., April 8, 2014 /PRNewswire/ -- 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.

Number of New Antibiotics Approved by FDA

"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. 

Photo - http://photos.prnewswire.com/prnh/20140408/LA99615



CONTACT:

Sideromics LLC


www.sideromics.com


Investor & Public Relations:


Stacey Lense – Email:   [email protected]


Rachel Stone – Email:   [email protected]


(800) 552-1680

 

 

SOURCE Sideromics LLC

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
"There's plenty of bandwidth out there but it's never in the right place. So what Cedexis does is uses data to work out the best pathways to get data from the origin to the person who wants to get it," explained Simon Jones, Evangelist and Head of Marketing at Cedexis, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Agile has finally jumped the technology shark, expanding outside the software world. Enterprises are now increasingly adopting Agile practices across their organizations in order to successfully navigate the disruptive waters that threaten to drown them. In our quest for establishing change as a core competency in our organizations, this business-centric notion of Agile is an essential component of Agile Digital Transformation. In the years since the publication of the Agile Manifesto, the conn...
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
"We're developing a software that is based on the cloud environment and we are providing those services to corporations and the general public," explained Seungmin Kim, CEO/CTO of SM Systems Inc., in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Codigm is based on the cloud and we are here to explore marketing opportunities in America. Our mission is to make an ecosystem of the SW environment that anyone can understand, learn, teach, and develop the SW on the cloud," explained Sung Tae Ryu, CEO of Codigm, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Data scientists must access high-performance computing resources across a wide-area network. To achieve cloud-based HPC visualization, researchers must transfer datasets and visualization results efficiently. HPC clusters now compute GPU-accelerated visualization in the cloud cluster. To efficiently display results remotely, a high-performance, low-latency protocol transfers the display from the cluster to a remote desktop. Further, tools to easily mount remote datasets and efficiently transfer...
"CA has been doing a lot of things in the area of DevOps. Now we have a complete set of tool sets in order to enable customers to go all the way from planning to development to testing down to release into the operations," explained Aruna Ravichandran, Vice President of Global Marketing and Strategy at CA Technologies, in this SYS-CON.tv interview at DevOps Summit at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, introduced two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a multip...
In his session at 21st Cloud Expo, James Henry, Co-CEO/CTO of Calgary Scientific Inc., introduced you to the challenges, solutions and benefits of training AI systems to solve visual problems with an emphasis on improving AIs with continuous training in the field. He explored applications in several industries and discussed technologies that allow the deployment of advanced visualization solutions to the cloud.