FDA Grants QIDP Designation to LMB for Mino-Lok™, a Novel Antibiotic Lock Therapy in Development to Treat Catheter Related Blood Stream Infection (CRBSI)

Oct 12, 2015, 17:25 ET from Leonard Meron Biosciences, Inc. (LMB)

CRANFORD, N.J., Oct. 12, 2015 /PRNewswire/ -- Leonard Meron Biosciences, Inc. (LMB) today announced that the U.S. Food and Drug Administration (FDA) has granted a Qualified Infectious Disease Product (QIDP) designation for the antibiotic lock solution, Mino-Lok.  The lock solution technology was developed at The University of Texas MD Anderson Cancer Center by Dr. Issam Raad, the G. P. Bodey, Sr., Distinguished Professor and Chair, Department of Infectious Diseases, Infection Control and Employee Health. Mino-Lok (Minocycline-EDTA-EtOH) is an antimicrobial solution designed to salvage and sterilize infected central venous catheters (CVCs) in bacteremic patients. Mino-Lok is entering phase III trials.

"CVCs are a lifeline for many critically ill or chronically ill patients. However, CVCs are frequently associated with bloodstream infections (CRBSIs) which are the leading cause of healthcare associated infections (HAIs) in the United States with substantial patient morbidity and mortality. The current standard of care is treating the bacteremia with culture-directed systemic antibiotic therapy with the removal of the infected CVC and replacement with a new CVC at a different site. With cancer and hemodialysis patients, this may be difficult or impossible because of the unavailability of a suitable vascular site. Also there is a high degree of relapse and poor response to therapy when replacing CVCs," said Dr. Raad, who is considered one of the leading experts in the world in the field of vascular catheter and healthcare related infections.  "Mino-Lok therapy has the potential to be significantly safer than replacing a CVC. Many bacteremic patients have underlying coagulopathy making replacement risky. There are also mechanical complications (misplacement, arterial puncture, hemopneumothorax, etc.) associated with CVC removal and reinsertion; and, there is significant patient discomfort in the CVC replacement procedure."

"The FDA's decision to grant QIDP designation supports our belief that salvaging an infected central venous catheter in patients with bloodstream infections represents a clinically meaningful outcome. Mino-Lok could make a difference in serving this area of critical medical need," said Myron Holubiak, LMB's CEO. "Currently, there are no approved antibiotic lock therapies for the treatment of CRBSI. We are aware of efforts in developing lock solutions as preventative measures, and we sincerely encourage their development; however, there is a significant unmet medical need in treating the catheters that are infected and frequently are the source of the bacteremia.  We believe Mino-Lok may represent a major advance in treating CRBSI, salvaging CVCs and providing significant cost savings. We hope to begin phase III trials early next year."

About QIDP and the GAIN ACT

The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, Title VIII (Sections 801 through 806) of the FDA Safety and Innovation Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Mino-Lok is now eligible for additional FDA incentives in the approval and marketing pathway, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; highly virulent Gram-positive bacteria, including methicillin-resistant Staphyloccocus aureus (MRSA),Streptococcus pneumoniae, Streptococcus pyogenes; and fungi, including Candida species. The GAIN Act extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotic products.

About Leonard Meron Biosciences, Inc.

Leonard Meron Biosciences, Inc. (LMB) is a private, late-stage specialty pharmaceutical company focused on the development and commercialization of critical care products with a concentration on anti-infectives. The Company is developing Mino-Lok, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections, or CRBSIs. 

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report's "Best Hospital's" survey. It has ranked as one of the nation's top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

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SOURCE Leonard Meron Biosciences, Inc. (LMB)