Leonard-Meron Biosciences (LMB) is a late-stage specialty pharmaceutical company focused on the development and commercialization of critical care products with a concentration on anti-infective drugs. LMB is developing Mino-Lokâ„¢, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections that is entering phase 3 trials. Leonard-Meron Biosciences (LMB), Inc. is a wholly owned subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) referred as Citius, is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a pipeline of anti-infectives in oncology, adjunct cancer care, stem cell therapy and unique prescription products.

It has been demonstrated that chelators such as edetate disodium have the ability to enhance the activity of tetracycline antibiotics (e.g., minocycline) against microbial organisms embedded in biofilm, and also serve as anti-clotting agents. The safety of a lock solution containing minocycline and edetate disodium has been well established through clinical and non-clinical studies and both are approved for intravenous use. However, though effective, they require a prolonged dwell time of at least 24 hours in order to demonstrate activity. In a clinical setting, this lengthy dwell time may prove clinically infeasible for patients whose indwelling catheter must be used for other purposes. Additional studies and preliminary data demonstrate that a highly effective antimicrobial lock solution, which adds 25% ethanol to the antibiotic lock therapy combination of minocycline and edetate disodium, is highly efficacious in eradicating organisms embedded in biofilm on catheter surfaces and is well tolerated by patients. Ethanol has broad-spectrum antimicrobial activity against microbial organisms embedded in biofilm after a dwell time of only 1 to 2 hours; however, to use ethanol alone as a lock therapy would require a concentration higher than 40% to inhibit biofilm growth. Such high concentrations of ethanol as a catheter lock solution may be associated with side effects such as headache, dizziness, nausea, light-headedness, or dyspnea.

 The use of only 25% ethanol in combination with minocycline and edetate disodium, however, has been shown to enhance the rapidity with which the lock solution works to eradicate microbial organisms embedded in biofilm without the risk of toxicity that may accompany a high concentration of ethanol.

 A recently concluded prospective pilot study investigated the safety and efficacy of Mino-Lok Therapy (MLT) as an instrument for CVC (Central Venous Catheter) salvage in cancer patients. Thirty patients with CRBSI/CLABSI (Catheter-Related or Central Line- Associated Bloodstream Infection) were enrolled and received MLT for 2 hours daily for the first 5 to 7 days in combination with standard antimicrobial therapy. The first 5 doses were administered sequentially once daily (QD) for the first 5 days following enrollment, and the subsequent doses were administered over the following 2 weeks. Patients were followed for 1-month post-therapy. In 27 patients who received at least 5 doses of MLT, the CVCs (Central Venous Catheter) were retained for a mean duration of 91 days following study enrollment. Data demonstrates that MLT was safe and well tolerated, and that it was efficacious in achieving CVC salvage in the setting of CRBSI/CLABSI