CTXR~~Citius Pharma Offers Status Report On Mino-Lok, CITI-002
9:49 am ET December 19, 2018 (Benzinga) Print
Mr. Myron Holubiak, CEO of Citius, said, "While there are significant challenges involved with studying an adjunctive therapy in patients with underlying serious life-threatening diseases, we are extremely pleased with the progress that has been made in the Phase-3 Mino-Lok® clinical trials. Our investigators confirm that there is a great need for an effective solution to salvaging infected central lines in patients with catheter-related blood stream infections (CRBSIs) so that they can have an alternative to removing and replacing these catheters in these very sick and compromised patients. It is important to have evidence from a controlled trial that an antibiotic lock can be as effective as catheter removal, especially in Staph. infections. Also, as it relates to CITI-002, our plans to use a more potent corticosteroid have proceeded well; and, we feel we can be ready to conduct the necessary animal toxicity study that is necessary with that type of change, and quickly move into phase 2b trials. Both treatments have shown significant potential in addressing their respective underserved markets. Additionally, Citius has secured patents for Mino-Lok® in both the US and Europe that protect the product throughout the year 2036, and will be pursuing a patent for CITI-002. Management has successfully raised capital to use toward developing both products and, assuming clinical success and sufficient resources, we look forward to advancing into commercialization stage in the near future."
Mino-Lok®
Mino-Lok® is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs). CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs), and in hemodialysis patients where venous access presents a challenge. The Mino-Lok® Phase 3 Trial is planned to enroll 700 patients in 50 participating institutions, all located in the U.S. There will be interim analyses at the 50% and 75% point of the trial as measured by the number of patients treated. Currently, there are 20 active sites enrolling patients including such academic centers as MD Anderson Cancer Center, Henry Ford Health Center, Georgetown University Medical Center, University of Chicago, and others. There are 15 additional well renowned medical centers in startup mode. When these study centers are activated, site recruitment will have reached 70% of the target institutions planned; and, there are another 30 centers in feasibility stage.
Mino-Lok received notice from MD Anderson Cancer Center ("MDACC") that the US Patent and Trademark Office ("USPTO") issued United States Patent Number 10/086,114 entitled "Antimicrobial Solutions with Enhanced Stability" on October 2, 2018. Protection on Mino-Lok extends to November 4, 2036.
There are currently no approved therapies to salvage infected central venous catheters (CVCs).
Mino-Lok® is under investigation and not approved for commercial use.
CITI-002: Hemorrhoid Topical Program
The original topical preparation, CITI-001, was a combination of hydrocortisone acetate and lidocaine hydrochloride. The new formulation, CITI-002, will combine lidocaine with the higher potency corticosteroid for symptomatic relief of the pain and discomfort of hemorrhoids. While not used in combination in currently marketed products, the proposed corticosteroid is included as an FDA-approved topical product to treat a variety of dermatological disorders. The changes in the program are as follows:
Selection of higher potency corticosteroid for the Phase 2b trial to improve efficacy and faster onset of symptomatic relief;
Target population to include patients with Grade 2 and 3 hemorrhoids;
One month dog toxicity study planned prior to initiation of clinical trial;
Possibility of extended intellectual property as compared to hydrocortisone combination; and,
Program revised as discussed with the FDA.
In March 2018, Citius held a Type C meeting with the FDA to discuss the results of the Phase 2a study and to obtain the Agency's view on development plans to support the potential formulation change for the planned Phase 2b study. Citius also requested the Agency's feedback on the Phase 2b study design, including target patient population, inclusion/exclusion criteria, and efficacy endpoints. The pre-clinical and clinical development programs for CITI-002 are planned to be similar to those conducted for the development of CITI-001 to support the design for a planned Phase 3 clinical trial.
In August 2018, the Company raised $10 million with the intent to use the capital from the raise towards our Phase 3 clinical Mino-Lok trial for the treatment of catheter related bloodstream infections (CRBSIs), and Phase 2b clinical trial of CITI-002 for the symptomatic treatment of hemorrhoids. More than $23 million has now been invested into the Company privately by
