CMOs speed Citius Pharmaceuticals into Phase 3
- Two large contract manufacturers have signed on to produce components of Citius Pharmaceuticals' Mino-Lok product for clinical trials, speeding the New Jersey-based specialty pharma towards initiation of clinical development by early 2017.
- Citius Pharmaceuticals’ Mino-Lok is a minocycline-based antibiotic lock solution that can be used to treat patients with catheter-related bloodstream infections (CRSBIs) as well as salvaging infected central venous catheters.
- According to the company, about 7% of central venous catheters become infected, leading to CRSBIs, which can be dangerous for already vulnerable patients.
Central venous catheters (CVCs) are life lines for many patients, delivering vital intravenous drugs and allowing blood tests without the need for frequent blood draws and needle insertions. However, among the 7 million CVCs put in each year, nearly 500,000 cause CRSBIs.
Citius' Mino-Lok, used in combination with systemic antibiotics, is designed to eradicate bacteria in the CVC so the catheter can remain in place, avoiding the complications tied to catheter removal, along with related costs. For some patients, such as those on chemotherapy and dialysis, there may be few suitable alternative sites.
The two components of Mino-Lok will be packaged separately, and then mixed at the clinical trial site. Work has started at both CMOs: a large global CMO will manufacture the minocycline, and then pass it on to a US-based CMO, which will package the two components.
A previous Phase 2b clinical trial showed a 100% efficacy rate in salvaging infected CVCs and a Phase 3 trial is planned for 2017.
Mino-Lok has no direct competitor for catheter salvage, according to Myron Holubiak, Citius Pharmaceuticals’ president and CEO.
- Citius Pharmaceuticals Statement
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