Date: 2015-09-19
Type of information: Interim results
phase: 3
Announcement: interim results
Company: Macrocure (Israel)
Product: CureXcell®
Action
mechanism: cell therapy. CureXcell® is containing activated homologous white blood cells prepared from donated healthy whole blood. These cells have been activated to facilitate the healing process and stimulate wound closure.
Disease: chronic venous leg ulcers
Therapeutic area: Cardiovascular diseases
Country: USA
Trial
details: The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo. (NCT02130310)
Latest
news: * On August 19, 2015, Macrocure, a clinical-stage biotechnology company focused on advancing its novel therapeutic platform to address chronic and hard-to-heal wounds, announced that a pre-specified, futility analysis conducted by the Data Safety Monitoring Board for CureXcell® - the Company\'s lead product candidate in its Phase 3 pivotal clinical study (MC-105) for venous leg ulcers (VLU) - determined that this study is not expected to meet its primary endpoint. Macrocure will evaluate the data collected in this study to determine an appropriate course of action, including the potential initiation of a third Phase 3 study in patients with chronic wounds below the knee. The company is also on track to report study results from its pivotal, Phase III Diabetic Foot Ulcer (DFU) clinical trial in October 2015. The primary endpoint of the study is the proportion of subjects with superior time to 100% closure at 12 weeks and sustained complete closure for four additional weeks (p-value ≤0.05). There are 265 patients enrolled in the study. Primary Outcome Measures: Time to complete closure of Target Ulcer at any time during the 12-week Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart. Secondary Outcome Measures: Proportion of complete closure of Target Ulcer within the Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart. Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase. Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.
