Company
 

Milestones achieved

  • Proteo received approval to operate a gene technology facility
  • Successful completion of studies on acute toxicity of Elafin in mice and rats
  • Exclusive license- and collaboration-agreement with Artes Biotechnology GmbH for an expression technology
  • Results of a double-blind, placebo-controlled Phase I clinical trial with Elafin in healthy volunteers: The study demonstrated that Elafin was well tolerated over the dose ranges tested, which included the doses to be evaluated in Phase 2 trials
  • Elafin ranked as a Top 10 Cardiovascular Drug Development
  • European Commission granted Orphan Drug Designation to Elafin for the treatment of PAH
  • Proteo and Minapharm, Egypt, entered into a license agreement for clinical development, production and marketing of Elafin in Egypt, Middle Eastern and African countries
  • European Commission granted Orphan Drug Designation for Elafin for the treatment of esophageal cancer
  • Results of a double-blind, placebo-controlled Phase II clinical trial with Elafin in patients undergoing esophagectomy for esophageal cancer: Treatment with Elafin resulted in a significantly shorter intensive care unit stay. The favorable safety profile of Elafin was confirmed
  • FDA granted Orphan Drug Designation for Elafin for the treatment of pulmonary arterial hypertension
  • FDA granted Orphan Drug Designation for Elafin for the prevention of inflammatory complications of transthoracic esophagectomy
  • Results of a double-blind, placebo-controlled Phase II clinical trial in patients undergoing coronary bypass surgery: Significant reduction of cardiac troponin I within first 6 hours after Elafin treatment. The favorable safety profile of Elafin was confirmed
  • Proteo received Protocol Assistance from the Committee for Medicinal Products for Human Use at the European Medicines Agency ("EMA") with respect to the strategy for further clinical development and marketing authorization of Elafin for the prophylactic treatment of acute postoperative complications after resection of esophageal cancer
  • EMA paediatric committee adopted a positive opinion regarding Proteo's application for a product-specific paediatric investigation plan waiver for Elafin in the treatment of esophageal cancer
  • Proteo received GLP Certificate from Competent Authority

https://proteo.de/pages/company/milestones-achieved.html – printed on 2019-11-19 0:01:23