Xenetic Biosciences recently announced that the drug developer’s Phase I clinical trial of its new cystic fibrosis treatment PulmoXen has yielded positive results in the treatment of the disease. The announcement comes as promising news for the 30,000 patients with CF who live in the United States, and who remain in serious need of a new generation of effective cystic fibrosis therapies that can improve lung function and mitigate lung infections associated with the disease.
The recently completed clinical trial marks a critical step for the biopharmaceutical company, as the development of a novel cystic fibrosis treatment has been one of its main focuses in an effort to develop next-generation biologic drugs. This recent Phase I study was conducted in collaboration with Xenetic’s partner, OJSC Pharmsynthez, in Russia. The study, which was the first of its kind in testing humans for PulmoXen administration, was conducted on twelve volunteers, who inhaled a daily series of two doses of 2500 IU and 5000 IU of the experimental therapy for seven days, as part of an effort to establish both safety and efficacy. Data confirmed that PulmoXen was found to be a safe and well tolerated drug for cystic fibrosis patients.
PulmoXen is a novel, modified form of recombinant human DNase I (rhDNase I), which is designed to function as a next-generation version of Pulmozyme, a well known treatment in the CF market that is frequently prescribed to patients. The enzymatic function of DNase I is related to the digestion of the DNA. When the therapy is delivered directly into the lungs, it can reduce the viscosity of infected lung secretions, as well as reduce bacterial biofilm formation in the lungs. As a result, DNase I can facilitate clearance of sputum, which contains significant amounts of extracellular DNA in CF patients. The result is an overall general improvement of lung function in cystic fibrosis patients.
Scott Maguire, CEO of Xenetic Biosciences said, “The positive data on this next-generation molecule targeting cystic fibrosis, a debilitating Orphan Disease, will allow Xenetic to pursue an Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA), in order to advance toward FDA-sanctioned Phase 1 clinical development.” He added that, “These Phase 1 results demonstrate the success and effectiveness of our business strategy to pursue initial development of our clinical pipeline through human trials with our Russian partners, providing Xenetic a potential pipeline of therapies while mitigating drug development risk. We look forward to working with the FDA to further advance the clinical development of PulmoXen.”
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