BRIGHTON, United Kingdom -- (Marketwired) -- 05/20/13 -- Clinical stage pharmaceutical company Destiny Pharma today announced the further progression of the Phase I US clinical trial of its lead drug XF-73 to Part 2 of the trial.
Part 1 investigated XF-73's safety, tolerability and distribution, while the forthcoming Part 2 will additionally investigate the efficacy of the drug for nasal decolonization of Staphylococcus aureus (SA) in modified gel formulations when applied for several days under conditions akin to those experienced in hospitals.
The trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is taking place at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland.
The clinical trial is studying Staphylococcus aureus (SA) decolonization (i.e. the clearance of SA from the nostrils of carriers) as well as safety and tolerability in more than fifty subjects who are treated with XF-73 or placebo. Further information about this clinical trial is available at http://clinicaltrials.gov/ct2/show/NCT01592214.
SA infection remains a worrying complication for hospital admissions. In the US alone it is estimated drug-resistant forms of SA, such as methicillin-resistant SA (MRSA) result in more than 19,000 deaths annually (1), whilst the annual cost of all SA infections in surgical patients is put at $12.3 billion (2).
Nasal decolonization of SA to reduce the risk of infection has been used in many countries and individual institutions, particularly for the patients at risk from MRSA. The continuing problem of bacterial resistance is a significant issue for widespread adoption of nasal decolonization in all patients at risk of SA infection. This is because SA can and already has demonstrated its ability to generate resistant strains to the main antibiotic (mupirocin) currently used for nasal decolonization. Increased use of the antibiotic might lead to increased prevalence of resistant SA strains which could become dominant.
New guidelines (3) jointly published in February 2013 by the US Surgical Infection Society (SIS), the American Society of Health-System Pharmacists (ASHSP), the Infectious Diseases Society of America (IDSA), and Society for Healthcare Epidemiology of America (SHEA) reflect the benefits that can be seen from extension of nasal decolonization beyond MRSA to all SA strains in higher risk surgeries. At the same time the guidelines highlight the concerns of emergent resistance against mupirocin.
Compared with existing antibiotics, XF-73 has a novel structure and mechanism of action, kills SA rapidly and does not appear to generate resistance in SA (4). It is administered nasally. Its creators at Destiny Pharma believe that these features make it an ideal candidate to widen the scope of SA nasal decolonization beyond the highest risk patient groups to all those at risk who may benefit - a target perhaps unattainable for existing agents due to the existence and fear of resistance development.
Most Popular Stories
- Accenture Gets 8 Percent Bump in Q1
- Insurance Rule Change Angers Industry
- Revised GDP Up 4.1 Percent in 3rd Quarter
- Obama Opens Last-Minute Loophole in Insurance Law
- Obama's Dad Was Abusive Drunk, Half Brother Says
- Alex Kinsey, Sierra Deaton Crowned 'X-Factor' Champs
- Economic Growth Boosts U.S. Futures
- The Costs of Repealing Obamacare
- Lockheed Martin Ends Gifts to Boy Scouts Over Gay Ban
- Verizon to Issue Transparency Report