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Part 2 of NIAID-Funded US Clinical Trial of Anti-Staphylococcal Nasal Gel XF-73 Begins Enrollment

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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.

Dr Bill Love, CEO of Destiny Pharma commented: "Progression into Part 2 of this important US clinical trial for XF-73 is a significant milestone. The new clinical guidelines underline the need for new therapies that are not associated with a risk of resistance development, something that we obviously believe XF-73 will be able to provide."

XF-73 is a novel dicationic porphyrin with rapid bactericidal activity against Gram-positive bacteria including Staphylococcus aureus (methicillin sensitive and multi-drug resistant strains including MRSA).

References:

1. http://www.cdc.gov/mrsa/statistics/MRSA-Surveillance-Summary.html

2. Noskin GA, et al. National trends in Staphylococcus aureus infection rates. Impact on economic burden and mortality over a 6 year period (1998 -2003). Clinical Infectious Disease, (2007), 45, 1132-40.

3. Bratzler et al. Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery. Am J Health Syst Pharm, (2013),70,195-283 http://www.ashp.org/DocLibrary/BestPractices/TGSurgery.aspx.

4. Farrell D, et al. Investigation of the Potential for Mutational Resistance to XF-73, Retapamulin, Mupirocin, Fusidic Acid, Daptomycin, and Vancomycin in Methicillin-Resistant Staphylococcus aureus Isolates during a 55-Passage Study. Antimicrobial Agents and Chemotherapy, (2011), 55, (3), 1177-81

About Destiny Pharma:

Destiny Pharma, a clinical stage pharmaceutical company, was founded in 1997. The Company focuses on the R&D of new antimicrobial drugs, with an emphasis on novel mechanisms of action which seek to address a top 3 global healthcare issue, namely, microbial drug resistance. XF-73 is the Company's lead drug which has completed Phase I clinical development in the UK. Through its extensive business network and strategic partnerships, Destiny Pharma intends to globally commercialise candidates from the XF Drug platform which are differentiated by design from traditional antibiotics.

About the NIH and NIAID:

NIH, the U.S. medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research-at NIH, within the U.S. and worldwide-to study the causes of infections and immune-mediated diseases and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website at www.niaid.nih.gov.

Forward Looking Statement:

This press release contains forward looking statements that are subject to risks and uncertainties and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Destiny Pharma disclaims any intent or obligation to update forward looking statements except as required by law.

For further information about NIAID, visit www.niaid.nih.gov.



Contacts:
Destiny Pharma
+44 1273 704440
pressoffice@destinypharma.com
www.niaid.nih.gov



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