BRIGHTON, UNITED KINGDOM — (Marketwire) — 03/26/12 — Clinical stage pharmaceutical company Destiny Pharma today made two important announcements about its lead drug for the prevention of post-surgical Staphylococcal infections, XF-73. The drug has progressed through the Food and Drug Administration (FDA) to an open Investigational New Drug (IND) status and Phase I clinical evaluation is being initiated in the US. The clinical trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This latest evaluation follows three successful XF-73 clinical trials in the UK.
The clinical trial will study Staphylococcus aureus (SA) decolonization as well as safety and tolerability in more than fifty subjects who are treated with XF-73 or placebo. The study will go beyond the UK trials by more accurately simulating patient SA decolonization, important in mitigating the risk of subsequent SA infection.
Infection remains a worrying complication for hospital admissions. The most common cause of infection is the bacteria Staphylococcus aureus (SA). Methicillin-Resistant Staphylococcus aureus (MRSA) decolonization is now practiced in many countries, but the continuing problem of bacterial resistance prevents the protection being extended to the larger number of patients who could benefit. There is global need for drugs that can effectively prevent SA infections in patients without succumbing to bacterial resistance. In the US alone it is estimated drug-resistant forms of SA such as MRSA result in 19,000 deaths per year(2). The annual cost of Staphylococcus aureus infection in the US is put at $9.5 billion(3).
Studies to date have shown XF-73 is rapidly bactericidal and has unique abilities to prevent bacterial resistance(1). Its creators at Destiny Pharma believe XF-73 could be used to prevent potentially fatal SA infections, an approach which is becoming compromised due to a limited number of antibiotics and antibiotic-resistance.
NIAID-s funding is part of its commitment to explore innovative approaches to the problem of antimicrobial resistance. The Institute uses its clinical research infrastructure to support the evaluation of drugs that may be able to address significant public health needs.
Dr Bill Love, CEO of Destiny Pharma commented: “We-re very pleased to have the IND open for XF-73 which is a significant milestone for the Company on the route to the global development of this important new antibacterial drug. We could not have better partners in the form of NIAID and look forward to the next stages of developing this drug and enabling its use in hospitals.”
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. 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: 1177-1181 No. 3
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3. Noskin GA, et al. The burden of Staphylococcus aureus on hospitals in the United States: an analysis of the 2000 and 2001 Nationwide inpatient sample database. Arch Intern Med (2005); 165: 1756-61
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 nation-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 .
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 .
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 .
Contacts:
Destiny Pharma
Vicky Hoad
+44 7725 554895 or +44 1273 704440