NovaBay Pharmaceuticals (NYSE Amex: NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces that in tests conducted at a third-party laboratory, NovaBay’s lead Aganocide, NVC-422 has shown in vitro activity against the “superbug” New Delhi Metallo-beta-lactamase-1 (NDM-1)-encoded Klebsiella pneumoniae at a very low concentration of 2 micrograms per milliliter. In comparison, Imipenem, which is a mainstay antibiotic for the treatment of antibiotic-resistant bacterial infections, is not effective against NDM-1-encoded strains.
NovaBay currently is engaged in testing additional strains of E. coli and K. pneumoniae encoded with NDM-1 gene. The company previously reported that NVC-422 was effective in vitro against resistance phenotypes of E. coli and K. pneumoniae, including extended-spectrum beta-lactamase (ESBL) and multidrug-resistant (MDR) strains. NovaBay intends to publish and present the full data set at the upcoming Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
K. pneumoniae and E. coli have been identified as a cause of severe infections, sepsis and possibly death. In a number of non-systemic/topical opportunities of interest to NovaBay’s development, both these superbugs are major risk factors. These include catheter-associated urinary tract infections (UTIs); respiratory tract infections, including those caused by cystic fibrosis; and wound infections, including venous stasis, pressure ulcers and diabetic ulcers.
Dr. Ron Najafi, CEO of NovaBay Pharmaceuticals, said, “We were very excited to see the in vitro activity results of NVC-422 against NDM-1 strains. In fact, we have collected data indicating that NVC-422 is also effective in vitro against all six highly resistant pathogens know as ESKAPE: Enterococcus faecium, Staphylococcus aureus, Klebsiella species, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter which are the cause of much of the hospital-associated infections today. We intend to translate this activity into products that will benefit patients in need. Both UTI and chronic non-healing wounds will be the future breeding ground for NDM-1 producing bacteria.”
NovaBay is currently engaged in a Phase 2 human trial for urinary catheter blockage and encrustation (UCBE) leading to urinary tract infections, and the company and its partner Galderma S.A. are engaged in the clinical development of its lead compound for the treatment of impetigo, a highly contagious infection with potential benefit in chronic wound care management.
About the NDM-1 gene
NDM-1 is an enzyme that makes bacteria resistant to a broad range of beta-lactam antibiotics. These include the antibiotics of the carbapenem family, which are a mainstay for the treatment of antibiotic-resistant bacterial infections. The gene for NDM-1 is one member of a large gene family that encodes beta-lactamase enzymes called carbapenemases. Bacteria that produce carbapenemases are often referred to in the news media as “superbugs” because infections caused by them are difficult to treat.
NDM-1 was first detected in a Klebsiella pneumoniae isolate from a Swedish patient of Indian origin in 2008. It was later detected in bacteria in India, Pakistan, the United Kingdom, the United States, Canada, Japan and Brazil. The most common bacteria that make this enzyme are Gram negative such as Escherichia coli and Klebsiella pneumoniae, but the gene for NDM-1 can spread from one strain of bacteria to another by horizontal gene transfer.
NovaBay’s Aganocide® compounds are novel, synthetic N-chlorinated antimicrobial molecules specifically designed and developed to mimic the body’s natural defense against infection. The topical Aganocide compounds maintain biological activities while demonstrating improved stability over the naturally occurring N-chlorinated antimicrobial molecules. In preclinical testing, NovaBay’s Aganocide compounds have been shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA), viruses and fungi. NovaBay’s Aganocide compounds have the potential to deliver the same or better efficacy than antibiotics, and to address the growing problem of antibiotic resistance by employing a novel mechanism of action.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary and patented topical Aganocide compounds, which are novel, synthetic anti-infective product candidates with equivalent activity to the active antimicrobial molecules generated within white blood cells. NovaBay’s topical Aganocide compounds are being developed to treat and prevent a wide range of infections without causing bacterial resistance. NovaBay has internal development programs aimed at addressing hospital infections, chronic non-healing wounds, UCBE and onychomycosis. The company has a license and research collaboration agreement with Alcon, Inc. for use of its Aganocide compounds to treat eye, ear and sinus infections as well as for contact lens care. NovaBay has also entered into an agreement with Galderma S.A. to develop and commercialize Aganocide compounds in acne, impetigo and other dermatological indications. For more information on NovaBay, visit: www.novabaypharma.com
Cautionary Information Regarding Forward-Looking Statements
This release contains forward-looking statements, which are based upon NovaBay’s current expectations, assumptions, estimates, projections and beliefs. The statements in this press release of NovaBay’s expectations regarding (i) the publication of the full data set at the upcoming ICAAC, (ii) NovaBay’s intention to translate its Aganocide® compound activity into products that will benefit patients in need and (iii) the safety and efficacy potential for its Aganocide® compounds, as well as other statements that relate to future events or results, are forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to: the risk that NovaBay may incur unexpected charges or need to or determined to engage in research and development not previously planned, which could delay or prevent it from conducting the trials it expects; the risk that regulatory requirements and approvals will not be met or obtained, which would prevent NovaBay from commercializing its products; and results obtained in pre-clinical trials are not necessarily indicative of results that would be obtained in human clinical trials. Other risks relating to NovaBay and its Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s Quarterly Report on Form 10-Q for the period ended September 30, 2010, under the caption “Risk Factors” in Item 1A of Part II of that report, filed with the Securities and Exchange Commission on November 12, 2010. The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
NovaBay Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson
The Investor Relations Group