month=01
year=2010
04 January 2010
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For Immediate Release
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4
January 2009
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NovaBiotics Ltd
(“NovaBiotics” or the “Company”)
Successful Phase IIa Clinical
Development of its Nail Fungus Treatment, Novexatin®
Biotechnology company NovaBiotics, confirms that is has successfully completed
the dosing phase and initial analyses of its Phase IIa clinical trial for its
lead product Novexatin®, a brush on treatment for fungal nail
infection and is now in active discussions to outlicense the clinical
development of this product.
In the Phase IIa study,
48 patients have been dosed daily on one infected toe nail with Novexatin® over a 28 day period. The results of the study thus far have been very
encouraging with the end points of safety and tolerability having been
achieved. Moreover, the pharmacodynamic
assessment to determine the extent to which the drug candidate could penetrate
the nail revealed that samples from the majority of patients had no viable dermatophyte
fungi present after a month’s exposure to Novexatin®
or placebo control.
The study remains blinded until all follow-ups are complete, but
1/3 of the patients are on placebo control and 2/3 on active drug candidate. This rate of indicative
mycological cure after only 1 month of treatment is higher than has been
reported for existing remedies but importantly there is no evidence of any of
the potentially serious side effects reported for those treatments, most
notably liver damage.
Novexatin®
is part of a wider portfolio of products which are being developed. The next product in the pipeline will be Novamycin,
a candidate treatment for potentially life-threatening blood-stream and deep
tissue yeast and mould infections (predominantly Candida) which should enter
clinical development in 2010.
Dr Deborah
O’Neil, Founder, commented: “This study confirmed what we anticipated. Novexatin® is a unique product that can
address the global market of fungal nail infection, which is poorly served at
the moment. As such, Novexatin® has the
potential to access a significant proportion of a global market worth $5
Bn. .
We are now
actively in discussions with potential partners to further the clinical
development of this product and the availability of this very encouraging data
should now enable us to achieve our aim of taking this product to market.”
For
further information please contact:
For
further information please call:
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NovaBiotics
Ltd
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Dr Deborah O’Neil
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01224
711377
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Buchanan Communications
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Diane Stewart / Tim Anderson
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0131 226 6150 / 0207 466 5000
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Notes to
Editors
NovaBiotics is a clinical-stage biotechnology
company which was founded in 2004 and focuses on the design and development of novel
peptide antifungal and antibacterial therapeutics.
The Company offers an attractive mix of a
clinical product, unique platform technology and a robust product pipeline which
the directors believe have the ability to treat a range of poorly served and
economically significant infections including.
- Fungal nail infection
- Life-threatening blood stream and
deep tissue yeast and mould infections (e.g Candida)
- Respiratory Psuedomonal infections
and those associated with Cystic Fibrosis
- Antibiotic resistant and
susceptible dermal, blood stream and tissue Staphylococcal infections
- Acne and polymicrobial dermal
infections
The company has
a strong lead product in its first application for the topical treatment of
nail fungus (“NP213/NovexatinTM”).
Competitive
Landscape
The efficacy and
safety shortcomings of current therapies are such that patient usage is
restricted. In general, they involve lengthy application regimes, are costly
and associated with a high degree of relapse.
Available systemic treatments are also associated with potentially very
serious side effects and toxicity.
Novexatin®
has an established preclinical safety and toxicological profile and can be
delivered to the nail in such a way as to improve appearance and hydration of
the nail. Novexatin® penetrates
full-thickness nail, remaining active in the nail bed, without being absorbed
into the skin. All of these factors
are unique to Novexatin® which has also been designed with
cost-effective manufacture and flexibility of formulation in mind.