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PRESS RELEASE
NicOx granted IND status for clinical testing of HCT 1026 in the US
Sophia Antipolis – France, January 7, 2002- NicOx S.A. (Nouveau Marché: NICOX) today announced that its Investigational New
Drug application (IND)* has been accepted by the US Food and Drug Administration (FDA) for the clinical testing of HCT 1026, its
nitric oxide-releasing derivative of flurbiprofen, for the treatment of urinary incontinence.
This approval will allow future clinical studies to be carried out in the US, expanding on the first Phase I & II clinical studies conducted
in Europe. A Phase II trial of the drug in overactive bladder has just been completed in the UK and the results are currently being
evaluated.
An estimated 110 million people worldwide suffer from some form of urinary incontinence and annual healthcare costs for the condition
have been estimated at over $16 billion. Drug therapy still represents only a small fraction of this value due to unmet medical needs. The
disorder becomes more prevalent with advancing age.
NicOx is pursuing a unique pharmacological approach to the condition based on the rationale that inhibition of prostaglandin synthesis
may reduce instability of the bladder muscle, which is a leading cause of urinary urge incontinence. The improved gastric tolerability of
HCT 1026 compared to the conventional NSAID (non-steroidal anti-inflammatory drug) flurbiprofen has the potential to allow its
administration for extended periods at fully active doses. The pharmacological activity of nitric oxide is also expected to enhance the
drug performance.
Michele Garufi, Chairman and CEO of NicOx, said:
“ The receipt of the US IND is an important step in the development of our lead compound and will enable us to conduct further
international trials in the urinary incontinence field. After the encouraging results last year from the pilot Phase II study in neurogenic
bladder, we expect to disclose the results of the second Phase II study in overactive bladder early this year and therefore make HCT 1026
an attractive product to potential licensing partners. We believe HCT 1026 represents an important new approach to the distressing and
increasingly prevalent condition of urinary incontinence. In addition, HCT 1026, as a novel and safe anti-inflammatory agent, is also in
development in a wide range of therapeutic areas such as Alzheimer’s and bone metabolism diseases”.
*An IND is an authorization from the FDA to administer an investigational drug or biological product to humans. Once the IND is submitted, the sponsor
(usually the manufacturer or potential marketer) must wait 30 calendar days before initiating any clinical trials. During this time, the FDA has an
opportunity to review the IND for safety to ensure that subjects will not be subjected to unreasonable risk.
NicOx is an emerging pharmaceutical company harnessing recently-discovered properties of nitric oxide to design and develop safer and more
effective drugs. NicOx is targeting several major pharmaceutical markets including pain and inflammation, cardiovascular diseases, respiratory
disorders, inflammatory bowel diseases, urinary incontinence, osteoporosis, certain dermatological disorders, certain liver diseases, Alzheimer’s
disease and cancer. Headquartered in Sophia-Antipolis, France, NicOx is a Public Company listed on the Nouveau Marché of Euronext Paris.
CONTACTS
NicOx
Corinne Hoff
Corporate Communications Manager
Tel: +33 (0)4.92.38.70.20
[email protected]
www.nicox.com
Financial Dynamics
Jonathan Birt/ Sarah Mehanna
Tel: +44 (0)20 7 831 3113
NicOx S.A.
2455, route des Dolines
Espace Gaia II –B.P. 313
06906 Sophia Antipolis, France
Tel: +33 (0)4 92 38 70 20
Fax: +33 (0)4 92 38 70 30