Start of Phase II Studies
November 27 2003 - 1:00AM
UK Regulatory
RNS Number:5502S
Henderson Morley PLC
27 November 2003
Henderson Morley PLC
27 November 2003
Start of Phase II studies
Following Croma Pharma's successful completion of the initial (Phase I) work on
the ocular application of ICVT, the Directors of Henderson Morley are pleased to
announce the start of patient recruitment in an International, multi-centre,
randomised, double-blinded placebo controlled phase ll clinical trial. The study
will examine the safety and efficacy of Ionic Contra Viral Therapy (ICVT), the
Company's lead technology, when used to treat Adenovirus Keratoconjunctivitis.
The study, funded by Croma, will recruit 140 patients and be carried out in six
centres in Austria and Slovakia.
Patients will be monitored by slit lamp microscope at several stages of the
infection, and only patients who have a positive diagnosis of adenovirus
infection (confirmed using molecular biological techniques) will be included in
the study. The treatment will be in the form of aqueous drops applied during the
course of the infection and it is anticipated that patients will not require
treatment for longer than 21 days.
Adenovirus Keratoconjunctivitis
Adenoviral keratoconjunctivitis is a highly contagious disease that occurs
worldwide sporadically and epidemically. Although not permanently blinding,
adenoviral ocular infections remain the most common external ocular viral
infection worldwide. The natural course of the acute phase of adenoviral
keratoconjunctivitis has a wide spectrum of duration and intensity of local
symptoms. After an incubation period of 2 to 14 days, symptoms usually begin in
one eye, and the other eye becomes symptomatic after 2 to 4 more days. Typical
symptoms include conjunctival hyperemia and chemosis, swelling of the
conjunctival plica, and intense tearing. Conjunctival pseudomembranes occur in
some cases. The corneal involvement sets the adenoviral keratoconjunctivitis
apart from other forms of viral conjunctivitis. During the course of the
infection corneal subepithelial opacities frequently develop. These nummular
opacities or infiltrates can impair visual function and can persist for months
to years, and therefore make treatment of this debilitating condition desirable.
Currently, no specific antiviral therapy is available to shorten the course of
the infection, to improve the distressful clinical symptoms, to stop viral
replication, or to avoid the development of corneal opacities.
Ionic Contra Viral Therapy
ICVT is an innovative compound for treating virus infections. It exploits the
little known finding, that many of the biological processes involved with virus
DNA synthesis are sensitive to local potassium ion concentrations.
ICVT uses a proprietary combination of two established drugs currently used in
cardiovascular medicine that have no prior use as anti-virals. The component
drugs used in ICVT cause depletion of intracellular potassium and inhibit the
replication of DNA viruses, while normal host cell metabolism and function is
only minimally affected. By combining two compounds that act on ion transport in
different ways, the antiviral effect is enhanced. This combination therefore
offers the prospect of preventing viral replication with little or no adverse
effects.
The anti-viral effects of the two drugs in ICVT are synergistic. The effects of
ICVT on host cell metabolism have been measured in a variety of cell lines and
the rate of cell metabolism is unaffected by prolonged incubation with ICVT.
Pilot human studies have not demonstrated any local or systemic toxicity when
used at anti-virally effective doses.
Additionally, the component drugs used in ICVT have a long history of being
widely co-prescribed in the treatment of cardiovascular disease. As such, ICVT
offers potential in the treatment of a range of viral infections for which
current therapy is inadequate, such as adenovirus.
The directors believe that no other antiviral treatments are under clinical
development for Adenovirus Keratoconjunctivitis, and if further studies prove
successful ICVT could address a sizeable market of unmet medical need.
ICVT is currently being investigated as a treatment for several other DNA virus
infections, and clinical developments will be reported in due course.
Timeline of Phase II studies
Croma anticipates providing early verbal results in February 2004, and formal
written results in April 2004.
Andrew Knight, Chairman of Henderson Morley, commented: "This is a very
important study for both Croma and Henderson Morley. Not only will the resultant
data be used to take the technology on to a Phase III trial but it will be used
to secure out licenses in other territories, not covered by the original Croma
agreement."
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Copies of this announcement will be available free of charge to the public at
the Company's registered office at Metropolitan House, 2 Salisbury Road,
Moseley, Birmingham, B13 8JS and at the offices of Brewin Dolphin Securities
Ltd, 34 Lisbon Street, Leeds LS1 4LX for 14 days.
Enquiries:
HENDERSON MORLEY PLC Tel: 0121 442 4600
Andrew Knight, Chairman
BREWIN DOLPHIN SECURITIES LTD Tel: 0113 241 0126
Neil Baldwin
BISHOPSGATE COMMUNICATIONS Tel: 020 7430 1600
Maxine Barnes Mobile 07860 489571
This information is provided by RNS
The company news service from the London Stock Exchange
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