ICVT - Phase II Study Starts
02 Abril 2003 - 7:14AM
UK Regulatory
RNS Number:5319J
Henderson Morley PLC
02 April 2003
HENDERSON MORLEY PLC
2 April 2003
ICVT - PHASE II STUDY STARTS
The Directors of Henderson Morley are pleased to announce that the Phase ll
study to examine the use of Ionic Contra Viral Therapy ("ICVT") against a
genital infection known as VIN* has now started and the first patients have been
successfully recruited. The study is under the supervision of Professor Alison
Fiander, a leading expert in the field of Gynaecology, at the University Of
Wales, College Of Medicine.
Preliminary results are expected by the end of this year. The data created by
this study will be used to attract further commercial partners for the ICVT
platform.
This open label**, dose-escalating*** Phase ll study is directed against VIN,
which is caused by the Human Papilloma Virus, typically types 16 and 18. It
affects the genital tract of women and these viruses are also associated with
cancer of the vulva and vagina, and cancer and pre-cancer of the cervix.
The only treatments generally used against VIN are surgical - either removing or
destroying the infected tissue by laser or conventional surgery. This study will
examine the effects of ICVT when applied to infected tissue and has been
described by Professor Fiander's team as "a very important study".
The Company believes success in this study should have important implications
for the treatment of these other conditions.
Cancer of the cervix is the second most common cancer in women on a global basis
and causes an estimated 450,000 new cases and 200,000 deaths annually****. More
than 2.5 million women are diagnosed with low grade CIN (Cervical
Intra-epithelial Neoplasia or mild to moderate pre-cancerous changes)and a
further 200,000-300,000 are diagnosed with high grade dysplasia (more severe
pre-cancerous changes) each year in the USA alone. Worldwide the incidence is
much higher. (WHO figures)
*VIN or Vulval Intraepithelial Neoplasia is a disease of the female genital
tract caused by strains of HPV which, if untreated, may become cancerous. It is
unclear from previous studies what proportion of patients with VIN become
cancerous. Most patients with this condition will have symptoms of pain and
discomfort.
**.Open label studies are when the patient and the doctor treating them are both
aware of the drugs being used in the study.
*** Dose escalating studies are when the dose of drug being used to treat the
patient is gradually increased from very low doses to higher doses, depending on
the clinical response.
****Source: National Network of STD/HIV Prevention Training Centers Curriculum
Committee figures
ENDS
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
BARNES AND WALTERS LTD Tel: 020 7430 1600
Maxine Barnes Mobile 07860 489571
Editor's Notes
Human Papillomavirus ("HPV") is one of the most common causes of Sexually
Transmitted Disease ("STD") in the world. Experts believe that as many as 24
million Americans are infected with one of the 60-plus known types of HPV, with
this number appearing to be on the increase.
At present there is no cure for HPV, and no prevention besides abstaining from
skin-to-skin contact with the infected areas. Although a variety of treatments
are available, they typically act by killing the cell in which the virus lives
and not by directly killing the virus itself. This means the side effects of
treatment are often severe. These treatments can take various forms; for
example, chemical procedures, freezing or laser treatment. In extreme cases
surgery may be required to remove warts that have not responded to other
treatments.
A person infected with HPV may exhibit no visible symptoms; the virus may lie
dormant for many years. This can make it very difficult to identify an
infection, prevent transmission to others and reduce the chance of
complications. While many low-risk types of HPV cause little or no discomfort,
some high-risk types of HPV are very aggressive; HPV is responsible for over 99%
of all cervical cancers and over 50% of other anogenital cancers.
HPV is also the cause of genital warts that, with at least 1 million new cases
diagnosed in the USA alone every year, is the fastest growing viral STD.
Genital warts are spread by sexual contact with an infected partner and are very
contagious, with approximately two-thirds of people who have had sexual contact
with an infected person developing warts of their own. Genital warts are
particularly hazardous to pregnant women, possibly causing problems during
delivery. It is also rare - but not unheard of - for infants born to women with
genital warts to develop the potentially life-threatening condition Laryngeal
Papillomatosis (warts in the throat).
A doctor can usually diagnose genital warts by visual examination, but a Pap
smear test may be necessary to identify the presence of a cervical HPV
infection. Typically, a pre-cancerous cervical disease such as this is readily
treatable using destructive methods such as laser or cryotherapy.
This information is provided by RNS
The company news service from the London Stock Exchange
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