Result of pilot med. trial
Futura Medical PLC
21 April 2004
Draft Press Release 21 April 2004
Futura Medical announces successful
pilot stage of FLD500 study
Futura Medical plc ('Futura'), the AIM-quoted pharmaceutical drug and medical
device group that develops innovative products for the sexual healthcare market,
announces the completion of the pilot stage of a clinical trial in healthy
female volunteers ('Subjects') at the internationally-renowned Porterbrook
Clinic in Sheffield.
Four Subjects completed a single-blind, placebo-controlled trial, during which
they received placebo as well as three different-strength doses of the compound
under development.
Two Subjects (50%) demonstrated enhanced blood circulation on exposure to the
compound. Of these, one responded to the two highest doses while the second
responded to the highest dose. The pattern of these responses mimics exactly
the blood flow changes in women during clitoral stimulation and sexual arousal.
There were no corresponding responses by any of the Subjects to placebo doses.
Application of the formulation to the Subjects was found to be safe and well
tolerated. There were no adverse events in any Subject at any dose, nor
clinically significant changes in blood pressure, haematology and biochemistry
profiles.
In accordance with the original study protocol a further six subjects are now
being recruited to support these early observations, as well as providing the
opportunity to use higher dose levels to further increase response rates without
compromising Subject safety or tolerability.
James Barder, Chief Executive of Futura, said: 'This pilot study demonstrates
that local application of our compound can improve blood flow in a way that
mimics the female physiological response during clitoral stimulation and sexual
arousal. Increased lubrication caused by the compound could provide a
therapeutic intervention for women with certain sexual problems such as low
libido and/or poor lubrication. Furthermore, enhanced lubrication resulting
from increased blood flow would reduce the risk of condom slippage and breakage
during sexual intercourse.
'It is estimated that two out of every five women experience some form of sexual
dysfunction during their lives and that approximately 2% of condoms slip off
during intercourse increasing the risk of unwanted pregnancies and the
transference of sexual transmitted infections.'
For further information:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 845 670
mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk
Media enquiries:
Bankside
Peter Curtain / Alex Tweed Tel: +44 (0) 20 7444 4140
mailto:alexandra.tweed@bankside.com www.bankside.com
Notes to Editors:
Futura Medical ('Futura' or 'the Company') is an AIM-listed pharmaceutical drug
and medical device group developing innovative products for sexual health. The
Company is developing a portfolio of products with the intention of licensing
their manufacture and distribution to major pharmaceutical and healthcare
groups. Several agreements have been signed.
Futura's primary focus is on Over the Counter ('OTC') products with particular
appeal to men and women who are reluctant to discuss potentially embarrassing
sexual matters with their doctors.
In June 2003 the Company's first product, MED2001, a rub-on cream for erectile
dysfunction (ED), completed its Phase II study, which demonstrated a good safety
profile and efficacy trends. MED2001 is likely to enter Phase III trials later
in 2004, prior to a regulatory submission in 2005.
A trial to assess the safety of MED2001 in angina patients is underway. Normal
medications taken by angina patients prevent the use of available ED treatments
such as Viagra(TM), Cialis(TM) and Levitra(TM).
The Company's second product is CSD500, a latex condom incorporating within its
teat a gel to help healthy men maintain an erection throughout intercourse, so
reducing the likelihood of condom slippage. The regulatory dossier is scheduled
for submission in 2004. An exclusive agreement with SSL International plc, the
maker of DurexTM, to distribute the product is expected to be income generating
in 2005.
FLD500, aimed primarily at female partners of male condom users, will help women
maintain lubrication during intercourse, thereby reducing the risk of condom
failure.
www.futuramedical.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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