Futura Medical PLC
15 November 2004
Press Release 15 November 2004
Futura Medical announces preliminary
results from 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 clinical trial in healthy female volunteers ('
Subjects') at the internationally renowned Porterbrook Clinic in Sheffield, UK.
Ten Subjects completed a single-blind, placebo-controlled, phase I trial. Four
Subjects received placebo and three different lower-strength doses of Glyceryl
Trinitrate ('GTN'), whereas the remaining six Subjects received placebo and
three different higher-strength doses of GTN.
Application of the compound to the Subjects was found to be safe and well
tolerated at the lower-strength doses, with no adverse events experienced during
the twelve exposures. Subjects receiving the higher-strength doses reported
dose-related adverse events, predominately headaches, ranging from mild to
severe in intensity. No clinically significant changes in blood pressure,
haematology or biochemistry profiles were seen in any Subjects at any of the
dose levels.
Efficacy was assessed by monitoring vaginal microcirculation using
photoplethysmography. Positive responses were more frequent in the group
receiving the lower-strength doses, where the compound was also considered safe
and well tolerated. The pattern of changes observed mimic the blood flow
changes seen in women during clitoral stimulation and sexual arousal. These
preliminary results will allow Futura to select the preferred doses from the
lower-strength group for pivotal studies.
James Barder, Chief Executive of Futura, said: 'We are encouraged by these
preliminary results of this pilot study for FLD500. We will be discussing them
with our potential distribution partner in the near future before moving on to
conducting a pivotal study in 2005.'
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:
Abchurch
Peter Curtain / Alex Tweed Tel: +44 (0) 20 7398 7700
mailto: alex.tweed@abchurch-group.com www.abchurch-group.com
Notes to Editors:
Futura Medical plc
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 (now reformulated as MED2002),
a rub-on cream for erectile dysfunction ('ED'), completed its Phase II study,
which demonstrated a good safety profile and efficacy trends. MED2002 is
currently undergoing a final pharmacokinetic and dose evaluation study prior to
entering Phase III trials in Q2 2005.
A trial to assess the safety of MED2002 in angina patients has already been
successfully completed. Subject to regulatory approval the Company intends to
recruit men suffering from ED with mild to moderate angina into the Phase III
trial. Normal medications taken by angina patients prevent the use of available
ED treatments such as ViagraTM, CialisTM and LevitraTM.
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. An exclusive agreement with SSL
International plc, the maker of DurexTM, to distribute the product has been
signed.
FLD500, aimed primarily at female partners of male condom users, will help women
maintain lubrication during intercourse, thereby reducing the risk of condom
failure.
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.
www.futuramedical.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.