Futura Medical PLC
21 November 2005
For immediate release 21 November 2005
Futura Medical plc
Announces preliminary results
from MED2003/5 pharmacodynamic study
Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device group
that develops innovative products for the sexual healthcare market, announces
the completion of the second of two clinical trials in healthy male volunteers
(Subjects) to evaluate three novel formulations of its topical gel for the
treatment of erectile dysfunction (ED).
Fifteen healthy males have completed a placebo controlled, double-blind,
randomised study. Each Subject received four different doses of glyceryl
trinitrate (GTN) in gels that were applied directly to the penis. The gels have
been designed to deliver GTN into the penile tissues more efficiently than
previous formulations.
As with the initial pharmacokinetic study, the results of which were announced
on 7 November 2005, an excellent safety profile was observed. Dose-dependent
side effects, which were predominantly mild headaches resolving without the need
for treatment, were seen in fewer than 10% of all dosing events. No serious
adverse events were recorded and no falls in blood pressure occurred in any of
the subjects at any GTN dose. As with the pharmacokinetic study, GTN doses up
to 0.25mg were found to be safe and well tolerated.
The effects of GTN on penile blood flow were assessed during this study using
Doppler ultrasound technology. Despite the lack of sexual stimulation, many
Subjects displayed penile blood flow changes following GTN dosing which were
consistent with those seen during sexual arousal. In particular, the rate of
blood flow into the penis, as recorded by the Peak Systolic Velocity (PSV),
demonstrated increases in most of the Subjects on application of drug relative
to baseline and compared with placebo. For example, with the preferred
formulation approximately 70% of Subjects showed a greater increase in PSV
relative to baseline compared with placebo, an outcome that was statistically
significant.
Dr Paul Sidhu, a consultant radiologist at King's College Hospital, London, and
one of the leading experts in penile Doppler ultrasound, confirmed that the
changes recorded by Doppler ultrasound after exposure to the gels were
consistent with those seen during sexual arousal. He also felt this was an
encouraging indicator of the potential efficacy of the gels for the treatment of
erectile dysfunction which will need to be verified by the Phase III clinical
programme.
James Barder, Chief Executive of Futura, said: 'These results are excellent.
When considered with the recent pharmacokinetic results we believe that they
provide an excellent platform for our Phase III programme. Futura is firmly on
track to developing the world's first 'non-prescription' treatment for erectile
dysfunction.'
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:
Buchanan Communications
Mark Court / Tim Anderson / Rebecca Dietrich Tel: +44 (0) 20 7466 5000
Notes to Editors:
Futura Medical plc
Futura Medical 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. Exclusive
worldwide distribution agreements have already been signed in respect of
Futura's two condom safety products, CSD500 and FLD500, with SSL International
plc, the makers of Durex(TM) condoms.
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 March 2005 Futura announced it had entered into exclusive discussions until
31st December 2005 with a major global pharmaceutical group on a proposed
agreement for the worldwide development and marketing of MED2002 (MED2003,
MED2004 & MED2005 are revised formulations of MED2002).
This was to allow time for discussions, joint co-operation and certain
development work on MED2002 to be completed with a view to entering into a
potential global distribution agreement.
Phase III trials are scheduled to commence in 2006.
For further information please visit: www.futuramedical.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange