Photopharmica Phase 2 Data
IP Group PLC
04 July 2007
For immediate release 04 July 2007
IP Group plc
IP GROUP SPIN-OUT COMPANY, PHOTOPHARMICA, ANNOUNCES SUCCESSFUL PHASE II DATA
IP Group plc (LSE: IPO) ('IP Group'), the intellectual property
commercialisation company, is delighted to note that Photopharmica Holdings
Limited ('Photopharmica' or 'the Company'), a University of Leeds spin-out
company in which, as at the date hereof, IP Group has a 51.54% stake, has
announced the successful completion of the first ever Phase II
placebo-controlled clinical trial using topical photodynamic therapy (PDT) for
the treatment of microbial disease in wounds.
The trial employed Photopharmica's proprietary drug, PPA 904, a member of the
phenothiazinium family of photosensitisers. Photodynamic therapy with PPA 904
involves two stages: 1) the topical administration of PPA 904 to a site of
infection where the drug is absorbed by resident bacteria; 2) the application of
visible light of a pre-defined wavelength which triggers PPA 904 to release
highly potent 'singlet' oxygen, thereby killing those bacteria that have taken
up the drug.
The Phase IIa randomised, blinded, placebo-controlled study showed that a single
PDT treatment achieved a statistically significant reduction in the bacterial
load of chronic leg ulcers and diabetic foot ulcers compared with placebo.
Further analysis showed that several types of bacterial species were killed in
these treatments including MRSA.
In addition, there was evidence of a treatment effect on ulcer healing. For the
leg ulcer group, 4 of 8 patients on active drug (50%) achieved complete healing
within 3 months, whereas only 1 of 8 patients (12.5%) achieved complete healing
in the placebo group.
The treatment was found to be safe and well-tolerated by patients. No
treatment-related adverse events were reported.
Photopharmica plans to carry out further trials of PPA 904 in bacterially
colonised chronic ulcers commencing in 2008. The Company regards the success of
this first Phase II trial as a proof of principle which could lead to the
application of its antimicrobial technology to a range of infective conditions
involving skin and wounds.
The Company, which was established in 2001 to develop novel photosensitisers as
products for medical use, has opened up new applications of topical photodynamic
therapy and produced photosensitisers that have improved properties compared
with those previously available. Photopharmica's first clinical trial was
conducted in 2004.
Alan Aubrey, Chief Executive of IP Group, said: 'We are delighted that
Photopharmica has received successful phase II data. Photopharmica is the first
company in the IP Group portfolio to have reached this significant milestone
and, as such, demonstrates the continued development, depth and breadth of our
life sciences portfolio.'
Professor Stanley B Brown, Chief Scientific Officer of Photopharmica and
Director, Centre for Photobiology and Photodynamic Therapy at the University of
Leeds, said: 'Our novel antimicrobial photodynamic therapy has been in
laboratory development for several years but, for the first time, we now have
convincing proof from a randomised, controlled clinical trial, that it works in
patients and also evidence that it kills antibiotic resistant 'superbugs' like
MRSA. The data are especially promising in showing evidence that wound healing
may be accelerated in patients with long-standing, chronic leg ulcers. These are
exciting results which we hope will lead to this novel therapy becoming
available for the benefit of patients with a wide range of conditions.'
For further information, please contact:
IP Group plc
Alan Aubrey, Chief Executive Officer 020 7444 0050
Liz Vaughan-Adams (Communications) 020 7444 0062/07979853802
Buchanan Communications 020 7466 5000
Tim Anderson, Mary-Jane Johnson, Mark Court
Photopharmica 0113 384 5634
John Lyon, CEO
Professor Stanley B Brown, CSO
Notes for Editors
About IP Group
IP Group Plc is an intellectual property (IP) commercialisation company that
specialises in commercialising university technology. Founded in 2001, IP Group
listed on AIM in October 2003 and moved to the Official List in June 2006. It
has made two acquisitions to date - Techtran, a company set up to commercialise
university intellectual property under a long term contract with the University
of Leeds, in 2005 and Top Technology Ventures, an investment adviser to early
stage technology venture capital funds, in 2004.
IP Group has formed long-term partnerships with ten universities - the
University of Oxford, King's College London, CNAP/University of York, the
University of Leeds, the University of Bristol, the University of Surrey, the
University of Southampton, Queen Mary (University of London), the University of
Bath and the University of Glasgow.
As at 31 December 2006, 53 spin-out companies had been created among IP Group's
university partners. Of those, eight have listed on the AIM market of the London
Stock Exchange, one on PLUS Markets and there have been two trade sales. IP
Group also has three 'Modern-themed' subsidiaries - Modern Biosciences, Modern
Water and Modern Waste. Modern Water was the first of these subsidiaries to
float on AIM in June 2007.
For more information, please visit our website at www.ipgroupplc.com.
About Photopharmica
Diseases due to infection by micro-organisms, including bacteria, viruses, fungi
and parasites continue to present major problems to health. Concern about the
resistance to antibiotics and the consequent evolution of 'superbugs' has
increased enormously in recent years with governments, international agencies
and health care providers calling for new approaches to antimicrobial therapies.
Photopharmica has developed a new approach to antimicrobial therapy based on the
activation of novel photosensitizing drugs by light. This is analogous to the
photodynamic therapy (PDT) which has been used very successfully in
ophthalmology, but requires photosensitising drugs with the special
antimicrobial properties which Photopharmica has developed. The new technology
is applicable to a very wide range of diseases and is likely to be much less
susceptible to drug resistance than antibiotic therapy. The properties of
Photopharmica's drugs include:
• Broad spectrum kill - Photopharmica's light-activated drugs have already
been shown in vitro to kill many of the most common disease-causing
organisms including Gram positive bacteria (eg Staphylococcus aureus), Gram
negative bacteria (eg Pseudomonas aeroginosa and Esherischia coli), fungal
organisms (eg Candida albicans) and Leishmania parasitic organisms.
• Killing of antibiotic resistant bacteria (superbugs) - in vitro
Photopharmica's drugs kill MRSA as easily as the antibiotic sensitive form.
• Good selectivity for microbial versus host tissue.
• Drugs are easily made pure and scaled up to commercially required
quantities
For more information, please visit the website at www.photopharmica.com.
About the Phase IIa randomised, placebo-controlled clinical trial
Using its lead antimicrobial drug PPA 904, Photopharmica has completed the
first-ever controlled clinical trial in microbial disease using this novel
approach. This was carried out in 32 patients with chronic ulcers (leg ulcers or
diabetic foot ulcers) which were colonised by bacteria. These types of ulcer can
be of very long duration (months to years), can seriously impair the quality of
life of sufferers and, in the case of diabetic foot ulcers, can lead to
life-threatening conditions. They also represent a severe financial burden on
health care services. There is evidence that bacterial levels in the ulcer in
excess of 105 colony forming units (cfu) per cm2 can inhibit healing. The
rationale for the trial was therefore to use PPA 904 PDT to try to reduce the
bacterial colonisation of these chronic ulcers.
16 patients with chronic, colonised leg ulcers and 16 diabetic subjects with
chronic, colonised, foot ulcers, were recruited for the study. Drug or placebo
was applied topically followed by red light. Patients were given a single
treatment of either drug plus light or placebo plus light.
The trial primary end point was to determine if PDT can reduce the bacterial
levels of chronic ulcers in patients receiving PPA 904 and light, compared with
patients receiving placebo and light. The trial succeeded in reaching its
primary end point, demonstrating a statistically significant reduction in
bacterial load in ulcers of patients on active drug compared with those on
placebo. For the diabetic foot ulcer group analysed separately and for the leg
ulcer group analysed separately, in each case there was a statistically
significant decrease in bacterial load for patients on active drug, but there
was no significant decrease in patients on placebo.
The secondary end point was to see if there was any evidence for improved
healing in those patients receiving active therapy compared with those on
placebo, though the trial was not powered to demonstrate significance in
healing. For the leg ulcer group, 4 of 8 patients on active drug (50%) achieved
complete healing, whereas only 1 of 8 patients (12.5%) achieved completed
healing in the placebo group. In the diabetic foot ulcer group, insufficient
patients completed three months of study to permit statistical analysis.
Further analysis showed that several types of bacterial species were killed in
these treatments including MRSA. The treatment was found to be safe and
well-tolerated by patients. No treatment-related adverse events were reported.
The University of Leeds
The University of Leeds has a long history of successful entrepreneurial
activity based on leading edge research, generating more than 70 spin-out
companies to date. In the last 18 months three University of Leeds companies
have floated on AIM.
The White Rose Technology Seedcorn Fund
An early stage investment in Photopharmica was made in 2002 by White Rose
Technology Seedcorn Fund, an early stage seedcorn fund, which invests in
exciting new technology emerging from the universities of York, Leeds and
Sheffield.
The £9 million Fund provides venture capital funding of up to £250,000 (and
above for exceptional opportunities) to enable the transition from promising
research work to commercial reality.
Its portfolio of investee companies represent the commercialisation of high
quality science and technology combined with professional management teams to
produce investor-ready and partner-ready opportunities.
The Fund is owned by the Universities of York, Leeds and Sheffield, and managed
by Aberdeen Asset Managers.
Yorkshire Cancer Research
Yorkshire Cancer Research has a minority stake in Photopharmica, having
supported much of the PDT research at the University of Leeds which led to the
spin-out of Photopharmica. Since Yorkshire Cancer Research was set up in 1925,
it has become the most successful regional medical research charity in the UK.
It funds internationally recognised research into the cause and cure of cancer
at universities and their associated teaching hospitals throughout Yorkshire.
The concentration of specialists and expertise in this region means that cancer
sufferers in Yorkshire and throughout the world have access to some of the
world's best treatment and therapy.
For more information, please visit the website at www.ycr.org.uk.
ENDS
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