Pergamum to extend Phase II clinical trial for prevention of post-surgical adhesions
(Thomson Reuters ONE) -
Stockholm, Sweden - February 14, 2011. Pergamum AB - the Karolinska Development
dermatology and wound healing company - has received approval from the German
Regulatory Authority and the Independent Ethics Committee to begin a Phase II
clinical trial in Germany. The trial will monitor efficacy and safety of PXL01
for the prevention of post-surgical adhesions in patients undergoing hand
surgery.
"At this juncture, we feel very confident about the program and the strength of
our approach to investigate the effects of PXL01. The trial is currently ongoing
at several sites in Sweden and in Denmark. Extending the study to German centers
is an important milestone for our ongoing clinical program. I am delighted to
see that we add several world-leading clinical centers in Germany for
participation in our clinical program. This is an important foundation, not only
for this study, but also for future investigations in our therapeutic area",
said Jonas Ekblom, CEO of Pergamum.
The Phase II clinical trial monitors the safety and documents the efficacy of
PXL01 in reducing adhesion formation following flexor tendon repair surgery.
This indication allows for measurement of objective endpoints, rather than
subjective measurements of pain. The objective of the efficacy part of the study
is to see an improvement in finger mobility compared to placebo following
surgery. Success in the Phase II proof-of-concept study may enable the
development of similar treatments for a broad range of surgical procedures.
Annually, approximately 30 million surgical procedures are performed in the US
and Europe where the patient is at risk for the formation of surgical adhesions.
The company estimates that the global market for surgical sealants, wound
closure and anti-adhesion is in excess of EUR 7bn in 2011. Currently, there are
no pharmaceutical products available for prevention of adhesions after flexor
tendon surgery. A successful Phase II trial would open up the possibility for
the development of similar treatments for a variety of surgical procedures.
"Pergamum is indeed an important company within the portfolio of Karolinska
Development. I believe that following the consolidation of several of our
portfolio companies last year we have created a world class speciality pharma
company within dermatology and wound healing" said Torbjørn Bjerke, CEO of
Karolinska Development.
For further information, please contact:
Jonas Ekblom, President and CEO
Pergamum AB
Phone: +46 (0)70 551 66 60
jonas.ekblom(at)pergamum.com
Torbjørn Bjerke, CEO
Karolinska Development AB
Phone: +46 (0)72 744 41 23
torbjorn.bjerke(at)karolinskadevelopment.com
TO THE EDITORS
About Pergamum
Pergamum is a clinical-stage biopharmaceutical company developing state-of-the-
art products, based on therapeutic peptides for local application in
dermatology, wound healing and anti-infection. The peptides in development are
structurally derived from human motifs and optimized in terms of their
biopharmaceutical properties. Four programs are currently in clinical phase.
Pergamum recently merged and integrated three innovative biotech start-ups
(DermaGen, PharmaSurgics and Lipopeptide) into one operational company. This
unique business model enables Pergamum to pursue multiple exit and partnering
opportunities, and to improve return on venture capital.
About Karolinska Development
Karolinska Development aims to create value for investors, patients, and
researchers by developing innovations from world class research into products
that can be sold or out-licensed with high returns. The business model is to:
SELECT the most commercially attractive medical innovations; DEVELOP these to
the stage where the greatest return on investment can be achieved; and
COMMERCIALIZE the innovations through the sale of companies or out licensing of
products. This will result in upfront payments, milestone payments and
royalties.
An exclusive deal flow agreement with Karolinska Innovations, along with
cooperation agreements with other leading Nordic universities, ensures the first
right of refusal to a continuous flow of innovations.
Karolinska Developments flexible exit strategy enables projects to be exited at
whichever stage of development offers the greatest return on investment, usually
after Phase II clinical trials have indicated the desired pharmaceutical effect
on patients - this being an important value enhancing step.
Today, the portfolio consists of over 40 projects at various stages, from
concept development to Phase II clinical trials, twelve projects are in clinical
trials with six in Phase II. The portfolio is particularly strong in the areas
of cancer, dermatology, inflammation, cardiovascular disease, women's health and
diseases that affect the central nervous system. www.karolinskadevelopment.com
Press release as PDF:
http://hugin.info/143071/R/1488118/423603.pdf
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Source: Karolinska Development AB (publ) via Thomson Reuters ONE
[HUG#1488118]
Unternehmensinformation / Kurzprofil:
Datum: 14.02.2011 - 07:00 Uhr
Sprache: Deutsch
News-ID 51412
Anzahl Zeichen: 6029
contact information:
Town:
Solna
Kategorie:
Business News
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