Pharmasurgics to Begin Phase II Clinical Trial for Prevention of Post-Surgical Adhesions
By Pharmasurgics Ab, PRNEWednesday, December 2, 2009
GOTHENBURG, Sweden, December 3 - Pharmasurgics AB - part of the Karolinska Development
dermatology and wound healing company "Pergamum" - today announced that
Pharmasurgics has received approval from the Swedish Medical Products Agency
to begin a Phase II clinical trial. The trial will begin in December 2009 and
will monitor the safety and efficacy of PharmaSurgics' novel candidate drug
for the prevention of post-surgical adhesions in patients undergoing hand
surgery. Post-surgical adhesions are bands of scar tissue connecting anatomic
sites in the body that should not normally be connected. These develop after
almost every type of surgery and can cause severe symptoms. PXL01 is based on
an endogenous human peptide with pronounced anti-inflammatory and
antimicrobial effects. It is formulated in a gel that provides a burst of the
active pharmaceutical ingredient directly after application combined with
slow release during the healing period.
PharmaSurgics' Managing Director, Margit Mahlapuu, said,
"Entering Phase II development is an important milestone for the company. It
follows a strong preclinical program and good safety and tolerability results
from the Phase I trial. Current treatment options for preventing
post-surgical adhesions are all based on physical barriers and have failed to
meet the efficacy levels demanded by surgeons. PXL01 has the potential to
deliver improved efficacy and to become the first anti-adhesion product on
the market based on pharmaceutical properties."
Jorgen Thorball, Pergamum's Chairman, commented,
"PharmaSurgics has developed an extremely interesting and novel approach in a
market with significant unmet medical needs. Success in the Phase II
proof-of-concept study will enable the development of similar treatments for
a very broad range of surgical procedures. Considering the substantial costs
that post-surgical adhesions represent in today's healthcare systems there is
tremendous market potential for new, more efficacious treatments."
The Phase II clinical trial will monitor the safety and
document 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 strength and mobility compared to placebo following surgery. The
prospective, randomized, double-blind and placebo-controlled trial will be
conducted at three of Sweden's leading hand surgery clinics and will include
approximately 140 patients.
Conny Bogentoft, CEO of Karolinska Development, said,
"PharmaSurgics is making excellent progress. It also provides a good example
of how Karolinska Development's business model is able to take a scientific
concept from bench to clinical development extremely quickly and efficiently.
Our overall portfolio, and particularly the Pergamum group, continues to go
from strength to strength as more companies reach Phase II."
About PharmaSurgics
PharmaSurgics in Sweden AB is a biotech company that develops
and commercializes novel treatments for the prevention of harmful scarring
and promotion of wound healing after surgery. PharmaSurgics' product concept
is based on proprietary synthetic peptides which have strong
anti-inflammatory and anti-infectious properties. The company is located in
Gothenburg, Sweden and was founded in 2005 based on extensive research by Dr.
Inger Mattsby-Baltzer and Professor Kjell Olmarker at Sahlgrenska University
Hospital, Gothenburg, Sweden. PharmaSurgics is part of the Pergamum group of
companies.
www.pharmasurgics.se
About Pergamum
Pergamum AB is a new kind of biopharmaceutical company focusing solely on
dermatology and wound healing markets. The company currently has four
Operating Units, which it supports with strategic management, business
development, drug development and operational assistance as required.
Pergamum is a Karolinska Development AB company.
www.pergamum.com
About Karolinska Development
Karolinska Development manages one of the largest portfolios of life
science companies in Europe. Using a unique, highly cost-efficient business
model, the management team guides the commercialization of world-class life
science innovations, helping to shape the next-generation pharma industry.
Since 2003, Karolinska Development has built a portfolio of some 40
companies; among the company's projects 12 compounds are undergoing clinical
trials. The portfolio also includes a total of 19 potential
first-in-class products.
www.karolinskadevelopment.com
For further information, please contact: Margit Mahlapuu, CSO, Managing Director, PharmaSurgics in Sweden AB Phone: +46(0)31-762-29-02 / Mobile: +46(0)706-310-109 E-mail: margit.mahlapuu@pharmasurgics.se Jorgen Thorball, Chairman, Pergamum AB Phone: +45(0)307-786-27 E-mail: jorgen.thorball@pergamum.com Conny Bogentoft, CEO, Karolinska Development AB Phone: +46(0)70-668-61-43 E-mail: conny.bogentoft@karolinskadevelopment.com
For further information, please contact: Margit Mahlapuu, CSO, Managing Director, PharmaSurgics in Sweden AB, Phone: +46(0)31-762-29-02 / Mobile: +46(0)706-310-109, E-mail: margit.mahlapuu at pharmasurgics.se; Jorgen Thorball, Chairman, Pergamum AB, Phone: +45(0)307-786-27, E-mail: jorgen.thorball at pergamum.com; Conny Bogentoft, CEO, Karolinska Development AB, Phone: +46(0)70-668-61-43, E-mail: conny.bogentoft at karolinskadevelopment.com
Tags: Gothenburg, Pharmasurgics Ab, sweden