Modex Completes the Enrollment Milestone for EpiDex(TM) Phase II Trial
LAUSANNE, Switzerland, Jan. 22 /PRNewswire/ --
Modex Therapeutics Ltd (SWX New Market: MDXN) announced today that it had
completed the enrollment of the first 40 patients for a Phase II clinical
trial with its EpiDex(TM) skin replacement product.
This clinical trial is a comparative study between the tissue engineered
skin product, EpiDex(TM), developed by Modex, and the surgical autograft,
currently regarded as the gold standard for the treatment of the most severe
chronic skin ulcers. The trial is being conducted at twelve centers in Europe
of which four are in Switzerland and eight are in Germany. This first part of
the study, which involved the treatment of 40 patients with very hard to heal
skin ulcers will yield intermediary results in the second quarter of 2001. To
complete the trial, a further 40 patients will be enrolled during the first
quarter of 2001, giving a total of 80 participants.
The objective of the trial is to establish the clinical efficacy of
EpiDex(TM) as an alternative treatment to the expensive, painful, and
unpopular split thickness mesh grafting currently in use. EpiDex(TM)
application is a simple, non-surgical procedure that can be carried out in the
doctor's surgery, without the need for hospital admission.
The current EpiDex(TM) trial is a milestone trial in the field of
Dermatology in that it is the first time that an artificially produced human
skin equivalent is being compared to the current gold standard treatment of
the surgical autograft.
The trial is an open, randomized, multi-center Phase II trial with 50% of
the patients receiving EpiDex(TM) treatment and 50% the split thickness mesh
grafting. The first endpoint will be the rate of complete healing after
12 weeks of receiving the treatment. The second endpoint will be the time to
complete healing. The intermediate results of the first 40 patients in the
trial will be published in the second quarter of 2001.
"We are very pleased that we have met our enrollment target for this key
trial," commented Dr Jacques Essinger CEO of Modex. "The enrollment target of
40 patients by the end of 2000 was one of the key milestones we committed to
during our IPO roadshow in June, confirming the development of EpiDex(TM) is
on target."
A Leader in the Field of T3R
Modex Therapeutics Ltd is a Swiss biotechnology company based in Lausanne
with a focus on tissue repair, replacement and regeneration (T3R). T3R
heralds a new era for healthcare, aiming at regenerating cells for the repair
or replacement of deficient tissue proprietary and exclusively licensed
technologies. The strategy of the company is to in-license advanced and
promising T3R technologies, to drive them to a mature stage, and to realize
the added value by licensing or selling the developed products to
pharmaceutical, biotechnology or medical device companies.
Further information regarding Modex can be found on the web site
mdxn.ch .
SOURCE Modex Therapeutics Ltd
Web Site: mdxn.ch |
