Press release
Break-through in cancer
treatment in Denmark
MEABCO A/S anti-cancer drug
BP-C1
Continues in phase IIB Clinical
trials
Meabco’s product portfolio
consists of a new class of cancer therapeutics, which set new norms
for future treatment of cancer diseases with significant advantages
for patients as well as the public health care system.
After
obtaining promising results from Clinical Phase I/II trials of its
anti-cancer drug BP-C1 with patients in Denmark, Meabco A/S will now
continue with phase IIB clinical trials.
As a first
indication, BP-C1 has been tested in clinical trials on breast
cancer patients with advanced cancer (mainly phase IV). The trials
have confirmed, that the use of BP-C1 on patients with this type of
cancer has good effect with very few, mild, transient adverse side
effects. These mild side effects should be viewed in conjunction
with a highly positive response rate. BP-C1 is administered as an
intramuscular injection. The treatment period is approximately one
month, and patients are normally not hospitalized.
The breast
cancer clinical trials began in Denmark at the end of 2005. In June
2006 the Danish Medicine Agency gave permission for the continuation
of the clinical trials of BP-C1.
The phase IIB
clinical trials will include patients with advanced breast cancer
and will be conducted as a series of randomized, placebo-controlled,
double blind tests – the so-called confirmative trials.
BP-C1 will
only be available in connection with the planned controlled trials
which are designed with the aim of obtaining a confirmative efficacy
and safety profile. On conclusion
of the clinical trials all data will be filed with the Danish health
authorities (the regulatory authorities) in order to obtain
marketing approval for the drug.
The breast
cancer trials will be followed by clinical trials of other cancer
indications, where preliminary positive patient results already
exist. Application for permission to conduct clinical trials on
such additional indications is expected to be filed in 4th
quarter of 2006.
The research
and development of the BP-C therapeutics started in mid 90ies. The
ongoing research is today conducted between Danish experts and the
company’s Russian researchers, who have been responsible for the
research and development activities in the initial phase. This
cooperation will strengthen in the years to come.
According to
Stig Löfberg, the managing director of Meabco A/S, the company has
developed a very interesting product-portfolio in the field of
cancer treatment and the breast cancer clinical trials will soon be
complemented with additional initiatives in the treatment of cancer
diseases.
