MagForce Nanotechnologies AG, the Berlin-based medical technology company
majority owned by Nanostart
AG, today announced the successful completion of phase II clinical trials
demonstrating the efficacy of its Nano-Cancer® therapy in patients with
recurrent glioblastoma, a frequent form of brain tumor which is highly malignant.
The actual study results significantly exceeded the study objective.
According to a previous study among a large patient population, the median
survival time following diagnosis of a glioblastoma recurrence and treatment
with conventional therapy (surgery, chemotherapy and radiation) is 6.2 months.
The primary objective for the Nano-Cancer® therapy study was to demonstrate
an extension of the median survival time in the recruited patient group by three
months compared to this historical control group.
In fact, the median survival time of the 59 patients participating in the phase
II clinical trials was 13.4 months following treatment with Nano-Cancer®
therapy in conjunction with radiation. The median survival time was thus significantly
greater, more than double that of the control population.
The results were even more remarkable in that Nano-Cancer® therapy was
tested not on newly diagnosed patients with primary tumors but rather as a study
involving patients who had already endured treatment with conventional therapies,
as well as the unpleasant effects generally associated with these. Following
regulatory approval of the new therapy, it is expected that it will also be
available for use in treating other types of localized tumors, as these are
generally responsive to the same principle of using warmth to destroy or degrade
cancer cells.
MagForce founder and chief scientific officer Dr. Andreas Jordan commented,
“The results demonstrate the potential of Nano-Cancer® therapy, which
at the same time has minimal patient side effects. Our vision is to establish
this new technology alongside surgery, chemotherapy and radiation as an additional
pillar of cancer therapy.”
Marco Beckmann, CEO of Nanostart AG, went on to add, “We enthusiastically
congratulate Dr. Jordan and his team on the superb study results. It is my belief
that we may thank nanotechnology for a historical advance in medical science.”
In addition to its high efficacy of which has now been conclusively demonstrated,
Nano-Cancer® therapy offers an additional and very significant advantage
compared to the existing conventional therapy alternatives of surgical intervention,
chemotherapy and radiation: Nano-Cancer® therapy is tolerated extremely
well by patients and, despite its high efficacy, has no serious or unpleasant
side effects.
The results of these clinical trials will now form the basis of application
for EU regulatory approval for the new therapy, which will be submitted before
the end of this year. Once EU regulatory approval has been obtained, MagForce
will be able to market its Nano-Cancer® therapy throughout the European
Union. The detailed study results will be published shortly in a medical journal.
Nano-Cancer® therapy represents a completely new way to fight cancer and
is world’s first approach to use magnetic nanoparticles to treat tumors
with virtually no side effects. This is done by injecting specially coated iron
oxide nanoparticles directly and precisely into the tumor so that they remain
concentrated in the tumor and do not diffuse into the surrounding healthy tissue.
The nanoparticles within the tumor are then heated to an exact temperature by
externally applying an external magnetic field. In this way, tumor temperatures
of up to 70°C (158°F) can be precisely attained within a fraction of
a degree. This heat damages the tumor or destroys it completely. During the
treatment procedure, patients feel only a moderate warming sensation.
Nanostart AG has been Lead Investor in MagForce Nanotechnologies since 2004
and currently holds approx. 77% of its shares.