FOR INVESTORS
The Delcath System
Targeted delivery of high doses of
chemotherapy: The Delcath System allows
delivery of chemotherapy to the liver and removal
of the drug from the blood prior to return of
the blood from the liver to the patient's circulatory
system. The filtration protects other parts
of the body from the harmful side-effects of
chemotherapy, and allows for much higher doses
of drug and, potentially, improved efficacy.
NCI-Led Phase III trials underway:
The Phase III protocol received Fast Track designation
from the FDA and the trial is being conducted
under a Special Protocol Assessment (SPA). Patients
are being enrolled at the NCI and the University
of Maryland. Delcath will be expanding this
trial to additional centers to accelerate enrollment
and increase awareness.
5-year CRADA in place: In March
2007 Delcath Systems and the NCI expanded their
Cooperative Research and Development Agreement
(CRADA) for an additional five years, allowing
for collaboration in the joint development and
evaluation of the Delcath system, to continue
Phase II and III clinical trials and to evaluate
additional agents for use with the Delcath system.
Repeatability of process, potential
with other agents and organs: Unlike
regional delivery of chemotherapy to the liver
which requires a surgical procedure, the Delcath
system is non-invasive and, therefore, is repeatable.
The Delcath system’s versatility provides
it the potential to be used with different therapeutic
agents including oxaliplatin and interferon,
and for the isolated treatment of cancers in
limbs, the kidney and pancreas.
New management team brings focus:
Delcath has a new, experienced and capable management
team dedicated to advancing development of the
Delcath system. Strategic business experience
will be instrumental in building the company
and capitalizing on its technology assets.
|
