SU5416:
The Company initiated Phase I clinical testing in September 1997 with
its lead angiogenesis inhibitor, SU5416, a Flk-1/KDR TK inhibitor, which is
designed to inhibit the growth and spread of cancer by preventing the formation
of new blood vessels (angiogenesis) required to nourish the tumor. To date,
SU5416 has shown an excellent safety profile in over 100 patients with a range
of solid tumors, including advanced colorectal, lung and renal cell cancers, and
AIDS-related Kaposi's sarcoma; anecdotal indications of activity have been
observed in a number of patients, including prolonged periods of stable disease
and some instances of tumor shrinkage. After extensive consultation with
numerous oncology opinion leaders, the Company announced plans to accelerate the
development of SU5416 with the initiation of Phase III clinical trials in non
small cell lung and colorectal cancers, and Phase II/III studies in AIDS-related
Kaposi's sarcoma in the U.S. and Europe this year. Meanwhile, the Company will
be working with certain investigators on NCI-sponsored Phase II studies in other
cancer indications. This strategy may expedite the commercialization of SU5416,
which has the potential to become the first specific angiogenesis inhibitor to
reach the U.S. market. There can be no assurance that this commercialization
strategy will result in accelerated commercialization of SU5416 or that other
angiogenesis inhibitors will not receive regulatory approval prior to any
approval of SU5416.
from 10-K filed today |
