Insmed Initiates Phase I Clinical Study for Novel Anti-Tumor
2004-09-08 16:30 (New York)
Protein
Health/Medical Writers / Business Editors
BIOWIRE2K
RICHMOND, Va.--(BUSINESS WIRE)--Sept. 8, 2004
Insmed, Inc. (NASDAQ: INSM) announced today the
initiation of a Phase I clinical study for the company's novel
anti-tumor agent, recombinant human Insulin-Like Growth Factor Binding
Protein-3 (rhIGFBP-3). The Phase I clinical study is an open-label,
dose-escalation study designed to evaluate for the first time in
humans, the safety, tolerability and pharmacokinetics of a single
intravenous dose of rhIGFBP-3. The primary goal of this 30 patient
study is to identify the appropriate dose of rhIGFBP-3 for a planned
Phase II clinical trial in 2005.
"The FDA's approval of growth factor inhibitors to treat cancer
not only validates this approach but also encourages the development
of other growth factor inhibiting agents, such as rhIGFBP-3" noted
Laura Shiry, Ph.D., Insmed's head oncology scientist. "Our research
shows that rhIGFBP-3 is an essential regulator of the IGF signaling
pathway, which is known to be permissive to tumor growth while
facilitating other tumor-promoting pathways, including EGF and VEGF.
We have what we believe to be solid preclinical evidence demonstrating
that rhIGFBP-3 could provide substantial benefit in treating a number
of human cancers, including those of the breast, prostate, colon and
lung."
The Role of rhIGFBP-3 in the Tumor Growth
Insulin-Like Growth Factor Binding Protein-3 (IGFBP-3) is a
naturally occurring protein in the body whose normal role is to
regulate the activity of Insulin-Like Growth Factor-I (IGF-I).
Although the IGF-I is critical for normal growth and metabolism,
aberrant signalling through this pathway is closely linked to the
abnormal and unregulated growth of a variety of tumors. Blocking
tumor-associated IGF signaling has been proven to prevent tumor growth
in a variety of preclinical models. In preclinical models, rhIGFBP-3
has demonstrated efficacy in preventing tumor formation and
progression. Based on these findings, Insmed is developing rhIGFBP-3
as a novel anti-IGF-I treatment for cancer.
About Insmed
Insmed is a biopharmaceutical company focused on the discovery and
development of drug candidates for the treatment of metabolic diseases
and endocrine disorders with unmet medical needs. For more
information, please visit www.insmed.com. |
