Insmed Reports Update on Pivotal Clinical Trial with
2004-07-20 16:05 (New York)
SomatoKine: Statistically Significant Increase in Growth Rate Observed at Six Months
RICHMOND, Va.--(BUSINESS WIRE)--July 20, 2004
Insmed Incorporated (Nasdaq: INSM) today provided an
update on the Company's ongoing pivotal Phase III clinical trial
evaluating SomatoKine(R) (rhIGF-I/rhIGFBP-3) in children with severe
short stature due to growth hormone insensitivity syndrome (GHIS). The
six-month data analysis showed a statistically significant increase
(p<0.0001) in height velocity in children receiving SomatoKine(R) as a
once-daily injection. The profile of activity observed at six months
with once-daily injections of SomatoKine(R) was similar to that
observed by Pharmacia(Pfizer(NYSE: PFE)) in their pivotal study in
which twice-daily injections of rhIGF-I were given to a similar
population of patients. SomatoKine(R) was well tolerated and safely
increased and sustained circulating IGF-I (insulin-like growth
factor-I) levels in the study population. The full results from this
pivotal trial will be presented in a scientific forum in 2005.
This prospectively designed Phase III trial is intended to
evaluate the safety and efficacy of SomatoKine(R) in prepubescent
children with GHIS. The multi-center, open label study is led by a
formal Steering Committee of GHIS thought leaders consisting of Louis
Underwood, M.D., Professor of Endocrinology, University of North
Carolina, Chapel Hill, Martin Savage, M.D., Professor of Pediatric
Endocrinology, St. Bartholomew's Hospital, London and Cecilia
Camacho-Hubner, M.D., Reader of Pediatric Endocrinology, St.
Bartholomew's Hospital, London. The Steering Committee was established
to prospectively identify GHIS patients for this clinical trial and to
evaluate the safety and efficacy of SomatoKine(R) in this patient
population on an ongoing basis.
GHIS is a genetic condition in which patients produce insufficient
IGF-I to stimulate normal linear growth. IGF-I is essential for proper
growth and metabolism. Children with GHIS do not recognize or respond
to endogenous or exogenous human growth hormone, and as a result, fail
to produce physiologically relevant levels of IGF-I.
More on SomatoKine(R)
Insmed's SomatoKine(R) (Mecasermin rinfabate) is a proprietary
delivery composition of insulin-like growth factor-I (IGF-I) bound to
its primary binding protein, IGFBP-3. The novel compound is
administered as a once-daily subcutaneous injection, which can restore
IGF-I levels to physiological relevant levels. In diabetic subjects,
administration of SomatoKine(R) demonstrated a significant improvement
in blood sugar control and a significant reduction in daily insulin
use. Following severe burn injury, in both children and adults,
administration of SomatoKine(R) demonstrated a significant improvement
in muscle protein synthesis and a significant reduction in the
inflammatory response associated with the trauma. Following recovery
from hip fracture, administration of SomatoKine(R) has demonstrated a
significant improvement in functional recovery and bone mineral
density. SomatoKine(R) is currently in a pivotal Phase III clinical
trial for the treatment of Growth Hormone Insensitivity Syndrome
(GHIS), a severe growth disorder. |
