Insmed Reports Results from Nine Months of SomatoKine Therapy
2004-09-13 11:21 (New York)
for a Patient with Extreme Insulin Resistance at the 43rd Meeting of the
European Society of Pediatric Endocrinology
Health/Medical Writers / Business Editors
43rd Annual Meeting of the European Society of Pediatric
Endocrinology
RICHMOND, Va.--(BUSINESS WIRE)--Sept. 13, 2004
Results Show Lowered HbA1c From 7.6% to 6.1%
Insmed Incorporated (NASDAQ: INSM) today reported on results from
a nine-month analysis of therapy with SomatoKine(R) (rhIGF-I/rhIGFBP-3
(mecasermin rinfibate) for a patient with Leprechaunism, the most
extreme form of insulin resistance. The nine-month analysis
demonstrated substantial improvements in growth, metabolic control,
and neurological development. Of significant importance, the patient
has surpassed the average expected life-span for Leprechaunism, and
continues to receive therapy to date. No adverse effects related to
SomatoKine treatment were observed.
The results from the nine-month analysis were presented at the
43rd Annual Meeting of the European Society of Pediatric Endocrinology
(ESPE) by Marc De Kerdanet, M.D. of the University Center Hospital,
Rennes, France and Andreas Sommer, Ph.D., Insmed's Chief Scientific
Officer.
The patient, referred to as Rennes-1, was a 4-month old female
diagnosed with Leprechaunism. The diagnosis was confirmed by
identification of two mutations in the insulin receptor gene. Prior to
treatment, the patient had extremely high insulin levels (5490uU/mL),
severe growth retardation (-3.3 SDS in height; -3.4 SDS in BMI), and
poor blood sugar control.
After nine-months of treatment with SomatoKine(R), the following
observations were made:
1. IGF-I levels were restored within normal range,
2. HbA1c, a primary measure of blood sugar control, was reduced
from 7.6% to 6.1%,
3. Circulating mean insulin levels were reduced 742% from
5490uU/mL to 652uU/mL,
4. Standard height deviation improved from -3.3 to -2.2 SDS, Body
Mass Index (BMI) improved from -3.4 SDS to -1.7 SDS,
5. No adverse effects related to SomatoKine treatment were
observed.
The abstract is available on Insmed's corporate website,
www.insmed.com.
About Leprechaunism
Leprechaunism is characterized by extreme insulin resistance
associated with a genetically defective insulin receptor resulting in
hyperinsulinemia, uncontrolled glycemic variation, failure to thrive
and short life expectancy. Leprechaunism is the most severe form of
insulin resistance amongst a group of extreme insulin resistance
syndromes that include Type A syndrome, Rabson-Mendenhall syndrome and
type B syndrome.
More on SomatoKine(R) (rhIGF-I/rhIGFBP-3)
Insmed's rhIGF-I/rhIGFBP-3 is a proprietary delivery composition
of insulin-like growth factor-I (IGF-I). The novel compound is
administered as a subcutaneous injection, which can restore IGF levels
to physiological relevant levels. In diabetic subjects, administration
of rhIGF-I/rhIGFBP-3 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 rhIGF-I/rhIGFBP-3 demonstrated a significant
improvement in muscle protein synthesis and a significant reduction in
the inflammatory response associated with the trauma. In recovery from
hip fractures, administration of rhIGF-I/rhIGFBP-3 has demonstrated a
significant improvement in functional recovery and bone mineral
density. rhIGF-I/rhIGFBP-3 is currently in a pivotal Phase III
clinical trial for the treatment of Growth Hormone Insensitivity
Syndrome (GHIS).
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. |
