First-In-Class Oral Calcimimetic Shown To Reduce Parathyroid Hormone Levels In Chronic Kidney Disease
PHILADELPHIA, PA, November 3, 2002
- Amgen (Nasdaq: AMGN), the world's largest biotechnology company,
today announced phase 2 data for Amgen's investigational compound
AMG 073 (cinacalcet HCl) suggesting that AMG 073 can reduce and
maintain parathyroid hormone (PTH) levels within the target range
in end stage renal disease (ESRD) patients with secondary hyperparathyroidism
(HPT). Elevated PTH is associated with bone pain, fractures, and
increased mortality risk. The data was presented at the 35th annual
meeting of the American Society of Nephrology (ASN).
Data were also presented that suggest that AMG 073
may also reduce the frequency of self-reported cognitive problems
(such as confusion, difficulty thinking, and forgetfulness) in patients
with secondary HPT. The improvement seen in the AMG 073 group was
due, at least in part, to reductions in PTH.
Achieving Target PTH Levels
The study was a randomized, placebo-controlled, double-blind, 12-week
trial. AMG 073 was given at doses up to 180 mg to 82 hemodialysis
patients with pre-study PTH levels >300 pg/mL -- a high level
-- despite receiving standard therapy. AMG 073 reduced PTH to the
target level in 54% of patients who were not controlled on current
therapy. Concomitant vitamin D and phosphate binder use was similar
between treatment groups. AMG 073 was well-tolerated and adverse
events were similar in the two treatment groups.
"AMG 073 reduced PTH levels to the target range
in the majority of these patients who were not previously controlled
with standard care," said Dr. Block. "These results demonstrate
the potential benefit of AMG 073 as a novel therapy for the chronic
treatment of secondary hyperparathyroidism. Because AMG 073 appears
to reduce PTH without increasing Ca x P levels, it may offer advantages
over current therapies." [ASN poster # SU-P0509; Block, et
Promising New Class and Compound
AMG 073 is the first compound in the Calcimimetics drug class. Calcimimetic
compounds bind to and modulate the calcium-sensing receptors on
the parathyroid gland, increasing sensitivity of the receptors to
calcium levels in the bloodstream, which leads to a rapid reduction
in PTH secretion from the gland. Calcimimetic agents, such as AMG
073, may provide therapeutic benefits in controlling PTH and ameliorating
bone disease without increasing Ca x P levels. The current standard
of care for these patients typically includes vitamin D sterols,
which can result in interruptions of vitamin D therapy, and elevations
of blood calcium and/or phosphorus levels.
Phase 3 trials for AMG 073 were launched December
Other AMG 073 Studies Presented at ASN
Two-Year Treatment with
Calcimimetic AMG 073 in Hemodialysis Patients with Secondary Hyperparathyroidism
Another study presented at the conference supports the benefit of
long-term calcimimetic administration in addition to standard therapy.
At the end of one year of treatment, 50 percent of AMG 073 patients
had a 30 percent or greater reduction in PTH from baseline levels,
compared to 12 percent of placebo patients. After this one-year
study period, patients continued receiving AMG 073 for a second
year. After two years total study duration, 55 percent of AMG 073
patients had a 30 percent or greater reduction in PTH. AMG 073 treatment
also prevented Ca x P levels from increasing over two years of treatment.
Elevated Ca x P levels have been linked to increased risk of cardiovascular
complications and death. [ASN poster #SU-P0508; Moe, et al.]
Self-Reported Cognitive Functioning in Hemodialysis
Patients with Secondary Hyperparathyroidism: The Effect of the Calcimimetic
Prior research in animal models and humans suggests that high levels
of PTH may impair cognitive function in patients with secondary
HPT. Reducing and maintaining target levels of PTH may lower the
frequency of self-reported cognitive problems (e.g., confusion,
difficulty thinking, forgetfulness, etc.) in patients with secondary
HPT. This pooled analysis of two phase 2 studies suggests that the
frequency of self-reported cognitive problems may be reduced with
AMG 073, as compared to placebo, at least in part due to reductions
in PTH. Larger controlled studies are needed to further clarify
these findings. [ASN poster #SU-P0800; Chertow, et al.]
The Effects of One-Year Treatment with the Calcimimetic
AMG 073 on Bone Health in ESRD Patients with Secondary Hyperparathyroidism
In this study, no deleterious effects on bone histology were seen
in patients receiving AMG 073 for one year. The observed trends
toward improving bone histology in the small number of patients
studied who received AMG 073 will need to be confirmed in larger
studies. These findings suggest a potential benefit of AMG 073 on
bone disease in patients with ESRD. [ASN poster #: SU-P0510; Quarles,
AMG 073 (cinacalcet HCl) is a pipeline product from Amgen, the company
that revolutionized anemia treatment with the discovery of recombinant
erythropoietin, which is currently marketed by Amgen as EPOGEN®
and by Johnson & Johnson as Procrit®.
Amgen also developed Aranesp® (darbepoetin alfa)
which provided another option in anemia treatment that resulted
in a unique molecule with an approximately three times longer half-life
and greater biological activity than Epoetin alfa with the added
benefit of less-frequent dosing schedules, while also retaining
a similar safety profile.
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Cary Rosansky, 805/447-4634 (investors)
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