Biotech Tracker News - AMG073 Moves Forward
November 04, 2002 Amgen (NASDAQ: AMGN) and NPS's (NASDAQ: NPSP) AMG073 (cinacalcet) continues to generate phase II data supporting ongoing pivotal trials for the treatment of hyperparathyroidism. The current data, presented at the 35th annual meeting of the American Society of Nephrology (ASN), demonstrate AMG073’s ability to reduce and maintain parathyroid hormone (PTH) levels within the target range in end stage renal disease (ESRD) patients with secondary hyperparathyroidism (HPT). These studies add to the strength of earlier mid-phase data, including those presented at last year’s American Society for Bone and Mineral Research meeting that showed treatment effects in primary hyperparathyroidism. Phase III trials of the agent were launched December 2001.  In the first of several presentations at ASN, a methodologically sound, randomized, double-blind, placebo-controlled, 12-week trial enrolled 82 dialysis-dependent patients with refractory secondary hyperparathyroidism. AMG073 was administered at doses up to 180 mg. AMG073 contributed to PTH reductions to target levels in 54% of study subjects. The effects of co-administered drugs appeared to be well-matched between groups. In an ancillary investigation, AMG073 administration was also associated with a reduction in frequency of self-reported cognitive problems such as confusion, difficulty thinking, and forgetfulness. The degree to which these effects prevailed was not clearly established. Its adverse effect profile was reassuring, and evidence existed that suggests that calcium- and phosphorus-related longer-term adversities may be reduced compared with competitors.  A second presentation provided an update regarding promising two-year data for dialysis-dependent patients with secondary hyperparathyroidism. After one year of treatment, 50% of AMG073 recipients versus 12% of placebo recipients experienced at least 30% PTH reduction. For extension-phase AMG073 recipients, after two years, 55% experienced at least 30% PTH reduction. The compound’s adverse effect profile was reassuring, and additional evidence of the potential diminution of calcium- and phosphorous-related complications was evident.  In a third presentation, AMG073 was not associated with adverse effects at the level of bone microarchitecture after one year of use.  AMG073 is Amgen’s lead calcimimetic compound. Like calcium itself, the compounds interact with calcium dependent receptors on the parathyroid glands, increasing their sensitivity to blood calcium levels and leading to diminished PTH secretion. Elevated PTH, in all of its forms, is associated with bone pain, fractures, and increased mortality.
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