Abgenix Begins Phase 1 Study of ABX-PTH in Patients with Secondary Hyperparathyroidism
Tuesday February 3, 6:01 am ET
[It would really be interesting to hear what Abgenix think that they are doing. "Partner" Amgen already have a small molecule drug which is on cusp of approval for PTH. What does Abgenix believe their drug will do that Cinalcet does not? And where is the partner they say that they will always have for new drug development projects?].
FREMONT, Calif.--(BUSINESS WIRE)--Feb. 3, 2004--Abgenix, Inc. (Nasdaq:ABGX - News) announced today that the company has started a phase 1 clinical trial of ABX-PTH, a fully human monoclonal antibody generated by Abgenix's technology platform that targets and neutralizes the action of parathyroid hormone (PTH). The trial initiation follows acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA).
"This important achievement expands and broadens our development pipeline," said Ray Withy, Ph.D., president and chief executive officer of Abgenix. "It also meets our goal to advance one non-oncology product candidate into the clinic this year, as we continue to deliver on the promise of antibody therapeutics."
ABX-PTH is being developed for the treatment of secondary hyperparathyroidism (SHPT). SHPT is a chronic disorder that is frequently observed in patients with chronic kidney disease. Preclinical studies demonstrate ABX-PTH to be highly potent in in vivo models of SHPT.
"There is a clear medical need for new therapies to treat SHPT, which is characterized by elevated parathyroid hormone serum levels in response to abnormal calcium and phosphorus metabolism in serum and bone," said Gisela Schwab, M.D., chief medical officer of Abgenix. "Our fully human antibody ABX-PTH takes a novel approach to addressing SHPT, because it directly lowers serum levels of free parathyroid hormone."
About Secondary Hyperparathyroidism
As renal function declines, abnormal calcium and phosphorus metabolism and impaired vitamin D synthesis combine to increase serum PTH. Typically, the condition begins to manifest before dialysis and worsens while on hemodialysis often resulting in enlarged parathyroid glands that are refractory to treatment. SHPT can lead to significant morbidity including bone disease, soft tissue calcification and increased cardiovascular disease.
SHPT: An Unmet Medical Need
There are approximately 300,000 hemodialysis patients in the US (US Renal Data System), a significant proportion of whom suffer from SHPT. Currently available therapies including calcium supplements, nonabsorbable phosphate binders and vitamin D, have limited efficacy, poor compliance and/or are associated with significant toxicities. ABX-PTH could provide a significant therapeutic advance for the SHPT population by directly reducing bioactive PTH levels, rather than relying on the indirect mechanisms provided by current therapies. |
