NPS reports interim Preos carcinogenicity results
SALT LAKE CITY, UTAH, Aug 15, 2002 -- NPS Pharmaceuticals reported interim results from an ongoing 24-month preclinical carcinogenicity study with Preos, its proprietary drug candidate for treating osteoporosis.
A planned histopathological evaluation of a sub-set of rats confirmed that osteosarcoma has not yet been observed in study animals. The Company cautioned that this interim result reflects 12 months of treatment with Preos, and that final results will be available after the 24-month study is completed in 2003.
The absence of osteosarcomas after 12 months of dosing was expected, based on previously reported studies using peptides related to PTH such as teriparatide or analogs of parathyroid hormone-related peptide (PTHrP). It should be noted that in the teriparatide study an increased incidence of osteosarcoma in rats was observed in the final 12 months of the study.
While osteosarcomas have not yet been observed with Preos, it is possible that such lesions may appear at later stages of the study and that Preos will be shown to be similar to teriparatide in this respect. The next histopathological examination of tissues is scheduled at the end of the 24-month dosing period.
Preos is recombinantly produced human parathyroid hormone. It is being developed by NPS as a possible treatment for osteoporosis. Previous clinical studies in humans and animal studies have shown that daily sub-cutaneous injections of Preos can stimulate the growth of bone.
Posted: August 2002