--(BUSINESS WIRE)--Patients who start and eventually stop regimens
of a common class of osteoporosis drugs called bisphosphonates may be
unable to benefit from parathyroid hormone (PTH), which can rebuild
bone mass lost due to advanced stage osteoporosis. PTH has been proven
to increase the volume and strength of the honeycomb-like bone
infrastructure, the inner mesh that begins to diminish in old age.
Bisphosphonates, the active ingredient in widely prescribed
osteoporosis medications such as Fosamax, Actonel, and Boniva are
currently taken by more than thirty million Americans.
"These medicines work by preventing further bone loss," explains
Dr. Warren Levy, president and CEO of Unigene Laboratories, Inc.
"However, recent reports suggest that some patients using
bisphosphonates may be unable to repair or replace older or damaged
bone. Furthermore, it has been reported that the prior use of certain
bisphosphonates may blunt the effects of PTH, which could render the
only currently available bone growth drug ineffective. Since
bisphosphonates typically deposit in the bones for years, the use of a
bisphosphonate could compromise the ability to grow new bone later in
life when it is most needed."
Estrogen alternatives have grown in recent years, including
calcitonin, a naturally occurring hormone involved in calcium
regulation and bone metabolism. In third-party clinical trials,
calcitonin demonstrated a 62% reduction in the incidence of new
vertebral fractures for a subgroup of women over seventy-five years of
age, one of the most significant reductions demonstrated by any
current osteoporosis therapy.
"Calcitonin has a proven, thirty-five-year record of safe human
use with virtually no significant side effects and can be taken
simultaneously with other medications," said Dr. Levy. "Since it is
rapidly cleared by the body, it does not build up in the bone and may
allow the patient to effectively employ PTH therapy in subsequent
years if necessary."
Although, PTH injections have been shown to reduce the incidence
of fractures by restoring bone, the treatment can be very costly and
requires daily injections. Unigene and GlaxoSmithKline are jointly
developing a low-cost, orally administered PTH treatment, and Unigene
is currently performing a Phase I clinical study in the U.S.
Twenty-four healthy postmenopausal women are enrolled in the study,
which is designed to assess product safety and measure PTH blood
levels.
The tablets being tested utilize the improved Enteripep(R) oral
delivery technology. "One pill a day to treat bone fractures would be
ideal for patients who need to take this medicine for life," adds Dr.
Levy. For more information on osteoporosis and calcitonin, visit
www.unigene.com.
CONTACT: IRG
Janet Vasquez, 212-825-3210
SOURCE: Unigene Laboratories, Inc.
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