UTHR news
<<United Therapeutics Initiates Patient Enrollment in Second Phase
3 Study of
Beraprost for Peripheral Vascular Disease
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Jan. 31 /PRNewswire/
-- United Therapeutics Corporation (Nasdaq: UTHR) announced today the
initiation of patient enrollment in a Phase 3, randomized, double-blind,
placebo-controlled study of Beraprost in patients with peripheral vascular
disease (PVD). This condition affects millions of people in the United
States. PVD usually presents itself as pain in the lower leg, cramps, muscle
ache or severe fatigue upon exercising, which can lead to marked impairment in
patients' quality of life. The pain is thought to result from inadequate
blood flow to the lower limbs. Beraprost, a stable prostacyclin analog, has
potent vasodilator and antiplatelet effects, and thus is expected to address
two of the fundamental pathophysiologies underlying the impaired blood flow
and resulting pain.
"This trial represents an important milestone for United Therapeutics as
we continue to rapidly progress our lead compounds through the clinical
development process," said Roger A. Jeffs, Ph.D., Director of Research,
Development and Medical at United Therapeutics. "This approximately
688 patient trial represents the second of the two well-controlled pivotal
studies required as the basis for drug approval. The first trial of Beraprost
was conducted in Europe in a similar population of patients and showed
significant improvements in patients' ability to walk free of pain, the main
measure of therapeutic efficacy in this population of patients. This trial is
designed to confirm both the safety and efficacy results of the European study
in a US patient population. In addition, United Therapeutics has successfully
completed an End-of-Phase 2 meeting with the FDA and this development is
consistent with the guidance of the FDA." >>
quote.bloomberg.com |
