Phase II (TAR01-201 ) trial data reported at the American Society for Bone and Mineral Meeting. Oral calcitonin was superior to placebo in increasing BMD at the lumbar spine in 129 postmenopausal women with low bone mass (osteopenia), and its safety profile did not differ substantially from placebo .
Phase II TAR01-201 trial evaluated the ability of oral recombinant salmon calcitonin to improve BMD at the lumbar spine in 129 postmenopausal women with low bone mass (osteopenia) at increased risk of fracture. The primary endpoint was the change in BMD at the lumbar spine over the course of the year-long study. Oral calcitonin was superior to placebo in increasing BMD at the lumbar spine and its safety profile did not differ substantially from placebo. 
Positive safety and efficacy data reported from the ORACAL trial show that Ostora achieved all of the efficacy endpoints in the trial and indicate that the safety profile of Ostora did not substantially differ from nasal calcitonin or placebo. The majority of adverse events were mild or moderate, and Ostora was also significantly less immunogenic than nasal calcitonin spray .
ORACAL study is a Phase 3 multinational, randomized, double-blind, double-dummy placebo-controlled trial of oral recombinant salmon calcitonin compared to commercially available synthetic salmon calcitonin administered by nasal spray (n=565 postmenopausal women). The primary endpoint was % change in lumbar spine BMD. The results of the study demonstrated that oral salmon calcitonin was significantly superior to placebo and non-inferior to nasal salmon calcitonin spray in increasing BMD at the lumbar spine after one year of treatment. 
Tarsa´s oral calcitonin preparation is given once daily & has been shown in clinical studies to deliver the desired blood levels of calcitonin & reduce levels of bone resorption biomarkers .
Patient enrolment in the global PIII ORACAL trial has completed. The independent Data Monitoring Committee (DMC) has completed two separate safety reviews of patient data and recommended that the trial proceed as planned. The company anticipate reporting data from the trial in 2011. The company state that their product could be the first FDA-approved and commercially available oral formulation of calcitonin .
NCT00959764: A PIII randomised double-blind, placebo-controlled 48-week study started in Jun 09 comparing oral calcitonin vs nasal spray in 520 women with postmenopausal osteoporosis. It is being conducted in US, EU and S. Africa. Expected completion date Sep 10 .
Unigene, who produce recombinant calcitonin under a patented SecraPep E. coli manufacturing technology, licensed its PIII programme to Tarsa Therapeutics in 2009 [1,2]