-Completes Patient Enrollment in Phase II Osteoporosis Prevention Trial-
-Will Present Full Data Set on Phase III ORACAL Treatment Trial at
ASBMR- -Closes Additional Tranche of a Financing That Has Raised
a Total of $24.5 Million-
PHILADELPHIA, PA - July 12, 2011 -Tarsa Therapeutics today reported
progress in its two ongoing clinical development programs for its
oral recombinant salmon calcitonin for the treatment and prevention of
postmenopausal osteoporosis. Patient enrollment in the Phase II
osteoporosis prevention trial has been completed, and the full set of
data from the Phase III ORACAL trial has been accepted for an oral
presentation at the American Society for Bone and Mineral Research
(ASBMR) 2011 Annual Meeting in September. Separately, Tarsa also
announced that it has closed an additional tranche of a financing that
has raised a total of $24.5 million for the company.
Patient enrollment is now completed in TAR01-201, a double-blind Phase
II study comparing Tarsa's oral recombinant salmon calcitonin to
placebo in approximately 120 postmenopausal women who have low bone
mass (osteopenia) and are at increased risk of fracture. This
proof-of-concept study is evaluating the ability of oral calcitonin to
prevent osteoporosis and maintain bone mass in this population.
Interim six-month data from this trial, which is being conducted
entirely in the US, are expected to be available in early 2012.
Earlier this year, Tarsa reported that the Phase III ORACAL trial of
its oral recombinant salmon calcitonin in the treatment of
postmenopausal osteoporosis had yielded statistically significant,
positive top-line results. That protocol had been agreed to in a
Special Protocol Assessment with the US Food and Drug Administration
(FDA) and was subject to Scientific Advice from the European Medicines
Agency. Data from the ORACAL study will be presented at the ASBMR
2011 Annual Meeting that will be held September 16-20, 2011 in San
Diego. A New Drug Application (NDA) submission to the FDA is targeted
for late 2011.
Separately, Tarsa announced that it has closed an additional tranche
of a financing that has raised a total of $24.5 million. All of the
company's existing investors participated in the financing, including
MVM Life Science Partners, Quaker BioVentures, Novo A/S and Unigene
Laboratories. The company plans to use the proceeds to advance the
clinical development of its oral calcitonin, including the planned NDA
submission to the FDA later this year, and for general corporate
purposes.
"We are encouraged by the continued positive developments in our oral
calcitonin program," said David Brand, President and CEO of Tarsa.
"We are looking forward to presenting the full set of efficacy and
safety data from the ORACAL trial this fall at the ASBMR meeting, the
most important US medical meeting in the osteoporosis field. We view
the rapid completion of enrollment in our Phase II prevention study as
another sign of the potential interest among physicians and patients
for access to additional options for managing and preventing
osteoporosis. Finally, we are pleased at the ongoing strong support
from our investors in helping to finance our continued progress."
Calcitonin is approved for the treatment of postmenopausal
osteoporosis, but its use has been limited by the fact that it is
currently available only in intranasal and injectable forms. Tarsa's
oral calcitonin product has been shown in prior clinical studies to
deliver the desired blood levels of calcitonin and reduce levels of
biomarkers of bone resorption.
For more information about the ORACAL osteoporosis treatment trial and
the TAR01-201 osteoporosis prevention trial, visit
www.clinicaltrials.gov/ct2/results?term=tarsa.
Tarsa is developing its oral calcitonin product under a licensing
agreement with Unigene Laboratories that provides Tarsa with exclusive
development and worldwide commercialization rights to Unigene's oral
calcitonin product, with the exception of China.
About Tarsa Therapeutics
Tarsa Therapeutics is a venture-backed, clinical-stage biotechnology
company developing an oral formulation of calcitonin for the treatment
and prevention of postmenopausal osteoporosis. Calcitonin has a long
history of safety and efficacy, and availability of an oral form is
expected to generate wider use. Tarsa recently reported positive
top-line results from the Phase III ORACAL trial of its oral
calcitonin in the treatment of postmenopausal osteoporosis, and a
Phase II osteoporosis prevention trial is underway. Tarsa is based in
Philadelphia, PA. For more information, visit
www.tarsatherapeutics.com.