Navigation Links
Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing Its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase III Osteoporosis Treatment Trial

SAN DIEGO, and PHILADELPHIA, Sept. 19, 2011 /PRNewswire/ -- Tarsa Therapeutics today reported that it presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA™, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.  These data were presented at the American Society for Bone and Mineral Research 2011 Annual Meeting by ORACAL investigator Neil Binkley, MD, who is an Associate Professor of Endocrinology and Geriatrics at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin.

The ORACAL study was a Phase III multinational, randomized, double-blind, double-dummy, placebo controlled trial of Tarsa's oral recombinant salmon calcitonin compared to placebo and to commercially available, synthetic salmon calcitonin administered by nasal spray.  The trial enrolled 565 postmenopausal women in six countries with established osteoporosis.

Earlier this year, Tarsa reported top-line efficacy and safety results from the ORACAL trial.  The data reported today 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.  

"These are encouraging results that may be of particular relevance for the women with osteoporosis who are reluctant to take or unable to tolerate currently available treatments," said Dr. Binkley.  "Potential safety issues with current drug therapies, while rare, have led some osteoporosis patients to discontinue therapy or avoid beginning treatment.  Calcitonin has a long history of safety for postmenopausal osteoporosis treatment, and potential availability of this once-daily oral formulation could make it a useful new option for osteoporosis patients and their physicians."

According to the International Osteoporosis Foundation, studies indicate that up to half of osteoporosis patients stop their treatment after just one year.  In one study, two-thirds of osteoporosis patients said their medication interfered with their lives in some way and over 20% of the women who missed or stopped their treatment said it was due to side effects.

"The encouraging efficacy and safety data presented at the ASBMR meeting, including data showing that OSTORA demonstrated superior efficacy to nasal calcitonin, reinforces our view that OSTORA has the potential to address an unmet need in current therapy," noted David Krause, MD, Chief Medical Officer of Tarsa.  "Data suggest that approximately two million women in the U.S. alone have discontinued osteoporosis treatment for various reasons, which include poor tolerance or the perceived risk of adverse effects, leaving them more vulnerable to potentially disabling fractures.  Reports from the field suggest many other newly diagnosed osteoporosis patients have not started drug treatment as a result of safety concerns.  The data presented today indicate that once-daily OSTORA may have the potential to provide an effective, safe and convenient new option for these millions of women and their physicians."

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.  Prior clinical studies show that Tarsa's oral calcitonin tablet delivers calcitonin effectively and reduces blood levels of bone resorption biomarkers.

"We view the new OSTORA data presented today as very promising news for osteoporosis patients and their physicians seeking additional treatment options," said David Brand, President and CEO of Tarsa.  "We look forward to filing a New Drug Application for OSTORA with the Food and Drug Administration and to submitting a Marketing Authorization Application to the European Medicines Agency thereafter.  We also are advancing our ongoing Phase Il trial in osteoporosis prevention, an indication for which our oral calcitonin could be especially relevant."

Tarsa's oral calcitonin is also being assessed in a double-blind Phase II study comparing the OSTORA tablet to placebo in 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.  

Tarsa is developing its OSTORA oral calcitonin 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.  For more information on Unigene, see

The American Society for Bone and Mineral Research 2011 Annual Meeting, the premier scientific meeting discussing the latest concepts and innovations in bone and mineral research, is being held September 16-20, 2011 in San Diego, California.  For more information, visit .

"Results of the ORACAL Trial: A Phase 3 Randomized Trial of the Safety and Efficacy of Orally Administered Recombinant Salmon Calcitonin Tablets in Postmenopausal Women with Osteoporosis," Neil Binkley MD, Michael Bolognese MD, James P Gilligan PhD, David S Krause MD.  Presented at the ASBMR 2011 Annual Meeting, Oral Session 23, 2:30pm PDT, September 18, 2011.

*The International Osteoporosis Foundation. Osteoporosis: The Inside Story. Fact sheet. Retrieved August 29, 2011, from

About Tarsa Therapeutics

Tarsa Therapeutics is a venture-backed clinical stage biotechnology company developing OSTORA™, 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 efficacy and safety results from the Phase III ORACAL trial of its OSTORA tablet 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

GendeLLindheim BioCom Partners
Barbara Lindheim or Jennifer Anderson

SOURCE Tarsa Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis
2. Tarsa Therapeutics Completes Phase III Trial of its Oral Calcitonin for Treatment of Postmenopausal Osteoporosis and Initiates Phase II Trial in Osteoporosis Prevention
3. Silence Therapeutics Announces Issuance of Japanese Patent for Screening Therapeutics Against Key Pathway Associated with Cancer and Other Diseases
4. Echo Therapeutics Receives Registered Trademarks for Symphony® and Prelude®
5. Nektar Therapeutics President and CEO, Howard W. Robin, to Present at the UBS 2011 Global Life Sciences Conference in New York City
6. ViroPharma and Halozyme Therapeutics Announce Initiation of Phase 2 Evaluation of Subcutaneous Delivery of Cinryze® (C1 Esterase Inhibitor [Human]) with Hyaluronidase (rHuPH20)
7. Rare Disease Therapeutics, Inc. Selects Accredo Health Group to Distribute Anascorp® for the Treatment of Centruroides Scorpion Sting Envenomation
8. Silence Therapeutics and InteRNA Technologies Sign Collaboration to Develop Novel microRNA Therapeutics
9. Nile Therapeutics to Present at Rodman & Renshaw Global Investment Conference
10. Regulus Therapeutics to Present New Advancements in microRNA Therapeutics for Treatment of Metabolic Diseases and Cancer
11. Global Sepsis Therapeutics Industry
Post Your Comments:
(Date:11/30/2015)... Calif. , Nov. 30, 2015 /PRNewswire/ ... today that Matt Hogan , Chief ... Oppenheimer Healthcare Conference on Tuesday, December 8 ... is being held at the Westin Grand ... also be available for one-on-one meetings at ...
(Date:11/30/2015)... , Nov. 30, 2015 Next week, December ... of Things (DoT ) co-located events covering the latest ... Internet of Things, will draw more than 3,000 design ... Convention Center. The events, combined show floor will ... --> --> ...
(Date:11/30/2015)... Nautilus Medical Inc. today announced worldwide availability of MatrixRay, ... The release of MatrixRay to the entire medical healthcare ... America) in Chicago - the ... --> --> MatrixRay is the first ... worldwide via a peer-to-peer exchange network of physicians and ...
Breaking Medicine Technology:
(Date:11/30/2015)... MN (PRWEB) , ... December 01, 2015 , ... ... is the latest carrier to offer individual vision insurance plans on ... the unique ability to rate and review products, allowing consumers to compare, quote ...
(Date:11/30/2015)... ... 2015 , ... During the National Family Caregivers Month, the ... webinars on topics of ‘Medical and Palliative Care Decisions,’ and ‘Self-Care for Caregivers.’ ... , With a loved one's diagnosis of mesothelioma, the closest family member is ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... surgery and dermatology, is proud to announce that its ThermiRFR temperature controlled radiofrequency ... ThermiRF is an innovative multi-application radiofrequency platform which uses temperature as a clinical ...
(Date:11/30/2015)... ... November 30, 2015 , ... The ... this summer, ushering in a new era of publicly accessible automated technology. Now, ... will continue to offer guests an up-close look at the shuttle at MOSI’s ...
(Date:11/30/2015)... ... 30, 2015 , ... On Saturday, October 24th, 2015, at the Mill Race ... event, a 5K walk known as “Making Strides Against Breast Cancer”. Patients and staff ... also located in Battle Creek, joined in for this campaign that sought to raise ...
Breaking Medicine News(10 mins):