Navigation Links
Tarsa Therapeutics Completes Phase III Trial of its Oral Calcitonin for Treatment of Postmenopausal Osteoporosis and Initiates Phase II Trial in Osteoporosis Prevention
Date:2/14/2011

PHILADELPHIA, Feb. 14, 2011 /PRNewswire/ -- Tarsa Therapeutics, Inc. today announced completion of its global Phase III ORACAL trial testing the company's once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis.  Results from the ORACAL trial are expected in early spring.  In addition, Tarsa announced initiation of a new Phase II study of its oral calcitonin for the prevention of postmenopausal osteoporosis.  

The ORACAL study is a multinational, randomized, double-blind, active and placebo-controlled Phase III trial that enrolled 565 postmenopausal women with osteoporosis.  Analysis of the trial data is currently underway.  

The new Phase II prevention trial is a randomized, double-blind, placebo-controlled study designed to enroll approximately 120 postmenopausal women with low bone mass at increased risk of fracture.  The trial will assess the efficacy of Tarsa's oral calcitonin in the prevention of bone loss in these women, as well as its safety and tolerability.  The prevention trial is being conducted at multiple centers in the US.

"The conclusion of our Phase III ORACAL osteoporosis treatment trial and initiation of our Phase II prevention trial are major milestones in Tarsa's oral calcitonin program," said David Brand, President and CEO of Tarsa.  "Our tablet has the potential to offer calcitonin's 30-year record of safety and efficacy with the advantage of once-daily oral administration to the millions of postmenopausal women with osteoporosis or at risk of osteoporosis.  We look forward to releasing ORACAL safety and efficacy data in the coming months.  If positive, we believe that our product has the potential to be the first FDA-approved oral formulation of calcitonin to reach the market."  

Tarsa plans to submit a New Drug Application to the US Food and Drug Administration for the use of its oral calcitonin as a treatment for postmenopausal osteoporosis later this year, and a Marketing Authorization Application to the European Medicines Agency next year.

Calcitonin is currently 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.  

Dr. David Krause, Chief Medical Officer of Tarsa, commented, "Osteoporosis is a common condition that poses major health risks to individuals as they age, but it can be both treated and prevented.  Calcitonin has a long history of safety and efficacy as an osteoporosis therapy, and we believe the availability of Tarsa's easy-to-use, once-daily oral calcitonin tablet will be welcomed by the many health care providers and patients seeking additional treatment options, especially in view of continuing concerns about potential long-term safety issues with other popular classes of osteoporosis drugs."

Tarsa's Phase II prevention trial will also explore the optimal dosing regimen for oral calcitonin by administering the tablets either with the evening meal or at bedtime.  Calcitonin helps maintain bone mass by acting on osteoclasts to limit bone resorption.  Most bone resorption occurs while individuals are sleeping; therefore some researchers believe that nighttime administration would be ideal for an anti-resorptive agent such as calcitonin.  

For more information on the Phase II osteoporosis prevention trial, visit: http://www.clinicaltrials.gov/ct2/show/NCT01292187?term=tarsa&rank=2

About Tarsa TherapeuticsTarsa Therapeutics is 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 completed the Phase III ORACAL trial of its oral calcitonin for 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.Contact:GendeLLindheim BioCom PartnersBarbara Lindheim212-918-4650
'/>"/>

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

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) to Report Fourth Quarter and Year-End 2010 Financial Results on February 16
2. Cephalon Signs Option Agreement to Acquire Assets from Alba Therapeutics
3. Amicus Therapeutics Initiates Phase 2 Clinical Trial Evaluating Amigal™ Co-administered with Enzyme Replacement Therapy
4. Prime Therapeutics President and CEO Eric Elliott Presents Keynote Address at 2011 PCMA Managed Markets Educational Forum
5. NewCardio Study of QTinno Accuracy Selected for Presentation at the National Scientific Meeting of the American Society of Clinical Pharmacology and Therapeutics
6. DSM and NKT Therapeutics Sign Contract for Lead Product Development and Manufacture
7. JumpStart Ventures and Cleveland Clinic Invest in SironRX Therapeutics
8. Amarin to Present at the Leerink Swann Hot Topics in Therapeutics Roundtable Conference
9. CardioVascular BioTherapeutics Submits FDA Application for Fast Track Status for CVBT-141B, CVBTs Biological Treatment for Diabetes Patients
10. PTC Therapeutics and Parent Project Muscular Dystrophy Advance Drug Discovery Program to Improve Heart Function in Duchenne/Becker Muscular Dystrophy Patients
11. Mederi Therapeutics Announces Receipt of FDA 510(k) Clearance for the MDRF1 Radiofrequency Generator
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... SPRING, Md. , Feb. 4, 2016 In ... Califf , the FDA,s Deputy Commissioner for Medical Products and ... action plan to reassess the agency,s approach to opioid medications. ... epidemic, while still providing patients in pain access to effective ... The FDA will: , Re-examine the risk-benefit paradigm ...
(Date:2/4/2016)... Mass. , Feb. 4, 2016  Blueprint ... in discovering and developing highly selective investigational kinase ... announced the appointment to its board of directors ... executive with nearly 30 years of industry-related experience. ... Officer of Blueprint Medicines. "Lonnel,s strong strategic experience ...
(Date:2/4/2016)... , Feb. 4, 2016 SONIFI™ Health, ... solutions, today announced that MonteCedro, an innovative retirement ... Engagement System. The system provides a simple and ... access through a tablet PC. ... engagement system provides access to a wide spectrum ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... 05, 2016 , ... In sleep, when the defenses of the day are ... of patients with eating disorders is significant self-criticism, and consequently these patients experience this ... regarded as maladaptive means for coping with this unease, but also leads to a ...
(Date:2/5/2016)... ... 2016 , ... California Mobile Kitchens , a company ... latest mobile kitchen model, featuring customizable stainless steel interiors and a new, 26-foot ... use anywhere in the U.S. Many of their units can be seen at ...
(Date:2/5/2016)... ... 05, 2016 , ... Calls Blacklist has just been updated by mobile app ... the developer has fixed known bugs within the app. Calls Blacklist allows its users ... not consuming any of their device’s battery power or memory. It provides a powerful ...
(Date:2/5/2016)... ... ... –This week, Atascadero water heater company First Call Plumbing has ... the report, click here or see below. , There are two ... cons, the type chosen is almost entirely up to personal preference. However, tankless water ...
(Date:2/5/2016)... ... ... one is tired of trying to cram belongings into spare space that just isn’t there, ... unit, but before hastily spending money on a unit, take these tips into consideration. , ... one is often not told when utilizing these services are some tips on how to ...
Breaking Medicine News(10 mins):