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:10/11/2017)... , Oct. 11, 2017  True Health, a ... amplified its effort during National Breast Cancer Awareness ... cancer risks. ... Oncology calculated that more than 10 million American ... mutations in BRCA1 or BRCA2 and have not had ...
(Date:10/7/2017)... Texas , Oct. 6, 2017   Provista, ... with more than $100 billion in purchasing power, today ... news and information. The Newsroom is the ... and industry trends, infographics, expert bios, news releases, slideshows ... having access to a wealth of resources at their ...
(Date:10/4/2017)... 2017 OBP Medical , a ... devices, today announced regulatory approval from ... Agência Nacional de Vigilância Sanitária (ANVISA)) to market ... retractor with integrated LED light source and smoke ... exposure of a tissue pocket or cavity during ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has ... least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a ... centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “The Journey: ... faced every danger possible to save lost souls in the Philippines. “The Journey: From ... Carole is a dedicated teacher of the Bible. She has taught all ages and ...
(Date:10/12/2017)... ... 12, 2017 , ... CitiDent and San Francisco dentists, Dr. ... Oventus O2Vent technology. As many as 18 million Americans are estimated to suffer ... Oral appliances can offer significant relief to about 75 percent of people with ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... delivery system that we intend to develop to enable prevention of a major ... to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is ...
Breaking Medicine News(10 mins):