Navigation Links
Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol to FDA for Comment
Date:7/23/2008

LA JOLLA, Calif., July 23 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced today that it has submitted for comment a synopsis of a proposed Phase 3 clinical study for its lead drug, ATPace(TM), to the U.S. Food and Drug Administration's (the "FDA") Division of Cardiovascular and Renal Products.

Based on recent communications with the FDA, including a face-to-face meeting held on April 16, 2008, Duska believes that the proposed single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia (PSVT) should be sufficient to demonstrate clinical safety and efficacy. The proposed primary endpoint of the study is dose-dependent conversion of PSVT to normal sinus rhythm. The FDA has expressed willingness to review and comment on the proposed trial design according to the Special Protocol Assessment (SPA) procedure.

PSVT is a rapid regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases of PSVT per year in the United States alone. PSVT is one of the most common cardiac arrhythmias.

Duska has already compiled clinical data on the safety and efficacy of adenosine triphosphate (ATP), which is the active pharmaceutical ingredient in ATPace(TM), in the treatment of patients with PSVT. In addition, Duska has its own safety database on ATPace(TM), which was obtained in Phase 1 and 2 clinical trials. Based on these data, Duska believes that upon successful completion of the proposed Phase 3 trial, it would have all the clinical data necessary to support the filing of the NDA for ATPace(TM) under section 505(b)(2), the drafting of which has already commenced.

Dr. James Kuo, Duska's Chairman and CEO, said, "After our recent interactions with the FDA, I believe we have a clear plan to acquire all the data that would be necessary to support the filing of a NDA for ATPace(TM)
'/>"/>

SOURCE Duska Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Duska Therapeutics Obtains Standard & Poors Listing
2. Roche starts acquisition process of ARIUS to gain access to new screening platform for antibody therapeutics
3. CV Therapeutics to Announce 2008 Second Quarter Financial Results on Thursday, July 31, 2008
4. Lorus Therapeutics Reports Fourth Quarter Results for Fiscal Year 2008
5. Zenobia Therapeutics, Inc. Begins Operations as a Fragment-Based Lead Discovery Company
6. Northwest Biotherapeutics to Present at Next Generation Vaccine Conference
7. Organizational Changes at Silence Therapeutics
8. Genzyme Corporation and PTC Therapeutics Announce Collaboration on Small Molecule for Genetic Diseases
9. Arno Therapeutics Announces New Ticker Symbol
10. Lorus Therapeutics Receives $600 Thousand From Escrow Account
11. Silence Therapeutics Announces Successful Opposition of Glover Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/26/2015)... 2015 PRC Clinical, a Silicon-Valley based ... management and executive appointments effective immediately. , Mike Catelani ... and member of the Board of Directors. Daniel Head ... Sue Dowden will assume the position of Senior Director ... Operations Officer (COO), has been appointed to the position ...
(Date:3/26/2015)... 2015 Neogen Corporation (NASDAQ: NEOG ) ... quarter of fiscal 2015, which ended Feb. 28, increased ... $6,575,000. Earnings per share in the current quarter were ... net income increased 17% over prior year to $24,142,000, ... per share, for the same period a year ago. ...
(Date:3/26/2015)... WriteResult, a premier provider of ePRO technologies ... School of Public Health and New Haven Farms to ... month-long project. The goal of the study was to ... free access to fresh produce and nutrition education on ... high blood pressure, diabetes and weight gain. Patients completed ...
(Date:3/25/2015)... 25, 2015 The surging prevalence ... have fuelled social media growth, with over 50% ... in social networking. Insurance companies are making use ... clients and promote a diversity of their services ... increasingly exploiting social networking services as part of ...
Breaking Biology Technology:PRC Clinical Announces Key Management Appointments and Launches East Coast Operations 2PRC Clinical Announces Key Management Appointments and Launches East Coast Operations 3Neogen reports 13% increase in net income 2Neogen reports 13% increase in net income 3Neogen reports 13% increase in net income 4Neogen reports 13% increase in net income 5Neogen reports 13% increase in net income 6Neogen reports 13% increase in net income 7Neogen reports 13% increase in net income 8Yale and New Haven Farms Improving Patient Health with WriteResult's myPROpad™ 2Yale and New Haven Farms Improving Patient Health with WriteResult's myPROpad™ 3Social Media Role in Global Insurance Industry Examined by Timetric in New Market Research Report Published at MarketPublishers.com 2Social Media Role in Global Insurance Industry Examined by Timetric in New Market Research Report Published at MarketPublishers.com 3
... from the National Institute of Allergy and Infectious Diseases ... determined a key mechanism by which Bacillus anthracis ... by immune system scavenger cells. The finding, made by ... picture of early-stage anthrax infection and supports efforts to ...
... the second year in a row, a pair of ... Manufacturing Design Competition held by the American Society of ... Casey Hoffman and Jaron Kuppers won top honors in ... Elastomeric Tooling (SET) process. The SET process offers a ...
... a range of everyday products from computers to shampoo can ... has shown. Research by the University of Edinburgh suggests ... risks that different types of nanoparticles pose to workers who ... smaller than the width of a human hair are ...
Cached Biology Technology:NIH scientists show how anthrax bacteria impair immune response 2Rensselaer mechanical engineers win first place at ASME student manufacturing design competition 2Rensselaer mechanical engineers win first place at ASME student manufacturing design competition 3Rensselaer mechanical engineers win first place at ASME student manufacturing design competition 4
(Date:3/20/2015)... Markets ( http://www.researchandmarkets.com/research/vkzvcs/iris_biometrics ) has announced the addition ... report to their offering. This report analyzes ... report provides separate comprehensive analytics for the US, ... Europe , Asia-Pacific , ... . Annual estimates and forecasts are provided for ...
(Date:3/18/2015)... As mobile payments become more prevalent ... and apps continue to be introduced into the market place ... payment industry in focus today are:  NXT-ID, Inc. (NASDAQ: ... BABA ), Apple Inc. (NASDAQ: AAPL ), Google ... FB ) NXT-ID, Inc. (NASDAQ: ...
(Date:3/17/2015)... SAN DIEGO , March 17, 2015 /PRNewswire/ ... and emotion analytics software, today announced general availability ... on-demand web service for the analysis of facial ... they experience advertising, media content, products and services. ... customer attention, engagement and sentiment - as derived ...
Breaking Biology News(10 mins):Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 2Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 4Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 5Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 2Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 3Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 4Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 5Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 6New Emotient Web Service Measures Audience Response Using On-Demand Facial Expression Analysis 2New Emotient Web Service Measures Audience Response Using On-Demand Facial Expression Analysis 3New Emotient Web Service Measures Audience Response Using On-Demand Facial Expression Analysis 4
... for Biophysics have developed a new method for the ... target proteins. The pharmaceutical industry has already taken notice ... supposed to be implemented to investigate pharmacological agent-protein interactions ... various major European pharmaceutical companies. "We now have a ...
... Germany, September 04, 2012 - Eurofins MWG Operon, one ... sequencing (NGS), has added an Illumina HiSeq 2500 and ... sequencers. With this new equipment, the company will be ... accuracy rate and shorter turnaround time (TAT)., Whilst technological ...
... ever of DDT in breast milk have been measured in ... lie well over the limits set by the World Health ... Africa, sprayed indoors to fight malaria. "To our ... is one of the most effective agents against malaria. And ...
Cached Biology News:New infrared spectroscopy technique 2New infrared spectroscopy technique 3High levels of DDT in breast milk 2
...
... Fernbach-style culture flask is designed for culturing organisms ... It can also be used in serum production. ... achieve maximal oxygen transfer to culture medium. Beaded ... cotton plugs or No. 13 rubber stoppers. This ...
These are replacement caps for No. CLS6980 5mm PYREX NMR tubes. Proper method to remove caps is to slice them from the tube. Caps come in eight assorted/mixed colors. Packed in bags of 100....
... dye for nucleic acid electrophoresis in ... sequencing. Preparation Quantity Equivalency: A final ... 2% stock solution can be made ... comp: Dye content ~ 75% ...
Biology Products: