Navigation Links
FDA Grants Fast Track Designation to CTI BioPharma's Pacritinib, a Novel JAK2 Inhibitor for the Treatment of Myelofibrosis
Date:8/6/2014

re application can be reviewed. NDA review usually does not begin until the company has submitted the entire application to the FDA. A drug program with Fast Track designation enables the company to have early and frequent communication with the FDA in the development and review of the product candidate, often leading to faster drug approval and access by patients.

About the PERSIST Phase 3 Development Program of Pacritinib

Based on pacritinib's efficacy and tolerability profile demonstrated to date, CTI is pursuing a broad approach to advancing this therapy for patients with myelofibrosis by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial.

PERSIST-1:
In July 2014, CTI completed enrollment in the PERSIST-1 trial that was designed to enroll approximately 320 patients and is a randomized, open-label, multicenter trial comparing the efficacy and safety of pacritinib with that of best available therapy, other than JAK inhibitors, in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, without exclusion for low platelet counts. The primary endpoint is the percentage of patients achieving a greater than or equal to 35 percent reduction in spleen volume measured by MRI or CT from baseline to 24 weeks of treatment.

PERSIST-2:
In March 2014, CTI announced the initiation of the PERSIST-2 trial, which will evaluate pacritinib compared to best available therapy, including approved JAK2 inhibitors that are dosed according to product label, in patients with myelofibrosis whose platelet counts are less than or equal to 100,000/uL. The trial is designed to enroll up to 300 patients in North America, Europe, Australia and New Zealand. In October 2013, CTI reac
'/>"/>

SOURCE CTI BioPharma
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. PTC Therapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
2. US Patent Office Grants McCord Research Endothelial Cell Treatment Patent
3. FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis
4. FDA Grants Orphan Drug Designation to Omeros OMS721 for Complement-Mediated Thrombotic Microangiopathies
5. FDA Grants Approval of IND to Commence a Phase 3 Pivotal Study for ST10 for the Treatment of Iron Deficiency Anaemia in Chronic Kidney Disease
6. Auxilium Pharmaceuticals, Inc. Announces Court Grants Upsher-Smith Laboratories Motion For Summary Judgment
7. FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Aspergillosis
8. RadSite Grants Accreditation to First Wave of MIPPA Program Applicants
9. NASDAQ Grants China Jo-Jo Drugstores 180-Day Extension to Regain Compliance with Bid Price Requirement
10. U.S. FDA Grants Orphan Drug Designation for KaloBios KB001-A in Treatment of Cystic Fibrosis Patients
11. FDA Grants 510(k) Clearance for Innovative Fuse Gastroscope from EndoChoice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/31/2015)... Israel, Aug. 31, 2015  Chiasma, Inc. (NASDAQ: ... developing octreotide capsules for the orphan condition acromegaly, ... ended June 30, 2015 and provided a corporate ... been a transformative time for Chiasma, as we ... announced that our first New Drug Application (NDA) ...
(Date:8/31/2015)... , Aug. 31, 2015  Daktari Diagnostics today announced a ... United States and Canada , ... The deal, worth up to $8.5 million over the next ... clinical validation and regulatory approval of Daktari,s HCV test. ... point-of-care instrument that can detect low levels of virus directly ...
(Date:8/31/2015)... -- The Wolf Administration today announced 289 drug overdoses ... State Police and local police departments have begun ... and opioid overdose are the leading cause of accidental ... individuals than those involved in fatal motor vehicle accidents. ... overdose. " Pennsylvania ...
Breaking Medicine Technology:Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 2Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 3Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 4Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 5Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 6Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 7Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 8Chiasma Reports Second Quarter 2015 Financial Results and Recent Business Highlights 9Daktari Enters Collaboration Agreement with Merck to Develop Test for Hepatitis C Virus 2Daktari Enters Collaboration Agreement with Merck to Develop Test for Hepatitis C Virus 3Departments of Drug & Alcohol Programs and Health Announce Report 289 Pennsylvanian Lives Saved by Naloxone 2Departments of Drug & Alcohol Programs and Health Announce Report 289 Pennsylvanian Lives Saved by Naloxone 3
... (Nasdaq: CDXS ) today announced the company will ... 2012 at 4:30 p.m. Eastern Time to discuss its fourth ... ended December 31, 2011.  The call and webcast will follow ... after market close.  A recorded version of the call will ...
...  Virtify, Inc., will host an online roundtable on January ... by senior executives from four multinational pharmaceutical companies on ... comply with the July 2, 2012 EVMPD reporting mandate.  A ... http://photos.prnewswire.com/prnh/20110131/NE38689LOGO ) Roundtable panelists will ...
Cached Medicine Technology:Codexis to Announce Fourth Quarter and Fiscal Year 2011 Financial Results on February 7, 2012 2Roundtable of Industry Experts to Discuss Impact, Implications of EVMPD Mandate 2
(Date:8/31/2015)... ... 31, 2015 , ... Since 1946, the doctors and staff at Clifton Dental ... a patient arrives at the office, the staff will make them feel welcome and ... patient to create a complete dental treatment plan that is unique to each smile! ...
(Date:8/31/2015)... ... August 31, 2015 , ... With the FCPX LUT Soft pack from Pixel Film Studios, editors ... Table that contains a mathematical formula for modifying an image. The LUT changes every pixel's ... CUBE LUT files. , FCPX LUT Soft requires Final Cut Pro X 10.2 or ...
(Date:8/31/2015)... (PRWEB) , ... August 31, 2015 , ... According to ... the University of Sweden showed that most adolescents who underwent bariatric surgery “felt significantly ... the 88 adolescent bariatric patients who participated in the study felt that their “mental ...
(Date:8/31/2015)... ... ... The dental implant and prosthetic market in the U.S. is projected to reach ... Room ) More than 30 million Americans are missing all their teeth in one ... implants, the National Association of Dental Laboratories (NADL) created the “What’s In Your Mouth?” ...
(Date:8/31/2015)... ... ... Finnleo is pleased to announce another in a long line of ... and design of our newest sauna model, the Terrace combines high quality and a ... very attractive price-point. , Before outdoor saunas were a dream for many customers, ...
Breaking Medicine News(10 mins):Health News:NJ Top Dentists Presents, Clifton Dental Associates! 2Health News:Pixel Film Studios, FCPX Plugin Developer, Releases FCPX LUT Soft 2Health News:Article on Adolescent Bariatric Surgery Demonstrates the Powerful Effect of Being in Control, Notes Dr. Michael Feiz 2Health News:Article on Adolescent Bariatric Surgery Demonstrates the Powerful Effect of Being in Control, Notes Dr. Michael Feiz 3Health News:Dental Association Raises Awareness as Implant Industry Grows 2Health News:Dental Association Raises Awareness as Implant Industry Grows 3Health News:Dental Association Raises Awareness as Implant Industry Grows 4Health News:Say “Hello” to the Brand New Finnleo Terrace Outdoor Saunas 2
... CLEVELAND, March 17 JumpStart Inc. ... the progress of high growth early-stage businesses, and ... capital and technology validation fund at Case Western ... $375,000 in Neuros Medical, Inc. , a Cleveland, ...
... Invasive Treatment for Prostate Cancer and Benign Prostatic ... 16 Mexico HIFU in conjunction with International ... a global leader in the development, manufacturing and ... will host the very first multiday Sonablate(R) HIFU ...
... PLYMOUTH MEETING, Pa., March 16 /PRNewswire-Asia-FirstCall/ -- BMP,Sunstone Corporation ... the "Company"),today announced that the Company is calling its ... 2009 (the "Original Notes"). In addition, the,Company announced ... -- Exchanged $1.0 million in principal amount ...
... BEACH, Fla., March 16 With a reputation as ... new initiative, MorseLife Learning Institute (MLI), will expand ... practices in leadership, healthcare and Kosher culinary.Already noted ... MorseLife to provide online and onsite clinical education ...
... ranked among Top 10 Companies for Supplier Diversity and for ... Care Service Corporation (HCSC) as one of its Top 50 ... In 2009, the company ranks 22, up 12 spots ... Top 10 Companies for Supplier Diversity as well as the ...
... elective medical proceduresEAGAN, Minn., March 16 Consumers can ... information through Care Comparison(R), a new online tool introduced ... Care Comparison allows nearly two million Blue Cross members ... as quality, safety and accessibility information for dozens of ...
Cached Medicine News:Health News:JumpStart and Case Technology Ventures Invest in Neuros Medical 2Health News:JumpStart and Case Technology Ventures Invest in Neuros Medical 3Health News:JumpStart and Case Technology Ventures Invest in Neuros Medical 4Health News:JumpStart and Case Technology Ventures Invest in Neuros Medical 5Health News:High Intensity Focused Ultrasound Physician Training Seminar in Mexico City 2Health News:BMP Sunstone Exchanges and Calls Outstanding Notes Due May 2009 2Health News:MorseLife Launches Learning Institute to Teach Best Practices in Leadership, Healthcare and Kosher Culinary 2Health News:Health Care Service Corporation Ranked as One of the Most Diverse Companies in the Country for 5th Consecutive Year 2Health News:Health Care Service Corporation Ranked as One of the Most Diverse Companies in the Country for 5th Consecutive Year 3Health News:Health Care Service Corporation Ranked as One of the Most Diverse Companies in the Country for 5th Consecutive Year 4Health News:Blue Cross Puts New Online Shopping Tool in Hands of Consumers 2Health News:Blue Cross Puts New Online Shopping Tool in Hands of Consumers 3
... a radial-type endoscope with a built-in electronic ... flicker-free, high-resolution image under echo. It is ... direct visual observation. The EG-3630UR has achieved ... endoscope as well as exceptional ultrasound imaging ...
... provides a wide range of diagnosis by using ... to obtain a clear image of blood flow ... Flow Angio. An accessory elevator has been incorporated ... make it possible for more advanced and accurate ...
... you to maximize your testing options even ... This fully automated system offers superior technology, ... robotics, to ensure testing accuracy and efficiency ... is backed by our high-quality service to ...
The SYNCHRON CX7-S workstation offers a broad menu, advanced data management and more. Targeted to the mid-volume lab, the CX7-S is easy to use, easy to maintain and easy to acquire....
Medicine Products: