Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

CTI Begins Enrollment in Phase 3 PERSIST-1 Trial of Pacritinib

Published: Thursday, January 10, 2013
Last Updated: Wednesday, January 09, 2013
Bookmark and Share
Company initiates clinical trial sites and enroll patients for the treatment of myelofibrosis.

Cell Therapeutics, Inc. (CTI) has announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis.

The randomized trial is expected to enroll 270 patients and will evaluate the safety and efficacy of pacritinib compared to best available therapy, excluding JAK inhibitors, in patients with myelofibrosis.

Pacritinib is a selective oral JAK2 inhibitor that demonstrated meaningful clinical benefits and good tolerability in myelofibrosis patients in Phase 2 clinical trials, without apparent drug-related thrombocytopenia or anemia.

Myelofibrosis patients will be enrolled in the PERSIST-1 trial without exclusion for low platelet counts.

Principal Investigators for the trial are Ruben A. Mesa, M.D., Deputy Director, Mayo Clinic Cancer Center and Chair, Hematology and Medical Oncology, Mayo Clinic in Arizona, and Claire Harrison, M.D., Consultant Hematologist, Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital, London, United Kingdom.

"Current treatment of myelofibrosis by targeting JAK2 inhibition has been shown to be effective in managing the debilitating symptoms that are associated with this disease, although thrombocytopenia and anemia continue to be a challenge in managing this disease," said Steven E. Benner, M.D., Chief Medical Officer of CTI.

Benner continued, "Data from earlier studies of pacritinib showed a clinically meaningful improvement in symptoms without suppression of platelets or red blood cells. We believe that pacritinib has the potential to offer an effective and well-tolerated treatment option for myelofibrosis patients, and are pleased to be initiating the Phase 3 PERSIST-1 clinical trial."

Myelofibrosis is classified as a myeloproliferative neoplasm and is a chronic bone marrow disorder.

Myelofibrosis is caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response, scarring the bone marrow and limiting its ability to produce red blood cells prompting the spleen and liver to take over this function.

Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue and pain. It is estimated that the prevalence of myelofibrosis is approximately 30,000 in the United States.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

CTI Opens Enrollment for PERSIST-2 Phase 3 Trial of Pacritinib for Myelofibrosis Patients
This trial, together with PERSIST-1, to support registration in the U.S. and Europe.
Tuesday, March 04, 2014
CTI Announces UK NCRI AML Cooperative Group Phase 2 Trial Evaluating Pacritinib for AML Patients
Trial sponsored by Cardiff University and supported by Cancer Research UK.
Tuesday, February 04, 2014
CTI Announces GOG Completes Patient Enrollment in GOG-0212
Patient enrollment in Phase 3 clinical trial of Opaxio™ as maintenance therapy in ovarian cancer.
Thursday, January 30, 2014
CTI Reaches Agreement with Novartis
Agreement to reacquire rights to two anti-cancer compounds.
Monday, January 13, 2014
CTI Announces Removal of the Partial Clinical Hold on Tosedostat
Company has received notification from the U.S. Food and Drug Administration.
Thursday, January 02, 2014
CTI and GKV-SV Reach Agreement on Pricing of PIXUVRI® (pixantrone) in Germany
Decision applies to patients with aggressive B-cell non-Hodgkin lymphoma who have failed two or three prior lines of therapy.
Wednesday, December 04, 2013
CTI Announces Data Presentations at the 55th ASH Annual Meeting
Pacritinib phase 2 analysis of myelofibrosis patients with thrombocytopenia (low platelets) accepted for oral presentation.
Monday, November 11, 2013
Cell Therapeutics Announces Agreement with the FDA on SPA for PERSIST-2 Trial
PERSIST-2 trial expected to initiate in fourth quarter of 2013.
Tuesday, October 08, 2013
Market Access Granted in France for Aggressive NHL Treatment, PIXUVRI®
CT will reassess the ASMR rating for PIXUVRI within two years.
Wednesday, August 21, 2013
CTI Announces Results from Sub-Set Analyses of Data from Phase 3 EXTEND Clinical Trial
Results presented at 18th Congress of the European Hematology Association.
Monday, July 15, 2013
Market Access Granted in Italy for PIXUVRI®
Access granted by AIFA for the aggressive non-Hodgkin lymphoma treatment.
Monday, July 08, 2013
Comprehensive Summary of Preclinical and Clinical Data for Pacritinib Published
Comprehensive article was published in the journal Drugs of the Future 2013.
Thursday, July 04, 2013
Cell Therapeutics Announces Resignation of Chief Medical Officer
Resignation of Steven E. Benner for personal reasons.
Monday, July 01, 2013
CTI Secures $15 Million Loan Financing Agreement
Company has entered into loan agreement with HTGC.
Tuesday, May 28, 2013
G-BA Issues Final Assessment Report for PIXUVRI®
Pricing negotiations to begin in June.
Tuesday, May 21, 2013
Scientific News
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos