Data from Three Phase II Trials to be Presented at the 51st American Society of Hematology Annual Meeting Demonstrate that INCB18424, a Selective JAK1/JAK2 Inhibitor, Has Potential in Multiple Hematology Conditions
- Continues to Demonstrate Rapid and Durable Clinical Benefits in Myelofibrosis Patients
- Provides Clinically Meaningful Improvements in Patients with Advanced Polycythemia Vera and Essential Thrombocythemia
- Demonstrates Clinical Benefit in Patients with Secondary Acute Myeloid Leukemia
Srdan Verstovsek, M.D., Ph.D., Associate Professor,
“Additionally, in an exploratory trial in highly refractory patients with secondary acute myeloid leukemia and other leukemias for which no standard therapies are likely to lead to a durable remission, it is encouraging to see patients obtain clinical benefit including the achievement of stable disease as well as complete and partial responses. Our experience with INCB18424 in these highly refractory leukemia patients, along with the growing body of evidence indicating that JAK activation may play a determining role in a number of hematologic malignancies, suggests that use of a selective JAK inhibitor may help provide underserved patients in multiple hematological cancers with improved clinical outcomes.”
“COMFORT-I and II are currently enrolling patients diagnosed with myelofibrosis, either primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, regardless of the presence or absence of the JAK V617F mutation. Additionally, in both studies, patients not randomized to receive INCB18424 will have the opportunity to cross over to receive this investigational therapy.”
For information on the INCB18424 Phase III trials go to:
- INCB18424: COMFORT-I Phase III Trial in the US,
Canada andAustralia http://www.clinicaltrials.gov/ct2/show/NCT00952289?term=incyte&rank=4 - INCB18424: COMFORT-II Phase III Trial in
Europe http://www.clinicaltrials.gov/ct2/show/NCT00934544?term=INCB018424&rank=10
For patient referral information on COMFORT-I and COMFORT-II please go to: http://www.comfortstudy.com or call 1-877-9-MFSTUDY.
INCB18424 Oral Presentations at ASH
Below are the titles, sessions, times and names of the presenters for the three oral presentations involving INCB18424. Copies of the presentations will be available immediately after each oral presentation at: http://www.incyte.com/
- A Phase II Study of INCB018424, An Oral, Selective JAK1/JAK2 Inhibitor, in Patients with Advanced Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Refractory to Hydroxyurea (Abstract #311)
|
Session Name: |
Myeloproliferative Syndromes: Clinical |
||||||||
|
Presentation Time: |
8:00 a.m. Monday, December 7, 2009 |
||||||||
|
Name of Presenter: |
Srdan Verstovsek, M.D., Ph.D. MD Anderson |
- Significant Activity of the JAK2 Inhibitor, INCB018424 in Patients with Secondary, Post-Myeloproliferative Disorder Acute Myeloid Leukemia: Results of An Exploratory Phase II Study (Abstract #631)
|
Session Name: |
Acute Myeloid Leukemia -Therapy, excluding Transplantation II |
||||||||
|
Presentation Time: |
4:30 p.m. Monday, December 7, 2009 |
||||||||
|
Name of Presenter: |
Farhad Ravandi, M.D. - MD Anderson |
- Long-Term Follow up and Optimized Dosing Regimen of INCB018424 in Patients with Myelofibrosis: Durable Clinical, Functional and Symptomatic Responses with Improved Hematological Safety (Abstract #756)
|
Session Name: |
Myeloproliferative Syndromes: Myeloproliferative Neoplasms - Clinical Features and Therapeutics |
||||||||
|
Presentation Time: |
5:45 p.m. Monday, December 7, 2009 |
||||||||
|
Name of Presenter: |
Srdan Verstovsek, M.D., Ph.D. - MD Anderson |
ASH Webcast Information
The discussion will feature Srdan Verstovsek, M.D., Ph.D., Associate Professor,
About INCB18424
INCB18424 is
About Myeloproliferative Neoplasms (MPNs)
MPNs are a related group of hematological neoplasms characterized by dysfunction of the bone marrow resulting in either over production of blood cells or ineffective hematopoiesis leading to production of blood cells in the spleen and resulting in massive splenomegaly. The three main MPNs are polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF). Approximately 10 to 20% of patients with PV and ET progress to MF and MF can also develop without a prior history of PV or ET. There are no adequately effective therapies to treat these disorders.
About Secondary Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML), also known as acute myelogenous leukemia, is characterized by the rapid growth of abnormal white blood cells of the myeloid lineage called blasts that accumulate in the bone marrow and blood, and interfere with the production of normal blood cells. Adult AML is uniformly fatal if not treated but is potentially curable with standard chemotherapy, with or without stem cell transplantation.
While the cause of AML remains unknown, when AML arises in patients previously diagnosed with a myeloproliferative neoplasm, myelodysplastic syndrome or other hematologic disorders, it is known as secondary AML. Secondary AML is more likely to be associated with resistance to standard chemotherapy and has a poor overall prognosis. Secondary AML is also most often seen in elderly patients and estimated to account for approximately 25 - 40% of cases in this group.
About
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to the ongoing clinical experience with INCB18424 and the dosing regimen for the Phase III program which has the potential to be well tolerated and provide durable clinical improvement in splenomegaly and constitutional symptoms, plans to describe the most current data from the ongoing Phase II clinical trials of INCB18424 in myelofibrosis, PV and ET and AML at ASH, are all forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development and clinical trials, the uncertainty of the
Source:
Incyte Corporation
Pamela M. Murphy, 302-498-6944
Vice President, Investor Relations/Corporate Communications