Navigation Links
Phase I trial indicates ponatinib may thwart most resistant CML
Date:12/6/2010

ORLANDO A new drug appears to help chronic myeloid leukemia patients who are out of treatment options after first- and second-line drugs have failed them or because their cancer cells have a mutation that makes them resistant from the start, researchers reported at the 52nd Annual Meeting of the American Society of Hematology.

In a Phase I clinical trial, the drug ponatinib produced major or complete hematologic responses (absence of CML cells in the blood) and cytogenetic responses (absence of leukemia cells in the bone marrow) among two groups of patients:

  • Those who have tried two or three of the drugs that have revolutionized treatment of CML imatinib (Gleevec), nilotinib (Tasigna) and dasatinib (Sprycel) and developed resistance to them.

  • And those whose leukemia cells carry the T315I mutation, which resists all current therapies.

"Ponatinib seems to be filling the gap we had for patients who right now have no good treatments left," said Jorge Cortes, M.D., professor in The University of Texas MD Anderson Cancer Center Department of Leukemia, who presented the group's findings. "We are very encouraged by such strong results in the Phase I setting and have begun a pivotal Phase II clinical trial."

Preclinical research had indicated that ponatinib, developed by ARIAD Pharmaceuticals, inhibits all mutations that cause resistance to drugs that stifle the BCR-ABL protein which drives CML. BCR-ABL is produced by the aberrant gene bcr-abl, which occurs when two chromosomes swap portions of their DNA from separate bcr and abl genes. The abnormality is called the Philadelphia chromosome.

As of July 2010, 67 patients were enrolled in the study: 57 with CML, including 42 in the chronic, or early, stage, seven in the accelerated stage and eight in the blast phase, the most advanced form of the disease. Three had Philadelphia-positive acute lymphoblastic leukemia, three had acute myeloid leukemia and four were divided among other blood malignancies.

A total of 48 patients were evaluable at the time of reporting. Of these:

  • 30 of 32 patients (94 percent) in CML chronic phase had complete hematologic responses; 20 (63 percent) had major cytological responses, 12 complete and eight partial. Of these 20 cytogenetic responders, 18 remained on the treatment with no disease progression.

  • All 11 chronic phase CML patients who had the T315I mutation had complete hematologic response and nine had major cytogenetic responses, eight of which were complete.

  • For 16 CML patients in accelerated or blast phase or with Philadelphia-positive acute lymphocytic leukemia, five (31 percent) had a major hematological response and three (19 percent) had a major cytogenetic response.

  • Of nine CML patients in accelerated or blast phase or with Ph+ALL who also carried the T315I mutation, three (33 percent) had major hematologic response and two (22 percent) had major cytogenetic response.

Researchers also noted responses in patients with heavily resistant disease with no mutations and among patients with other mutations resistant to existing drugs.

The most common side effects were low platelet counts (24 percent of patients), headache (14 percent), nausea (14 percent), joint pain (13 percent), fatigue (13 percent), anemia (11 percent), increased lipase (11 percent), muscle spasms (11 percent), rash (11 percent), muscle pain (10 percent) and pancreatitis (10 percent). All dose-limiting toxicities were reversible.


'/>"/>

Contact: Scott Merville
smerville@mdanderson.org
713-516-4855
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert  

Related medicine news :

1. Assessing positive outcomes of phase III trials
2. Professor Zvi Ram presents phase III recurrent glioblastoma survival and quality of life data from the first pivotal study of the NovoTTF-100A at 15th Annual Society for Neuro-Oncology Scientific Meeting
3. Nutrition rating enhancing front-of-package nutrition rating systems and symbols: Phase 1
4. New Phase II study shows first-line promise of lung cancer drug PF-299
5. Pazopanib shows promise in Phase II trial for relapsed/refractory urothelial cancer
6. Phase III study shows everolimus delays tumor progression in hard-to-treat neuroendocrine tumors
7. Front-of-package symbols and systems: IOM phase 1 report
8. Vaccine extends glioblastoma patients survival in phase II trial
9. Operation Unified Response: 3 phases of disaster care in Haiti
10. Aeras and Crucell announce Phase II clinical trial start in Kenya
11. Sickle cell treatment developed at LA BioMed enters Phase 3 clinical trial
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Phase I trial indicates ponatinib may thwart most resistant CML
(Date:9/21/2017)... FL (PRWEB) , ... September 21, 2017 , ... 38-Year-Old ... Aesthetic Surgery Center in Naples, Florida is pleased to announce that Plastic Surgeon Kiranjeet ... Top 40 Under 40 is an annual award that was started in ...
(Date:9/21/2017)... Chicago, IL (PRWEB) , ... September 21, 2017 , ... ... set to run from September 11 to the end of November. , The Chicago, ... out to their community and teach them about the ease of taking their personal ...
(Date:9/21/2017)... ... September 21, 2017 , ... Promotional ... http://www.fdanews.com/products/54818-promotional-communication      , In the competitive world of drug and device marketing ... in compliance with FDA rules. , The FDA has issued two draft guidances ...
(Date:9/21/2017)... ... September 21, 2017 , ... Demonstrating a consistent and ... departments have been awarded five-year accreditation status through the Public Health Accreditation ... served by a PHAB-accredited health department now extend to more than 203 ...
(Date:9/21/2017)... ... 21, 2017 , ... In addition to sticking with the ... holistic approach and use natural alternatives for all house cleaning products, disinfectants, respiratory ... guaranteeing that, the new line of essential oils, are all 100% organic and ...
Breaking Medicine News(10 mins):
(Date:9/9/2017)... 2017 Dealmed Medical Supplies, New ... equipment, supplies, drugs, vaccines, and specialty medical products and ... agreement to acquire Vantage Medical Supplies, a major distributor ... Holtsville, New York . ... emerging medical practices, will operate under the Dealmed name ...
(Date:9/7/2017)... Sept. 7, 2017  For nearly two decades, New Life Agency has ... Reproduction Insurance industry. Today, New Life Agency announces a powerful three-way partnership ... ... ... http://pharmacarecard.com/ (PRNewsfoto/PharmaCareCard) ...
(Date:9/7/2017)... 7, 2017  Zimmer Biomet Holdings, Inc. (NYSE and ... announced that it will be participating in the Morgan ... the Grand Hyatt hotel in New York.  Zimmer Biomet ... a.m. Eastern Time. A live webcast of ... Relations website at http://investor.zimmerbiomet.com .   ...
Breaking Medicine Technology: