Navigation Links
AACR news: Rigosertib Phase 1 results lead to disease-focused Phase 2 development
Date:4/9/2013

Results of a phase 1 clinical trial reported at the American Association for Cancer Research (AACR) annual conference show that orally administered Rigosertib is well tolerated in patients with advanced solid tumors. This is the first trial in which orally administered Rigosertib, a dual kinase inhibitor, was studied in solid tumors. Intravenously rigosertib is already in phase 3 clinical trials for myelodysplastic syndrome and pancreatic cancer and oral rigosertib is being studied in a pair of Phase II trials in lower-risk transfusion dependent MDS patients. The drug candidate is being developed by Onconova Therapeutics, Inc., of Pennington, NJ.

Overall, 48 patients were included in the Phase I trial with oral rigosertib, and 7 remained on study for at least six months. Six head and neck cancer patients included in this study had failed platinum-based therapies, and 2 of these patients showed a response to Rigosertib one with the disappearance of lung metastasis and another with greater than 50 percent decrease of liver metastasis. These 2 patients have received oral rigosertib treatment for 98 and 48 weeks.

"The results from the head and neck cancer patients are interesting, revealing that the drug worked in a subset of patients," says Antonio Jimeno, MD, PhD, investigator at the University of Colorado Cancer Center and director of the university's Head and Neck Cancer Medical Oncology Program. "To learn more about the relationship between response and genetic make-up of the tumor, we've been investigating molecular correlates in a surrogate Phase 2 trial in patient-derived animal models of head and neck cancer."

As highlighted in the AACR presentation, genetic analysis of tumor samples from the Phase 1 trial and continuing genetic analysis of animal models, performed at both the Colorado Molecular Correlates Laboratory (CMOCO) and Dr. Jimeno's research laboratory, detected several potential biomarkers, including the genes PIK3CA and PTEN, which are both members of the signaling pathway targeted by the drug. Whole-exome sequencing of patient samples also revealed what Jimeno calls, "a short list of core alterations in genes for further exploration as predictive biomarkers."

"These promising results from human trial combined with relevant animal models established in our laboratories are helping us learn more about this drug and its mechanism of action. Based on these studies, we are initiating an 80-patient, multi-institutional Phase 2 trial," says Jimeno. In this trial, tissue samples from patients will be analyzed by sequencing and using other genomic tools to fully explore the predictive capability of these candidate biomarkers.

"We have seen meaningful activity in a subset of patients in the Phase I trial and we confirmed this in the surrogate animal model," Jimeno says. "The hope is that broad genetic analysis will help identify biomarkers for accurately matching the drug with the right patients in the future."

"It's an exciting time for an exciting drug," Jimeno says.


'/>"/>

Contact: Garth Sundem
garth.sundem@ucdenver.edu
805-559-2023
University of Colorado Denver
Source:Eurekalert

Related medicine news :

1. Good news: Migraines hurt your head but not your brain
2. Grape News: Global Wine Manufacturing Industry Market Research Report from IBISWorld has Been Updated
3. Actos Lawsuit News: Bernstein Liebhard LLP Notes Latest Scheduling Order in Actos Bladder Cancer Litigation
4. Zoloft Lawsuit News: Bernstein Liebhard LLP Notes New Pretrial Order in Federal Zoloft Litigation Establishing Tentative Date for First Bellwether Trial
5. MinuteHound News: Top Three Ways To Save Money With Biometric Time and Attendance Solutions
6. Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes Upcoming Status Conferences in Federal Transvaginal Mesh Litigations
7. Da Vinci Robotic Surgery Lawsuit News: Ohio Law Firm Investigates Da Vinci Robotic Surgery Complications as Settlement is Reached in Louisiana Da Vinci Robot Lawsuit
8. DrugRisks Center NuvaRing Lawsuit News: Drug Maker May Have Concealed Risks
9. Stryker Hip Replacement Lawsuit News: Mass. Woman Files First Known Federal Stryker ABG II Hip Lawsuit, Rottenstein Law Group Reports
10. ALS patients differ on treatment choices in later phases of disease
11. Reach2HD, a Phase II study in Huntingtons disease, launched
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... ... ... A recent article published June 14 on E Online details ... to state that individuals are now more comfortable seeking to undergo not only the ... and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) notes ...
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
(Date:6/24/2016)... ... , ... People across the U.S. are sharpening their pencils and honing their ... in which patients and their families pay tribute to a genetic counselor by nominating ... of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... OTTAWA, Ontario , June 27, 2016  VMS ... the Company,s Board will take whatever measures required to ... the Company,s stock which is currently listed on the ... S Wexler, Company Chairman and CEO, "We are seeing ... be difficult to understand, not only by the Company, ...
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... CLEMENTE, Calif. , June 24, 2016  American Respiratory Labs ... company, is now able to perform sophisticated lung assessments in patients, ... Technologies , Inc. Patients are no longer limited ... ndd,s EasyOne PRO ® , ARL patients like Jeanne R. of ... done in the comfort of her own home. ...
Breaking Medicine Technology: