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:6/27/2016)... ... ... "FCPX editors can now reveal their media with growing colorful split screen ... - CEO of Pixel Film Studios. , ProSlice Color brings the split screens ... reveal the media of their split screens with growing colorful panels. , ProSlice Color ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to ... of individuals in the United States and Canada wear eyeglasses. Once considered to be ... vision and make a fashion statement. Even celebrities use glasses as a way of ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Revolutionary technology includes ... Oticon , industry leaders in advanced audiology and hearing ... Oticon Opn ™, the world,s first internet connected hearing ... IoT devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ... number of ,world firsts,: , TwinLink™ - ...
(Date:6/23/2016)... Research and Markets has announced ... Analysis (United States, China, Japan, Brazil, United Kingdom, Germany, ... offering. Surgical Procedure ... planners, provides surgical procedure volume data in a geographic ... in-depth analysis of growth drivers and inhibitors, including world ...
(Date:6/23/2016)... , June 23, 2016  The National ... has joined the health policy research organization as ... Romano , MD, senior vice president and chief ... company,s representative on the NPC Board of Directors. ... pleased that Mallinckrodt has joined us in support ...
Breaking Medicine Technology: