AACR news: Rigosertib Phase 1 results lead to disease-focused Phase 2 development

Promising Phase I clinical trial of Rogosertib leads to multi-institutional Phase II trial

2013-04-09

(Press-News.org) 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. ### END

ELSE PRESS RELEASES FROM THIS DATE:

AACR news: Little molecule makes big difference in bladder cancer metastasis

2013-04-09

In order to kill, bladder cancer must metastasize, most commonly to the lung – what are the differences between bladder cancers that do and do not make this deadly transition? Research presented by the Director of the University of Colorado Cancer Center at the AACR Annual Meeting 2013 shows that one big difference is a little molecule known as hsa-miR-146a. Messenger RNA or mRNA carries gene blueprints to sites where the plans are read and made into proteins, and to a large degree microRNA or miRNA tells mRNA what to do. Theodorescu's work shows that in 256 samples of ...

AACR news: Six2 homeoprotein allows breast cancer cells to detach and metastasize

2013-04-09

In results presented at the AACR Annual Meeting 2013, researchers from the University of Colorado Cancer Center show that the Six2 homeoprotein, while not involved in primary tumor growth, allows cells to detach from substrate and survive their transition through the bloodstream to faraway sites of metastasis. "Here we show for the first time that Six2 causes breast cancer progression. It's this metastasis, especially to the lung, that can eventually be deadly and so perhaps even more so than affecting the size of the primary tumor, we are especially excited to present ...

1-2 punch could be key in treating blindness

2013-04-09

EAST LANSING, Mich. — Researchers have discovered that using two kinds of therapy in tandem may be a knockout combo against inherited disorders that cause blindness. While their study focused on man's best friend, the treatment could help restore vision in people, too. Published in the journal Molecular Therapy, the study builds on earlier work by Michigan State University veterinary ophthalmologist András Komáromy and colleagues. In 2010, they restored day vision in dogs suffering from achromatopsia, an inherited form of total color blindness, by replacing the mutant ...

High pressure gold nanocrystal structure revealed

2013-04-09

A major breakthrough in measuring the structure of nanomaterials under extremely high pressure has been made by researchers at the London Centre for Nanotechnology (LCN). Described in Nature Communications, the study used new advances in x-ray diffraction to image the changes in morphology of gold nanocrystals under pressures of up to 6.5 gigapascals. Under high pressures, imaging methods such as electron or atomic force microscopy are not viable, making x-ray diffraction imaging the only option. However, until recently, focusing an image created with this method ...

Nanotechnology imaging breakthrough

2013-04-09

Washington, D.C.— A team of researchers has made a major breakthrough in measuring the structure of nanomaterials under extremely high pressures. For the first time, they developed a way to get around the severe distortions of high-energy X-ray beams that are used to image the structure of a gold nanocrystal. The technique, described in April 9, 2013, issue of Nature Communications, could lead to advancements of new nanomaterials created under high pressures and a greater understanding of what is happening in planetary interiors. Lead author of the study, Wenge Yang ...

Dedicated cleaning staff shown to reduce C. difficile contamination in hospital rooms

2013-04-09

With rates and deaths associated with Clostridium difficile (C. difficile) at historically high levels, many hospitals have taken extra steps to reduce these infections. New research finds that a dedicated daily cleaning crew who adequately clean and disinfect rooms contaminated by C. difficile using a standardized process can be more effective than other disinfection interventions. The study is published in the May issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America (SHEA), in a special topic issue focused ...

Decontamination of unused medical supplies reduces health-care costs

2013-04-09

CHICAGO (April 9, 2013)– In rooms of patients with multidrug-resistant organisms (MDROs), the outside of the packages containing sterile items can become contaminated. Unused medical supplies are often thrown away to prevent the items from becoming pathways for transmission of drug-resistant microbes, and in the process this leads to increased healthcare costs. Researchers at Johns Hopkins Hospital found that hydrogen peroxide vapor (HPV) is an effective way to sanitize the outside of the packages of these sterile supplies. In addition to protecting patients, use of ...

Copper surfaces reduce the rate of health care-acquired infections in the ICU

2013-04-09

CHICAGO (April 9, 2013)– Placement of copper objects in intensive care unit (ICU) hospital rooms reduced the number of healthcare-acquired infections (HAIs) in patients by more than half, according to a new study published in the May issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America, in a special topic issue focused on the role of the environment in infection prevention. In the United States, HAIs result in 100,000 deaths annually and add an estimated $45 billion to healthcare costs. HAIs often contaminate ...

Sea level rise: Jeopardy for terrestrial biodiversity on islands

2013-04-09

Terrestrial species on low-lying islands and coastal regions are vulnerable to sea level rise due to climate-change, the most vulnerable species being endemics with limited ranges and rare species that are endangered already. That is the key message of a study by Florian Wetzel and colleagues of the Konrad Lorenz Institute of Ethology (KLIVV) of the University of Veterinary Medicine, Vienna (Vetmeduni Vienna) and Walter Jetz of the Department of Ecology and Evolutionary Biology at Yale University, USA. The new study is the first of its kind in terms of geographic scope ...

IDRI and Medicago to present data at the World Vaccine Congress

2013-04-09

IDRI (Infectious Disease Research Institute), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that they will be presenting positive interim Phase I clinical results for their H5N1 Avian Influenza VLP vaccine candidate "H5N1 vaccine" at the World Vaccine ...

AACR news: Rigosertib Phase 1 results lead to disease-focused Phase 2 development

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: