Scientists may have a way to double the efficacy and reduce the side effects of radiation therapy. Georgia Health Sciences University scientists have devised a way to reduce lung cancer cells' ability to repair the lethal double-strand DNA breaks caused by radiation therapy. "Radiation is a great therapy - the problem is the side effects, " said Dr. William S. Dynan, biochemist and Associate Director of Research and Chief, Nanomedicine and Gene Regulation at the GHSU Institute of Molecular Medicine and Genetics. "We think this is a way to get the same amount of cancer cell death with less radiation or use the same amount and maybe cure a patient that could not be cured before." Radiation therapy capitalizes on radiation's ability to kill cells by causing double-strand breaks in DNA. But the fact that varying levels of radiation are essentially everywhere - food, air, the ground, etc.
Boehringer Ingelheim announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335, its investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). The extensive study programme is underway at more than 350 sites in 15 countries and together encompasses nearly 2, 000 treatment-experienced as well as treatment-naĆ ve patients. Key regions in the programme include the European Union, Japan, U.S., Canada, Taiwan, Korea and Russia. The programme consists of three Phase III trials, that will be conducted to evaluate BI 201335 plus the standard backbone treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. Most HCV patients are infected with genotype-1 virus and belong to the most challenging HCV group to treat.
Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced that enrollment has started to the Phase 3 pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba™ (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes. The Phase 3, multicenter, double-blind, placebo-controlled, randomized clinical trial evaluating Menerba is currently open for enrollment. A total of 50 clinical sites in the U.S. will enroll 1, 200 postmenopausal women between the ages of 40 and 65 years. Participants will be randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks. The primary aims of the study are to determine the safety and efficacy of two doses of Menerba compared to placebo after 12 weeks of treatment.
Cancer researchers are developing a catalog of potential targets for novel treatments while they continue to identify genetic mutations powering different cancer subtypes. Recently, the University of Michigan Comprehensive Cancer Center and Michigan Center for Translational Pathology (MCTP) completed a pilot investigation. The goal of the study was to solve the practical challenges researchers face in quickly and systematically sequencing genetic material from individuals suffering with advanced or treatment-resistant cancer so that they can be matched with existing clinical trials based on the biomarkers identified. Findings from the exploratory investigation, known as the Michigan Oncology Sequencing Project (MI-ONCOSEQ) are published in Science Translational Medicine. Co-lead investigator Dr.
The Presidential Commission for the Study of Bioethical Issues has issued its report concerning federally-sponsored research involving human volunteers, concluding that current rules and regulations provide adequate safeguards to mitigate risk. In its report, "Moral Science: Protecting Participants in Human Subjects Research, " the Commission also recommended 14 changes to current practices to better protect research subjects, and called on the federal government to improve its tracking of research programs supported with taxpayer dollars. President Obama requested that the Commission undertake an assessment of research standards following the October 2010 revelation that the U.S. Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases without their consent.