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Archive - Jun 3, 2017

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Increasing Patient Access to Investigational Drugs Is Focus of Early Afternoon Session on Day 1 at Personalized Medicine World Conference (PMWC) 2017 at Duke

PMWC 2017 at Duke Co-Chair Ralph Snyderman, MD, introduced the two panelists for a discussion of “Increasing Patient Access to Investigational Drugs,” as the two leading people in the country working to make such drugs available to patients, and noting that for patients this is perhaps the best of times and the worst of times—best in that we are learning so much so rapidly and worst due to the difficulty of patients gaining access to potentially helpful drugs. One panelist was Ellen V. Sigal (photo), PhD, Founder of Friends of Cancer Research (https://www.focr.org/), an organization that has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. Dr. Sigal introduced herself by noting that her PhD is actually in history and she had worked as a real-estate developer until her sister was diagnosed with breast cancer and died two days after receiving a bone marrow transplant. Then, Dr. Sigel began her unstinting work to help cancer patients. Dr. Sigal is Vice Chair, and currently Acting Chair, of the Inaugural Board of Directors of the Reagan-Udall Foundation (http://www.reaganudall.org/), which was designed to be a vehicle for bringing an array of resources and perspectives to bear on high-priority FDA regulatory science projects. The foundation fosters collaborations between patient groups, industry, academia, and FDA scientists to design and conduct regulatory science research. Dr. Sigal also serves on the Board of the Foundation for the National Institutes of Health, where she chairs its Public Private Partnerships Committee. In 2016, Dr.

Yale Chemists Forge New Path in Search for New Antibiotics; Achieve Elusive Full Synthesis of Pleuromutilin

Yale University scientists have developed a novel chemical process that may lead to the creation of a new class of antibiotics. The discovery comes at a time when more types of bacteria are becoming resistant to existing antibiotics, increasing the occurrence of lethal infections. The ability to create new antibiotics would have significant ramifications for medical treatment and public health, said the researchers. "This is one way to focus our talents as synthetic chemists in a direction that can immediately help patients," said Seth Herzon, PhD, a Chemistry Professor at Yale and member of the Yale Cancer Center. Dr. Herzon is principal investigator of a new study published in the June 2, 2017 issue of Science. The article is titled “A Modular and Enantioselective Synthesis of the Pleuromutilin Antibiotics.” Yale postdoctoral fellow Stephen Murphy, PhD, and Yale graduate student Mingshuo Zeng are co-authors of the study. Both are members of the Herzon Lab. The new process makes it possible to create molecules related to the natural product pleuromutilin from simple commercial chemicals in the laboratory. Pleuromutilin is produced by a fungus and was found to have useful antibacterial properties in the early 1950s. Since then, scientists in academia and the pharmaceutical industry have created thousands of pleuromutilin derivatives by a process known as semisynthesis, which involves chemically modifying pleuromutilin itself. However, a large proportion of these derivatives only vary at a single position in the molecule. A practical full synthesis, which would make a wealth of additional antibiotics possible, has remained elusive. Dr. Herzon first attempted to find a solution in 2008.

Adding Abiraterone to Standard Treatment Improves Prostate Cancer Survival by 37 Percent

Adding abiraterone to hormone therapy at the start of treatment for prostate cancer improves survival by 37 per cent, according to the results of one of the largest-ever clinical trials for prostate cancer presented at the 2017 ASCO Annual Meeting in Chicago and published in the New England Journal of Medicine on Saturday, June 3. The NEJM article is titled “Abiraterone Acetate Plus Prednisolone for Hormone-Naïve Prostate Cancer.” The ASCO abstract (LBA5003)is titled “Adding Abiraterone for Men with High-Risk Prostate Cancer (PCa) Starting Long-Term Androgen Deprivation Therapy (ADT): Survival Results from STAMPEDE (NCT00268476). The results from the Cancer Research UK-funded STAMPEDE trial could change the standard of care for men with prostate cancer, making abiraterone a first-line treatment alongside hormone therapy. This part of the STAMPEDE trial recruited approximately 1,900 patients. Half the men were treated with hormone therapy, while the other half received hormone therapy and abiraterone. In men who were given abiraterone there was a 70 per cent reduction in disease progression. The drug is usually given to men with advanced prostate cancer that has spread and has stopped responding to standard to hormone therapy, but this study shows the added benefit to patients who are about to start long-term hormone therapy. Professor Nicholas James, Chief Investigator of the Cancer Research UK-funded STAMPEDE trial from the University of Birmingham, said: "These are the most powerful results I've seen from a prostate cancer trial -- it's a once-in-a-career feeling. This is one of the biggest reductions in death I've seen in any clinical trial for adult cancers. Abiraterone is already used to treat some men whose disease has spread, but our results show many more could benefit.