Clinical News Roundup: Sanofi Invests To Bring Clinical Trials Home
By Ed Miseta, Chief Editor, Clinical Leader
Clinical research company Science 37 has raised $31 million in a Series B round of funding to expand clinical trial access to “anyone, anywhere, anytime.” Some of the funding was provided by Series A investors Lux Capital, dRx Capital, and Sanofi Genzyme BioVentures. Sanofi will also provide Science 37 with technical and strategic guidance via interactions with their development teams and clinical affiliates.
Science 37 seeks to bring clinical trials into patient homes, a process that would decentralize setup, increase study enrollment, and reduce the cost of trials. The company will supplant trial sites with a single metasite, made possible by a cloud-based mobile research platform connecting investigators and patients.
LLS Launches Precision Medicine Master Trial In Blood Cancer
LLS has launched an offensive against acute myeloid leukemia (AML) by announcing a multi-site, multi-treatment, collaborative Master Trial in blood cancer. Despite advances in treating other blood cancers, the standard of care for AML patients has seen little change in the last 40 years. AML is the most deadly blood cancer with a 5-year survival rate below 20% for patients over age 60.
The Beat AML Master Trial hopes to develop highly targeted, effective treatment approaches. This precision medicine approach will include a cross-collaboration of world-renowned researchers, top cancer centers, pharmaceutical companies, and a genomics provider.
The trial will initially launch at five leading cancer centers: The Ohio State University Comprehensive Cancer Center, Memorial Sloan Kettering Cancer Center, OHSU Knight Cancer Institute, Dana-Farber Cancer Institute, and Massachusetts General Hospital Cancer Center. Patients will be placed in one of four treatment “arms,” with investigational drugs provided by Alexion, Boehringer Ingelheim, Celgene, and Gilead Sciences.
Clinical Trials: A Gateway To Treatments Of The Future
There are many ways physicians can generate patient interest in clinical trials. Dr. Mahsa Mohebtash, chief of medical cardiology and hematology at Medstar Union Memorial Hospital’s Cancer Center, lets her breast cancer patients know a trial is one way they can gain access to treatments of the future.
“I’m very upfront with patients,” she says. “I think it is a privilege to be in a clinical trial. It may have an added benefit—or it may not. But you will have the opportunity to get the drug of the future now.” She adds that patients taking part in a clinical trial receive extremely intensive care, are closely monitored, and have their own nurse with whom they meet one-on-one. It is also a benefit to society, as trials will help patients in 5 to 10 years.
A recent article in Forbes noted the highest rate of study enrollment is in cancer trials, but participation in the U.S. still hovers around 5 percent. Dr. Elias Zerhouni, president of Global R&D for Sanofi and former director of the U.S. National Institutes of Health, wrote that patients don’t seem to be afraid of taking part in such trials. The problem is a lack of information about them.
Nearly half of adults surveyed do not understand the purpose of clinical trials. When educated about them, a third of adults note they would take part in them. Therefore, encouraging physicians to talk to patients about the benefits of clinical studies, and encouraging patients to become self-advocates for their own care, is part of the solution.
New Drug Could Halt Progression Of Alzheimer’s Disease
Human trials have begun in Australia for a new drug that has been shown to halt the progression of Alzheimer's disease in mice and to reverse memory loss. Volunteers diagnosed with mild to moderate Alzheimer's are being sought to take an oral medication and be monitored on its effects.
The study's lead researcher, Austin Health associate professor Michael Woodward, said the drug, called CT1812, had been found in mice to negate the effects of the toxic protein amyloid beta – which is thought to cause Alzheimer's – at both cellular and behavioral level, and to improve memory. He notes the new drug could slow or halt the human progression of Alzheimer's, from which 350,000 Australians currently suffer and another one million projected to be diagnosed by 2050.
Susan Catalano, chief science officer of the trial's backers, private U.S. biotech company Cognition Therapeutics, or CogRx, said previous therapies had focused on trying to eliminate plaques caused by the build-up of amyloid beta in the brain. The new approach focused on how these proteins link together to form clumps called oligomers, which bind to receptors in the synapses responsible for communication between brain cells. The binding process kills off parts of the receptors and, in turn, disables the synapses, causing Alzheimer's symptoms to appear.
Allergan And SonarMD Develop Patient Engagement Platform
Allergan and SonarMD have partnered to develop clinical decision support and patient engagement tools to improve diagnosis and monitoring of patients with diarrhea-predominant irritable bowel syndrome.
The companies will leverage SonarMD’s cloud-based care management platform, which enables health care providers to engage, monitor, and manage patients between visits via secure ongoing health assessments of symptoms, quality of life, and treatment effects. The data can alert physicians to changes in a patient’s condition and potentially improve health outcomes and decrease costs.
“Traditionally, the limited diagnostic and therapeutic options available for patients suffering from irritable bowel syndrome, combined with the reluctance of those patients to discuss their symptoms with healthcare practitioners, has presented a major barrier to providing them with the most effective care,” says Jonathan Rosenberg, medical director for SonarMD. “The collaboration between SonarMD and Allergan is focused on developing tools which will help providers more efficiently identify IBS-D patients, deliver quality care, and simultaneously foster meaningful patient engagement.”
Novo Nordisk And QuintilesIMS Win SCRS Eagle Award
Novo Nordisk and QuintilesIMS were the recipients of the 2016 Society for Clinical Research Sites (SCRS) Eagle Award. The awards were presented in front of 860 attendees at the annual SCRS Global Site Solutions Summit held in Boca Raton, FL. The Eagle Award recognizes the sponsor and CRO most dedicated to creating positive relationships with sites, as voted on by the sites. Winners are judged on leadership, professionalism, integrity, passion, and dedication to advancing the clinical research profession through strong site partnerships. Over 3,000 votes were cast from around the globe.
"The winning sponsor and CRO of the 2016 Eagle Award were selected exclusively on votes cast from the sites," states Christine Pierre, SCRS president. "From the record number of votes cast this year, it is clear there was great enthusiasm to recognize the sponsor and CRO who have exemplified an exceptional working relationship with the sites. SCRS applauds the efforts of Novo Nordisk and QuintilesIMS to raise the industry standards by initiating strong partnerships with the clinical research sites."
The selection criteria for finalists included a willingness to collaborate on protocol design and execution, availability of a qualified staff to support the sites, financial consideration to the sites, and potential for future partnership. SCRS members nominated the sponsor and CRO they had worked with in the past 18 months that they believed exemplified these characteristics. The final nominees were sponsors and CROs that ranked in the 75th percentile or higher of initial nominations.
Other sponsor finalists included Amgen, Eli Lilly, GlaxoSmithKline, Merck, Nektar, Novartis, and Pfizer. Other CRO finalists included INC Research, Medpace, PRA, and Target Health.