Transparency Life Sciences (TLS), a drug development company based on open innovation, is collaborating with Dr. Matthew Galsky, associate professor of medicine, division of hematology/oncology at the Icahn School of Medicine at Mount Sinai, to design and conduct a pilot trial assessing metformin as a potential treatment for prostate cancer. Metformin is a widely prescribed diabetes drug that has shown promising activity against prostate and other cancers in preclinical and clinical studies.
A second objective of the trial is to test the feasibility of using crowdsourcing to obtain broad-based input to the design of the clinical protocol and telemonitoring to replace most patient site visits, with the aim of increasing participation in cancer trials through greater engagement and by reducing the burden on patients. Crowdsourcing and telemonitoring are key elements of TLS’s drug development strategy. TLS is partnering with AMC Health, a comprehensive provider of telehealth services, to conduct the metformin study.
Galsky said, “One goal of this pilot study is to obtain a preliminary assessment of whether metformin can affect rising prostate specific antigen (PSA) levels in men who have been treated for localized prostate cancer. A second goal is to test whether it is feasible to conduct a cancer trial that incorporates crowdsourcing into the study design and uses telemonitoring to eliminate most patient site visits. Our prior research demonstrates that cancer trials are highly inefficient and geographically inaccessible to a large proportion of cancer patients. We are optimistic that a greater number of patients would participate if they were more engaged in the process and the burden of site visits were reduced.”
“This study fits the TLS model perfectly,” said Tomasz Sablinski, M.D., Ph.D., CEO of Transparency Life Sciences. “It is using a crowdsourced clinical protocol and telemonitoring to replace site visits. In addition, metformin is a great example of a drug with potential in a new indication that has not been adequately tested because it is off-patent. Our patient-centric, low-cost approach to clinical development is especially well-suited to these types of drugs.”
TLS incorporates insights gathered from a global crowd into its clinical protocols using the company’s Protocol Builder, an online tool that elicits input from patients, physicians and researchers to help design clinical trials more efficiently and with greater relevance to clinical practice and patients’ needs.
Metformin is widely prescribed for type 2 diabetes. It has demonstrated promising anti-prostate cancer activity in preclinical models, epidemiologic studies and retrospective cohort studies. These showed that metformin has a positive impact on overall survival in men with prostate cancer. One large retrospective cohort study of more than 2,900 patients undergoing radiation therapy for localized prostate cancer found that metformin use was independently associated with improvement in several different measures of survival.
TLS received FDA clearance to initiate a phase II study assessing the utility of the antihypertensive drug lisinopril as an adjunctive therapy in multiple sclerosis. The clinical protocol for that trial is the first to use crowdsourcing in its design, and is among the first to make intensive use of telemonitoring and other remote methods of patient data collection.