NEW YORK, Nov. 19, 2013 /PRNewswire/ -- Transparency Life Sciences, LLC (TLS), the world's first drug development company based on open innovation, today announced that it 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.
Dr. Galsky commented, "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," noted Tomasz Sablinski, MD, PhD, 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. To view the Protocol Builder for the metformin prostate cancer study, click here.
Metformin is the most widely prescribed drug worldwide 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.
Prostate cancer is the most common malignancy in US men. In 2013, approximately 238,600 men are expected to be diagnosed with prostate cancer. Most of these patients have localized cancer and are treated with surgery or radiation. Many will be cured, but the disease recurs in 30-40%, with recurrence typically manifested by a rise in PSA levels. However, PSA levels can also rise as a result of other factors. This uncertainty and the risk of disabling side effects from current therapies make many men with rising PSA levels reluctant to undergo additional treatment. A safe and affordable drug such as metformin might represent an attractive option for these patients, if its potential anticancer efficacy were confirmed.
Earlier this year 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.
Visit the TLS website to access currently available Protocol Builders. In addition, the company's Indication Finder offers the opportunity to consider promising new indications for existing drug candidates. For more information on Transparency Life Sciences, visit: www.transparencyls.com.
For more information about AMC Health, visit www.amchealth.com.
The pilot trial is funded, in part, by the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.
About Transparency Life Sciences
Transparency Life Sciences (TLS) is the world's first drug development company based on open innovation. TLS acquires promising new chemical entities (NCEs) and repurposed generics addressing significant unmet medical needs and tests them in clinical trials that leverage crowdsourcing methods, advances in telemedicine and full data transparency. The company expects this innovative approach to result in significantly reduced costs and clinical timelines. For more information, visit: www.transparencyls.com.
SOURCE Transparency Life Sciences, LLC