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Transparency Life Sciences and Lakewood Amedex Launch Protocol Design for New Clinical Trial on Chronic Diabetic Foot Ulcers

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Transparency Life Sciences (TLS) today announced a partnership with the Lakewood Amedex Inc. for crowdsourced design of a Phase 2a/b protocol to test a novel class of synthetic broad-spectrum antimicrobials and antifungals for the treatment of Chronic Diabetic Foot Ulcers (cDFU). The partnership uses TLS novel patient-centric protocol builder for clinical trials called Transparency Protocol Crowdsourcing (TPC) to solicit input from patients, caregivers, and health care professionals to contribute to the setup and design of trials using a proprietary online survey tool. The results are then analyzed using AI-enabled natural language processing and TLS proprietary advanced analytic tools to draft protocols more relevant to patient needs and clinical practice.

Diabetic foot infections are one of the most common complications for people who suffer from diabetes and a frequent cause of hospitalization. According to the American Diabetes Association, approximately 8.3 percent of the US population suffers from diabetes, and in 2006 there were 65,700 nontraumatic amputations performed on diabetic patients. Earlier trials of the Lakewood Amedex therapy indicated it was well tolerated for safety and the cohort treated with the 2 percent solution demonstrated improvement in ulcer healing in the small number of subjects. For the next phase, Lakewood Amedex has partnered with TLS to discover optimal protocol preferences for a variety of voices involved in the study, from patients to providers to caregivers. The survey will ask for feedback on dosing intervals, delivery mechanisms, and inclusion/exclusion criteria.

Patients needing treatment for cDFU face many obstacles, as mobility and dependency on others is a big part of their care, in addition to their own suffering from the condition itself, said Harry Glorikian, chief executive officer of Transparency Life Sciences. With so many considerations, and the drive to want to help find new therapies to help themselves and others with the condition, its important to provide a way for the patient, the caregiver and their physician to be involved with designing a trial that can quickly benefit everyone.

This partnership is the first for TLS with the new TPC product, relaunched in May 2020. The company has increased its focus on making clinical trials more accessible to patients through the use of technology while supporting the R&D mission of pharmaceutical and biotechnology companies. To find out more about Transparency Life Sciences and how the company is blending technology and service to support the changing needs of effective clinical trials, visit www.transparencyls.com.

About Transparency Life Sciences

Transparency Life Sciences (TLS) is a leader in digital drug development services offering virtual and hybrid clinical trials. Rapid advances in digital technology and strong regulatory support create a historic opportunity for TLS to catalyze a fundamental transformation in clinical trial design and execution, significantly improving the quality of clinical trials while reducing their overall cost. TLSs approach combines crowdsourcing and digital health technology to progress clinical trials with greater efficiency, patient engagement, and regulatory relevance. For more information, visit transparencyls.com/.

Andrea Vuturo

Vuturo Group for Transparency Life Sciences

[email protected]

415-689-8414