Pittsburgh, PA, November 9, 2018 – Therapeutic Research in Neuromuscular Disorders Solutions (TRiNDS), a specialty contract research organization, and Italfarmaco SpA, a privately held Italian multinational pharmaceutical company, together announced a new partnership to provide patient advocacy services in the United States (US) for EPIDYS, a Phase 3 Clinical Trial of Givinostat. Under this new agreement, TRiNDS will support trial enrollment and retention by conducting patient outreach and education in the US.
Italfarmaco SpA is committed to its mission of contributing to the improvement of the quality of life and prolongation of human lifespan. Italfarmaco is conducting its phase 3 clinical trial of Givinostat for Duchenne muscular dystrophy (DMD) at sites in the United States, Canada, and Europe (NCT02851797). EPIDYS is a randomized placebo-controlled trial to evaluate the safety and efficacy of Givinostat among ambulatory patients with DMD.
“We are thrilled to support Italfarmaco with patient advocacy and recruitment into their important Phase 3 clinical trial of Givinostat. TRiNDS fills a need for the Italian base company in the US,” said Lauren Morgenroth, Chief Operating Officer of TRiNDS.
TRiNDS’ Patient Science Liaison will support patient outreach and community engagement efforts in the United States.
About Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD) is a progressive, ultimately fatal, genetic neuromuscular disorder. DMD is caused by mutations in the DMD gene for dystrophin, a protein which prevents damage to muscle cells. According to the Centers for Disease Control and Prevention, the prevalence of DMD is approximately 1 in 7,250 males ages 5 to 24 years old.1 Patients with DMD experience increasing muscle weakness and fibrosis in skeletal, cardiac, and respiratory muscles over time. As patients grow weaker, they lose the ability to walk and ultimately require the use of power mobility, invasive or non – invasive ventilation, and comprehensive medical management.
Givinostat is an investigational drug being evaluated for possible safety and efficacy for the treatment of DMD. Givinostat inhibits histone deacetylases (HDAC) activity inside the cell. HDAC activity inhibits muscle cell regeneration and microfiber adaptation to contraction. In preclinical studies in a murine model of DMD and in a clinical study in DMD boys, treatment with Givinostat was shown to significantly increase the amount of muscle and to significantly reduce the amount of fibrotic tissue. Moreover treatment with Givinostat significantly reduces tissue necrosis and fatty replacement, two other parameters related to disease progression2.
TRiNDS, LLC is a neuromuscular and rare disease contract research organization associated with the Cooperative International Neuromuscular Research Group (CINRG). TRiNDS combines a strong history of conducting international clinical trials and studies, regulatory agency compliant project and data management services, and a network of key opinion leaders. It also provides clients with support for study design, endpoint selection, and patient advocacy. TRiNDS was founded in 2016 and continues to serve as the coordinating center for the CINRG a global academic consortium. TRiNDS offers customized solutions to support academic and industry sponsored drug development projects, clinical trials, and post marketing studies.
Italfarmaco SpA is a private Italian multinational company located in Milan, operating in Italy and abroad in both the pharmaceutical and fine chemical industries through its controlled and/or subsidiary companies. Italfarmaco was established in 1938. The mission of Italfarmaco is to contribute to the improvement of the quality of life and the prolongation of human lifespan through the manufacturing of products and pharmaceutical services related to serious health disorders.
Italfarmaco Givinostat Program:
+39-026443 extension 2524
+1 (412) 224 - 2030
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