Clementia Clinical Program: Queensland University of Technology (QUT) Institute of Health and Biomedical Innovation (IHBI) Begins Enrolling Patients in Palovarotene 2B Extension Study
MONTREAL, CANADA, November, 18, 2016 – Clementia is pleased to announce that the Queensland University of Technology (QUT) Institute of Health and Biomedical Innovation (IHBI) is treating FOP patients in Part B of the Phase 2 Open-label Extension Trial (PVO-1A-202). Prof. Dr. Matthew Brown is principal investigator QUT trial site; Dr Sateesh Shankaranarayana is sub-investigator; and Linda Bradbury (+61 3443 7077 firstname.lastname@example.org) is the site coordinator.
More details and all enrollment criteria can be found on www.clinicaltrials.gov/ct2/show/NCT02279095.
This trial is now hosting clinical research sites on four continents to serve patients globally. Other sites are the Hospital Italiano in Buenos Aires, Hôpital Necker-Enfants Malades in Paris, the Mayo Clinic in Rochester, Minnesota, the Royal National Orthopaedic Hospital in London, the University of California San Francisco, and the University of Pennsylvania in Philadelphia.
About Fibrodysplasia Ossificans Progressiva (FOP)
FOP is a rare, severely disabling myopathy characterized by heterotopic ossification (HO) of muscle and soft tissues. Heterotopic bone formation progressively restricts movement by locking joints and leads to cumulative loss of function, disability, and increased risk of early death. Virtually all newborns with FOP have a hallmark toe malformation in which both big toes are shortened and bent inwards. FOP is caused by a mutation in the ACVR1 gene resulting in increased activity of the activin receptor type I (ALK2) involved in the bone morphogenic protein (BMP) pathway, a key pathway controlling bone growth and development. There are currently no approved treatments for FOP.
Palovarotene is a retinoic acid receptor gamma agonist being investigated as a treatment for FOP. Preclinical studies demonstrated that palovarotene blocked both injury-induced and spontaneous heterotopic ossification, maintained mobility, and restored skeletal growth in mouse models of FOP. Clementia licensed palovarotene from Roche Pharmaceuticals, which previously evaluated the compound in more than 800 subjects. Palovarotene received Fast Track designation from the U.S. Food and Drug Administration (FDA) and orphan designations for the treatment of FOP from both the FDA and the European Medicines Agency (EMA).
About Clementia Pharmaceuticals Inc.
Clementia is a clinical stage biopharmaceutical company committed to delivering treatments to people who have none. The company is developing its lead candidate palovarotene, a novel retinoic acid receptor gamma agonist, to treat fibrodysplasia ossificans progressiva (FOP) and other diseases. For more information, please visit www.clementiapharma.com.