Unfortunately, there is no cure for CLOVES. Surgery and other types of medical interventions are the only treatments for CLOVES overgrowth, vascular anomalies and other related medical issues.
Compassionate Use Access of PIQRAY (formerly BYL719/alpelisib) [7-9-19]
he Novartis Managed Access Program (MAP) for PIKRAY use in PROS is available to patients in the US where PIKRAY is available for commercial use (as well as other countries where not approved). The FDA approved PIKRAY for HR+/HER2- advanced breast cancer, and thus PROS patients may seek access to the medication through MAP.
Patients should contact their treating physicians who can, if clinically appropriate, make a request to Novartis for access to treatment using this link on the Novartis website https://www.novartis.com/our-focus/healthcare-professionals/managed-access-programs/managed-access-request-form.
New Research Opportunity: MOSAIC - ARQULE [6-5-19]
ArQule is currently conducting the MOSAIC (Miransertib in Overgrowth Syndromes in Adults and Children) clinical trial for patients who have been diagnosed with either Proteus syndrome (PS), which involves a mutation in the AKT gene, or those who have been diagnosed with one of a number of distinct overgrowth disorders characterized by a mutation in the PIK3CA gene, referred to as PIK3CA-related overgrowth spectrum (PROS). There are currently no approved medicinal treatments for PS and PROS, leaving patients with minimal treatment options.
The MOSAIC trial aims to determine whether miransertib, a drug which inhibits the biological pathway that both AKT and PIK3CA mutations affect, can effectively treat patients who are diagnosed with overgrowth syndromes associated with these mutations.
Based on the mechanism of action of miransertib, trial participants must have a mutation in either the AKT1 or PIK3CA gene to be eligible to participate in the MOSAIC trial. Learn more about how miransertib works below.
Additional information about the MOSAIC trial can be found here.
New Research Opportunity: BYL719/NOVARTIS [6-13-18]
A medical first: CLOVES Syndrome and overgrowth syndromes:remarkable improvement in the health of 19 pediatric and adult patients using a new therapeutic strategy called Alpelisib BYL719. Dr. Guillaume Canaud at the Necker-Enfants Malades Hospital – AP-HP, the Paris Descartes University, Inserm (INEM Institute Necker Enfants Malades – Centre for Molecular Medicine) and his team recently demonstrated the efficacy of a novel medication, a specific inhibitor called BYL719, in a cohort of 19 patients treated at the Necker-Enfants Malades Hospital – AP-HP and suffering from CLOVES Syndrome (Congenital Lipomatous Overgrowth, Vascular Malformation, Epidermal Naevi) or similar disorders.
Link to stay up to date on Dr. Canaud's research (use google Chrome to translate if need be)
Opportunity for CLOVES Research (ongoing)
Segmental Overgrowth Study (Cambridge, UK)
The SOS are a group of scientists and doctors based in Cambridge, United Kingdom and study CLOVES and related conditions featuring overgrowth of one part of the body, and normal growth elsewhere. As part of our research study we are able to screen genes that are known to cause CLOVES and thereby offer a genetic diagnosis.
For more information: http://www.overgrowthstudy.medschl.cam.ac.uk/
April 23, 2013 --- Research Opportunity with National Institutes of Health (NIH)
Announcement from CLOVES Syndrome Community
Letter from National Institues of Health
Questions and Answers about research with NIH