“We seek SAB members who are both experienced clinicians and diligent researchers, and who also possess a strong passion to develop new treatment options and compassion for patients and their safety,” said Ben Machielse, Drs., President and Chief Executive Officer of Vtesse, Inc. “Dr. Berry-Kravis brings this unique combination to our SAB, which will support the clinical development of VTS-270. Her clinical research experience in rare diseases, such as Fragile X Syndrome, will help us advance our efforts with VTS-270. Dr. Berry-Kravis is serving as a co-lead principal investigator in our Phase 2b/3 clinical study of VTS-270 in addition to joining our SAB.”
Dr. Berry-Kravis established the comprehensive Fragile X Clinic and Research Program at Rush University Medical Center in 1992, through which she provides care and support to over 400 patients with Fragile X Syndrome (FXS) for management of neurological, medical, behavioral and genetic issues. Her clinical research projects involve studies of epilepsy and psychopharmacology in Fragile X, clinical trials of new promising medications in FXS and development of outcome measures and biomarkers for such trials in the FXS population. She received a Bachelor's degree in chemistry from the University of Notre Dame in 1979, a Ph.D. in biochemistry in 1983 and M.D. in 1985 from the University of Chicago. She completed a pediatrics residency in 1987 and pediatric neurology fellowship in 1990, also at the University of Chicago, and moved to Rush University Medical Center in 1992.
“As a physician committed to studying potential new treatments for children facing rare and fatal diseases, I'm very pleased with the opportunity to co-lead the clinical trial for VTS-270 in NPC and to serve on the SAB of Vtesse,” said Dr. Berry-Kravis. “With VTS-270, Vtesse has both a unique package of high-quality, pre-clinical data that clearly outlines the potential benefits of the drug candidate and encouraging clinical data from a Phase 1 trial. It's rewarding to now be treating children with VTS-270 as part of this trial. It provides us with the opportunity to gather the data required to advance the regulatory process and move toward U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval for VTS-270.”
Mr. Massaro's primary responsibilities as Vtesse's Vice President, Clinical Operations, focus on directing all clinical activity for the company, with a particular emphasis on the advancement of VTS-270. He has over 20 years of experience in biopharmaceutical development. Most recently, as the Vice President of Global Operations for global clinical research organization Quintiles, he managed a top client, which included overseeing more than 100 clinical trials in every phase of clinical research. Prior to Quintiles, Mr. Massaro served as Vice President of Development for Wound Solutions Ltd., and was the Director of Clinical Planning at MedImmune, a wholly-owned subsidiary of Astra-Zeneca.
“Ensuring that the development of VTS-270 is held to the strictest operational standards while rapidly advancing the pivotal trial will be one of the core responsibilities of our new Vice President Michael Massaro,” said Drs. Machielse. “Michael's background in the management of every phase of clinical research and his passion for his work make him an obvious candidate and choice to fill this role.”
“I'm honored to join the Vtesse team as we continue to explore and move VTS-270 forward as a potential treatment for NPC,” said Mr. Massaro. “This is an important unmet medical need, and I'm driven to help provide a solution to the thousands of individuals living with NPC throughout the world.”
For more information on Vtesse's pivotal Phase 2b/3 clinical trial, visit www.theNPCstudy.com.
Vtesse, Inc. is a rare disease company dedicated to developing drugs for patients suffering from diseases that are underserved. Vtesse is working collaboratively with the NIH and other leading academic centers to advance clinical study of VTS-270 for NPC, and to conduct pre-clinical discovery and development of other novel drugs for NPC and other lysosomal storage diseases (LSDs). Vtesse is led by a highly experienced management team that has been involved in the development of more than 20 approved drugs and vaccines. Its experienced consortium of investors, led by New Enterprise Associates, has committed initial funding that is expected to bring this compound through pivotal clinical trial. Vtesse is based in Gaithersburg, Maryland and is the first spin-out company from Cydan Development, Inc. For more information, visit www.vtessepharma.com.
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