TMCnet News
Rafael Pharmaceuticals Partners with Sara's Cure and SARC for the Launch of Phase 2 Clinical Trial for CPI-613® (devimistat) in Combination with Hydroxychloroquine for Patients with Clear Cell Sarcoma of Soft TissueCRANBURY, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced it will initiate a Phase 2 clinical trial of CPI-613®(devimistat) in combination with hydroxychloroquine in patients with clear cell sarcoma of soft tissue. In partnership with Sara’s Cure and Sarcoma Alliance for Research through Collaboration (SARC), Rafael will begin enrolling patients into the Simon two-stage design trial at sites across the United States. “Our daughter’s battle with clear cell sarcoma was very eye opening around the lack of treatment options for patients with clear cell sarcoma, largely due to the rarity of the disease,” said Lennie Woods, Founder and Executive Director of Sara’s Cure. “When we learned about Rafael’s dedication to fighting rare diseases, we immediately connected to discuss if devimistat can potentially be a solution in treating this disease. We are so grateful to have a partner like Rafael that truly cares about helping people like our daughter, and reminds our entire community that we are not alone in this fight.” Woods founded Sara’s Cure after Sara, her teenage daughter, was diagnosed with clear cell sarcoma. Traveling to the top hospitals across the country, Woods and her family discovered how difficult it is to treat this disease, and even once it is successfully treated, it often returns. Clear cell sarcoma is most often found in teens and young adults in their 20s. “We are honored to partner with Lennie and Sara’s Cure to fight this disease and launch one of the very few trials for clear cell sarcoma, as part of our continued mission to provide hope for patients with hard-to-treat cancers,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “Both Sara’s Cure and SARC share our passion in being a voice for those battling this rare disease.” “This study is an outstanding example of the value of collaborative efforts among advocacy, biotech and academia. Recognizing the need to better understand and treat clear cell sarcoma, SARC, as an academic research consortium will leverage the strengths of SARC to assist with this important trial,” said Steven Young, President and CEO of Sarcoma Alliance for Research Collaoration. SARC has been instrumental in assisting with the study design, correlative studies, identifying key sites to run the trial as well as coordinating with Sara’s Cure. “Clear cell sarcoma most often affects young adults, but it is seen in all ages,” said Robin Jones, M.D., of the Institute of Cancer Research and principal investigator on the trial. “The opening of this trial not only has the potential to provide a promising treatment option for those affected by this disease, but it sparks the hope that many of us have been waiting for, for a long time.” Being part of this trial gives me hope that we are truly turning a corner in how we treat this childhood-stealing disease,” said Matteo Trucco, M.D., Director of the Children’s Cancer Innovative Therapy Program of the Cleveland Clinic. “I’m honored to be part of this journey.” “Clear cell sarcoma is truly one of the most challenging sarcomas to treat,” said Rashmi Chugh, M.D., medical oncologist and Professor of Internal Medicine at University of Michigan. “Our hope is that with the initiation of this important study, we will learn some critical lessons about how to successfully treat this aggressive disease.” The Company is deeply appreciative for the many principal investigators who will be part of this critical trial. In the United States, sites to open include Seattle Children’s Hospital, Indiana University Melvin and Bren Simon Cancer Center, Cleveland Clinic Taussig Cancer Center and University of Michigan. Additional sites are also planned to be opened in the United Kingdom and Scotland. About CPI-613® (devimistat) About Rafael Pharmaceuticals, Inc. Safe Harbor Statement In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements. ### Rafael Media Contact: Vanessa Donohue [email protected] (201) 465-8036 |