XYMOGEN to supply multivitamin preparation for prestigious, federally funded clinical Trial to Assess Chelation Therapy (TACT2)
ORLANDO, Fla. (September 27, 2016)—XYMOGEN is proud to announce that it has been chosen by Mount Sinai Medical Center of Florida and the Duke Clinical Research Institute to manufacture and supply the oral vitamin and mineral preparations that will be tested in the second Trial to Assess Chelation Therapy (TACT2), a $37M federally sponsored clinical trial.
Chelation is a process by which a medication, such as edetate disodium (Na2EDTA), can "grab" toxic metals like lead or cadmium—which are present in most individuals' bodies—and allow for their removal in the urine. Standard chelation therapy is typically given in conjunction with oral vitamins and minerals, which XYMOGEN will provide for the study.
TACT2 is funded by the National Center for Complementary and Integrative Health, the National Heart, Lung and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Environmental Health Sciences of the National Institutes of Health (NIH). TACT2 will examine the use of intravenous chelation therapy in combination with the oral vitamins supplied by XYMOGEN to determine if either chelation, oral vitamins and minerals, or both will reduce cardiovascular events in patients with diabetes and a history of a heart attack. An earlier 10-year study suggested that chelation therapy in conjunction with high dose vitamins was beneficial. Based on these results, the Mount Sinai and Duke scientists who conducted the trial felt that a repeat study was important to carry out. This present study will be carried out in patients with diabetes and a prior heart attack, common medical conditions.
XYMOGEN will be providing high quality, oral multivitamin and mineral formulations as well as the matching placebos for TACT2. XYMOGEN CEO and Founder Brian Blackburn said, "Our company is proud to be partnering with Mount Sinai Medical Center and Duke Clinical Research Institute and contributing to integrative medicine research."
The study chairman for TACT and the upcoming TACT2 is Dr. Gervasio Lamas, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai, which is located in Miami Beach, Fla. "The hallmark of science is the ability to replicate results," said Lamas. "Therefore, in collaboration with the Duke Clinical Research Institute and NIH scientists, we secured funding for TACT2."
"XYMOGEN's reputation in the medical community, coupled with its flexibility to design and manufacture the formulations necessary for this scale of clinical trial is essential for a successful study," Dr. Lamas said, "We will finally find out if high doses of multivitamins and minerals have a positive impact on cardiovascular health. We look forward to a long, productive relationship with the XYMOGEN team."
Participant enrollment for TACT2 will begin in the fall of 2016. The study plans to enroll about 1200 patients from over 100 clinical research sites in the U.S. and Canada. Those who are 50 years of age or older, have had a heart attack in the past, and are living with diabetes may meet the eligibility criteria for enrollment.
Potential clinical sites and patients interested in participating may contact the study team through www.tact2.org or may contact Dr. Lamas' team directly at email@example.com.
XYMOGEN, a family-owned health sciences company headquartered in Orlando, Fla., has been providing high-quality dietary supplements to licensed healthcare practitioners for more than a quarter century. The nutraceutical company has introduced numerous innovations to the functional medicine community; its Medical Board of Advisors consists of clinical practitioners who are industry experts in a broad range of specialties. XYMOGEN's strength as a company has been reinforced eight of the last nine years, as it was recognized again in 2015 by Inc. magazine as one of the 5000 fastest-growing, best-run, most innovative and most inspiring private companies in America. The company's 136,000 square-foot manufacturing facility is GMP (good manufacturing practices) and GMP for Sport Athletic Banned Substances Program registered by NSF International and TGA Certified. For more information on XYMOGEN, visit XYMOGEN.com, email us at pr@XYMOGEN.com or call 800-647-6100.
About Mount Sinai Medical Center
Founded in 1949, Mount Sinai Medical Center is the largest independent, private, not-for-profit teaching hospital in South Florida. Mount Sinai's mission is to provide quality healthcare to a diverse community enhanced through teaching, research, charity care and financial responsibility. Mount Sinai's Centers of Excellence combine technology, research and academics to provide innovative and comprehensive care in cardiology, neuroscience, oncology, urology and orthopedics. One of Florida's original statutory teaching, Mount Sinai is the hospital of choice for those who seek the level of expertise and care that only a teaching hospital can offer. Mount Sinai currently offers six convenient locations in Miami-Dade County. For more information on Mount Sinai Medical Center, visit www.msmc.com or call 305-674-CARE (2273).
About the Duke Clinical Research Institute (DCRI)
Its mission is to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making more than 40 years after its founding.