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Summa Health System, Mayo Clinic and IC-MedTech Continue Collaboration on Breakthrough Medication

Date: 03.04.2013
Contact: Erica Rosenthal Phone: (330) 375-3052

AKRON, Ohio, March 4, 2013 – Leaders in research, science and medicine from Summa Health System, Mayo Clinic and IC-MedTech will come together on Friday, March 8 at Summa Akron City Hospital to discuss the success, current research and future of Apatone®, an oral medication made of Vitamin-C and Vitamin-K3. This seminar, part of the Apatone® Development Project, is part of a collaborative research agreement signed in 2011 between the three organizations to study the usage of the drug for a variety of diseases and conditions.

Originally developed in 2005 to help fight cancer, Apatone works to prime tumor cells to be more easily killed by chemotherapy and radiation and suffer from less inflammation. Researchers at Summa tested this among patients with urologic tumors (bladder, prostate and kidney cancers), as well as colon, ovarian, lung, melanoma, myeloma and neuroblastoma cancers.

In addition to cancer, researchers at the Mayo Clinic have studied Apatone for the treatment of polycystic kidney and liver diseases, and at Summa Health System through a clinical trial for patients with chronically painful joints as a result of a prosthetic knee implant.

The seminar on March 8, titled “The Apatone® Development Project – Better Quality Care, Affordably,” will educate medical, research and healthcare professionals about the history of Apatone, its usage, research results, collaborations and strategies going forward to help even more patients across the country.

Seminar presenters include:
• Nicholas LaRusso, M.D., Medical Director of the Center for Innovation, Mayo Clinic
• Vincent Torres, M.D., Ph.D., Division of Nephrology and Hypertension, Mayo Clinic
• Tetyana Masyuk, Ph.D., Department of Internal Medicine, Mayo Clinic
• Thomas Miller, Founder and CEO, IC-MedTech, Inc.
• Steven Schmidt, Ph.D., Vice President of Clinical Research and Innovation, Summa Health System
• James Jamison, Ph.D., Director of the Apatone Development Laboratory, Summa Health System
• Thomas Bear, M.D., Ian Gradisar, M.D., and Patrick Flanagan, M.D., orthopaedic surgeons, Crystal Clinic Orthopaedic Center, a partnership with Summa Health System
• Mark Kovacik, Research Investigator, Center for Clinical Trials, Summa Health System
• Karen McGuire, Ph.D., Post-doctoral Student, The Apatone Development Center, Summa Health System
• Tom Strauss, President and CEO, Summa Health System

“The Apatone study has proven to be extremely beneficial to helping find potential breakthroughs for an array of serious illnesses,” said Steven P. Schmidt, Ph.D., vice president of clinical research and innovation at Summa. “There remains a great deal of research to be done, but the results to date are very encouraging and show that Apatone could have an enormous impact on the health and well-being of people with a variety of debilitating conditions.”

Additionally, Summa and IC-MedTech recently requested Breakthrough Therapy designation from the U.S. Food and Drug Administration. If approved, it will allow the FDA to accelerate the drug’s approval process, which would bring it to market sooner.

“We’re thrilled to be working with Summa Health System and the Mayo Clinic to demonstrate the success of Apatone and hopefully officially commercialize the drug in the near future,” said Tom Miller, founder and CEO of IC-MedTech, which licensed Apatone in 2004. “It’s truly breakthrough technology that’s not only innovative, but safe, effective and affordable.”

Open Clinical Trial for Patients with Pain after Total Knee Replacement Surgery
Summa is offering a clinical trial to study Apatone-B® for patients who are suffering from a chronically painful joint as a result of a prosthetic knee implant. Having a B designation for bone indications, the drug is a lower concentrated combination of Vitamin-C and Vitamin-K3 that work together to target inflammation as a means of fighting disease and regulating abnormal cell activity. Cells that produce the proteins associated with inflammation are targeted by the drug, while healthy tissue is spared. The goal of Apatone-B is to relieve these conditions and possibly extend the life expectancy of the artificial joint.

Preliminary lab investigations show that a single-dose of Apatone-B reduced key inflammatory material by as much as 50 percent and showed a cell growth of approximately 20 percent in affected cells. Approximately half of the patients have also shown a dramatic decrease in bone inflammation and breakdown and reported little to no side effects.

The clinical trial is enrolling orthopaedic implant patients who are beyond one year post-surgery that have developed inflammation and discomfort in their replaced knee joint that is not due to infection. Half of the enrollees are given a daily dose of oral Apatone-B and half receive an oral placebo throughout the course of 13 weeks. Blood specimens and a synovial fluid sample from the joint are taken at the beginning and end of the trial to compare the level of inflammation and bone loss in order to assess the effectiveness of Apatone-B.

Additional information regarding the study can be obtained by calling 1-800-23SUMMA (1-800-237-8662). For more information about the Department of Orthopaedics and their activities, please call 330-379-5661.

About Summa Health System
Summa Health System is one of the largest integrated healthcare delivery systems in Ohio. Encompassing a network of hospitals, community health centers, a health plan, a physician-hospital organization, a multi-specialty physician organization, research and multiple foundations, Summa is nationally renowned for excellence in patient care and for exceptional approaches to healthcare delivery. Summa's clinical services are consistently recognized by the American Nurses Credentialing Center (Magnet status), U.S. News and World Report, Thomson Reuters and The Leapfrog Group. Summa also is a founding partner of the Austen BioInnovation Institute in Akron. For more information, visit www.summahealth.org or find us on Facebook at www.facebook.com/summahealth and Twitter at www.twitter.com/summahealth.
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NOTE: Media are invited to attend “The Apatone® Development Project – Better Quality Care, Affordably” seminar on Fri. March 8 from 10 a.m. to 2 p.m. in the POD meeting rooms at Summa Akron City Hospital (located in the basement level of 55 Arch St., Professional Center South). Please contact Erica Rosenthal if interested in attending or speaking with one of the presenters.