Mayo Clinic and IC-MedTech enter collaborative research agreement with Summa Health System

Researchers from the Mayo Clinic and representatives from IC-MedTech signed a collaborative research agreement with Summa Health System to study the usage of Apatone®, a proprietary combination of Vitamin-C and Vitamin-K3. The Mayo Clinic entered into the collaboration with Summa Health System and IC-MedTech in order to conduct research and development for the prevention and/or treatment of polycystic liver and kidney disease.

“I think we've seen just the beginning of the disease entities for which Apatone can ultimately be beneficial”

Under the agreement, the Mayo Clinic will conduct pre-clinical and potentially clinical research using Apatone provided by IC-MedTech, who holds the license to Apatone. Summa's Apatone Development Center, located at Summa St. Thomas Hospital, will provide their expertise to investigators at Mayo.

Originally developed to supplement cancer treatment, the first clinical trial of Apatone began in 2005 to evaluate the drug in prostate cancer patients. The conclusion of the trial demonstrated promising results by showing delays in the biochemical progression in end-stage prostate cancer patients, which demonstrated the safety and efficacy of orally administered Apatone. Currently, Apatone is being studied in laboratory research as well as clinical trials for a variety of diseases that have inflammation as a significant component.

"I think we've seen just the beginning of the disease entities for which Apatone can ultimately be beneficial," said Steven P. Schmidt, Ph.D., vice president of Clinical Research & Innovation for Summa Health System and interim president and COO of the Summa Foundation. "We first studied Apatone as a supplement for cancer treatment, it's currently being researched in a clinical trial for patients with chronically painful joints as a result of a prosthetic knee implant, and now we're looking at a potential application for polycystic liver and kidney disease. We are pleased that Mayo researchers reached out to us to explore alternate applications of the drug and we look forward to working with them on this new research endeavor."

As originally developed for cancer, Apatone works to selectively lower the level of compounds in tumor cells that protect against chemotherapy, thus weakening the cancer cells and making them more susceptible to treatment. Essentially, it is a non-toxic approach that primes tumor cells to more easily be killed by chemotherapy and radiation.

Earlier this year, researchers in Summa Health System's Walter A. Hoyt, Jr. Musculoskeletal Laboratory opened a clinical trial to study Apatone-B® for patients with a chronically painful joint as a result of a cellular response to a prosthetic implant. Having a B designation for bone indications, Apatone-B 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. Any cell that produces the proteins associated with inflammation is targeted by the drug, while healthy tissue is spared.

Currently in progress, the clinical trial intends to enroll orthopaedic implant patients who have developed inflammation and discomfort in their replaced knee joint that is not due to infection. The basis for this is that Apatone-B resembles glucose, the primary source of energy for cellular activity. By exploiting the increased uptake of glucose by inflamed cells, Apatone-B can selectively enter and treat only inflamed cells. Once retained by the cell, Apatone-B uses a double-barrel attack: first as an anti-oxidant to reduce free radicals and secondly as an anti-inflammatory agent by reducing a prominent inflammatory factor linked to the break-down of bone.

In regards to the latest Apatone research, James Jamison, Ph.D., director of The Apatone Development Center at Summa Health System, explained: "Cell proliferation and cell cycle deregulation are considered to be the major contributors to polycystic kidney disease and polycystic liver disease. Pharmacological targeting of the cell cycle machinery by Apatone is expected to decrease cell hyper-proliferation and reduce hepatic and renal cyst formation."

Apatone was licensed in 2004 to IC-MedTech, a privately held California corporation. Tom Miller, founder and CEO of IC-MedTech, said, "We are happy to collaborate with Summa Health System and the Mayo Clinic and take the research of Apatone to another level. This important research will help us achieve our goal to bring Apatone to market as a safe, effective and affordable drug."

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