May 21 2010
Competitive Technologies, Inc. (NYSE Amex:CTT) today announced the issuance of an abstract from a study which has shown the successful treatment of patients suffering from pain associated with chemotherapy-induced peripheral neuropathy (CIPN) using CTT's Calmare® Pain Therapy Treatment. The abstract cites results of the study led by principal investigator, Thomas J. Smith, M.D., Endowed Chair of Palliative Care Research and Medical Director of the Thomas Palliative Care Unit Virginia Commonwealth University's Massey Cancer Center, which will be presented at the American Society of Clinical Oncology Annual Meeting on June 8, 2010.
Calmare, which treats chronic neuropathic and oncologic pain, received FDA certification for sales in the U.S. in February 2009. In June 2009, clinical investigators at the VCU Massey Cancer Center began the first U.S. independent clinical study, to specifically examine the ability of CTT's Calmare pain therapy treatment to decrease pain associated with CIPN.
"The Massey Cancer Center team, led by Dr. Smith, was the first independent group in the U.S. to conduct its own clinical study using the Calmare pain therapy device to treat CIPN in cancer patients. CIPN is a very debilitating side effect for some 30-40 percent of cancer patients, causing sharp pain in their hands and feet. CIPN affects cancer patients worldwide, including an estimated 4 million cancer patients in the U.S. Calmare pain therapy is the only highly effective treatment for CIPN without harmful, adverse side effects," said John B. Nano, CTT's Chairman, President and CEO. "Finding new, non-invasive ways to treat pain other than prescribing opioids such as morphine is a key focus of our mission to improve the quality of life for cancer patients. We expect to create a paradigm shift in how chronic pain, which impacts over 75 million in the U.S. alone, is treated globally."
Significant abstract highlights:
- "We evaluated the effect of the MC5-A Calmare therapy device on CIPN. The device is designed to generate a patient-specific cutaneous electrostimulation to reduce the abnormal pain intensity.
- "The primary goal of a 20% in numeric pain scores after day 10 was achieved in 15 of 16 [patients].
- "The primary endpoint of CIPN pain score fell by 59% from day 1 to day 10.
- "Adjusting for the correlations and the variability between patients and daily scores with a repeated measures analysis, there was an overall 64% reduction in pain.
- "A daily treatment benefit was seen with a significant difference between the pre and post daily scores.
- "Four patients had their CIPN reduced to 0. No toxicity was seen.
- "Some responses have been durable without maintenance, and some patients had return of normal sensation and motor function.
- "Conclusions: Patient-specific cutaneous electrostimulation with the MC5-A Calmare device appears to dramatically reduce pain in refractory CIPN patients with no toxicity."
The abstract is available at http://abstract.asco.org/AbstView_74_49144.html.
"We are proud of the results achieved with this breakthrough treatment in the clinical research study at VCU Massey Cancer Center, a National Cancer Institute-designated center that helps lead our nation's cancer research agenda," said Aris D. Despo, CTT's Executive VP, Business Development. "We are excited about the investigators' success using Calmare in treating pain without the harmful side effects of opioids. This abstract confirms our approach to providing a solution to the needs of cancer patients and to improving palliative healthcare globally.
"Our Calmare pain therapy is also in use at the Paul Carbone Cancer Center at the University of Wisconsin, Madison, under the direction of Dr. Toby Campbell, M.D. The University of Miami Pain Management Center is using Calmare as well, under the direction of Dr. Salahadin Abdi, MD, PhD, Professor and Chief, University of Miami Pain Management Center," Mr. Despo continued. "Both universities are treating patients, evaluating the efficacy of our Calmare pain therapy in treating debilitating pain."
Calmare is being used to treat U.S. patients in clinics in Massachusetts, New York, Virginia, Florida, Connecticut and Rhode Island. In addition to treating pain associated with cancer and cancer treatments, the Calmare device also successfully treats chronic neuropathic pain resulting from shingles, failed back surgery, phantom limb syndrome, sciatica, spinal stenosis and other maladies.
The non-invasive Calmare pain therapy device, which uses the biophysical "Scrambler Therapy" technology, was developed in Italy by CTT's client, Professor Giuseppe Marineo. The Calmare device is currently being manufactured for sale by CTT's partner, GEOMC Co. Ltd. of Seoul, Korea. For more information on the device, visit visit www.calmarett.com.
Competitive Technologies, Inc.