GW Medical Technologies' LymPro(TM) Pilot Study Preliminary Results Confirm Ability to Differentiate Probable Alzheimer's Disease (AD) From Other Dementias
Posted on: Thursday, 7 July 2005, 09:00 CDT
GW Medical Technologies LLC announced today that its LymPro(TM) Test pilot study far exceeded original expectations and clearly demonstrate the potential to differentiate probable AD patients from other dementia subjects.
The pilot study involved 92 subjects; 34 from healthy participants, 32 with clinically diagnosed probable AD and 26 patients diagnosed with other dementias. The analysis involved the evaluation of 11 independent immune system antigens by flow cytometry, coupled with a sophisticated analytical algorithm for data processing in an effort to clearly define the molecular relationship of these antigens and the test's performance in this regard. The company was elated to find in its preliminary analysis a remarkable 91% co-positivity and 85% co-negativity relationship to the clinical diagnosis of AD.
"This is the first time a blood diagnostic test has shown this much agreement with the clinical diagnosis for Alzheimer's disease," said William Gartner, president and CEO of GW Medical Technologies LLC. "It is our expectation that the LymPro Test will become a significant adjunctive diagnostic tool to assist physicians in their diagnostic efforts associated with Alzheimer's disease. Ultimately, it is our hope that the LymPro Test will have its biggest contribution in improving the overall quality of life for patients and their families by accelerating the diagnosis of and treatment options for this devastating disease."
The Alzheimer's Association estimates that as many as 4.5 million Americans suffer with Alzheimer's disease, which can take up to 12 to 18 months to render a clinical diagnosis. As there is no cure for Alzheimer's, the current medications help slow the progression of the symptoms which can improve the quality of life for patients and their families. These drugs, however, have shown a much higher level of performance if prescribed early in the progression of the disease.
"Our pilot study not only had outstanding preliminary analytical results, it also provided both critical third-party method validation and confirmation of both internal and external cell cycle research work that has been published to date," said Donald Weber, vice president of licensing for GW Medical Technologies. "We recognize that more work remains as we continue to scrutinize our data and begin structuring our future study efforts. However, we believe this study has brought us significantly closer toward an earlier, more accurate diagnosis of the disease."
GW Medical Technologies began the pilot study in March 2005 and opened the blind on June 21, 2005, with Dr. Curtis Bay, a biostatistician and director of research support at Maricopa Integrated Health System, present as witness to the event. The subsequent retrospective analysis of the pilot study data is anticipated to be completed by the end of July. The company expects final results to remain close to or slightly better than the preliminary findings of the study.
About the LymPro Test
Developed and tested at the Paul Flechsig Institute of Brain Research at the University of Leipzig in Germany, the LymPro Test diagnoses probable AD by measuring disturbances of intracellular mitogenic signaling and then quantifying, among other cellular relationships, the CD69 presentations on the surface of selective peripheral blood lymphocytes (PBLs) with and without mitogenic stimulation.
In essence, this test focuses on the systemic disease-related dysfunction of proliferation control in Alzheimer's disease (AD) on cellular systems, which are easily accessible in patients' PBLs, the latter of which express a variety of cell surface receptors comparable to neurons. Moreover, control of proliferation and differentiation of lymphocytes involves signal transduction systems similar to neurons. Lymphocytes of AD patients are impaired in their proliferative response to metabolic products of Beta-amyloid Precursor protein (APP).
About GW Medical Technologies LLC
GW Medical Technologies LLC is a translational in-vitro diagnostic company focused on the diagnosis of Alzheimer's disease. The company plans to bring the LymPro Test to market as fast as possible on a reference lab basis as it completes its clinical studies for FDA approval. The company is in discussions with numerous national and international companies seeking licenses for the test.
Founded by Everett G. Warren, chairman, and William Gartner, president and CEO, GW Medical Technologies is located at 1440 E. Missouri Ave., Suite 225, Phoenix, AZ, and can be reached at 602-265-7862. For more information about the company and the LymPro Test, visit www.GWmedtech.com.
Source: Business Wire
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