NutraClinical Inc., has entered a collaborative agreement with Proxy Life Science Holdings Incorporated (Proxy) of San Diego California to conduct clinical evaluations of Proxy’s virtual biopsy technology.
Proxy Life Sciences Holding to Test Virtual Biopsy Technology for Clinical Applications in Cancer, Cardiovascular, Neurological and Inflammatory Diseases. NutraClinical has established a multiyear collaboration with Proxy Life Science Holdings for the clinical evaluation of its Proxysome™ virtual biopsy technology. Proxysomes™ are commonly known as microvesicles and exosomes. Using a simple blood test, the technology promises not only to detect early disease but also to pinpoint the affected organs/tissues.
The studies to be conducted by NutraClinical will explore the use of the technology in various disease categories including cardiology, immunology, neurology and cancer. The technology has been shown to have the potential to identify disease, its stage and the affected organ through a simple blood test. NCI will provide access to research centers and biological samples to explore and evaluate the clinical application of the Proxysome™ technology in various disease categories, including cardiology, immunology, neurobiology and cancer.
Financial details were not disclosed. Clinical studies are essential to any diagnostics development program, especially as they relate to the availability of and the access to relevant biological samples. They are critical tools in determining the analytical validity, clinical validity and utility of any new diagnostic test. However, obtaining relevant and properly handled biological samples can be a challenge and a bottleneck for most development programs. NCI has the expertise to organize, recruit, procure and manage multisite studies with appropriate QA, QC and compliance management systems. This collaboration will evaluate Proxy’s platform technology based on US Patent No. US 8,021,847 entitled “Microvesicle-Based Compositions and Methods“. The patent relates to methods of isolating RNA from blood borne exosomes and microvesicles for the detection and analysis of disease biomarkers which may then be traced back to the affected cells and organs which produced them.
“Our collaboration with NCI will play an important part in our efforts to bring our Proxisome™ virtual biopsy tests to market. Academia has taken notice of the fundamental value of microvesicles and exosomes and has responded with a flurry of exciting publications in recent years. Our job is to bring systematic development discipline to bear, to ensure that this biopsyless technology makes the transition from academic promise, to clinical reality. ” Stated Dr. Pietrzkowski, President and Co-founder. Proxy has coined the term Proxysomes™ to describe what are commonly known as microvesicles and exosomes in academic circles. Proxysomes™ are nano and micro-sized vesicle structures produced by cells and tissues, especially in response to disease, infection or stress. They are expelled from the affected cells and circulate in the blood stream and other bodily fluids. Importantly, Proxysomes™ share certain structures and components in common with their parental cells. They are essentially rich packets of circulating information loaded with a myriad of molecular markers such as RNA, microRNA, proteins, and other cellular components.
These biological structures have been shown to be at least in part, a fundamental communication mechanism between cells, a way for cells to shuttle SOS distress signals across short and long distances, a means to influence or even control the response of distant cells and tissues. This abundant source of information may also be decoded and translated to identify disease-related biomarkers, tissue-type biomarkers and their bio-signatures.
This data can then be used to pinpoint an affected organ and determine its health or disease status, giving Proxysomes™ the potential to replace certain tissue biopsies with a virtual blood-based test. By gathering ProxysomesTM via a simple blood draw, it may be possible to access information about distant cells, tissues and organs, including those originating from a multitude of diseases. “The implications for diagnostics, therapeutics, and drug delivery are truly tremendous.
Our Proxysome™ platform has the potential to significantly advance the field of molecular diagnostics enabling important advances in personalized medicine. Our collaboration with NCI will bring an important and key clinical component to our R&D program and will also add opportunities and value to our IP position. We have one of the earliest and broadest patents in the field, this gateway patent firmly positions our company to be a leader in the rapidly developing field.” stated Rey Magana, Vice President and Co-founder. About Proxy Life Science Holdings Proxy Life Sciences Holdings, Inc. is a privately held biotechnology company building an IP holding portfolio focused on exosome-based molecular diagnostics and therapeutics technologies. Its patented Proxysome™ virtual biopsy technology forms the core of the companies research and development program.
The company is actively seeking opportunities to out-license or co-develop its technology in the fields of discovery, diagnostics, and therapeutics for application in a wide-ranging set of human diseases and conditions.