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BioPAL(TM) Announces the Successful Development of Important New Technologies for Stem Cell Therapy.

WORCESTER, Mass. -- BioPhysics Assay Laboratory (BioPAL), Inc.:

Proprietary nanocolloids are being used to quantify in vivo administered stem cells. Tissue regeneration from stem cell therapy is measured with labeled microspheres. Unique gadolinium nanocolloids have been developed to simultaneously image and track injected stem cells in real time.

BioPhysics Assay Laboratory (BioPAL), Inc. announced today that the company has developed a panel of products that will help researchers track and image cells, such as stem cells, in cellular therapies. Furthermore, technology to measure the efficacy of stem cell delivery systems as well as any newly created tissue as a result of cellular therapy has been developed. Together these products provide the researcher or clinician the advanced tools needed to rapidly optimize the delivery and measure the efficacy of cellular-based therapies as they are being developed. These product developments were funded, in part, by two Phase I and one Phase II NIH SBIR grants.

Stem Cell Labeling

Medical researchers are making rapid progress developing cellular-based therapies, primarily with various types of stem cells, to treat diseases and repair tissue damage. A major analytic issue is the creation of new technologies that can track therapeutic cells after injection to determine the number of cells that remain at the desired location in the body versus the number of cells that escape and travel to other parts of the body such as the lungs, liver or spleen. Further, researchers want to maximize the delivery of therapeutic cells to target sites in the body in order to be able to control the dose and most efficiently use these expensive and difficult to obtain cells. Cells that migrate to other parts of the body may have undesirable side effects so their numbers need to be minimized. Once therapeutic cells arrive at the site of action, assays for the successful growth of new tissues to repair damage or correct a defect can help to assess directly the efficacy of a specific therapy, experimental protocol or delivery system. Such assays can help to speed the development of new therapies while providing efficacy data and surrogate end points for regulatory agencies.

For quantitative in vivo tracking, stem cells are labeled with nanometer-sized colloids developed at BioPAL. These colloids are made from a series of lanthanide metals that can be simultaneously measured in a single sample by BioPAL's neutron activation technology. Stem cells are injected into experimental animal models through a variety of routes in preclinical trials. By knowing the quantity of the label, on a per cell basis, the number of delivered therapeutic cells in any piece of tissue can be determined. Because neutron activation is matrix independent, tissue from any part of the body, including bone, can be assayed for the labeled stem cells. More than five labels are available so multiple experiments can be performed in the same model for direct comparison of cells and delivery systems.

Assessing Catheter Delivery Systems

Stem cells will most often be administered to experimental subjects by catheters fitted with injection systems, such as a needle. BioPAL has developed nanocolloids specifically for use with catheter delivery systems. These materials will either stay in the tissue at the site of injection, or if the labeled colloid reaches the blood, the nanocolloid will be removed from circulation by the liver. The samples from the site of injection and the liver can both be assayed for the label to determine the efficacy of injection. This technology can be used to both optimize these delivery systems and train/certify researchers and clinicians in their use.

Measuring Tissue Regeneration

In many cellular therapies, the goal is to promote the growth of new tissue to replace malformed or dead tissue such as repairing the damage from myocardial infarction. BioPAL microspheres are designed to be trapped in the microvasculature during in vivo testing. The number of trapped microspheres is a direct measurement of both the blood flow to a region of the body as well as a measure of the quantity of living tissue in that region. Since there are more than 12 uniquely labeled microspheres available, each one can be administered at a different time point during an experiment providing a snapshot of the blood flow and living tissue at that time. The researcher now has the analytic tools to measure first the death of tissue and then the subsequent growth of replacement tissue as a result of stem cell therapy. This technology provides researchers with an easy-to-use tool to directly quantify the success of any therapeutic protocol.

Tracking Stem Cells In Vivo by MRI

Stem cells often need to be administered by some type of minimally invasive procedure such as via a catheter delivery system particularly in human clinical trials. Researchers want to be able to visualize the delivery of the cells during such a procedure. Magnetic resonance imaging (MRI) allows for real time imaging during these procedures. Furthermore, MRI exhibits excellent spatial resolution. BioPAL has developed a novel, highly stable gadolinium-based nanocolloid for use as a contrast agent to label administered stem cells. Based on BioPAL's proprietary "Proton Cascade(TM)" technology, these colloids have a strong T1 signal leading to brightening of the administered stem cells. Previously researchers were restricted to iron-based T2 agents that provide a darkened image, which are poorly visualized and are subject to T2 artifacts. Now, researchers can use Proton Cascade technology to not only help develop better delivery technologies, but also can be used to train other researchers and physicians on the proper use of these delivery devices. In the future, clinicians may use this technology to aid in human clinical trials and for routine clinical practice.

Ernest Groman, Ph.D., VP R&D, said, "Our cell tracking nanocolloids are unique materials that have powerful properties including low toxicity, stability to sterilizing procedures and high assay sensitivity. In fact, the ability to image a gadolinium-based nanocolloid with MRI was thought to be impossible, but we have discovered a new technology that we have designated Proton Cascade which makes this important new contrast agent highly effective."

Christopher Reinhardt, Ph.D., President and CEO, commented, "BioPAL labeled microspheres are easy to use, very robust and have high sensitivity yielding superior measurements of blood flow and new tissue generation. Detection down to the level of single microspheres is possible. We are confident that all of these new products will play a central role in helping to bring effective cellular therapies to patients as soon as possible."

Over the past five years BioPAL's technologies have been validated through the award of NIH SBIR grants totaling more than $3 million.

Founded in 1997, Worcester-based BioPAL, Inc. is a privately held biotechnology company with proprietary, breakthrough technology in in vivo diagnostic assays. BioPAL's core technology is stable isotope labeling of functional probes and neutron activation analysis -- a technology that promises to significantly streamline the drug discovery process and improve clinical methods for measuring organ function. BioPAL is also developing innovative products for fluorescence and MRI imaging. BioPAL is a leader in the post-genomic fields of "new physiology" and systems biology. For more information, please visit www.BioPAL.com or call 508-770-1190.
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Date:Jun 30, 2005
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