SBIR-STTR Award

There is a growing need in medical imaging to detect and characterize different disease processes. Molecular optical imaging is a new imaging modality that generates molecular images using penetrating light rays and offers the possibility to employ fluorescently-tagged reported beacons to obtain specific molecular information about a particular disease state. VisEN Medical is pioneering the development of a novel optical imaging prove technology for clinical cancer imaging. This technology is based on near-infrared optical probes disease. Inside a human, the probes become activated or "imageable" only when they come in contact with the specific enzymes that they are designed to target, resulting in high specificity and signal amplification. We expect this molecular imaging technology to have a major impact on the screening, diagnosis, characterization characterize and optimize an optical molecular probe for future pre-clinical testing. We have chosen to target the enzyme cathepsin B using this technology, as it is known to be associated with many key steps in cancer growth and metastasis. PROPOSED COMMERCIAL APPLICATIONS: VisEn Medical plans to develop a cancer imaging probe for human testing within two years. Understanding diseases such as cancer at its molecular level will help to (1) detect early disease-even before morphological changes are present, (2) better characterize different disease states, and (3) improve, guide and monitor disease treatment.

Thesaurus Terms:
biomarker, chemical synthesis, fluorescent dye /probe, imaging /visualization /scanning, infrared radiation, neoplasm /cancer diagnosis, pathologic process cathepsin B, neoplasm /cancer classification /staging bioimaging /biomedical imaging, biotechnology

There is a growing need in the medical imaging sciences to better detect and characterize abnormal tissue and disease processes. Optical imaging in the near-infrared spectrum offers the possibility to employ fluorescently tagged reporter probes to obtain specific molecular information about a particular disease state. VisEn Medical, Inc. is pioneering the development of a novel optical molecular imaging technology platform that enables imaging of molecular activity in-vivo. This proprietary technology platform is based on near-infrared activatible optical probes that become activated only when they come in contact with the specific enzymes that they are designed to target. VisEn is currently developing a Cathepsin B enzyme-imaging probe for early clinical cancer detection. We have chosen to target the enzyme Cathepsin B as it is known to be associated with several different types of cancer, including colon and ovarian cancer, as well as other diseases such as arthritis and cardiovascular disease. The overall goal of this SBIR grant proposal is to test and characterize the different near infrared fluorochrome probes developed during Phase I of this project in different in-vivo disease models in order to select a candidate for clinical trials. The Specific Aims of this Phase II proposal are summarized below. 1. Test at least three different Cathepsin B probes in animal tumor models for their ability to detect cancer. 2. Evaluate the probes for their ability to detect different types of tumors, specifically colorectal and ovarian tumors. 3. Determine key preclinical Cathepsin B probe properties, including the pharmacokinetics, biodistribution and toxicity of the probes. 4. Conduct preliminary formulation and stability studies.

Thesaurus Terms:
biomarker, cathepsin B, chemical synthesis, fluorescent dye /probe, imaging /visualization /scanning, infrared radiation, neoplasm /cancer diagnosis, pathologic process colorectal neoplasm, dosage, neoplasm /cancer classification /staging, ovary neoplasm, pharmacokinetics athymic mouse, bioimaging /biomedical imaging, biotechnology