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Patent
Biotex, Inc. | Date: 2015-06-02

The present invention is directed to nucleic acid ligands to LL37, methods for producing said nucleic acid ligands, and methods for utilizing said nucleic acid ligands. In one exemplary embodiment, for example, this invention relates to nucleic acid ligands exhibiting high specific binding affinity to LL37 peptides, precursors and/or portions thereof. Further, the nucleic acid ligands may bind competitively with native ligands of LL37 and may also inhibit and/or interfere with LL37 function, such as by binding to LL37.


Patent
Biotex, Inc. | Date: 2016-06-13

The present invention is directed to nucleic acid ligands to LL37, methods for producing said nucleic acid ligands, and methods for utilizing said nucleic acid ligands. In one exemplary embodiment, for example, this invention relates to nucleic acid ligands exhibiting high specific binding affinity to LL37 peptides, precursors and/or portions thereof. Further, the nucleic acid ligands may bind competitively with native ligands of LL37 and may also inhibit and/or interfere with LL37 function, such as by binding to LL37.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 160.92K | Year: 2012

DESCRIPTION (provided by applicant): The goal of this Phase I SBIR application is to develop a new minimally invasive therapy for laser ablation of epileptogenic seizure foci. There is a large unmet need for better treatment options for the nearly one million epilepsy patients in the U.S. that are refractory to current medical treatments. While surgical removal of the epileptogenic foci offers relief in 70 percent of the well selected cases, most patients decide against this option due to the highly invasive nature of the procedure. We hypothesize that precise, image-guided laser thermal ablation of epilepsy foci would provide results approaching surgical resection in terms of seizure relief, and could be carried out with a far lower risk of surgical morbidity to the patient. In Phase I we will use our FDA-cleared technology (Visualase Thermal Therapy System), which is currently used for cancerous tumor ablation applications, to perform a pilot feasibility study in adult epilepsy patients who are refractory to medical therapy and have an identifiable lesion deemed responsible for their seizures. We will also develop hardware and software enhancements which will optimize the system for this application. In Phase II, we will perform expanded multi-center clinical studies on patients with broader inclusion criteria, including treatment of mesial temporal lobe epilepsies. Finally, we will construct a data registry with the goal of gathering clinical data necessary for the design of a successful definitive FDA trialin Phase III in which we will seek specific indications for the treatment of Epilepsy. PUBLIC HEALTH RELEVANCE: RELEVANCE Current medical therapy leaves 30 percent of Epilepsy patients without adequate control of their seizures. Developmentof a minimally invasive surgical option for thermally destroying the tissue in the brain responsible for seizures would have a significant impact on epilepsy patients and their families. This project will develop precise methods using MRI-guided laser technology, which if successful, has potential to be that minimally invasive option.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2012

Thousands of antibodies are produced every year by commercial companies. However, many of these antibodies are known to be poorly characterized and suboptimal across applications. Polyclonal antibodies lack the reproducibility of monoclonal antibodies. Theproduction of monoclonal antibodies is expensive and may take months. Even after production, a monoclonal antibody may not be specific for the target of interest, may not work in the needed assay, or could not be used in combination with other antibodiesdue to competition for overlapping binding domains. As such, the high cost associated with producing even small quantities of monoclonal antibodies represents a large barrier to cost-effective reagents for proteomic technology research and clinical adaptation. This project utilizes a new tool, massively parallel selection of DNA aptamers to rapidly identify high-affinity ligands to hundreds or even thousands of protein targets simultaneously. In this Phase II SBIR contract, we will utilize our platform to select aptamers to at least 75 important cancer biomarker proteins and characterize the new reagents for affinity and specificity. We will also demonstrate their performance in a number of common applications. The developed reagents will have tremendous value to the research community and potential to alleviate human suffering due to cancer.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 248.89K | Year: 2012

DESCRIPTION (provided by applicant): Project Summary The goal of this NIH-SBIR Phase I proposal is to develop a new point-of-care (POC) detection platform and methodology for assessment of human exposure to hazardous environmental compounds in the bloodstream. Because the mechanisms of transport of such chemicals into the body, their differing stabilities, and elimination are difficult to model, if possible, it is much more straightforward to assay for these compounds in the body rather than in the environment. The primary innovations in our approach are that a novel optical micro- to nano-fluidic device will be used along with unique aptamers and Raman reporter molecules to simultaneously measure several classes of compounds in a multiplexed fashion. The opto-fluidic device is an extremely sensitive surface enhanced Raman spectroscopy (SERS) nanochannel cartridge that was invented at Texas AandM University by professors Jun Kameoka and Gerard Cot . The aptamer functionalization chemistry as well as the overall integrated product will be developed at BioTex, Inc. The device being developed provides signal enhancements equal to or exceeding 1014 at the entrance to the nanochannel, enabling rapid quantification of femtomolar or smaller levels of targets in fluids. This SERS-based nanofluidic platform has been demonstrated through several publications and so the key question that need to be addressed by the company are can the aptamer chemistry perform as intended in progressively complex media including whole blood with this platform and can the platform be optimized for this application. Thus, the specific aims of this research are to develop the aptamer assay for specifically detecting model polychlorinated biphenyls (PCBs), bisphenol-A (BPA), and model phthalates. The resonant-SERS reporting and nanofluidic concentrator employed have the potential to provide orders-of-magnitude improved sensitivity over standard fluorescence and without the complicated multistep tasks of ELISA or full analytical chemistry analysis such as chromatography and mass spectrometry. PUBLIC HEALTH RELEVANCE: Project Narrative The goal of this research is to develop a new point-of-care (POC) detection platform and methodology for assessment of biological exposure to harmful chemical compounds. With the potential to greatly improve the sensitivity and ease of such measurements, the end-product of this research is expected to have considerable impact allowing toxicologists, environmental health professionals, and clinicians the ability to correlate the effects of toxic chemicals to disease states.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 976.99K | Year: 2011

DESCRIPTION (provided by applicant): Aptamers have emerged as one of the most promising classes of drug leads and diagnostic ligands presently available. Aptamers, nucleic acid ligands derived from large combinatorial libraries, typically have affinitiesand specificities that rival antibodies, yet they have a number of significant advantages for therapeutic and diagnostic applications. Unfortunately, the existing process for aptamer development is low-throughput and tedious as DNA or RNA libraries are screened against only a single target. This project focuses on developing the methods and tools to allow large combinatorial to be screened against arrays of thousands of proteins simultaneously. Such protein arrays are increasing available with content of high therapeutic and diagnostic value. The key to achieving this is developing the necessary steps to decipher which aptamers (once selected) correspond to which target. So-called next generation sequencing will greatly enable the proposed process coupledwith the necessary sequence-tagging approaches developed in this project. Once our massively parallel aptamer selection process is developed, we will be in a position to create high affinity aptamer ligands to thousands of proteins in roughly 1 week. The developed ligands can then be further characterized as promising drug candidates, diagnostic labels, and other research applications perhaps eventually including personalized medicine. PUBLIC HEALTH RELEVANCE: A recent white paper by the US Federal Drug Administration finds that there exists a critical problem in bringing novel drugs to market, something the FDA describes as the 'pipeline problem'. According to this and other reports drug companies spend an average of 0.8-1.7 billion dollars on the discovery, development and approval of any one individual drug. To make matters worse, the time from the initial testing of a drug candidate and to its eventual marketing can take up to 20 years. Thus, the FDA report strongly urges the incorporation ofnovel quantitative predictive tools for the assessment of safety and efficacy of new drug leads and diagnostic ligands early in the drug development process. This project provides for the parallel development and evaluation of enormous combinatorial libraries of DNA or RNA 'aptamers' against of thousands of protein targets of potential 'druggable' interest. If successful, the technology could provide for unprecedented throughput of drug leads and diagnostic ligands.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 162.82K | Year: 2012

DESCRIPTION (provided by applicant): The objective of the phase I proposal is to demonstrate the feasibility of a new and innovative insulin assay for its integration in a small benchtop device with the focus in clinical diabetes therapy: A) for assessmentof insulin impairment in type II diabetics, and B) as feedback control for diabetics with insulin infusion pumps. The significance of this technology is based on the fact that diabetes, primarily type 2 diabetes, continues to increase in prevalence throughout the world and current projections suggest a continued rise worldwide for at least the next quarter century. Insulin resistance, which frequently accompanies obesity, is known to be a key factor in the pathogenic development of type 2 diabetes. In fact, there are currently no clinical criteria by which an individual could be classified as being insulin sensitive or resistant or as having mild, moderate, or severe impairment of insulin secretion. Measurements of insulin sensitivity and secretion are currently done only for research purposes and are only comparable in individual studies. Furthermore, it is anticipated that the number of type 1 diabetics using insulin infusion pumps (currently approx. 200,000 users in the US or approx. 5%) will grow in the near future. Significant progress in developing a reliable closed loop system (insulin pump + glucose monitor) should accelerate the widespread use of insulin pumps further. However, current pump technologies do not provide any means to quantify the amount of insulin entering the blood stream. This can pose major risk to the health of the users in cases where the insertion needle may not deliver insulin due to improper placement, or scar tissue. In both cases, a much smaller amount, or no insulin at all may enter the body, causing the blood sugar to increase far above normal values. Even worse, a sudden increase of insulin infusion rate due to pump-malfunction could lead to a lethal overdose of insulin entering the body. Since current commercial insulin-detection technologies have significant shortcomings, such as large size, and high costs for hardware and assay components, there remains a significant need for an economical insulin assay that can be incorporated into a small device to be used in a doctor'soffice, or even at home for assessing insulin sensitivity, and/or for quantifying actual concentration of infused insulin (with a pump) in blood. BioTex, Inc therefore proposes to develop much-needed rapid and user-friendly assays for insulin to be used in the clinician's office (point of care). PUBLIC HEALTH RELEVANCE: The objective of the phase I proposal is to demonstrate the feasibility of a new and innovative insulin assay for its integration in a small benchtop device with the focus in clinical diabetes therapy: A) for assessment of insulin impairment in type II diabetics, and B) as feedback control for diabetics with insulin infusion pumps. The significance of this technology is based on the fact that diabetes, primarily type 2 diabetes, continues to increase in prevalence throughout the world and current projections suggest a continued rise worldwide for at least the next quarter century. Since current commercial insulin-detection technologies have significant shortcomings, such as large size, and high costs for hardware and assay components, there remains a significant need for an economical insulin assay that can be incorporated into a small device to be used in a doctor's office, or even at home for assessing insulin sensitivity, and/or for quantifying actual concentration of infused insulin (with a pump) i blood. BioTex, Inc therefore proposes to develop much-needed rapid and user-friendly assays for insulin to be used in the clinician's office (point of care).


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 292.11K | Year: 2012

DESCRIPTION (provided by applicant): The World Health Organization estimates that diabetes affects about 185 million people worldwide, with approx. 20 million individuals (approx. 6 percent by population) afflicted in the US (approx. 10 percent of this type 1 diabetes). Tighter glucose control within the euglycemic range was shown to be the single most important determinant for minimizing all long-term complications of type 1 diabetes. One method to achieve tighter blood glucose control involves the development of an artificial pancreas, consisting of a continuous glucose sensor, and an insulin infusion pump. In this application, BioTex scientists and engineers will investigate and develop a new paradigm of an affinity-sensor based dual-hormone extracorporeal automated glycemic control for improving diabetes therapy. The major objective in the Phase I is to demonstrate feasibility and efficacy of the blood-glucose regulation in a diabetic swine model (anesthetized), using real-time data from the FAS device,and run by a well- described, and validated model-predictive control (MPC) algorithm. If successful, in Phase II the validation of these results will then be performed in ambulatory experiment using diabetic pigs with a wireless FAS monitor, followed by pilot studies in humans. PUBLIC HEALTH RELEVANCE: The World Health Organization estimates that diabetes affects about 185 million people worldwide, with approx. 20 million individuals (approx. 6 percent by population) afflicted in the US (approx. 10percent of these type 1 diabetes). Tighter glucose control within the euglycemic range was shown to be the single most important determinant for minimizing all long-term complications of type 1 diabetes. One method to achieve tighter blood glucose controlinvolves the development of an artificial pancreas, consisting of a continuous glucose sensor, and an insulin infusion pump. In this application scientists and engineers of BioTex, Inc will develop and investigate a new paradigm of an affinity-sensor based dual-hormone extracorporeal automated glycemic control for improving diabetes therapy.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.06M | Year: 2012

DESCRIPTION (provided by applicant): The goal of this Phase II SBIR project is to continue development of an exciting platform based on integration of optical coherence tomography acquisition with real-time 3D spatial localization. In Phase I, in the context of gynecological diagnostic imaging, we demonstrated hardware and software for prototype image fusion between colposcopic/intravaginal imaging and OCT images of the cervix. We also demonstrated a promising methodology for simplified acquisition of 3D OCT data sets which may have broad application. In this project, we build upon these promising results to define and develop two new products. The first will be a clinical tracking and software system which augments an OCT imaging system to provide fusion between OCT and colposcopic images as well as tools for analyzing, reviewing, and reporting image findings. The second will consist of software and an imaging/tracking probe which can be readily coupled (by an end user) to commercially available OCT systemsand which, when installed, will allow reconstruction of 3D OCT datasets from simple manually scanned 2D data. Devices will be validated in phantoms and animal models as well as clinically. While this application continues to be focused on gynecological diagnosis, we will also lay important experimental groundwork for future development of this technology in other fields. PUBLIC HEALTH RELEVANCE: In 2010, approximately 12,200 cases of invasive cervical cancer are expected to be diagnosed in the United States, and it is estimated that incidence of noninvasive cervical cancer (carcinoma in situ) is about four times as high [://www.cancer.gov/cancertopics/types/cervical]. Approximately 4,210 women are expected to die from cervical cancer in the United States during 2010. Though mortality rates associated with cervical cancer have decreased dramatically over the last 50 years, the incidence of cervical precancers has increased, and it has been suggested that without improvement in current screening and diagnostic techniques, mortality rates associated with cervical carcinoma could increase, especially if human papilloma virus (HPV) seroprevalence continues to rise. Early detection of cervical precancerous lesions can have a dramatic impact on cervical cancer mortality rates, increasing five- year survival rates from 70% to about 100%. This project focuses on development of a novel imaging system for improving diagnosis and characterization of cervical tissue. The developed technology also has wide application in other diagnostic fields including cardiology, laparoscopy, and gastroenterology.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 714.23K | Year: 2016

DESCRIPTION provided by applicant The goal of this NIH SBIR Phase II effort is to develop a new point of care POC detection platform and methodology for assessment of human exposure to hazardous environmental compounds in the bloodstream Because the mechanisms of transport of such chemicals into the body their differing stabilities and elimination are difficult to model it is much more straightforward to assay for these compounds in the body rather than in the environment The primary innovations in our approach are that a novel optical micro to nano fluidic device will be used along with unique aptamers and Raman reporter molecules to simultaneously measure several classes of compounds in a multiplexed fashion The opto fluidic device is an extremely sensitive surface enhanced Raman spectroscopy SERS nanochannel cartridge that was invented at Texas Aandamp M University by professors Jun Kameoka and Gerard Cot The aptamer functionalization chemistry as well as the overall integrated product will be developed at BioTex Inc with aptamers discovered at sister company Base Pair Biotechnologies The device being developed provides signal enhancements equal to or exceeding at the entrance to the nanochannel enabling rapid quantitation of femtomolar or smaller levels of targets in fluids As demonstrated in Phase I the individual components of the system have been thoroughly tested and the Phase II study will therefore focus on the engineering integration and demonstration of overall system performance The resonant SERS reporting and nanofluidic concentrator employed have the potential to provide orders of magnitude improved sensitivity over standard fluorescence and without the complicated multistep tasks of ELISA or full analytical chemistry analysis such as chromatography and mass spectrometry Using aptamers to virtually any environmental compound of concern the fully developed platform will be able to provide quantitative andquot point of careandquot or field results in a matter of minutes PUBLIC HEALTH RELEVANCE The goal of this research is to develop a new point of care POC detection platform and methodology for assessment of biological exposure to harmful chemical compounds In contrast to most prior approaches which attempt to measure the amount of such compounds in the environment the technology developed here will have the sensitivity and specificity to detect toxic agents in human blood samples directly and thereby determine the toxicological andquot loadandquot within the patient The end product of this research is expected to have considerable impact allowing toxicologists environmental health professionals and clinicians the ability to correlate the effects of toxic chemicals to disease states

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