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ImaginAb Enters into Exclusive Licensing Agreement with UCLA for Immune Cell Imaging Agents

ImaginAb, Inc. and the Regents of the University of California, Los Angeles (UCLA) have executed a technology licensing agreement relating to novel immune cell-targeting agents for imaging with Positron Emission Tomography (PET). Inflammation and immune response play a fundamental role in a wide variety of diseases including cancer and autoimmune diseases. Under the agreement, ImaginAb gains exclusive access to novel imaging agents that target specific markers of murine T-cells, enabling a new understanding of response to immunotherapeutic drugs in pre-clinical models.

ImaginAb and Duke-NUS Launch Imaging Biomarker Development Lab (IBDL)

ImaginAb, Inc. recently announced that it has entered into a partnership with the Duke-NUS Graduate Medical School Singapore (Duke-NUS) to establish a joint corporate laboratory to develop new in vivo molecular imaging agents to study cancer biology and immune function. ImaginAb is a U.S. clinical-stage company that develops in vivo molecular imaging agents based on a proprietary antibody fragment technology platform. ImaginAb’s mission is to transform the clinical management of cancer and autoimmune diseases via targeted molecular imaging.

Alzheimer’s Markers Predict Start of Mental Decline

Scientists at Washington University School of Medicine in St. Louis have helped identify many of the biomarkers for Alzheimer’s disease that could potentially predict which patients will develop the disorder later in life. Now, studying spinal fluid samples and health data from 201 research participants at the Charles F. and Joanne Knight Alzheimer’s Disease Research Center, the researchers have shown the markers are accurate predictors of Alzheimer’s years before symptoms develop.

“We wanted to see if one marker was better than the other in predicting which of our participants would get cognitive impairment and when they would get it,” said Catherine Roe, PhD, research assistant professor of neurology. “We found no differences in the accuracy of the biomarkers.”

The study, supported in part by the National Institute on Aging, appears in Neurology.

The researchers evaluated markers such as the buildup of amyloid plaques in the brain, newly visible thanks to an imaging agent developed in the last decade; levels of various proteins in the cerebrospinal fluid, such as the amyloid fragments that are the principal ingredient of brain plaques; and the ratios of one protein to another in the cerebrospinal fluid, such as different forms of the brain cell structural protein tau.

The markers were studied in volunteers whose ages ranged from 45 to 88. On average, the data available on study participants spanned four years, with the longest recorded over 7.5 years.

The researchers found that all of the markers were equally good at identifying subjects who were likely to develop cognitive problems and at predicting how soon they would become noticeably impaired.

Next, the scientists paired the biomarkers data with demographic information, testing to see if sex, age, race, education and other factors could improve their predictions.

“Sex, age and race all helped to predict who would develop cognitive impairment,” Roe said. “Older participants, men and African Americans were more likely to become cognitively impaired than those who were younger, female and Caucasian.”

Roe described the findings as providing more evidence that scientists can detect Alzheimer’s disease years before memory loss and cognitive decline become apparent.

“We can better predict future cognitive impairment when we combine biomarkers with patient characteristics,” she said. “Knowing how accurate biomarkers are is important if we are going to some day be able to treat Alzheimer’s before symptoms and slow or prevent the disease.”

Clinical trials are already underway at Washington University and elsewhere to determine if treatments prior to symptoms can prevent or delay inherited forms of Alzheimer’s disease. Reliable biomarkers for Alzheimer’s should one day make it possible to test the most successful treatments in the much more common sporadic forms of Alzheimer’s.

Study: Amyloid imaging and CSF biomarkers in predicting cognitive impairment up to 7.5 years later

Source: EurekAlert!

NuView Life Sciences and Thomas Jefferson University Sign Agreement for Exclusive Development and Commercialization Rights to Novel Prostate Cancer Diagnostic

NuView Life Sciences (NLS), a privately-held company developing next generation imaging and in vitro diagnostic biomarkers with the ability to identify and locate disease at the earliest stages of development, today announced it has entered into an agreement with Thomas Jefferson University for exclusive development and commercialization rights to a novel urine screen for the early detection of Prostate and Bladder Cancer.

“We are excited to add this technology into the NuView Portfolio. This in vitro diagnostic is an excellent complement to our diagnostic imaging biomarkers in development,” stated Brian Dowd, Ph.D., Vice President of Clinical and Scientific Affairs at NLS. “Early and accurate detection of Prostate and Bladder Cancer should result in a significant reduction of invasive biopsy procedures and increase the probability for successful treatment outcomes in patients.”

This novel in vitro diagnostic (IVD) detects minute quantities of cancer cells shed into the urinary tract by measuring the expression of the vasoactive intestinal peptide/pituitary adenylate cyclase activating polypeptide receptor-1 (VPAC1) receptor. To date, the technology has displayed impressive sensitivity and specificity for the identification of Prostate and Bladder Cancer in human urine samples.

Previous work by Mathew Thakur, Ph.D., academic collaborator, Professor Radiology and Director of Radiopharmaceutical Research and Molecular Imaging at Thomas Jefferson University (TJU), Philadelphia, has shown Prostate Cancer cells express the oncogene product VPAC1 in high density on their cell surface. This occurs at a very early stage in oncogenic transformation, well before cell morphology alterations for histologic confirmation, and even well before the elevation of Prostate Specific Antigen (PSA). NuView is also developing NLS-VPAC1, a positron emission tomography (PET)-based imaging agent that measures VPAC1 expression levels for identification and localization of malignant Breast and Prostate tumors.

There remains a large unmet medical need for the accurate and early detection of Prostate and Bladder Cancer. Prostate cancer is the second leading cause of cancer death in American men and over 72,000 men and women are estimated to be diagnosed with Bladder Cancer in the U.S. in 2013. Mortality from Prostate and Bladder Cancer strongly correlates with the stage of disease upon diagnosis. Therefore, the ability to detect early-stage cancer before clinical presentation would have a dramatic effect upon patient outcomes.

Currently, routine screening of the general public for bladder cancer is not recommended by any major professional organization. This is due to lack of a sensitive and specific test that will detect bladder cancer in individual not presenting clinical symptoms of disease. Current screening for Prostate Cancer by digital rectal examination (DRE) and Prostate Specific Antigen (PSA) tests results in low cancer predictive ability and increases the number of referrals for invasive biopsy.

Source: PR Newswire

Positive Clinical Breast Cancer Data Presented for NuView’s Molecular Imaging Biomarker NLS-VPAC1

NuView Life Sciences (NLS), a privately-held company developing next generation imaging diagnostic biomarkers with the ability to identify and locate disease in the earliest stages of development, today announced the presentation of positive clinical results for its Breast Cancer imaging agent NLS-VPAC1 (TP3805) at the 2nd World Congress on Ga-68 in Chandigarh, India on Feb 28th. NuView Life Sciences possesses exclusive worldwide commercialization rights to NLS-VPAC1.

Mathew Thakur, Ph.D., academic collaborator, Professor of Radiology and Director of Radiopharmaceutical Research and Molecular Imaging at Thomas Jefferson University (TJU), Philadelphia, presented data from his investigator-lead, Phase 1 feasibility study that imaged Breast Cancer in 19 patients by utilizing NLS-VPAC1 (labeled with the radioisotope 64Cu) with PET (positron emission tomography) and PEM (positron emission mammography). NLS-VPAC1 unequivocally identified 100% (n=20) of the malignant lesions, irrespective of their hormonal status. In addition, NLS-VPAC1 detected four sentinel lymph nodes (100%). NLS-VPAC1 imaging can be performed within 15 minutes of injection and does not require patient fasting or monitoring of their glycemic levels (unlike F-18-fluorodeoxyglucose (FDG-PET), which is not a cancer-specific agent). Due to this rapid tumor uptake, NuView is additionally investigating use of NLS-VPAC1 labeled with the shorter half-lived isotope gallium-68. This pharmaceutical labeled with Ga-68 can be produced by generators at local radiopharmacies. NLS-VPAC1 imaging can be performed on any current or future PET-based instruments.

“We are very pleased about the results of NLS-VPAC1, these data are consistent with our hypothesis and its potential for non-invasive detection and localization of malignant tumors in the breast and potentially other tissues like prostate, bladder and lung,” stated Dr. Thakur.

“There are over 1.6 Million invasive breast biopsies performed each year in the U.S. at an average cost of $5,500 and over 80% result in a benign diagnosis,” stated Paul Crowe, CEO of NuView Life Sciences. “These results are an encouraging step for NuView and Dr. Thakur. NLS-VPAC1 clearly has the potential to provide early and accurate diagnosis to the physician, reduce pain and discomfort to the patient, and reduce the heavy financial burden on healthcare payors.”

NuView plans to initiate a multi-center Phase2 clinical trial in Breast Cancer in 2013. In addition, NuView and Dr. Thakur have been awarded a $2.6MM grant from the National Institutes of Health (NIH) to conduct an investigator-led, Phase 1 feasibility study with NLS-VPAC1 in Prostate Cancer patients. Planned initiation of this trial is 4Q 2013.

Source: PR Web