Syndicate content

Archive - 2015

November 24th

Therapeutic Solutions International (TSI) Announces Licensing of Patents to Subsidiary OmniBiome; Focus Is On Pregnancy Complications & Materno-Fetal Immunology; Iryna Dzieciuch Named OmniBiome CEO

Therapeutics Solutions International (TSI), Inc. (OTC PINK: TSOI) announced on November 18, 2015 that the company has licensed three patents to OmniBiome, Inc., a wholly-owned subsidiary of TSI focused on fetal-maternal health, with the company's goal to assist women in the treatment or prevention of pre-term birth and pregnancy complications. The following patent applications were recently filed by TSI, the subject of recent press releases, and are now licensed to OmniBiome: Application No. 62/213260 titled "Preventative Methods and Therapeutic or Pharmaceutical Compositions for the Treatment or Prevention of Pregnancy Complications" covers utility of vaccines and various agents to alter pathological conditions in which the maternal immune system induces a process of inflammation that culminates in placental alterations leading to either fetal loss or preterm labor. Press Release of (9/8/2015); Application No. 62/219020 "Diagnostic Methods For The Assessment Of Pregnancy Complications" a cytokine-based diagnostic kit aimed at stratifying risk of pre-term labor and other pregnancy-associated complications. Press Release of 9/21/2015; Application No. 62/232722 "A Medical Device for Reducing the Risk Of Preterm-Labor And Preterm-Birth" covering various medical devices aimed at immune modulating the cervical microenvironment in order to prevent preterm labor. Press Release of 9/29/2015. "We are very excited to announce today that we have licensed intellectual property to our wholly-owned subsidiary OmniBiome. In addition, Iryna Dzieciuch (photo), M.S. has accepted the appointment as CEO of OmniBiome with the vision and motivation to dominate the space of maternal-fetal immunology by leveraging the patents which are the subject of this licensing agreement," said Timothy Dixon, President and CEO of TSI.

Exosome Diagnostics Launches “Academic Bench to Clinical Diagnostics” Assay Commercialization Program; Approach Lauded by Renowned Harvard/MGH Researcher Xandra Breakefield

Exosome Diagnostics, the developer of the leading liquid biopsy platform that enables non-invasive diagnosis of disease states, aiming to obviate the need for tissue biopsies, has announced its “Academic Bench to Clinical Diagnostics” (A to D) Assay Commercialization Program. The “A to D” program will provide academic and clinical researchers a means for bringing their biomarkers and assays to the clinical laboratory, while simultaneously utilizing the experience of the Exosome Diagnostics team to navigate the regulatory approval, reimbursement, commercialization, and business development processes. Researchers are developing novel biomarkers and assays with the company’s patented exosome isolation and RNA extraction technology using the exoRNeasy research kits marketed by QIAGEN. The exoRNeasy kit enables a convenient, robust, and high-yield isolation of exosomal RNA from blood. Under this “A to D” program researchers will now be able to bring their assays to Exosome Diagnostics for further validation by leveraging the company’s expertise in exosome isolation and analysis and development on the company’s proprietary clinical testing platforms, ExoLution™ for RNA-based biomarkers and assays, and ExoLutionPlus™ for the addition of cell-free DNA (cfDNA) for increased sensitivity of rare mutations when necessary. The ExoLution platforms have been developed and will be manufactured under cGMP to enable the exosome biomarkers to be extracted for clinical use, and are only available directly through Exosome Diagnostics. Simultaneously, the Regulatory Affairs team at Exosome Diagnostics will work with the appropriate regulatory agencies worldwide to ensure the fastest route for diagnostics approval.

Indestructible Micro-Animal Found to Have Almost 18% Foreign DNA in Genome; Only Animal Known to Survive Extreme Environment of Outer Space; Extensive Horizontal Gene Transfer Plays Key Role

Researchers from the University of North Carolina (UNC) at Chapel Hill have sequenced the genome of the nearly indestructible tardigrade, the only animal known to survive the extreme environment of outer space, and found something they never expected: that tardigrades get a huge portion of their genome - nearly one-sixth or 17.5 percent - from foreign DNA. "We had no idea that an animal genome could be composed of so much foreign DNA," said co-author Bob Goldstein, Ph.D., faculty in the biology department in UNC's College of Arts and Sciences. "We knew many animals acquire foreign genes, but we had no idea that it happens to this degree." Tardigrades are water-dwelling, eight-legged, segmented micro-animals. The new work, published online on November 23, 2015 in PNAS, not only raises the question of whether there is a connection between foreign DNA and the ability to survive extreme environments, but further stretches conventional views of how DNA is inherited. The artivcle is titled “Evidence for Extensive Horizontal Gene Transfer from the Draft Genome of a Tardigrade.” First author Thomas Boothby, Ph.D., Dr. Goldstein, and collaborators revealed that tardigrades acquire about 6,000 foreign genes primarily from bacteria, but also from plants, fungi, and Archaea, through a process called horizontal gene transfer - the swapping of genetic material between species as opposed to inheriting DNA exclusively from parents. Previously, another microscopic animal called the rotifer was the record-holder for having the most foreign DNA, but it has only about half as much as the tardigrade. For comparison, most animals have less than one percent of their genome from foreign DNA.

Pigeons Almost Equal to Radiologists in Ability to Detect Malignant Human Breast Pathology from Images

Pigeons may be able to distinguish between benign and malignant breast histology and radiology, according to an animal behavioral study published on November 18, 2015 in the open-access journal PLOS ONE by Richard Levenson, M.D., from the University of California-Davis Medical Center, Edward Wasserman, Ph.D., from the University of Iowa, and colleagues. The article is titled “Pigeons (Columba livia) As Trainable Observers of Pathology and Radiology Breast Cancer Images.” Pathologists and radiologists spend years acquiring and refining their medically essential visual skills. To better understand these skills, scientists trained several cohorts of pigeons, which share many visual system properties with humans, to view and identify benign and malignant histopathology and radiology images in a series of experiments. After training with differential food reinforcement and controlling for various parameters, including image magnification, compression, and color and brightness, the birds quickly learned to distinguish benign from malignant human breast histopathology. Additionally, the pigeons were able to generalize what they had learned to novel image sets. The birds' histological accuracy, similar to humans, was modestly affected by the presence or absence of color, as well as by degrees of image compression, but the authors suggest these impacts could be ameliorated with further training. In radiology, the birds were similarly capable of detecting cancer-relevant microcalcifications on mammogram images. However, when given a different task--namely, classification of suspicious mammographic densities--the pigeons were only able to memorize the images and were not able to generalize to novel images.

November 17th

Scientists Find Cure for Fatal Chytrid Fungal Disease of Wild Amphibians; Chytrid Has Affected Over 700 Species Across Five Continents; First-Ever Successful Elimination from Wild

Research published today (Wednesday, November 18, 2015) details the first-ever successful elimination of a fatal chytrid fungus in a wild amphibian, marking a major breakthrough in the fight against the disease responsible for devastating amphibian populations worldwide. The highly-infectious chytrid pathogen has severely affected over 700 amphibian species worldwide; driving population declines, extirpations, and species extinctions across five continents. Results from the seven-year study show the first evidence of eradicating the chytrid pathogen Batrachochytrium dendrobatidis (Bd) affecting amphibians in situThe new paper in Biology Letters, the paper ACCESS details the outcome of a project led by scientists from the Zoological Society of London (ZSL), the National Museum of Natural History in Spain (MNCN-CSIC), and Imperial College London. The study combined anti-fungal treatment of Mallorcan midwife toad (Alytes muletensis) tadpoles with environmental disinfection. By using an antifungal to treat tadpoles and a common laboratory decontaminant to sterilize the environment, researchers were able to clear infection from populations of the toad over the research period. The article is titled “Successful Elimination of a Lethal Wildlife Infectious Disease in Nature.” Co-author Dr. Trenton Garner, Reader within ZSL's Institute of Zoology, said, "This study represents a major breakthrough in the fight against this highly-destructive pathogen; for the first time we have managed to rid wild individuals of infection for a continued period.” "Amphibian-associated chytrid fungi are a critical conservation issue that requires simple, straightforward, and transferrable solutions. Our study is a significant step towards providing these." Dr.

November 17th

Gold Nano-Prisms for Label-Free Nanoplasmonic-Based Short Noncoding RNA Sensing at Attomolar Concentrations Enable Quantitative, Highly Specific Assay of miR-10b in Biological Fluids & Exosomes; Tests Show Potential in Pancreatic Cancer

A simple, ultra-sensitive microRNA sensor, developed and tested by researchers from the School of Science at Indiana University-Purdue University Indianapolis (IUPUI), the Indiana University (IU) School of Medicine, and the IU Melvin and Bren Simon Cancer Center, holds promise for the design of new diagnostic strategies and, potentially, for the prognosis and treatment of pancreatic and other cancers. In a study published online on October 7, 2015 in an open-access article in ACS Nano, a peer-reviewed journal of the American Chemical Society focusing on nanoscience and nanotechnology research, the IUPUI researchers describe their design of the novel, low-cost, nanotechnology-enabled, re-usable sensor. They also report on the promising results from tests of the sensor's ability to identify pancreatic cancer or indicate the existence of a benign condition by quantifying changes in levels of microRNA signatures linked to pancreatic cancer. The ACS Nano article is titled “Label-Free Nanoplasmonic-Based Short Noncoding RNA Sensing at Attomolar Concentrations Allows for Quantitative and Highly Specific Assay of MicroRNA-10b in Biological Fluids and Circulating Exosomes.” MicroRNAs (miRNAs) are small molecules of RNA that regulate how larger messenger RNA (mRNA) molecules lead to protein expression. As such, miRNAs are very important in biology and disease states. "We used the fundamental concepts of nanotechnology to design the sensor to detect and quantify biomolecules at very low concentrations," said Rajesh Sardar, Ph.D., who developed the sensor. "We have designed an ultra-sensitive technique so that we can see minute changes in miRNA concentrations in a patient's blood and confirm the presence of pancreatic cancer." Dr.

Expanded DNA Marker Panel & Fixed Clinical Criteria Enable Improved Classification of Pancreatic Cysts; Benign Can Be Better Distinguished from Malignant, Hopkins Study Shows; Currently >20% of Cysts Surgically Removed Are Later Found to Be Benign

In a "look-back" analysis of data stored on 130 patients with pancreatic cysts, scientists at Johns Hopkins have used gene-based tests and a fixed set of clinical criteria to more accurately distinguish precancerous cysts from those less likely to do harm. The findings may eventually help some patients in real time safely avoid surgery to remove harmless cysts. A report on the findings is published in the November 2015 issue of Gastroenterology. The article is titled “A Combination of Molecular Markers and Clinical Features Improve the Classification of Pancreatic Cysts.” Currently, doctors must test fluid collected from a needle that penetrates the cyst during a procedure called an endoscopic ultrasound-guided biopsy. The fluid is tested for levels of proteins associated with cancerous cysts, and pathologists look for atypical cells signifying cancer. However, recent studies show that these current methods are accurate only 63 percent of the time, says Anne Marie O’Broin Lennon (photo), M.D., Ph.D., Associate Professor of Medicine at the Johns Hopkins University School of Medicine and Director of the Multidisciplinary Pancreatic Cyst Program at Hopkins. In addition to Dr. Lennon, the senior author, famed Hopkins physician scientists Bert Vogelstein, M.D., Kenneth Kinzler, Ph.D., Ralph Hruban, M.D., Nickolas Papadopoulos, Ph.D., and Luis Diaz Jr. M.D., were among the article co-authors,. The first author was Simeone Springer, a Hopkins graduate student in human genetics.

2015 Albert Lasker Award for Basic Medical Research Award Goes to Evelyn Witkin and Stephen Elledge for Discoveries Concerning the DNA-Damage Response

The 2015 Albert Lasker Basic Medical Research Award honors two scientists for their discoveries concerning the DNA-damage response, a mechanism that protects the genomes of all living organisms. Evelyn M. Witkin (photo), Ph.D., (Rutgers University), now 94, established its existence and basic features in bacteria, and Stephen J. Elledge, Ph.D., (Brigham and Women's Hospital) uncovered its molecular pathway in more complex organisms. The details of the two systems differ dramatically, yet they share an overarching principle. Both coordinate the activity of a large number of genes whose products shield creatures from potentially lethal harm. Throughout their lives, cells withstand an onslaught of insults to their DNA. External agents such as chemicals and radiation bash it, and it also sustains abuse from within when normal physiological processes blunder. In humans, such events deliver tens of thousands of genetic wounds every day. The DNA-damage response detects not only DNA anomalies, but also other dangers, such as interruptions in the DNA-copying process. Living creatures then implement a multi-pronged strategy to ensure survival. Bacteria, for instance, ramp up their DNA-repair capabilities, halt cell division to provide time to mend damage, and amplify their mutagenic facility. At first glance, the third activity might seem to conflict with the first two, but evolution has covered many bases—boosting the microbe's ability to fix DNA and also increasing variation within the population, thus enhancing adaptability. Like bacteria, mammalian cells construct DNA-repair equipment and arrest division when they detect genetic peril. In addition, when the extent of injury overwhelms DNA-restorative capacities, the DNA-damage response sparks cell suicide.

Pioneer in Cancer Immunotherapy Receives 2015 Lasker-DeBakey Award, Nation’s Highest Honor for Clinical Medical Research; MD Anderson's Jim Allison Recognized for Seminal Work Leading to Development of Melanoma Drug Ipilimumab

For inventing a completely new way to strike cancer by unlocking a shackled immune system attack, Jim Allison (photo), Ph.D., Chair of Immunology at The University of Texas MD Anderson Cancer Center, has been awarded the nation’s highest honor for clinical medical research. Dr. Allison was named the 2015 winner of the Lasker-DeBakey Clinical Medical Research Award from the Albert and Mary Lasker Foundation. The Lasker awards, in their 70th year, honor major achievements in basic science, clinical research, and public service around the world. Dr. Allison was presented with the prestigious award at the 2015 Lasker Awards ceremony held on September 18 in New York City. Each Lasker Award includes an honorarium of $250,000. “I’m honored and grateful to receive the Lasker Award. As a basic scientist, I was pleasantly surprised, really kind of stunned, to receive the clinical award,” Dr. Allison said. “This award is also important recognition of the early success of cancer immunotherapy and its great potential to extend survival of cancer patients for decades and ultimately to cure some types of cancer.” “Jim Allison found a way to remove the brakes that stop T cells from fighting tumor cells – a discovery that opens brand new and very effective ways to treat cancer,” said Joseph Goldstein, M.D., Chair of the Lasker Medical Research Awards Jury, Nobel Laureate, and Chair of Molecular Genetics at The University of Texas Southwestern Medical Center in Dallas. Dr. Allison’s research into the biology of T cells, white blood cells that serve as the immune system’s customized guided weapons, led him to develop an antibody that blocks an off switch on these cells, unleashing an immune response against cancer.

Codiak BioSciences Launched to Develop Exosomes As New Therapeutic Modality for Many Diseases, Including Cancer; Eric Lander Co-Founder, Jan Lötvall Scientific Advisor, MD Anderson Collaborator, Douglass Williams CEO; $80 Million Series A/B Funding

Codiak BioSciences, Inc., announced today (November 17, 2015) the closing of the first portion of a planned $80+ million Series A and B financing. The company also executed license and sponsored research agreements with The University of Texas MD Anderson Cancer Center in Houston. Leveraging recent advances in the biology of extracellular vesicles (EVs) and their role in intercellular communication, Codiak aims to become the world's leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. The company is founded in part on technology developed in the laboratories of Raghu Kalluri, Ph.D., Professor and Chairman of the Department of Cancer Biology, MD Anderson. Dr. Kalluri and his colleagues have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. Exosomes – small sub-cellular vesicles that leave cells and travel throughout the body – can mediate dramatic effects in animal models of disease. Dr. Kalluri's work with exosomes involves discoveries related to identification of double-stranded genomic DNA, exosome microRNAs and their biogenesis, exosome proteins, identification of cancer-specific exosomes and exosome-mediated therapies. Codiak is co-founded by Eric Lander (photo), Ph.D., President and Founding Director of the Broad Institute of the Massachusetts Institute of Technology and Harvard University. Dr. Lander is also Professor of Biology at MIT and Professor of Systems Biology at Harvard Medical School. His experience in molecular and computational analysis of the genome will be of great value to Codiak as the company explores the depth and reach of the diagnostic and therapeutic applications of exosomes. Dr. Lander will serve on Codiak's Board of Directors.