Category Archives: Healthcare

XSpline Cloud, first-in-class cloud platform for personalized cardiac resynchronization therapy, evaluated in International Clinical Trial

BOLZANO/ BOZEN, Italy, 19-Mar-2023 — /EPR BIOTECH NEWS/ — XSpline SPA, a start-up company incorporated in Bolzano (Italy) and the Ordensklinikum Linz Elisabethinen Hospital in Linz (Austria) today announced the first patient enrolled in a clinical study (ClinicalTrials.govID: NCT05327062) for the cardiac resynchronization therapy (CRT) guided by non-invasive electrical and venous anatomy assessment.  The international multicenter prospective study will include 150 patients from 16 centers in the U.S. and Europe.

XSpline Cloud provides a cloud-based non-invasive cardiac panoramic mapping technology to select individual CRT treatment strategy and predict outcomes.

Fast and fully automatic Artificial Intelligence based epi- and endocardial segmentation of cardiac structures, including coronary sinus veins, provides clear understanding of individual patient’s anatomy. The electrical assessment is based on a 3D panoramic electro-anatomical map based on 12 -lead ECG only, without requiring multichannel ECG recording or any kind of body surface potential mapping. XSpline Cloud is the first system in the world with AI based identification of the correct target zone for LV lead implantation.

The cloud-platform guarantees full operability with existing clinical standards and data formats; it supports IHE profiles, HL7 FIHR, DICOM, and a broad range of ECG formats. The platform also provides embedded medical grade visualization tools, such as an integrated multimodality DICOM viewer, an ECG viewer with measurement capabilities, a high-performance 3D viewer for segmented cardiac structures and electro- anatomical maps as well as an interactive navigator for LV lead placement.

Dr. Georgios Kollias, M.D., is the principal investigator for the clinical trial in Austria and performed the first procedure on a 71-year-old patient with ESV LV of 154 ml and EF LV of 20%.

“The XSpline Cloud software provides a unique approach to selecting an individualized CRT treatment strategy. It is a comprehensive tool for successful CRT implantation that can also predict outcomes, making the implantation procedure faster, easier, and safer for the patient. We are very pleased to start using this tool in our clinic”, said Dr. Kollias.

“XSpline SPA is supported by an international R&D team of skilled clinicians, mathematicians, and biomedical engineers with the shared goal of improving patient care. We think that the real-time visualization of each patient’s individual anatomy, the precise non-invasive electro-anatomical endo- and epicardial activation map and the interactive navigator will help to increase CRT responders”, said Mr. Werner Rainer, CEO of the company.

XSpline Cloud is an investigational device and not yet approved for commercial use.

SOURCE: EuropaWire

Clinical trial started to verify whether the use of a nasals spray preparation containing azelastine can help fight COVID-19

SAARBRÜCKEN / VIENNA, 17-Feb-2021 — /EPR BIOTECH NEWS/ — In the fight against the SARS-CoV-2 virus, a large number of pharmaceutical companies are looking for new approaches to combat the pandemic. In addition to vaccines, intensive research and development efforts around the world are focusing on identifying new anti-COVID therapeutics that includes re-evaluation of existing product portfolios with a view to re-purpose drugs that have antiviral properties.

With this goal in mind, URSAPHARM Arzneimittel GmbH, based in Saarbrücken, and the Vienna-based biotech company CEBINA GmbH (Central European Biotech Incubator and Accelerator) are collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic. Azelastine has been successfully used for many years in anti-allergic therapy.

Starting with a novel computational drug repurposing prediction method, developed and performed by Prof Dr Robert Konrat (University of Vienna), CEBINA selected already approved active substances for experimental testing in collaboration with Prof Dr. Ferenc Jakab (Virology National Laboratory, Szentágothai-Research-Center, University of Pécs, Hungary). This collaborative effort led to the identification of azelastine as a potent antiviral compound effective against SARS-CoV-2, a finding confirmed by now by several independent research groups. The potent anti-SARS-CoV-2 activity of azelastine was demonstrated in a reconstituted human nasal tissue model and was evident at a lower dose than present in commercially available nasal sprays [1].

A clinical trial has started on February 16th 2021 to verify whether the use of a nasal spray preparation containing azelastine can achieve a reduction in viral load in the the nasal cavity. The aim of the study is to show whether the anti-allergic medication Pollival® Nasal Spray, or a diluted version, can achieve a reduction in the viral load, therefore reducing transmission and positively influencing the course of the disease.

If positive results of the running clinical studies are demonstrated, URSAPHARM Arzneimittel GmbH and CEBINA GmbH believe this will be an important new approach to control viral spread and contain the current pandemic.

SOURCE: EuropaWire

Combined Shigella and ETEC vaccine candidate enters Phase 1 clinical study with radically innovative approach

VIENNA, 24-Sep-2020 — /EPR BIOTECH NEWS/ — Eveliqure Biotechnologies GmbH, an Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries.

Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non-endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor-countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world-leading vaccine organizations – the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH.

“Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” – commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”.

“Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.

Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations.

SOURCE: EuropaWire

CoapTech and Fidmi Medical to Collaborate on Groundbreaking G-Tube Systems

Baltimore, MD, 2019-Sep-18 — /EPR BIOTECH NEWS/ — CoapTech LLC (Baltimore, MD) and Fidmi Medical, Ltd. (Caesarea, Israel) announced today that they will be collaborating on bringing to market a set of next-generation products for the initial placement and long-term maintenance of gastrostomy tubes (G-tubes). The collaboration between CoapTech and Fidmi will focus on integrating the company’s two technologies and expanding their collective market opportunities.

Gastrostomy tubes, which help patients receive long-term nutritional support, are typically placed endoscopically and need to be replaced every 3-6 months.

CoapTech’s PUMA-G System allows initial gastrostomy tube placement by non-surgeons/ gastroenterologists, outside of the endoscopy suite, using point-of-care ultrasound at the patient bedside. This novel approach can be performed in the ICU, emergency room, and eventually outside of the hospital setting, substantially reducing costs for tube placement.

Fidmi Medical’s innovative low-profile gastrostomy system is unique in that it can be utilized for both initial placement and replacement and has several features which make it more durable and comfortable for patients. Gastrostomy tubes very often get dislodged, clogged, or infected, and need to be replaced frequently. Fidmi’s improved low-profile gastrostomy tube is placed just like any standard PEG tube but has an easily replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications with patients’ g-tubes, therefore potentially reducing healthcare costs for payers and healthcare systems; as well as providing a substantial improvement in quality of life for patients and their caregivers.

Fidmi Medical Chairman, Lloyd Fishman, commented, “We are excited to collaborate with CoapTech in development and marketing. Both companies have developed cutting-edge technologies that will improve patient care and contribute to the ease, efficiency and confidence of clinicians’ work in the gastrostomy field.”

Dr. Steven Tropello, CoapTech’s founder and CMO said, “In combination these systems will be compatible with Push or Pull methods, be implantable in a wide variety of clinical settings, and require minimal readmission to the hospital and fewer visits to the ER. The synergy will reduce both front and back-end costs for hospitals and payers, and make care safer and more patient-centered.”

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Mr RICHARD GUILLAUME IS APPOINTED TO THE DIAFIR BOARD OF DIRECTORS

RENNES, FRANCE, 2019-Apr-08 — /EPR BIOTECH NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors

Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.

Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.

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FINALLY, A REAL INNOVATION IN DENTAL CARE – THE ONLY DUAL MODE LIGHT THERAPY ELECTRIC TOOTHBRUSH LAUNCHES ON KICKSTARTER

Los Angeles, California, 2018-Mar-26 — /EPR BIOTECH NEWS/ — Bristl combines proven science of light therapy with sonic vibration to improve oral care. The company also offers a subscription service to replace brush heads, so having the best oral health is also convenient.

Available on Kickstarter on Monday, March 26th at 9am (PST)

The combination of Bristl’s features, convenience, and style make for true market disruption:

Gum Health
Visible Red light (620–750 nm in wavelength) has been clinically proven to heal gum tissue and prevent inflammation. The same technology is often used in skincare; Bristl is bringing it to the everyday tooth brushing routine.

Kill Bacteria
Visible blue light (450–495 nm in wavelength) has been clinically proven to kill and prevent oral bacteria that causes gingivitis and other gum disease. This safe and natural blue light is proven to be effective, and Bristl is proud to bring it to market.

Get Rid of Plaque
Bristl has three sonic vibration modes: regular, gentle, and off. Sonic vibration is recommended by dentists as it has the highest cleaning ability without damaging gums. The brush head is also particularly designed to reach in crack and crevices while letting light pass through the bristles.

A Few Stats
According to a study published in the Journal of Periodontology and Implant Science (Vol. 44: pp. 280-287), Bristl’s technology (even with only red light) was effective in achieving the following:

  • 86% reduction in bacteria that causes destruction of tooth supporting tissue
  • 117% improvement in PPD (Periodontal Pocket Depth) which indicates gum health
  • 80% improvement in CAL (Clinical Attachment Level) which is another metric for gum health

Why Us?
The Bristl Science team consists of a group of innovators and scientists looking to use advanced technology to improve everyday lives. While we of course wish to build a successful business, we are doing so responsibly; Bristl has committed to donating a percentage of every sale to America’s Toothfairy to provide underserved children with dental care. Whether a customer or an underserved child, we’re on a mission to maximize oral health everywhere.

This is just the beginning. The Bristl Science team will work tirelessly to innovate and build products that improve lives, maximize health, and promote good. The Bristl light therapy toothbrush is just the first step toward a healthier future.

Clinical backing, photos, founders quotes, and more information can be found in our Media Kit:
http://bit.ly/2HtKTJ8

Campaign Preview: https://www.kickstarter.com/projects/574806194/565862801?ref=450743&token=dbd4feaa

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International Symposium on the Accessibility to High-Value Medicine, December 5-6, 2017 in London

LONDON, Dec-3-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies.

The not-for-profit executive forum is organised by the London School of Hygiene and Tropical Medicine and analytica|LASER, a global research consultancy, to investigate topical questions around drug policy, global health systems sustainability and innovation funding through a combination of case studies, panel sessions, and roundtables. Delegations are registered from over 70 public and private organisations, including the World Health Organization, as well as health systems representatives from Belgium, England, Estonia, Croatia, France, Germany, Italy, Norway, Sweden, the United States and Wales. Multiple patient organisations support the meeting to ensure that the patient voice is reflected in all deliberations.

“Access to life-saving drugs is not a new challenge. The paradigm of accessibility was changed completely in the face of the deadly HIV epidemic. This time, however, accessibility concerns almost every domain of medicine such as cancer, auto-immune diseases and rare diseases. We must act now,” says Prof Peter Piot, Director of the London School of Hygiene & Tropical Medicine and former head of UNAIDS.

“There is an incredible challenge for the sustainability of health systems across the world”, says Prof. Lucien Abenhaim, London School of Hygiene & Tropical Medicine and Chairman of Analytica Laser. “It is critical that drug developers and health system engage on actionable proposals that address concerns around value, cost and overall access to innovation for the patients who need it. We are at an inflection point – the paradigms of the 1990’s can no longer guide us,” he adds.

Yann Le Cam, CEO of EURORDIS-Rare Diseases Europe, an alliance of over 700 rare disease patient organisations, commented, “The majority of people living with a rare disease have delayed or no access to the medicine they need. Only through a collective engagement between all stakeholders involved, including industry, competent authorities, health ministries, academics and regulators, can we break the access deadlock.” Le Cam will be presenting a new four-pillar approach to improve access to rare disease therapies in Europe.

The main plenary on December 6th features scheduled remarks by over a dozen authorities in the field, including Professor Baron Peter Piot (Director, London School of Hygiene & Tropical Medicine and former Head, UNAIDS), Dr. Olivier Brandicourt (Chief Executive Officer, Sanofi), Dr. Sarah Garner (World Health Organization), Prof. Dominique Le Guludec (President, French HAS), Sir Andrew Dillon (Chief Executive, National Institute for Health and Care Excellence UK) and Dr. Harold Paz (Chief Medical Officer, Aetna). The plenary is preceded by a scientific seminar on December 5th which gathers globally renowned academics to explore new frontiers on the methodology for the appraisal and valuation of high-value medicines.

Please contact the organisers for more information on the programming and media access, or refer to www.accessibility-symposium.org

SOURCE: EuropaWire

S-ACQUISITION CORP COMMENCES TENDER OFFER OF ASTRA LOGICS, INC.

New York, 2017-May-02 — /EPR BIOTECH NEWS/ — S-Acquisition Corporation is today commencing its tender offer for all 10,000,000 shares of Second Round financing of Common Stock of Astra Logics Inc., Hong Kong, at a price of US$7.00 per share, payable in cash. The offer, which has been unanimously approved and recommended by Astra Logic’s Board of Directors is being made pursuant to the agreement between the two companies.

The tender offer, which is currently scheduled to expire at 12:00 midnight EST on Thursday, June 1st, 2017 (unless extended) is subject to the tender by Astra Logic’s shareholders and would represent a majority of the outstanding shares on a fully diluted basis, as well as other customary conditions.

Astra Logics, Inc. aims to become a leader in advanced drug delivery systems with Graphine Oxide being the key component. After extensive research and testing the firm’s proprietary protocols are now nearing completion of initial phase clinical trials in Hong Kong. Ken Holland, Head of Corporate Affairs for Astra Logics said, “When completed, this tender offer provides the company with substantial cash reserves allowing for continued product development. Institutional sponsorship is critical to strengthening our market position for the long term”.

S-Acquisition Corp’s Director of Bio-Pharm Transactional Services, Mr. Craig Kirkman, stated “Astra Logics’ unique delivery platform offers tremendous upside potential in a sector providing boundless opportunity for return. Our firm shares the same long-term vision and commitment necessary to allow the company to progress”.

About S-Acquisition Corp.
S-Acquisition Corp. is a global corporate advisory with expertise in mergers and acquisitions, capital markets, financial restructuring, valuation, and strategic consulting. The firm serves corporations, institutions, groups and individuals worldwide and has its headquarters located in the United States.

About Astra Logics, Inc.
Astra Logics, Inc. is an independent biotech firm based in Hong Kong with a focus on the research and development of Nano-particle, bio-therapeutic drug delivery systems for the treatment of cancerous tumors, in particular lung cancer. The firm’s core objective is to deliver highly innovative cancer therapies that currently have few, if any, effective treatment options.

Contact-Details: S-Acquisition Corp.

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Study: New laser-based imaging technique can detect inflammation more accurately

GERMANY, Mar-30-2017 — /EPR Biotech News/ — Ulcerative colitis and Crohn’s disease are the most common inflammatory bowel diseases (IBD). Globally, more than 4 million people suffer from recurring inflammation of the intestinal mucosa. To date, non-invasive methods have not been able to detect these forms of IBD reliably. Researchers at the University Hospital Erlangen (Germany) have now shown for the first time how Multispectral Optoacoustic Tomography (MSOT) can more reliably detect early stages of inflammation when compared with other non-invasive diagnostic methods. These results have recently been published in the New England Journal of Medicine.

Evaluating the inflammatory activity of the intestines early and accurately helps to prevent complications associated with IBD and guide an optimal therapy regime. Currently, doctors frequently rely on an invasive endoscopy procedure to assess the intestinal mucosa of patients with IBD. Additionally, non-invasive imaging methods are increasingly used in the clinic. For example, ultrasound allows clinicians to examine the structure, thickness and blood perfusion of the intestinal wall with changes in perfusion patterns indicating an onset of inflammation.

“With the MSOT procedure, we additionally use laser light, by which we can detect inflammation earlier than previously possible with ultrasound”, explains Prof. Dr. Maximilian Waldner, Professor at the University Hospital Erlangen. “The earlier we detect signs of an upcoming flare – i.e., a change in blood content – the quicker we can react and start a preventive treatment”. The MSOT technology was developed by iThera Medical in Munich, and was first used on IBD patients last year.

The researchers of the University Hospital Erlangen have recently published their results in the renowned New England Journal of Medicine. “We examined 108 patients with Crohn’s disease using the MSOT technology and compared the results to established non-invasive diagnostic procedures as well as endoscopy and histology”, says Prof. Waldner. “We were able to demonstrate that hemoglobin values in the tissue measured with MSOT indicate very accurately the inflammatory activity in the intestines. The method appears to be superior to other non-invasive procedures, as MSOT for the first time was able to detect even low levels of inflammation without having to perform endoscopy”.

Dr. Ferdinand Knieling, a physician at the University Hospital Erlangen, adds: “We are hoping that this principle can be applied to many applications and, in particular, also be used to enable safe evaluations of children and adolescents. With this new examination method, many of the currently invasive procedures might become obsolete.”

In optoacoustic imaging, the physician scans the intestines transabdominally through the skin, applying pulsed laser light in the near-infrared region. The energy of the light absorbed in tissue is converted into acoustic signals which are then acquired by an ultrasound detector. Christian Wiest, CEO of iThera Medical, comments: “MSOT is a new diagnostic imaging modality that can detect changes in tissue composition associated with a variety of diseases, without the use of contrast agents. The technology has already been applied in other clinical feasibility studies, e.g. for the detection of melanoma metastasis in sentinel lymph nodes or for the assessment of suspicious breast lesions”.

The results of the IBD study at the University Hospital Erlangen were published on March 30th 2017 in the New England Journal of Medicine (Volume 376, Issue 13, pg.1292-1294).

SOURCE: EuropaWire

GenQual and R-Pharm collaborate to deliver predictive diagnostics for novel anti-IL-6 antibody for autoimmune diseases

Seattle, WA, San Francisco, CA and Moscow, Russia, 2016-May-25 — /EPR Biotech News/ — R-Pharm and GenQual are pleased to announce a new collaboration focused on the development of novel predictive diagnostic tools in the area of Rheumatoid Arthritis and Autoimmune diseases.

The GenQual proprietary real-time PCR platform, when applied to the genes that are involved in the manifestation of several autoimmune diseases, allows us to detect and assess single nucleotide polymorphisms. Here, allelic determination is used as potential predictor of the treatment response by the novel anti-IL6 antibody, which is currently in development by R-Pharm.

GenQual Founder and CEO Jonathan Mirich said, “This partnership is exciting for GenQual as we advance in our goal to deliver predictive diagnostic tools for the treatment of autoimmune disorders. We are very excited about the possibilities in this space and are thankful to have quality partners in R-Pharm.”

R-Pharm CEO Vasily Ignatiev indicated the importance of the Autoimmune diseases as an area of the development and growth for R-Pharm, as well as the development of novel diagnostic tools aimed to increase the level of predictive response and efficiency of the upcoming treatment paradigm.

About GenQual
GenQual develops proprietary biomarker diagnostics for autoimmune and oncology indications.  Our personalized medicine products are designed to facilitate early disease detection and diagnosis, and to improve treatment approaches at the molecular level.  GenQual is a privately-held corporation based in Seattle, WA area, USA.

About R-Pharm
R-Pharm is a private Russian pharmaceutical company founded in 2001. It employs over 3,500 highly qualified specialists in 60+ branches. R-Pharm operates in Russia and CIS, USA, Germany, Japan, Turkey/MENA.

The company is involved in R&D, manufacturing (finished dosage forms, biotech and chemical APIs), marketing, sales and distribution of innovative pharmaceutical products in hospital/specialty care therapeutic areas.

R-Pharm collaborates with major international pharmaceutical companies and universities in the fields of drug discovery, development, clinical trials, manufacturing and commercialization.  The company operates several  GMP compliant manufacturing sites in Russia and Germany, research, BD/licensing and marketing affiliates in Japan, Germany, Turkey and US.

Marketed portfolio and pipeline features drugs used in oncology, hematology, autoimmune diseases, HIV, HCV, neurology, diabetes, cardiology, as well as antibiotics, contrast media and anesthesia agents.

Contact

R-Pharm
info@rpharm.ru
www.r-pharm.com/en/

 

GenQual

info@genqual.com
206.659.7825
www.genqual.com

 

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Nu-Tek Bioscience Announces Availability of Pea Peptones

Allergen free Peptones for the use in probiotic cultures

Minnetonka, MN, 2016-May-10 — /EPR BIOTECH NEWS/ — Nu-Tek’s Pea Peptone is an excellent alternative to Dairy and Soy Peptones for the production of probiotic cultures. Consumers with known food allergies rely on ingredient labeling for guidance. An Allergen Control Plan is a critical component of a food ingredient manufacturer’s safety initiatives. It not only protects the health and confidence of the consumer, but also the reputation and financial success of the company.

An advantage of allergen management strategies include ingredient selection that eliminates allergens without negatively affecting the performance of the product. Formulating growth media using Nu-Tek Pea Peptone provides such an advantage. Nu-Tek Pea Peptone HPP-A is an excellent source of natural nitrogen and necessary growth factors needed for optimum probiotic culture fermentations.

Our Kosher Pea Peptones are obtained through enzymatic hydrolysis of Animal free and Non-GM pea protein. Pea protein hydrolysates do not require special allergen labeling. Independent university trials have shown excellent growth performance results that compare favorably with soy peptones. In addition, peptones have been shown to improve fermentations versus yeast extract “only” growth media. Today at Nu-Tek Bioscience announced immediate availability of Pea Peptones, enabling developers of probiotics to either enhance their current culture growth rate.

Pea Peptones

Pea Peptones Availability
Pea Peptones is an update driven by customer feedback and is part of Nu-Tek Bioscience’ continuing development of new technologies.

Founded in 2008, Nu-Tek Bioscience LLC is the worldwide manufacture and developer of specialty Peptones that have been designed to enhance Cell growth. The company offers a wide range of Peptones and Yeast Extracts.

For more information, press only:
Cyndi Mueller
952-936-3604
cmueller@nu-tekbioscience.com

For more information on Pea Peptones:
www.nu-tekbioscience.com

Austrianova expands its business area

SINGAPORE, January 26, 2016 — /EPR BIOTECH NEWS/ — Austrianova announced today that, having completed the set up of austrianova logoits new GMP facility, it is now offering clients a GMP cell banking (Master Cell Bank and Working Cell Bank) as well as a “Fill and Finish” service for cell therapy products, in addition to its encapsulation services and technology. Austrianova is able to offer the production of Master Cell and Working Cell Banks (MCB and WCB) at the size scale required for early (phase 1 and 2) stage clinical trials at highly competitive prices using its state of the art isolator based production facility, assuring that the highest quality standards are adhered to. The company can also fill bulk cell product into syringes or vials in its GMP facility. This new cell banking and filling service is called GMP4Cells. MCB’s and WCB’s are required for all cell therapy products such as stem cell therapies as well as biologics produced from cells such as vaccines, antibodies, recombinant proteins etc. Similarly, many companies, including those developing stem cell lines and products, are seeking high quality economic fill and finish for relative small lots.

“We see this as a natural add-on to our already established Cell-in-a-Box® cell encapsulation technology for which we have recently set up a GMP manufacturing facility in Thailand. This kind of MCB and WCB production as well as “Fill and Finish” services for cells are, however, stand alone services. Although these services are generally available to all customers, they should allow start up companies and academic based cell products, vaccines etc to enter clinical trials in a quality assured manner but at lower cost that other, more conventional, cell banking companies offer” stated Walter H. Gunzburg, Chairman and CTO of Austrianova.

“In addition to our state of the art facility, Austrianova offers services that comply with major international regulatory agencies using a customized German/Swiss based quality assurance system. Our team has many years experience with regulatory agencies around the world and has taken cell therapies into clinical trials” said Brian Salmons, CEO.

More information about the GMP4Cells cell banking but also the Cell-in-a-Box® and the related Bac-in-a-Box® encapsulation services can be found on our newly revamped website www.austrianova.com.

About Austrianova:
Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability for extending storage under lyophilized conditions and protection in stomach acid.

Austrianova Singapore Pte Ltd,
#05-19 Synapse,
3 Biopolis Drive,
Singapore 138623
Tel +65 6779 3867
Fax: +65 6268 4671

Austrianova Thailand Co., Ltd,
141 INC2 Building D, Room 401-404
Thailand Science Park,
Paholyothin Road, Klong 1,
Klong Luang, Pathumthani 12120,
Thailand

www.austrianova.com

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ISOLATOR

 

HD Biosciences, Co., Ltd. and E. J. Corey Institute of Biomedical Research Reached Agreement for Drug R&D Collaboration

HD Biosciences Co., Ltd. (HDB) and E. J. Corey Institute of Biomedical Research (CIBR) announced that they have reached a risk-sharing agreement on collaborative drug discovery and development in the therapeutic areas of infectious diseases, metabolic diseases, and oncology. This joint effort will focus on both international and Chinese markets to provide innovative medicines for unmet healthcare needs. The agreement includes lead candidate selection pre-clinical development, IND filing, clinical trials, and NDA approvals. Both companies will share financial returns from any successes or products launches.

“We are delighted to enter this partnership. The collaboration will leverage HDB’s extensive capabilities in preclinical drug discovery and development, and create long term potentials for the company.” stated Xuehai Tan, Ph.D., President & CEO of HDB. “In combination of CIBR’s expertise in drug development, we are confident to deliver novel drug candidates over the next few years, and to make this partnership a success.”

“Working with HDB gives CIBR a unique opportunity to showcase its strength in innovative drug discovery and development,” said Wuyi Meng, Ph.D., President of CIBR. “This partnership further demonstrates CIBR’s commitment in the betterment of patient’s lives by bringing forward novel medicines. We will collaborate closely with HDB to accelerate the progress of our collaborative programs”

About HD Biosciences Co., Ltd.
HD Biosciences Co., Ltd. is a Shanghai-based, biology-focused preclinical drug discovery contract research organization (CRO). The company offers comprehensive service platforms around target validation, plate-based pharmacology, hit identification and lead discovery, therapeutic antibody discovery, in vivo pharmacology, as well as other research and development services. The company currently collaborates with eight of the ten largest pharmaceutical companies in the world and has established strategic partnerships on many key R&D areas with impacts to their portfolios. The strong scientific expertise, high quality and consistency in deliveries, constantly meeting or exceeding expectations, has earned the company a great reputation in the industry, and helped the company to build its widely recognized leadership in preclinical contract research services.http://www.hdbiosciences.com

About E. J. Corey Institute of Biomedical Research
Located in the Jiangyin High-tech Industry Development Zone in Jiangyin, Jiangsu, E. J. Corey Institute of Biomedical Research (CIBR) is a non-profit research organization founded by Nobel laureate Prof. E. J. Corey with the support from Jiangyin and Jiangsu government. CIBR is committed to scientific research in the broad biomedical field and to the development of novel therapeutics to meet the unmet medical needs of patients. In addition to its strong internal research and discovery capabilities in biomedical research and drug discovery, CIBR has established solid external capabilities in translational medicine and molecular toxicology to support drug development. Under the guidance of Nobel laureate Prof. Corey, CIBR is well poised to contribute to the discovery and development of novel medicines. http://www.cibrnobel.org

Contact Details:
HD Biosciences
Ms. Jessie Yang
Email: yangxiaojie@hdbiosciences.com

CIBR
Dr. Jiaquan Wu;
Email: jwu@cibrnobel.org

 

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HD Biosciences and Anchor Therapeutics Form Collaboration for Co-marketing Pepducin-mediated GPCR Technology

HD Biosciences Co., Ltd (HDB) and Anchor Therapeutics, Inc. today announced that they have formed a strategic collaboration to co-develop and co-market Anchor’s proprietary pepducin technology and provide novel drug development solutions to global pharmaceutical companies with drug discovery efforts focused on G-protein coupled receptors (GPCR).

Pepducins are proprietary lipidated peptide modulators for GPCR signaling. They may stabilize receptor conformation, promote or inhibit dimerization, and modulate interaction of GPCR with signalosome. As a strong research tool, pepducin technology enables high throughput screening (HTS) campaigns for the identification of special class of compounds and allosteric ligands, facilitates biophysical studies via stabilization of GPCRs in different activation states and functionally de-orphanizes GPCRs to provide tools for interrogation of pharmacology in vitro and in vivo.

As a key component of HDB’s plate-based pharmacology service capabilities, GPCR assays and screenings is one of the most active research and development areas that attracts global clients and partners in drug discoveries. With over 200 recombinant GPCR cell lines in house, some of which are orphan receptors, combining a variety assay formats with pepducin technology allows HDB to enhance its capabilities for supporting hit identification, lead discovery and receptor selectivity profiling. The collaboration is also designed to provide broader exposure and accessibility of pepducin technology across pharmaceutical and biotechnology industries through HDB’s global client base. HDB’s clients will gain unprecedented access to not only the pepducin screening platform but also HDB-Anchor’s joint expertise in GPCR research.

“Anchor’s pepducin technology has provided a novel approach to search very special GPCR related compounds that have potential to alter the receptor functions. We believe this technology will be very valuable in GPCR related drug discovery.” commented Dr. Xuehai Tan, President and Chief Executive Officer of HDB. “As one of the global leaders in biology focused contract research services, HDB emphasizes on innovative and scientific driven technologies in order to deliver extra value to our clients. The partnership between HDB and Anchor is a perfect example to demonstrate our commitment to grow the expertise and strengthen our leadership in GPCR R&D.” Dr. Tan continues his comments.

“Anchor Therapeutics is extremely pleased to partner its pepducin technology with HD Biosciences, one of the leading companies providing state of the art high throughput screening services to pharmaceutical and biotechnology clients,” said Thomas J. McMurry, PhD, Anchor’s Interim President. Dr. McMurry continued, “Through this collaboration, Anchor and HDB will expand the validation of pepducin high throughput screening probes in order to provide HDB’s clients with access to innovative screens designed to facilitate access to novel small molecule pharmacophores.”

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LC Sciences Launches Online Searchable Knowledgebase

LC Sciences, LLC, a leading provider of microRNA analysis services, today announced the launch of a new online searchable knowledgebase that researchers can use to locate technical information on the company’s website. This announcement comes on the heels of the launch of LC Sciences’ re-designed company website last week. The knowledgebase contains technical information in the form of application notes, technical bulletins, customer publications, presentations, reviews of seminal publications in the field, etc. This documents database contains over one thousand entries and encompasses a wide range of research fields; from plant science to neuroscience. Additionally, all entries have been carefully meta-tagged to improve search results.

“Having served the microRNA research community for the past nine years, we’ve accumulated quite a large library of reference documents such as application notes and related customer publications. This new resource offers the community a simple, user friendly search interface that makes it easier for them to locate the information they’re looking for within that library.” – Chris Hebel (Vice President of Business Development, LC Sciences)

The knowledgebase is freely accessible to all at: http://www.lcsciences.com/Knowledgebase/

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Innovative Drug Discovery Business, Biosortia Pharmaceuticals, Lands Two Health Care Veterans

Kurt Dieck formerly SVP of Strategy and Business Execution at Cardinal Health, will lead early stage drug discovery business at Biosortia Pharmaceuticals. Dieck was named President and CEO in November 2012 and has quickly identified other key executives, including Dr. Guy Carter, former Natural Product head at Wyeth Pharmaceuticals, as his Chief Science Officer. In conjunction, other collaboration partners have joined the team, including NOAA (National Oceanic and Atmospheric Administration), NCI (National Cancer Institute) and key universities, to strategically accelerate the development of novel drug leads in the therapeutic areas of cancer, infectious diseases, inflammation and neurological disorders. Biosortia Pharmaceuticals has seen promising early results with dozens of novel compounds having already been requested, and are under evaluation with NCI and Eli Lilly.

Dieck has spent nearly 30 years in healthcare, including 18 years at Arthur Andersen as a global equity partner and then 10 years with Cardinal Health, a Fortune 20 public company, as a senior executive; there he worked with a broad spectrum of partners, including brand pharmaceutical manufacturers, throughout the supply chain. Dr. Guy Carter has over 30 years of experience working in pharmaceutical R&D, primarily in the discovery and development of microbial natural products. He previously was the leader of natural products drug discovery at Wyeth Research, as head of the Chemical Technologies Department.

“Kurt and Guy make a great team. Their complementary Pharma experiences and backgrounds create great opportunities to accelerate Biosortia’s objective to become the premier, aquatic natural products company with a primary focus in drug discovery,” says Ross Youngs, Biosortia’s Founder and Chairman. “Kurt and Guy bring a wealth of research and business experience along with deep industry relationships in building successful Pharma partnerships. Everyone involved with this young biotech is excited about the future.”

Industry observers have commented that late-stage R&D pipelines are not providing Pharma with the desired revenue growth the market is expecting. Therefore, large Pharma is evolving the way it performs R&D in order to optimize efficiency and to boost patent cliff defenses. These changes require shifting from relying solely on in-house chemistry-based R&D to acquiring and licensing external technologies and natural products based compounds in various stages of development. Biosortia’s ability to supply novel, highly active and potent compounds with drug-like characteristics will increase the productivity and success rate for Pharma as well as reduce the overall cost of the discovery process. The cost to discover, develop and launch a new drug is estimated to reach nearly $3B per drug by 2015. Biosortia’s business model is designed specifically to support Pharma’s needs.

“With nearly unlimited microorganisms (3.7 nonillion), the aquatic environment and its consortia represent an extraordinary opportunity…a new frontier, to access extremely potent and chemically diverse secondary metabolites with drug-like properties with unique mechanisms of action never researched before,” said Dieck. In describing the opportunity, Dieck goes on to say, “Biosortia is on the cutting edge of natural product discovery
and has the capabilities to deliver on its aspiration. Our powerful natural products research team, led by Dr. Guy Carter, in partnership with NOAA’s Dr. Peter Moeller, a leader in aquatic natural products research, has the experience and know-how to decipher the complex unexplored environment in a very efficient manner leveraging all the current state of the art instrumentation. The need for more efficient and effective approaches to drug discovery has never been more important. Biosortia’s innovative technologies, deep research skills and key relationships will efficiently provide thousands of unique natural products as candidates for drug discovery at a time when Pharma is in critical need for “high quality shots on goal.”

“Aquatic microbial consortia are a rich source of metabolically active organisms including microalgae, bacteria, fungi and their secondary metabolites,” states Carter. “Owing to the competitive nature of their habitat, chemical investigations of microbial consortia reveal unique structurally diversified natural products that are responsible for signaling and self-defense that have potential as therapeutics with novel mechanisms of action. Since they have been pre-optimized by nature, these compounds are typically closer to a drug candidate than a synthetic lead, thus requiring less optimization and shorter time when found as ‘hits’ in screening programs.”

The team has also focused on agreements with strategic collaboration partners as vital components to the strategy. Biosortia has recently entered into several collaboration agreements with NOAA, Analyticon and exclusive harvesting relationships, just to name a few. Several others will be advanced by the end of January. Biosortia’s cooperative research and development agreement (CRADA) with NOAA’s Center for Human Health Risk at Hollings Marine Laboratory provides a 5-year framework for research and development regarding the analysis and purification of novel bioactive compounds. According to NOAA’s Technology Partnerships Office, “Success will result in the commercial development of new and unique chemical compounds from the sea which have benefits to human health, either through disease prevention or new treatments for disease.”

Dr. Peter Moeller, NOAA’s Research Scientist who leads the Toxins Natural Products Program stated after analyzing fractions of Biosortia’s biomass, “Coupling NOAA’s mission of characterizing toxins affecting environmental and/or human health with Biosortia’s drug discovery focus turns one man’s toxin into another’s chemotherapeutic. The microorganisms analyzed in the Biosortia biomass identified more unique activity than I have seen in my 30 year career. The volumes achieved from a single harvest delivered an equivalent of 30 years of accumulation. This could materially change the landscape for natural products drug discovery research.”

As of December 31, 2012, Biosortia has identified more than 30 bioactive candidate compounds (hits) from a fresh water eutrophic lake consortium. Therapeutic areas of focus include treatments for cancer, infectious diseases, inflammation and neurological disorders. In addition, more than a dozen of its patent protected compounds are in initial evaluation stage within Eli Lilly’s Open Innovation Drug Discovery Program.

Dieck states, “Looking forward, it is with great optimism. We have a great team built around mutual respect, deep experience, and a desire to succeed and make a difference. We are aligning with the right partners and collaborators to execute our strategy with speed and discipline to provide Pharma with much high quality & diverse compounds vs. “me-too” drugs than they have had in the past 10 years. We are excited about what this company can accomplish, not only for its shareholders but also for the millions of people who have been diagnosed with various forms of chronic diseases who are looking for Pharma to identify better ways to help them extend their lives or live a more productive life. Biosortia can play a big role in identifying compounds that can help Pharma achieve these goals. I am looking forward to the challenge and opportunity to build an industry leading drug discovery company.”

Via EPR Network
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Microtissues® Inc. and Sigma-Aldrich® Sign Worldwide Supply and Distribution Agreement for the 3D Petri Dish®

Microtissues® Inc. announced today the signing of a Supply and Distribution Agreement with Sigma-Aldrich® Corporation (Nasdaq: SIAL) for the worldwide sales and marketing of the 3D Petri Dish®, a new technology for the culture of living cells in three dimensions (3D). Invented at Brown University, the 3D Petri Dish® maximizes cell-to-cell interactions critical for replicating the function of natural tissues and organs. Shown in numerous peer reviewed papers to work with over fifty different cell types, including cell lines, primary cells and stem cells, the 3D Petri Dish® has applications in cancer research, drug discovery, toxicity testing and regenerative medicine.

“Researchers are rapidly recognizing the importance of 3D cell culture and its ability to reliably mimic in vivo function” said Brian Morgan, Director of Business Development, Microtissues® Inc. “The 3D Petri Dish® creates a natural 3D environment without artificial scaffolds and we’re excited that this distribution agreement will bring our unique and innovative line of products to the worldwide research community.”

Unlike the conventional plastic Petri dish where cells are grown as a thin layer on the surface of the dish, the 3D Petri Dish® forms 3D aggregates of cells. Spheroid size is controlled by the number of cells seeded and hundreds of uniform sized spheroids are formed in a single pipetting step. Spheroids are formed in a well ordered array in a stable platform suitable for long term culture. All spheroids are positioned on the same optical plane making them easy to image (phase contrast, fluorescent). Spheroid size is controlled by the number of cells seeded and a mixture of cells forms mixed spheroids, suitable for investigating tumor-stroma interactions. Spheroids can be grown from single cells, applicable to the study of cancer stem cells. For histology, Western blots and RT-PCR, spheroids are harvested by simply inverting the 3D Petri Dish®. No need to dissolve or digest the gel. The 3D Petri Dish® is a new fundamental tool for the world wide industry of life sciences research.

About Sigma-Aldrich®: Sigma-Aldrich® is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich® customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich® is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich®, please visit its website at www.sigma-aldrich.com.

About Microtissues® Inc: Microtissues® Inc. is a privately held company located in Providence, RI, advancing technologies and applications of 3D cell culture. Microtissues®, Inc.’s products are designed to serve the needs of researchers in a wide range of areas including cancer research, stem cell biology, toxicity testing, developmental biology, drug discovery, regenerative medicine and tissue engineering. Microtissues®, Inc. has an exclusive worldwide license from Brown University to US and international patent applications on the 3D Petri Dish®. For more information on Microtissues®, Inc., please visit www.microtissues.com.

Sigma-Aldrich and Sigma are trademarks of Sigma-Aldrich Co. LLC registered in the US and other countries. Microtissues and 3D Petri Dish are registered trademarks of Microtissues, Inc.

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Is it a Moment or an Abuse: the Boom of iPSCs Research after 2012 Medicine Nobel Prize

On Creative Biomart website, we can read a report about the 2012 Nobel Prize in Physiology or Medicine regarding the two winners. They bring hope for organ or tissue repair for human or even for rejuvenation, i.e. for long life through induced pluripotent stem cells (iPSCs).

Since the first appearance in 2006, iPSCs became the hit and focus. But there are still lots of unknowns waiting for us before achieving the ideal status. Thus, numerous scientists, researchers and businessmen are struggling and investing for that goal. Here are some examples:

On Dec. 5, 2012, Roche (SIX: RO, ROG; OTCQX: RHHBY) and the Innovative Medicines Initiative (IMI) announced today the launch of StemBANCC, a new academic–industry partnership that unites ten pharmaceutical companies and 23 academic institutions. Initiated and coordinated by Roche and managed by Oxford University, StemBANCC aims to use human induced pluripotent stem cells as research tools for drug discovery with the goal of using this ground-breaking new technology to develop human disease models and enhance drug development.

On Oct. 29, 2012, on the PANS Journal there is an article about Cartilage tissue engineering using differentiated and purified induced pluripotent stem cells.

On Oct. 4, 2012, on Cell Stem Cell, there is a report with the title be Genome Sequencing of Mouse Induced Pluripotent Stem Cells Reveals Retroelement Stability and Infrequent DNA Rearrangement during Reprogramming.

On Jan. 30, 2012, on the PANS Journal, there is a report about modeling hepatitis C virus infection using human induced pluripotent stem cells, which make the individual and tailor therapy further.

Above are only a small part of such studies. People still wonder does it is the moment or an abuse on the iPSCs research. When someone reviewed one of the winners, Shinya Yamanaka, about his opinion on the challenge of iPSCs research, he said, “I have two research directions, the first is to establish human iPSCs bank that comply with clinical application standards. The second is to study the cell mechanism of iPSCs regenerating. And I think the current threat is still to be the safety problem as good research respects both scientific and ethical standards.”

But no one deny the great potential of iPSCs.

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Sprint Bioscience Strengthens Its Cancer Metabolism Portfolio

Sprint Bioscience, a Swedish company developing oncology therapeutics targeting cancer metabolism, announced today that it has raised money to strengthen its drug discovery portfolio.

The investment by Första Entreprenörsfonden and Almi Invest will enable the company to continue to build a pipeline of drug discovery projects within cancer metabolism.

“We are investing in Sprint Bioscience because we consider their entrepreneurial drive and their particular skills in drug development to be key success factors for the changing environment of the future pharmaceutical industry. Sprint Bioscience’s business strategy involves out-licensing or collaborating at an early stage of drug discovery to ensure that projects are developed with a focus on current and relevant market needs,” says Rune Nordlander, partner at Första Entreprenörsfonden.

Sprint Bioscience is a company founded by experienced drug hunters with an ambition to improve the drug discovery process. “We believe in small organisations with effective working procedures and collaborations throughout the sector,” says the company’s CEO and co-founder, Dr. Anders Ã…berg.

“Sprint Bioscience has developed an efficient, fragment-based drug discovery (FBDD) platform that can take parallel projects from initial idea to active molecules tested in cell-based systems in a very short time” Anders Ã…berg continues. Our goal is to align the early phase in the laboratory with pharmaceutical companies’ needs.

Targeting the metabolism in tumours provides exciting opportunities to develop drug therapies with novel mechanisms of action. This could be used to overcome the resistance that many cancer cells develop to current treatments.

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GenQual Announces Initial Closing Of Its First Preferred Equity Funding Round

GenQual is pleased to announce initial closing of its first preferred equity round. Financial terms were not disclosed. This inaugural funding round allows GenQual to pursue proof-of-principle testing for its companion diagnostic approach for IL-6 mAb and other JAK/STAT inhibitors for autoimmune diseases and oncology indications. GenQual aims to prospectively identify responders for clinical-stage therapeutics to improve drug trial response rates and improve chances for drug approval. The round remains open for further funding.

GenQual Founder and CEO Jonathan Mirich said, “This funding round allows GenQual to pursue its business development goals to deliver companion diagnostics for very expensive IL-6 monoclonal antibody treatment for autoimmune disease, chiefly rheumatoid arthritis, as well as certain oncology indications. It allows us to extend collaborative agreements for proof-of-principle testing. We are very excited about the possibilities in this space.”

About GenQual
GenQual develops proprietary biomarker diagnostics for autoimmune and oncology indications. Our personalized medicine products are designed to facilitate early disease detection and diagnosis, and to improve treatment approaches at the molecular level. GenQual is a privately-held corporation based in the Seattle area.

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