Category Archives: Biotech Solutions

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

Austrianova Secures Significant Investment from Real Tech Fund

 

SINGAPORE, 2021-Jul-7 — /EPR BIOTECH NEWS/ — Austrianova (the SG Austria group, Austrianova Singapore and Austrianova Thailand) is pleased and honoured to announce that, after extensive due diligence, Real Tech Fund (managed by Real Tech Holdings, Japan) has invested an undisclosed seven figure amount in Austrianova via its Real Tech Global Fund 1 to accelerate Austrianova’s growth. Real Tech Fund is a venture capital firm that invests specifically in innovative deep-technology startups mainly in Japan and Southeast Asia. Austrianova was assisted in this transaction by Square Associates. The financing from Real Tech coincides with, as well as bolsters, the Company’s next stage of growth in production capacity in order to satisfy the strong demand witnessed across the wide variety of applications that its unique protective cell encapsulation technology addresses. It also enhances and facilitates Austrianova’s entry into the Japanese market and specifically partnerships with clients benefiting from Austrianova’s Cell-ina-Box® and Bac-in-a-Box® technologies.

“We are pleased that Real Tech has decided to invest in Austrianova as well as that they are convinced of the value of the Cell-in-a-Box® and Bac-in-a-Box® technologies for solving serious problems faced by the planet and by humanity” stated Walter H Gunzburg, Chairman of Austrianova. “Real Tech already has proven to be a valued partner as well as a significant investor in Austrianova and we look forward to working closely together in the future” added Brian Salmons, CEO of Austrianova.

 

About Austrianova
Austrianova (the SG Austria Group), is a biotech company with a global footprint and operations in Singapore and Thailand. 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 as well as rebalancing the microbiome due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, enzymes, recombinant proteins, exosomes etc).

About Real Tech
Real Tech Holdings / Real Tech Fund is a joint venture fund between euglena Co.,Ltd and Leave a Nest Co., Ltd.  It supports change makers who give their heart and soul to solve societal and environmental challenges. Real Tech Holding’s manages Real Tech Fund, Japan’s leading deep-tech focused venture capital fund.
For more information: https://www.realtech.holdings

Forward-Looking Statements
This release includes forward-looking statements regarding Austrianova (the Company) and its respective businesses. Such statements are based on the current expectations of the management of each entity. The forward-looking events and circumstances discussed in this release, including completion of the public offering, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks affecting the Company, economic factors and the equity markets generally. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Austrianova undertakes no obligation to publicly update or revise any forwardlooking statement, whether as a result of new information, future events, or otherwise. This is not an offer or solicitation to buy or sell any securities.

Financial Information Contact: pierre.faddoul@square-associates.com
Company and Technology Contact: salmons@sgaustria.com
For more information: http://www.austrianova.com

SOURCE Austrianova

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

Complete protection of probiotics from destruction by stomach acid using Bac-in-a-Box technology

SINGAPORE, 2020-Nov-30 — /EPR BIOTECH NEWS/ — Austrianova announced today that a key publication on the ability of its patented technology, Bac-in-a-Box®, to completely protect probiotics from acidic conditions found in the stomach has been published in the well respected journal “Microbial Cell Factories”
https://rdcu.be/cbn0O.

Stomach acid is nature’s way of ensuring that any microbes in food are killed before they reach the intestines. In the same way, stomach acid is also a formidable barrier to the delivery of beneficial bacteria and yeast such as probiotics to the gut, necessitating the current million times “overdosing” of such bacteria. Even then, only a tiny fraction of probiotics survive transit through the stomach. The currently available protections and coatings are only partially effective and still result in the loss of millions of bacteria and the search is still on for novel protective agents and technologies to improve on this.

The stringently reviewed data presented in Austrianova’s Microbial Cell Factories paper show that Bac-in-a-Box® protects living micro-organisms (including probiotics) from stomach acid and bile, enabling them to reach the intestine in a viable state, thereby resulting in a greater beneficial effect. It also allows the use of ten thousand times lower doses, contributing to cost effectivity. Thus, Bac-in-a-Box® is ideal for enhanced and effective delivery of probiotics as well as of oral living vaccines, and it can even be used for microbial fecal transplantation (FMT or bacteriotherapy) where it provides a more patient friendly and acceptable means of delivering stool microbiota.

Brian Salmons, CEO of Austrianova, said “We are pleased that our publication on acid protection of encapsulated microbes has been published in Microbial Cell Factories, an open access, peer-reviewed journal, published by Springer Nature, that is the world leading, primary research journal fully focusing on Applied Microbiology.”

Elaborating on the significance of the paper, Prof. Walter H. Gunzburg said “The gut microbiota in humans and animals plays a key role in health by aiding digestion as well as regulating the immune system and protecting against disease causing pathogens. In recent years, changes or imbalances in the gut microbiota (dysbiosis) have been linked to many diseases as disparate as irritable bowel syndrome, dementia and diabetes, and evidence is
growing that restoring the balance of the microbiota by delivery of probiotic microorganisms can improve health. Orally delivered micro-organisms must survive transit through lethal, highly acid conditions in the stomach and current methods to protect probiotic microorganisms are still not effective enough. This paper reports that Austrianova’s proprietary encapsulation technology, Bac-in-a-Box®, protects members of the microbiota from stomach acid and bile. A number of probiotic strains were shown to survive low pH in vitro for at least 4 hours without appreciable loss in viability as compared to their respective non-encapsulated counterparts. Moreover, animal studies reveals that once the capsules arrive in the intestine (the site where they are needed to have beneficial effects), the probiotics are released and colonize the intestinal tract. Thus, Bac-in-a-Box® protects bacteria and yeasts from viability losses due to stomach acid, allowing the use of lower oral doses of probiotics and microbiota, whilst ensuring good intestinal delivery and release.”

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 to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, recombinant proteins etc).

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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

Cells for Cells and Austrianova announce publication on novel method to produce stem cell exosomes

SINGAPORE, 2020-May-22 — /EPR BIOTECH NEWS/ — Austrianova and Cells for Cells have just jointly published a ground breaking, peer reviewed, scientific publication on a novel, cost and time-saving method to generate extra-cellular vesicles (EVs) from encapsulated Mesenchymal Stem Cells (MSCs). These EVs are known to mediate many of the therapeutic effects of stem cells. The authors show that Austrianova’s proprietary Cell-in-a-Box encapsulation technology can be used to produce and deliver EVs from encapsulated MSC’s, as demonstrated using Cells for Cells proprietary MSCs.  The publication, which was co-authored with their academic partners, the University of the Andes, Chile and the University of Veterinary Medicine Vienna, Austria appeared in prestigious international journal “Frontiers in Pharmacology” (Front. Pharmacol., 21 May 2020 | https://doi.org/10.3389/fphar.2020.00679   https://www.frontiersin.org/articles/10.3389/fphar.2020.00679/full)

Currently, EVs have to be purified from cell culture conditioned media using tedious, costly and time-consuming protocols that are difficult to perform under Good Manufacturing Practices (GMP) conditions. The Cell-in-a-BoxÒ encapsulation technology allows efficient enrichment of EVs at high concentration since they are released from the encapsulated cells via the semipermeable pores, which selectively enable the release of small particles but not of the MSCs. Moreover, Cell-in-a-BoxÒ provides 3D culture conditions for the MSCs. The technology can be used in cell culture allowing GMP production. Alternatively, the encapsulated cells can be implanted into patients as a retrievable delivery device that shields the cells from clearance, whilst they continuously produce EVs, growth factors, hormones and other small therapeutically relevant molecules. Moreover, the EVs produced after encapsulation can themselves be used as drug-loaded delivery vehicles. This technology will be invaluable for the treatment of regenerative diseases and Inflammatory disease.

Maroun Khoury, CSO of Cells for Cells said “this is a multifaceted project bringing together different expertise  to support the burgeoning field of EV-based therapies. It will be interesting to test in the near future, the continuous  release of EVs in a in vivo context. At a personal level, it was  a great way to stay connected with colleagues that I met while living in Singapore ”.

Brian Salmons, CEO of Austrianova said “we are pleased that these results representing the culmination of a long term project with our colleagues at Cells for Cells are finally publicly available. The encapsulation of stem cells as a means to produce exosomes using our Cell-in-a-BoxÒ is an exciting technological breakthrough that is applicable for all stem cell types.”

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 to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, recombinant proteins etc).

About Cells for Cells

Cells for Cells is a Chilean biotechnological company dedicated to the research, development and commercialization of innovative cellular therapies, complying with high standards of scientific, technological and international quality, through manufacturing processes certified under ISO 9001: 2015. Each therapy is produced in our labs with GMP standards, being the first biotech company, with such high-quality standards at Latin American level. Our therapies are applied by duly certified specialists.

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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.”

Via EPR Network
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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.

Via EPR Network
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Global leader in flexible containment solutions ILC Dover expands its Irish production footprint by opening a location in Blarney, County Cork, Ireland

FREDERICA, DE, USA, 01-Nov-2018 — /EPR BIOTECH NEWS/ — ILC Dover, a global leader in flexible containment solutions for the pharmaceutical and biopharmaceutical industry is expanding its Irish production footprint by opening a location in Blarney, County Cork, Ireland.

The building will be operational in the first quarter of 2019 and outfitted with 4,000 square feet of

ISO 7 clean room capacity and 6,500 square feet of Class 8, both dedicated to the company’s pharmaceutical and biopharmaceutical product lines. When at full production, the company expects to hire 60-70 new ILC Dover employees. The company’s original operation in County Cork will be relocated to the Blarney site as part of the expansion project.

ILC Dover President and CEO Fran DiNuzzo expressed enthusiasm about the new launch: “The expansion of our production capabilities in Ireland will allow us to better serve our global customer base and strengthen our position as the leading single-use powder handling solutions provider to the global pharmaceutical and biopharmaceutical marketplace.”

In addition to production space, the new facility will contain state-of-the-art offices, meeting rooms and a product demonstration area for client visits. Curtis Gingles, Vice President and General Manager of the company’s Pharmaceutical Division, added, “Clients of ILC Dover will be happy to see that we’re focused on providing additional capacity located in the region with expanded technical resources. The market for our products is experiencing incredible growth and this expansion will ensure we can keep up with the growing demand for the high-quality products used in manufacturing lifesaving therapies.”

SOURCE: EuropaWire

Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence

LJUBLJANA, Slovenia, 21-Sep-2018 — /EPR BIOTECH NEWS/ — The latest study published in the World Journal of Urology (Comparison between erbium‑doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence – https://doi.org/10.1007/s00345-018-2445-x) provides further confirmation that Fotona SMOOTH® laser technology is a safe, effective and minimally-invasive solution for stress and mixed urinary incontinence (SUI and MUI). The article, written by Dr. Nobuo Okui, compares Fotona’s minimally invasive IncontiLase® Er:YAG laser therapy with the more conventional TVT and TOT surgical sling procedures.

Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence

In the study performed by Dr. Okui, 50 Japanese women were treated either surgically (tension-free vaginal tape – TVT or transobturator tape – TOT) or with a Fotona laser. The 1-h pad test, ICIQ-SF, and overactive bladder-symptom score were used to assess the patients before and 12 months after treatment. Laser therapy was performed by first applying a local anesthetic to the vaginal wall and then inserting a probe into the vagina. Laser irradiation was performed for 20 min with an Er:YAG wavelength of 2940 nm (Dynamis XS, Fotona) for a total of three treatments (alternating every month). Results of the 1-h pad test and ICIQ-SF showed comparable improvements in SUI in the sling and laser therapy groups, while some of the patients with MUI in the TVT and TOT groups showed exacerbation. In conclusion, the TVT and TOT procedures and the laser therapy are comparable for SUI; however, laser therapy is superior in terms of MUI and complications. The study thus once again confirms the safety and efficacy of Fotona SMOOTH® laser therapy for urinary incontinence.

Urinary Incontinence Treatment Options

Conventional treatment options for urinary incontinence are surgical, and include TVT or TOT sling procedures, which involve inserting a synthetic material. Problems often arise with artificial meshes that require new treatment methods. With the Fotona SMOOTH® Er:YAG laser thermotherapy (also known as IncontiLase®), the goal is to provide a minimally invasive therapy based on vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, which results in overall regeneration of aged or stressed vaginal tissues and subsequently greater support to the bladder.

Unique Fotona SMOOTH® Technology for Maximum Safety

Patient safety is the primary concern and, for this reason, the patented Fotona SMOOTH® technology holds a very unique position within the spectrum of gynecological treatment options. It is a non-surgical procedure (no incisions) and without implants or appliances. The Fotona SMOOTH® method of dual-tissue regeneration is completely non-ablative and therefore minimally invasive to the vaginal wall. The treatment involves an additional superficial heat-shocking mechanism of tissue regeneration, and a unique self-regulating safety feature. These dual-tissue regeneration characteristics of the Fotona SMOOTH® Er:YAG laser allow for an exceptionally high degree of safety and efficacy in thermotherapy of the vaginal wall. This is what makes Fotona SMOOTH® a significantly safer alternative to many widely used and more-invasive procedures.

Evidence-Based Laser Medicine

Over the past few years numerous (over 35) other studies on Fotona SMOOTH® laser therapy have been published by distinguished gynecologists from around the globe in some of the most trusted and renowned international scientific journals, all with favorable results (https://www.laserandhealthacademy.com/en/practitioners/recommended-reading/gynecology/). One such noteworthy clinical paper published in March 2018 by Dr. Adolf Lukanovic and Dr. Mija Blaganje is the first randomized controlled trial study (on 114 premenopausal parous women) to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative non-invasive treatment of SUI and the improvement of sexual gratification (published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018 (224): 153-158). The results from this study indicate that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo.

In another Asian study, Dr. Yi-Wen Tien et al. from the Chang-Hua Hospital in Taiwan examined the effects of laser treatment for female SUI on pad weight, urodynamics, and sexual function in 35 women (published in the International Urogynecology Journal. 2017; 28(3): 469-476). The study reveals that the effect of IncontiLase® treatment for mild SUI was moderate at the 6-month follow-up. Moreover, it improved LUTS, quality of life, and the sexual function of both partners. The authors conclude that the IntimaLase® procedure is very effective in the treatment of SUI and is not associated with any severe adverse effects.

Similarly, Dr. Yi-Hao Lin et al. from the Chang Gung Memorial Hospital in Taiwan obtained favorable results. Their study investigated the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, SUI and sexual function in 30 women with urodynamic stress incontinence (published in the Taiwanese Journal of Obstetrics & Gynecology. 2017 (56): 815-820). The results showed that IncontiLase® treatment can resolve SUI and coexistent OAB symptoms three months after therapy, while repeated laser therapy may be necessary after six months. The results also revealed that sexual gratification improved, while no major adverse effects were noticed.

The quantity and quality of the studies performed with Fotona SMOOTH® laser therapy is such that Fotona’s Dynamis has been cleared in the European Union for SUI (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause – GSM (RenovaLase®) and pelvic organ prolapse (ProlapLase®), giving women the option to choose a safer and less-invasive treatment alternative. In Asia, the Taiwan Food and Drug Administration has already cleared Fotona Dynamis for mild to moderate SUI, and the Singapore Health Sciences Authority has cleared the Dynamis for the treatment of SUI and GSM.

SOURCE: EuropaWire

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

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

 

VTU Technology and Research Corporation Technologies (RCT) entered into a development and commercialization agreement

VTU Technology to offer unique combination of technologies for the high-level production of proteins with human-like glycosylation using Pichia GlycoSwitch®

Tucson, Arizona and Grambach, Austria, December 03, 2014 — /EPR BIOTECH NEWS/ — VTU Technology and Research Corporation Technologies (RCT) announced today that they have entered into a development and commercialization agreement for VTU to combine both companies´ Pichia pastoris protein production technologies. Pichia GlycoSwitch® – a new expression system for the production of glycoproteins with human-like glycosylation patterns – and VTU´s yield enhancing Pichia pastoris expression platform are now available in one package from VTU. This unique combination of technologies acting synergistically is of great benefit for customers as it leads to a high performance production platform for recombinant glycoproteins with superior product yields and uniform Man5 – or other human-like glycoforms.

Under the terms of the agreement, RCT grants VTU Technology access to RCT´s Pichia GlycoSwitch® expression system for combination with VTU´s in-house high-yielding Pichia platform featuring different proprietary technologies such as AOX1 promoter libraries suited for both methanol-induced and methanol-free production. VTU Technology is now offering the combined technology suite as part of the company´s expression strain and corresponding bioprocess development contract services portfolio.

“We are delighted to offer Pichia GlycoSwitch® engineered with our broad portfolio of Pichia tools in this partnership with RCT and I am convinced that our yield enhancing technologies will give GlycoSwitch® an exciting extra edge for the production of glycoproteins with Man5 – or other human-like glycoforms”, states Thomas Purkarthofer, Ph.D., Head of Business Development of VTU Technology.

“Our partnership with VTU Technology brings together two technologies that will enable customers to uniquely tailor the glycosylation of their target protein and explore new biological functions. We are looking forward to working with VTU Technology to expand the potential of proteins manufactured in Pichia GlycoSwitch®”, states Kurt R. Gehlsen, Ph.D., Vice President and CSO of Research Corporation Technologies, Inc.

About Pichia

Pichia pastoris is a yeast widely used for recombinant protein expression. As a microbial eukaryotic organism, Pichia combines the post-translational modification systems similar to those found in mammalian cells, with the ease of use/manipulation of E. coli. Decades of processes development have been focused on efficiently growing Pichia to extremely high cell densities; and multiple generations of molecular biology tools have been created to engineer strains to produce tens of grams/liters of a recombinant protein product. Pichia can secrete high levels of properly folded, functional proteins into a simple, defined medium for easy purification. There have been more than 20,000 publications on the use of Pichia for the production of more than 5,000 proteins, with more than 70 products manufactured in Pichia on the market today. Pichia products include enzymes manufactured in 200,000-liter fermenters and two FDA-approved therapeutics.

Pichia GlycoSwitch® is a recombinant protein expression system that broadens Pichia’s applications to glycoproteins where N-linked glycosylation is important for biological function. Pichia GlycoSwitch® offers researchers the ability to control the glycosylation (sugar addition) of recombinant glycoproteins and explore the role of protein glycosylation and various glycan structures on protein function. Pichia´s typical high-mannose glycan patterns can also be eliminated to reduce immunogenicity caused by the unwanted hyperglycosylation. The Pichia GlycoSwitch® system consists of patents, strains and vectors that are useful for making proteins with a number of different human-like glycoforms.

For additional information about Pichia, please visit www.pichia.com.

About VTU Technology

VTU Technology, a leading contract research and development company, offers the broadest toolbox and most versatile technology platform available for Pichia pastoris recombinant protein expression / production enabling highest productivities delivering up to 22 g/L of secreted protein within a few weeks development time. VTU Technology´s powerful Pichia pastoris protein expression technology is based on its optimized gene design and cloning strategies, proprietary AOX1 promoter libraries & in-house expression platform and high-throughput screening & cultivation regime, combined with excellent know-how in fermentation and downstream process development.

Headquartered in Grambach/Graz, Austria, VTU Technology is a private company and a subsidiary of VTU Holding, an Austrian enterprise that combines several technology and engineering companies in chemistry, pharma & life science as well as power and fuel industry. For additional information about VTU Technology, please visit www.vtu-technology.com.

About RCT

RCT is a Tucson, Ariz.-based technology investment and management company that provides early-stage funding and development for promising biomedical companies and technologies. RCT focuses on technology investments with origins from universities and research institutions worldwide. RCT’s technology portfolio includes platforms and tools that support the discovery, development and manufacturing of therapeutics. Current platform technologies include Pichia and E.coli protein expression systems and novel protein binding scaffolds. To learn more about RCT, see www.rctech.com and www.pichia.com.

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VTU Technology and RCT announce partnership
VTU Technology and RCT announce partnership

RCT Color logo
RCT Color logo

VTU technology rgb
VTU technology rgb

For more information

Thomas Purkarthofer, Ph.D.
VTU Technology GmbH
Phone: +43 316 4009 4017
Email: thomas.purkarthofer@vtu.com

Kurt R. Gehlsen, Ph.D.
Research Corporation Technologies
Phone: 520-748-4460
Email: kgehlsen@rctech.com

ViroCarb’s anti HIV Crowd Funding Campaign

Toronto, Canada, December 01, 2014 — /EPR BIOTECH NEWS/ — ViroCarb Inc. has launched a worldwide crowd funding campaign to promote the development of its new HIV infection inhibitor.

WORLD AIDS DAY – Make a donation to save lives from AIDS! Support new treatment development at: https://www.indiegogo.com/projects/funding-a-new-therapy-against-drug-resistant-hiv/x/9240077

Despite the great progress made in HIV/AIDS treatment, there is still an urgent need for new drugs, particularly for people who have had to abandon existing treatments due to HIV drug resistance and side effects.

The current treatment of HIV/AIDS involves the use of three or more drugs from five main general classes, used in combination. While this antiretroviral therapy (ART) has helped to reduced morbidity and mortality from AIDS, long term toxicity and the emergence and transmission of drug resistant HIV strains limit the effectiveness. Thus, despite therapy which can render this a chronic, rather than acute fatal infection, development of new drugs to prevent infection and overcome drug resistant strains, is increasingly urgent.

ViroCarb Inc. is developing a novel technology that addresses infections by drug resistant HIV strains. Developed from the identification of a new, natural resistance factor against HIV infection by scientists at SickKids and Canadian Blood Services, ViroCarb’s inhibitor works against a previously overlooked target on the virus to block HIV from entering human cells, the very first step in the infection. It works against all HIV strains.

Funds are needed to aid in moving forward to support preclinical studies; therefore ViroCarb Inc. has started an international crown funding campaign to carry out these HIV model studies needed before conducting clinical trials.
Please support this new way to block HIV.

Contact-Details: Dr. Mario Huesca
479 Simonston Boulevard.
Thornhill ON.
L3T 4M4 Canada

Facebook: https://www.facebook.com/ViroCarb;
Website: http://www.virocarb.com

 

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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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Axcellerate Pharma, New Jersey aims to become a market leader in high-value, niche offerings to the US life sciences industry

Axcellerate Pharma establishes CMO/CRO and API manufacturing facility in New Jersey, US. Focus will be small molecule and biologics PR&D, innovative technology platforms, filling vial and bag operations, peptide synthesis, oligonucleotide production and related areas.

Axcellerate Pharma LLC (“Axcellerate”) is a JV set up by TCG Lifesciences USA LLC, an affiliate of TCG Lifesciences Limited, a leading CRO engaged in drug development and clinical trial services; with Dilip Mehta, Founder & CEO of PANORAMA Consulting and Engineering, Inc., a leading developer of lab scale to GMP manufacturing facilities; and Alfagen Pharma LLC, an affiliate of AlfaGene Bioscience, Inc., an innovative biotechnology company. The facility houses state-of-the-art technology/equipment/ infrastructure and is supported by leading industry personnel from each of the partner firms.

“We will initially target specialized CMC and CMO activities that are time sensitive and high value in nature, that are desirable to be located geographically close to our clients. Axcellerate intends to leverage the strong scientific talent pool, end-to-end capabilities and PR&D/intermediate production facilities of TCG Lifesciences Limited in India to support its operations. This opportunity represents another significant milestone for TCG Lifesciences’ continued expansion,” commented Swapan Bhattacharya, Managing Director of TCG Lifesciences “as this strategic alliance will expand TCG Lifesciences’ geographic footprint and enable us to service clients in the US with a local presence while being supported globally”.

Dilip Mehta, CEO and co-founder of Axcellerate commented “we will engineer the facilities to provide the highest level of efficiency, technology and cost effectiveness to our customers, given PANORAMA’s broad involvement and experience in all facets of the pharma/biotech sector. We are pleased to join hands with TCG Lifesciences, who will bring in the scientific and technical know how and expertise in the cutting edge areas of drug discovery and development.”

“AlfaGene Bioscience has developed proprietary assay platforms in a range of therapeutic indications and has a scientific team with extensive experience in biologics and biomedical research. We also have a network of global relationships in the API arena to bring to bear for the success of Axcellerate”, remarked Mayur Doshi, President and CEO, AlfaGene Bioscience.

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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.”

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