EPI

AzurRx BioPharma Announces Positive Results from Independent Data Monitoring Committee Review of Safety Data from Part 1 of RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Donnerstag, September 9, 2021

BOCA RATON, Fla., Sept. 09, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that an independent data monitoring committee (DMC) approved initiating patient enrollment in Part 2 of the ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-1022 is a proprietary, oral, tablet formulation of micronized niclosamide developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.

Key Points: 
  • The committees recommendation followed its review of safety data collected from 9 patients enrolled in Part 1 of the RESERVOIR trial.
  • James Sapirstein, President and CEO of AzurRx BioPharma, stated, We greatly appreciate the thoughtful analysis and guidance provided by the DMC following its review of the data from Part 1 of the RESERVOIR trial.
  • Consistent with our expectations, the early safety data supports the continued exploration of FW-1022 and the committee has recommended that we continue to Part 2 of the trial without modification.
  • Patients enrolled in Part 2 of the study will be chosen randomly to receive either niclosamide or a placebo.

AzurRx BioPharma to Present at the Virtual H.C. Wainwright 23rd Annual Global Investment Conference

Retrieved on: 
Dienstag, September 7, 2021

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Key Points: 
  • AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • The Company has a pipeline of two gut-restricted GI assets in three clinical indications.
  • The lead therapeutic candidate is MS1819, a recombinant lipase developed for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.
  • This press release may contain certain statements relating to future results which are forward-looking statements.

DGAP-News: ​​​​​​​New study in the BMC Cancer journal shows that Epi proColon(R) is an effective method to increase CRC screening rates in medically underserved populations

Retrieved on: 
Donnerstag, September 2, 2021
Colonoscopy, CRC, Death, Blood, Cancer, 970, AG, Incidence, Liver cancer, Communication, OTCQX, Insurance, MUP, DNA, Food, CE marking, Marketing, ECX, Email, Epigenomics AG, Mortality, FIT, Patient, CEO, DGAP, EPI, Colorectal cancer, FDA, BMC Cancer, News, Technology, 460, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Security (finance), Pharmaceutical industry

Greg Hamilton, CEO of Epigenomics AG, commented: "CRC still is the second leading cause of cancer mortality in the U.S., despite the ability to reduce it through screening.

Key Points: 
  • Greg Hamilton, CEO of Epigenomics AG, commented: "CRC still is the second leading cause of cancer mortality in the U.S., despite the ability to reduce it through screening.
  • Adherence to regular screening is key to earlier CRC detection thus reducing incidence and mortality.
  • In the U.S., many people are not up-to-date with CRC screening despite the available testing, with overall screening rates under 70%.
  • In the study, the patients were consecutively offered CRC screening by colonoscopy and FIT, according to the current guidelines for CRC screening.

$ 2.75 Bn Growth Opportunity in Epi Wafer Market 2021-2025 | Analysis of 25+ Companies | 17,000+ Technavio Research Reports

Retrieved on: 
Montag, August 30, 2021
CAGR, LED, Information technology, Growth, Geography, Adoption, ICS, MEMS, MEA, Application, IDMS, Light-emitting diode, EPI, USD, Applied Materials, Semiconductor

NEW YORK, Aug. 30, 2021 /PRNewswire/ -- A new market research report on the global Epi wafer market has been released by Technavio.

Key Points: 
  • NEW YORK, Aug. 30, 2021 /PRNewswire/ -- A new market research report on the global Epi wafer market has been released by Technavio.
  • Segmentation by Geography:The Epi wafer market size is analyzed across APAC, Europe, North America, South America, and MEA.
  • APAC is currently the largest market for Epi wafer and the region is expected to retain its position over the forecast period.
  • The global Epi wafer market is driven by the use of epitaxial deposition to improve the performance of devices.

Harris Williams Advises Riggs Distler & Company, Inc. on its Sale to Centuri Group, Inc.

Retrieved on: 
Montag, August 30, 2021
Finance, Consulting, Other Energy, Utilities, Banking, Oil, Gas, Professional Services, Energy, Other Professional Services, Company, PNC, Financial Conduct Authority, Farringdon Road, City, Technology, Georgian Industrial Group, Ownership, Engineering, Maintenance, FINRA, Electric power infrastructure on Bornholm, EV, Registrar, Investment, NYSE, Oaktree Capital Management, Pacific Century Group, Safety, Harris Williams & Co., Solution, EPI, VAT-free imports from the Channel Islands, HRB, Sale, SIPC, Financial system, Oak Tree, Centuri, View, Financial services, Rail transport

Riggs Distler is a leading provider of power and utility services throughout the Northeast and Mid-Atlantic regions of the United States.

Key Points: 
  • Riggs Distler is a leading provider of power and utility services throughout the Northeast and Mid-Atlantic regions of the United States.
  • Under the terms of the transaction, Centuri acquired a 100% ownership interest in Riggs Distler for $855 million.
  • Riggs Distler, based in Cherry Hill, New Jersey, is one of the largest utility contractors in the Northeast and Mid-Atlantic regions of the United States.
  • Harris Williams is a trade name under which Harris Williams LLC, Harris Williams & Co. Ltd and Harris Williams & Co. Corporate Finance Advisors GmbH conduct business.

DGAP-News: Epigenomics AG: Securities prospectus for the issuance of a mandatory convertible bond in the amount of up to EUR 16.5 million approved by BaFin

Retrieved on: 
Dienstag, August 24, 2021
Company, FSE, Results of the 2009 German federal election, AMERICA, Federal republic, Cancer, NOT, 970, AG, Trial of the century, Liver cancer, OTCQX, Acquisition, Epigenomics AG, DNA, EUR, Food, Person, CE marking, Marketing, Securities Act of 1933, ECX, Regulation, Email, Clinical trial, Prospectus, Hamburg Stock Exchange, DGAP, Publication, Sale, EPI, FDA, Colorectal cancer, News, Physikalisch-Technische Bundesanstalt, Technology, Regulation of tobacco by the U.S. Food and Drug Administration, Security (finance), Animal, Dietary supplement

The mandatory convertible bond consists of up to 165,000 notes with a nominal amount of EUR 100.00 each, which will initially be offered to the existing shareholders of Epigenomics AG by means of a rights offering.

Key Points: 
  • The mandatory convertible bond consists of up to 165,000 notes with a nominal amount of EUR 100.00 each, which will initially be offered to the existing shareholders of Epigenomics AG by means of a rights offering.
  • The rights offering is published on the Company's website ( https://www.epigenomics.com/news-investors/convertible-bonds-2027/ ) and is expected to be published in the German Federal Gazette on August 26, 2021.
  • Potential investors in partial bonds of the mandatory convertible bond 2021/2027 of Epigenomics AG are requested to inform themselves about such restrictions and to comply with them.
  • Any violation of these restrictions may constitute a violation of securities laws of certain countries, in particular the United States.

AzurRx BioPharma Announces Positive Topline Data For Phase 2 MS1819 Combination Therapy Trial in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency (EPI)

Retrieved on: 
Mittwoch, August 18, 2021
Company, Hand, CF, Standard of care, AES, Quality of life, Steatorrhea, Body mass index, U.S. Securities and Exchange Commission, Yarrowia, Incidence, GLOBE, CFA, Survival, Șaeș, Human, Cystic fibrosis, Absorption, Defecation, Malnutrition, Exocrine pancreatic insufficiency, Weight gain, Nutrient, Clinical trial, Niclosamide, NASDAQ, Safety, Cystic Fibrosis Foundation, CP, Patient, PERT, Coefficient, Diarrhea, CEO, EPI, Biopharma LLC, BOCA, Weight loss, COVID-19, Security (finance), Pharmaceutical industry, Medical imaging, Fertilizer

Topline data clearly show that combining MS1819 to the daily dose of PERT had clinical benefits for all patients and improved quality of life.

Key Points: 
  • Topline data clearly show that combining MS1819 to the daily dose of PERT had clinical benefits for all patients and improved quality of life.
  • Roughly 25% to 30% of refractory cystic fibrosis patients with severe EPI are unable to achieve adequate nutrition using PERT alone.
  • MS1819 is a recombinant lipase enzyme that is being developed for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.
  • The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.

AzurRx BioPharma Announces WHO Publication of “Adrulipase Alfa” as International Nonproprietary Name for MS1819

Retrieved on: 
Dienstag, August 17, 2021
Company, Standard of care, U.S. Securities and Exchange Commission, Technology, Yarrowia, GLOBE, International, INN, World Health Organization, Cystic fibrosis, Pharmacist, World, Exocrine pancreatic insufficiency, Nutrient, International nonproprietary name, Clinical trial, Niclosamide, NASDAQ, WHO, Cystic Fibrosis Foundation, Patient, PERT, Diarrhea, CEO, EPI, Biopharma LLC, Steatorrhea, BOCA, Weight loss, COVID-19, Security (finance), Pharmaceutical industry

The assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology, said James Sapirstein, President and CEO of AzurRx.

Key Points: 
  • The assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology, said James Sapirstein, President and CEO of AzurRx.
  • AzurRx is pursuing parallel monotherapy and combination therapy clinical pathways with MS1819.
  • The WHO is expected to render a final decision on the use of adrulipase alfa for MS1819 by November 2021.
  • AzurRx BioPharma, Inc. ( NASDAQ: AZRX ) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

AzurRx BioPharma Announces Appointment of Terry Coelho to its Board of Directors

Retrieved on: 
Montag, August 16, 2021
NASDAQ, MBA, Graduate School of Economics and International Relations, U.S. Securities and Exchange Commission, Arbutus Biopharma, Novartis, Committee, Niclosamide, DC, Mars, Clinical trial, CEO, Achievement, IBMEC, Company, American University School of International Service, Bachelor, COVID-19, International Service for the Acquisition of Agri-biotech Applications, GLOBE, EPI, Exocrine pancreatic insufficiency, Nature, Security (finance), Patient, Board, Growth, Sealed Air, Executive, Board of directors, BCPC, Knowledge, Diarrhea, Cystic fibrosis, BOCA, International relations, Management, Pharmaceutical industry

BOCA RATON, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (AzurRx or the Company) ( NASDAQ: AZRX ), a company specializing in the development of targeted non-systemic, therapies forgastrointestinal (GI) diseases, today announced the appointment of Terry Coelho to its Board of Directors effective immediately.

Key Points: 
  • BOCA RATON, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (AzurRx or the Company) ( NASDAQ: AZRX ), a company specializing in the development of targeted non-systemic, therapies forgastrointestinal (GI) diseases, today announced the appointment of Terry Coelho to its Board of Directors effective immediately.
  • Terry brings to AzurRx unrivaled financial and operational experience, which will be critical to our growth and long-term success.
  • On behalf of the Board, I am pleased to welcome Terry to AzurRx and look forward to benefitting from her knowledge and expertise.
  • I am honored to be joining the Board of AzurRx BioPharma, said Ms. Coelho.

AzurRx BioPharma Completes Initial Cohort Enrollment into Part 1 of its RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Donnerstag, August 12, 2021
EPI, SARS2, Niclosamide, Gastrointestinal disease, Institut Pasteur Korea, Infection, World, Recurrence, GLOBE, Security (finance), COVID, FDA, Safety, DMC, PCR, Vaccine, BOCA, Patient, NASDAQ, CEO, Cystic fibrosis, Gastrointestinal tract, Diarrhea, Food, Viral load, Clinical trial, Abdominal pain, U.S. Securities and Exchange Commission, Severe acute respiratory syndrome coronavirus 2, Part Two, Tablet, Company, Vomiting, Observation, Research, Part, Biopharma LLC, GI, World Health Organization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, WHO, Review, COVID-19, Disease, Exocrine pancreatic insufficiency, Data monitoring committee, Pharmaceutical industry

FW-1022 is a proprietary oral tablet formulation of micronized niclosamide for the treatment of COVID-19-related GI infections.

Key Points: 
  • FW-1022 is a proprietary oral tablet formulation of micronized niclosamide for the treatment of COVID-19-related GI infections.
  • Successful DMC review will then trigger enrollment into Part 2 of the trial, focused on demonstrating efficacy and extending safety observations.
  • The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study.
  • The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of niclosamide in patients with COVID-19 Gastrointestinal Infection.