ESLD

Ocelot Bio Receives FDA Orphan Drug Designation for OCE-205 for the Treatment of Ascites

Retrieved on: 
수요일, 12월 20, 2023
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Peritoneal cavity, Ascites, Food, Cirrhosis, Orphan, Cancer, Abdomen, Patient, Diagnosis, Therapy, ESLD, Hepatorenal syndrome, Pharmaceutical industry

“The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio.

Key Points: 
  • “The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio.
  • The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.
  • Orphan Drug Designation provides Ocelot Bio certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.
  • This is the second Orphan Drug Designation for OCE-205, which previously received the designation in hepatorenal syndrome.

Ocelot Bio Appoints Lise Kjems, M.D., Ph.D., as Chief Medical Officer

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화요일, 4월 18, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, Endocrinology, University, Therapy, Liver disease, Bio, Intarcia Therapeutics, Physiology, Multimedia, Biliary atresia, ESLD, Cirrhosis, EMA, Acute kidney injury, Hepatorenal syndrome, Novartis, Patient, Ocelot, Novo Nordisk, Ascites, Johnson & Johnson, Alagille syndrome, FDA, Cyclo, PFIC, Autoimmunity, Safety, Ionis Pharmaceuticals, Pharmaceutical industry

Dr. Kjems succeeds founding chief scientific & medical officer, Stan Bukofzer, M.D., who will provide continued guidance to Ocelot Bio as a Strategic Advisor.

Key Points: 
  • Dr. Kjems succeeds founding chief scientific & medical officer, Stan Bukofzer, M.D., who will provide continued guidance to Ocelot Bio as a Strategic Advisor.
  • View the full release here: https://www.businesswire.com/news/home/20230418005491/en/
    Ocelot Bio Appoints Lise Kjems, M.D., Ph.D., as Chief Medical Officer (Photo: Business Wire)
    “Dr.
  • “I am thrilled to welcome Dr. Kjems to the role of chief medical officer and am confident that her depth of experience leading successful clinical programs will add incredible value to the Ocelot Bio team.
  • Prior to joining Ocelot Bio, Dr. Kjems was the chief medical officer at Cyclo Therapeutics where she led its global program evaluating Trappsol® Cyclo™ in Alzheimer’s and rare disease.

Three NexCore Group developments named 2022 HREI Insights Award™ Finalists

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금요일, 2월 3, 2023
Doctor, Science, Healthcare real estate, Physician, Garden, Patient, Real estate, ESLD, Ageing, Anxiety, PORT, Health, MOB, Foot, Gallery, Mob, Nursing, Hospital

DENVER; HOUSTON; PORT ORANGE, Fla., Feb. 2, 2023 /PRNewswire-PRWeb/ -- Two healthcare facilities and one seniors housing community developed by NexCore Group, a national healthcare real estate investment and development company that focuses on purpose-built care facilities for healthcare, seniors housing, and science and technology, have been honored as Finalists in the Healthcare Real Estate Insights (HREI) magazine's annual awards program. Headquartered in Denver, NexCore developed the projects in Houston, Port Orange, and Livonia, a suburb of Detroit.

Key Points: 
  • Headquartered in Denver, NexCore developed the projects in Houston, Port Orange, and Livonia, a suburb of Detroit.
  • Jarrod Daddis, President of NexCore, remarked, "NexCore is pleased to once again be acknowledged by HREI with three finalists this year.
  • The 2022 NexCore Group HREI Insights Awards Finalists are:
    As a Finalist in the "Best New Development, MOBs and Other Outpatient Facilities, More than 100,000 square feet" Category, Doctors' Pavilion is a four-story, 112,505 square foot Medical Office Building (MOB) in the Houston suburb of North Cypress, Texas.
  • NexCore is headquartered in Denver, with regional offices in Bethesda, Charlotte, Dallas, Detroit, Houston, Indianapolis, Los Angeles, Orlando, Phoenix, and Seattle.

Ocelot Bio Presents Phase 1 Data Highlighting Activity and Safety of OCE-205 at AASLD The Liver Meeting®

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금요일, 11월 4, 2022
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Therapy, Overload, Food, Portal hypertension, Liver, Șaeș, Publication, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Extrapyramidal system, Interest group, FDA, Ocelot, Hepatorenal syndrome, AES, Digital, Venrock, American Association for the Study of Liver Diseases, Poster, Vasoconstriction, AUC, Institute of Liver and Biliary Sciences, AASLD, Acute kidney injury, Nature, Ascites, Safety, Novel, Liver disease, Peritoneal cavity, Fatty liver disease, Bio, Ischemia, DVM, SIG, Cirrhosis, ESLD, Association, Patient, American Association, Pharmaceutical industry, Fine chemical, Cmax, Tolerability

Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional.

Key Points: 
  • Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional.
  • The Phase 1 data presented at AASLD provide valuable information that will inform our clinical development strategy for OCE-205.
  • These data support further clinical development of OCE-205 as a potential treatment for conditions such as HRS-AKI and ascites.
  • Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease.

Ocelot Bio to Present Data Highlighting Pharmacodynamic Activity and Safety of OCE-205 at AASLD The Liver Meeting®

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월요일, 10월 24, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Physician, Bio, Orphan, Therapy, Ocelot, Liver disease, Hepatorenal syndrome, Science, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Liver support system, Interest group, Venrock, Acute kidney injury, Fatty liver disease, Liver, Food, American Association, Association, Cirrhosis, Safety, Ascites, American Association for the Study of Liver Diseases, Digital, Institute of Liver and Biliary Sciences, SIG, ESLD, Portal hypertension, AASLD, Poster, Pharmaceutical industry, Tolerability

We look forward to this opportunity to present, for the first time, data from our Phase 1 trial that underscores the potential of OCE-205 to address these limitations.

Key Points: 
  • We look forward to this opportunity to present, for the first time, data from our Phase 1 trial that underscores the potential of OCE-205 to address these limitations.
  • The full poster presentation will also be made available to registered meeting attendees via The Liver Meeting Digital Experience within 72 hours of presentation, and the poster will be available online at Ocelot Bios website.
  • The company has received Orphan Drug Designation for OCE-205 in the treatment of hepatorenal syndrome from the U.S. Food and Drug Administration.
  • Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease.

Experience Senior Living community in Naples will meet need for housing in fast-growing city

Retrieved on: 
수요일, 9월 7, 2022
Ageing, ESLD, CO, Nursing, Retirement, Housing, Population, Gallery, ESL, Transport, Hotel

DENVER, Sept. 7, 2022 /PRNewswire/ -- Experience Senior Living (ESL) is creating communities with purpose across the U.S. and will soon break ground on a new luxury community in Naples, Fla. located at 8480 Rattlesnake Hammock Road. The Gallery at Naples is 169,327 square feet consisting of 158 homes with 125 assisted living apartments and 33 memory care suites for seniors. ESL plans to break ground in Q4 2022. 

Key Points: 
  • The Gallery at Naples is 169,327 square feet consisting of 158 homes with 125 assisted living apartments and 33 memory care suites for seniors.
  • "We are very intentional about the locations we select for Experience Senior Living developments," Phill Barklow, president of ESL , said.
  • Experience Senior Living is a full-service, vertically integrated owner-operator of active adult, independent living, assisted living, and memory care communities.
  • Experience Senior Living is based in Denver, CO with communities either active or under development in six states: California, Colorado, Florida, Indiana, Maryland, Ohio, Virginia, and Washington.

Ocelot Bio Receives FDA Orphan Drug Designation for OCE-205 for the Treatment of Hepatorenal Syndrome

Retrieved on: 
월요일, 8월 22, 2022
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Kidney failure, Mortality, Fatty liver disease, Safety, Blood, Cirrhosis, Vasoconstriction, Institute of Liver and Biliary Sciences, Degenerative disease, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American Association for the Study of Liver Diseases, Overload, Bio, AASLD, Ocelot, Food, Orphan, Diagnosis, Ascites, Acute kidney injury, Venrock, Liver disease, FDA, Therapy, Hepatorenal syndrome, Association, MOA, Patient, American Association, Pharmaceutical industry, ESLD

Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of hepatorenal syndrome.

Key Points: 
  • Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of hepatorenal syndrome.
  • Receiving Orphan Drug Designation for OCE-205 underscores the urgent unmet medical need for patients with hepatorenal syndrome, said Katherine Vega Stultz, president and chief executive officer at Ocelot Bio.
  • The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.
  • Orphan Drug Designation provides Ocelot Bio certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

Ocelot Bio Closes $36 Million Series A Financing, Appoints Katherine Vega Stultz as President and Chief Executive Officer

Retrieved on: 
수요일, 3월 23, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Disease, Fatty liver disease, Bio, Risk, Company, Treatment, Hepatorenal syndrome, Therapy, Institute of Liver and Biliary Sciences, Acute kidney injury, Allegretti, Death, Mortality, Global Burden of Disease Study, IND, Survival, Ocelot, Liver, Incidence, The New England Journal of Medicine, Ascites, Prevalence, Liver transplantation, Liver disease, Kidney transplantation, ESLD, Kidney failure, Hepatology, Kidney, RA, FDA, Eli Lilly and Company, Pharmaceutical industry, Hospital, Medicine, Nephrology, Patient, Cirrhosis, Venrock

The company also announced today the appointment of Katherine Vega Stultz as president and chief executive officer taking over from founding CEO Geoff Harris.

Key Points: 
  • The company also announced today the appointment of Katherine Vega Stultz as president and chief executive officer taking over from founding CEO Geoff Harris.
  • She brings to the role a proven track record of success in building brands that have generated over $1B in annual revenue.
  • Katherines broad leadership background makes her an ideal choice to lead the Ocelot Bio team into this next, critical phase in OCE-205s path toward commercialization.
  • Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease.

Alnylam Announces Collaboration with Novartis to Explore Targeted Therapy to Restore Liver Function

Retrieved on: 
목요일, 1월 6, 2022
Biotechnology, Pharmaceutical, Health, Gene silencing, Novartis Institute for Tropical Diseases, Physiology, Safety, ESLD, COVID-19, Liver, RNA transfection, Novartis, Government, Growth, Therapy, Regenerative medicine, Nobel Prize, Private Securities Litigation Reform Act, Patient, Fatty liver disease, Palliative care, Alnylam Pharmaceuticals, Sirna, Biomedical Research, Transplant, Cell, Goal, Science, Nobel Prize in Physiology or Medicine, Central nervous system, Intellectual property, U.S. Securities and Exchange Commission, Twitter, Journal of Palliative Medicine, Medication, Security (finance), Disease, Liver transplantation, SEC, Cirrhosis, LinkedIn, Marketing, Institute of Liver and Biliary Sciences, Instagram, Regeneron Pharmaceuticals, RNA, Liver failure, CNS, Biology, Risk, Drug development, Nasdaq, PMID, Leadership, Pharmaceutical industry, Medicine, RNA interference

We are so pleased to collaborate with Novartis, said Kevin Fitzgerald, Ph.D., Chief Scientific Officer at Alnylam.

Key Points: 
  • We are so pleased to collaborate with Novartis, said Kevin Fitzgerald, Ph.D., Chief Scientific Officer at Alnylam.
  • A significant need exists for medicinal alternatives to transplantation that regenerate liver tissue and restore the essential metabolic and synthetic processes that are managed by the liver.
  • Were delighted now to work alongside Alnylam in this new collaboration, as the Alnylam siRNA platform is optimally suited to translate this concept to clinical investigation.
  • During the exclusive three-year research collaboration, Alnylam will develop and test potential siRNAs using target-specific assays developed by Novartis.