Colitis

New Research Study for Patients With Ulcerative Colitis Now Available in Ogden, Utah

Retrieved on: 
Tuesday, February 27, 2024

Adults in the Ogden, Utah area with moderately to severely active ulcerative colitis (UC) may have the opportunity to join a research study assessing a new investigational medication.

Key Points: 
  • Adults in the Ogden, Utah area with moderately to severely active ulcerative colitis (UC) may have the opportunity to join a research study assessing a new investigational medication.
  • There is no known cure for UC, though new therapies have become available in recent years that offer patients improved treatment options.
  • The ANTHEM-UC study from Janssen Research & Development seeks to assess if an investigational pill could help those patients whose UC is not adequately managed by currently available therapies.
  • The study is now enrolling for adults age 18 or older with moderately to severely active UC, who have not responded well to currently available therapies.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

Reese Pharmaceutical Launches New At-Home Colon Cancer Screening Test

Retrieved on: 
Tuesday, February 27, 2024

CLEVELAND, Feb. 27, 2024 /PRNewswire/ -- Reese Pharmaceutical is expanding its over-the-counter (OTC) diagnostic portfolio with the launch of ColoTest®, an at-home Fecal Immunochemical Test (FIT) that identifies the presence of hidden blood in the stool in support of the early detection of colon cancer or gastrointestinal disorders such as colitis, diverticulitis, and polyps.

Key Points: 
  • A recent report by the American Cancer Society revealed a troubling spike in new colon and rectal cancer diagnoses across the US.
  • "90% of colon cancer-related deaths are thought to be preventable if caught early, and yet more than 29 million Americans are not screening for it.
  • With colon cancer rates on the rise, it is more important than ever for people to be proactive.
  • This test is performed in the comfort of your own home with results at home as soon as 1 minute," said Jeffrey Reese, President, of Reese Pharmaceutical.

Nigeria’s street food: tasty but toxic? Expert shares advice to make it safer

Retrieved on: 
Thursday, February 8, 2024

From the sizzling suya snack in Abuja to the aromatic jollof rice in Lagos, street food has become an integral part of Nigerian life.

Key Points: 
  • From the sizzling suya snack in Abuja to the aromatic jollof rice in Lagos, street food has become an integral part of Nigerian life.
  • However, beneath these enticing flavours lies a critical question of public safety and health regulation.
  • Other studies have focused on the microbiological safety of street foods (for example, soy wara, a Nigerian curdled soy milk product), and the risk factors in street food practices.
  • While street food vendors provide affordable and accessible meals, the lack of regulation poses significant health risks.

Why street food can be unsafe

  • Inadequate access to clean water, inappropriate waste disposal, temperature abuse and lack of food safety knowledge are common challenges seen among street food vendors.
  • Generally, street food preparation in Nigeria mirrors traditional approaches to food preparation at home.
  • Similarly, many street food vendors operate in less than perfect environments for food processing: many street food vendor stands have flies, rodents and open waste bins which are risk factors for the contamination of foods.

Checking unsafe practices


A multifaceted approach to these issues must be adopted.
Training: First, basic food safety training for vendors is crucial. This training should cover essential hygiene practices, safe food handling and storage procedures. It can be done through local health departments and community organisations. This recommendation draws on established principles of hygiene and safe food handling. Continuous training on food safety has proved effective in promoting food safety.

  • This requires a balance between ensuring public health and not stifling the livelihoods of the vendors.
  • Supplying vendors with hygienic materials has proved to be valuable for preserving and enhancing food safety in low- and middle-income nations.


Inspection: Regular inspections should be conducted to ensure compliance with these regulations. These should not be punitive but rather supportive, helping vendors to meet the required standards. A food hygiene rating scheme should be put in place to identify vendors complying with food safety standards as this could motivate them to improve their sanitary conditions.
Awareness: Public awareness also plays a vital role. Consumers should be educated about the importance of food safety and how to identify vendors who adhere to hygiene standards. Consumer awareness can create a demand for safer practices, encouraging vendors to comply with regulations.
Research and development: Finally, research and collaboration with food scientists and public health experts can lead to innovative solutions that are tailored to the Nigerian context. For instance, exploring low-cost preservation techniques or developing mobile apps for health inspection ratings could revolutionise the way street food is regulated.

Regulations will save lives and livelihoods


Regulating street food in Nigeria is not just about preventing disease; it is about preserving a way of life in a safe and sustainable manner. At the heart of this issue are the vendors and consumers, whose lives and well-being are interconnected with the very essence of street food culture.
Helen Onyeaka does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

EQS-News: Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months

Retrieved on: 
Tuesday, January 30, 2024

Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US.

Key Points: 
  • Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US.
  • No new safety signals were detected in UC patients treated up to five years with oral, once-daily obefazimod.
  • Obefazimod follow-on candidate selection from miR-124 library: R&D work on potential follow-on drug candidates to be selected from Abivax’s compound library is ongoing.
  • Selection of the first follow-on drug candidate is expected in Q3 2024 to further strengthen the Abivax pipeline.

Organovo Presents FXR314 3D Human Tissue Model Findings That Show Improved Epithelial Barrier Function and Fibrosis Reduction at Crohn’s and Colitis Congress

Retrieved on: 
Thursday, January 25, 2024

FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD.

Key Points: 
  • FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD.
  • FXR314 broadly improved measures of epithelial barrier function in a subset of donors, and fibrotic markers in all Crohn’s disease donors.
  • In ulcerative colitis, FXR314 improved epithelial barrier function and fibrotic activity in all donors.
  • Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 2024, with targeted completion in 2025.

Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months

Retrieved on: 
Monday, January 22, 2024

Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US.

Key Points: 
  • Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US.
  • Recruitment into both induction trials, ABTECT-1 and ABTECT-2, is ongoing in all designated regions.
  • No new safety signals were detected in UC patients treated up to five years with oral, once-daily obefazimod.
  • Selection of the first follow-on drug candidate is expected in Q3 2024 to further strengthen the Abivax pipeline.

Enthera Pharmaceuticals Appoints Lisa M. Olson as CEO and Announces Clinical Trial Progress with Ent001

Retrieved on: 
Tuesday, January 23, 2024

Dr. Olson joins Enthera’s management team with over two decades of leadership experience in the biopharmaceutical industry including a successful career at AbbVie.

Key Points: 
  • Dr. Olson joins Enthera’s management team with over two decades of leadership experience in the biopharmaceutical industry including a successful career at AbbVie.
  • “We are entering the new year with positive momentum in Enthera’s corporate and clinical evolution with Lisa’s appointment as CEO and important progress with Ent001.
  • We are thrilled to have her join as CEO,” said Silvano Spinelli, Chairman of the Enthera Board of Directors.
  • Based on this, Enthera has initiated a multiple ascending dose (MAD) Phase 1b clinical trial in patients with moderately to severely active UC.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

Retrieved on: 
Tuesday, January 16, 2024

Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.

Key Points: 
  • Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.
  • The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.
  • On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
  • NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis.

Organovo To Present FXR314 IBD 3D Model Findings at Upcoming Crohn’s and Colitis Congress

Retrieved on: 
Tuesday, January 9, 2024

The invited oral presentation, entitled “Evaluation of the clinical stage FXR agonist FXR314 in human primary cell 3D models of Crohn’s disease and ulcerative colitis”, will be made on Friday, January 26, 2024 at 3:00 PM PST by Dr. Fabrice Piu, Vice President, Research & Development.

Key Points: 
  • The invited oral presentation, entitled “Evaluation of the clinical stage FXR agonist FXR314 in human primary cell 3D models of Crohn’s disease and ulcerative colitis”, will be made on Friday, January 26, 2024 at 3:00 PM PST by Dr. Fabrice Piu, Vice President, Research & Development.
  • “We initially identified a strong benefit of FXR agonism in IBD using our internal 3D models, then moved towards development of what we believe to be a best-in-class FXR agonist, FXR314, to treat IBD,” said Keith Murphy, Organovo's Executive Chairman.
  • Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 1H 2024, with targeted completion in 1H 2025.
  • The drug’s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that area through partnership collaborations with Organovo.