Transitional epithelium

CicloMed Announces Initiation of Phase 1B Trial of Fosciclopirox in Newly Diagnosed and Recurrent Urothelial Cancer Patients

Retrieved on: 
Tuesday, June 29, 2021

We are excited to have initiated this Phase 1B trial of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors, said Tammy Ham, CEO of CicloMed.

Key Points: 
  • We are excited to have initiated this Phase 1B trial of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors, said Tammy Ham, CEO of CicloMed.
  • We believe that fosciclopirox provides strong potential to improve treatment outcomes for patients with bladder cancer.
  • In September 2020, CicloMed was awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI), enabling the Phase 1B trial.
  • The initiation of this Phase 1B trial enables us to characterize the pharmacologic activity and mechanisms of fosciclopirox action following treatment in urothelial cancer patients, Weir added.

First Patient Dosed in Clinical Study of TLX250-CDx in Bladder Cancer

Retrieved on: 
Wednesday, June 23, 2021

The objective of the ZiP-UP (Zirconium-girentuximab PET in Urothelial Cancer Patients) study is to evaluate the feasibility of using TLX250-CDx PET/CT1 in the detection of localised and metastatic urothelial carcinoma or bladder cancer.

Key Points: 
  • The objective of the ZiP-UP (Zirconium-girentuximab PET in Urothelial Cancer Patients) study is to evaluate the feasibility of using TLX250-CDx PET/CT1 in the detection of localised and metastatic urothelial carcinoma or bladder cancer.
  • The trial will recruit 20 patients over 12 months: ten patients with known metastatic urothelial carcinoma or bladder cancer; and ten patients that require primary staging of localised urothelial carcinoma or bladder cancer.
  • Telix CEO, Dr Christian Behrenbruch added, We are pleased that a first patient has been dosed in this study exploring the clinical utility of TLX250-CDx to image other cancers, beyond renal cancer, and in indications where conventional imaging has limitations.
  • Bladder cancer is the sixth most commonly occurring cancer in men, and the tenth most common cancer overall worldwide.2 In 2020, 573,278 people worldwide were diagnosed with bladder cancer and 212,536 people died from their disease.3 Urothelial carcinoma (or UCC) accounts for ~90% of all bladder cancers.

Yale Cancer Center Study Shows Novel Test Can Detect New and Recurrent Bladder Cancer

Retrieved on: 
Friday, June 4, 2021

According to the American Cancer Society, an estimated 81,000 cases of bladder cancer will be diagnosed in the United States this year.

Key Points: 
  • According to the American Cancer Society, an estimated 81,000 cases of bladder cancer will be diagnosed in the United States this year.
  • Accurate detection of bladder cancer, or urothelial carcinoma (UC), is often difficult and expensive, requiring invasive camera-based testing methodology.
  • Yale Cancer Center (YCC) is one of only 51 National Cancer Institute-designated comprehensive cancer centers in the nation and the only such center in Connecticut.
  • The URO17 bladder cancer test developed by KDx may prove to be the most sensitive and specific for bladder cancer developed to date.

Infinity to Present at the 7th Annual Truist Securities Life Sciences Summit

Retrieved on: 
Tuesday, April 27, 2021

MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.

Key Points: 
  • MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.
  • MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq\xc2\xae and Abraxane\xc2\xae in front-line TNBC and in combination with Tecentriq and Avastin\xc2\xae in front-line RCC.
  • In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (AB928, a dual adenosine receptor antagonist) plus Doxil\xc2\xae in advanced TNBC patients.
  • With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-na\xc3\xafve, and front-line settings.

Merck Receives Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab) To Include Results of Phase 3 KEYNOTE-361 Trial in Certain Adult Patients with Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Tuesday, March 30, 2021

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Key Points: 
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma.
  • In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma.

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer

Retrieved on: 
Monday, March 8, 2021

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).
  • Patients being treated with Tecentriq for prior-platinum treated mUC should discuss their care with their healthcare provider.
  • While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients."
  • Tecentriq is a prescription medicine used to treat adults with:
    A type of bladder and urinary tract cancer called urothelial carcinoma.

Global Advanced Urotheilal carcinoma Pipeline Insight Report 2021 Featuring Rogaratininb (Bayer) & Sitravatinib (Mirati Therapeutics) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 23, 2021

The "Advanced Urotheilal carcinoma - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Advanced Urotheilal carcinoma - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Advanced Urothelial Carcinoma - Pipeline Insight, 2021," report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Advanced Urothelial Carcinoma pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Advanced Urothelial Carcinoma R&D.
  • Advanced Urothelial Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Thursday, February 18, 2021

"Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options."

Key Points: 
  • "Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options."
  • [2]
    "Advanced bladder cancer patients urgently need more treatment options," said Roger Dansey, M.D., Chief Medical Officer, Seagen.
  • "Based on recently presented clinical trial results, PADCEV could address a significant unmet need for more patients with advanced urothelial cancer after initial immunotherapy treatment."
  • EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors.

Seagen and Astellas Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Thursday, February 18, 2021

Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options.

Key Points: 
  • Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options.
  • Based on recently presented clinical trial results, PADCEV could address a significant unmet need for more patients with advanced urothelial cancer after initial immunotherapy treatment.
  • Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those with and without pre-existing diabetes mellitus.
  • EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors.

4D pharma Announces Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate MRx0518 in Combination with BAVENCIO® for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Monday, February 8, 2021

Under the collaboration, 4D pharma intends to commence a clinical trial in 2021 to evaluate BAVENCIO in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

Key Points: 
  • Under the collaboration, 4D pharma intends to commence a clinical trial in 2021 to evaluate BAVENCIO in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
  • With this second clinical trial collaboration for MRx0518 with a leading immune checkpoint inhibitor, 4D is able to evaluate MRx0518 in a new combination and earlier treatment setting.
  • The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA.
  • A fourth clinical trial of MRx0518 in combination with BAVENCIO (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc., is expected to initiate in 2021.