Ureas

ACADIA Pharmaceuticals Submits Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis

Retrieved on: 
Monday, June 15, 2020

The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.

Key Points: 
  • The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.
  • NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinsons disease psychosis.
  • If approved by the FDA, NUPLAZID would be the first drug approved to treat the hallucinations and delusions associated with dementia-related psychosis and would be the second indication for NUPLAZID.
  • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinsons disease psychosis.

AVEO Oncology Announces FDA Acceptance for Filing of a New Drug Application for Tivozanib as a Treatment of Relapsed or Refractory Renal Cell Carcinoma

Retrieved on: 
Monday, June 1, 2020

The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021.

Key Points: 
  • The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021.
  • The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.
  • We look forward to working closely with the FDA over the coming months during their review of our application.
  • AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers.

AVEO Oncology Announces Phase 1b/2 DEDUCTIVE Study of FOTIVDA® (tivozanib) in Combination with IMFINZI® (durvalumab) in Previously Untreated Metastatic Hepatocellular Carcinoma Advances to Phase 2

Retrieved on: 
Friday, May 29, 2020

We believe the safety we have seen in Phase 1 of this combination study supports the unique profile that would make tivozanib an attractive VEGF TKI to combine with immunotherapy.

Key Points: 
  • We believe the safety we have seen in Phase 1 of this combination study supports the unique profile that would make tivozanib an attractive VEGF TKI to combine with immunotherapy.
  • The trial is being conducted as part of a clinical collaboration between AVEO and AstraZeneca.
  • AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer.
  • AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers.

MiNA Therapeutics Presents Top Line Results from Phase Ib Study of MTL‑CEBPA in Combination with Sorafenib in Liver Cancer at 2020 ASCO Annual Meeting

Retrieved on: 
Friday, May 29, 2020

The study met its primary endpoints of safety and tolerability for MTLCEBPA administered either concomitantly or sequentially with sorafenib.

Key Points: 
  • The study met its primary endpoints of safety and tolerability for MTLCEBPA administered either concomitantly or sequentially with sorafenib.
  • The data will be presented during a poster session at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually from May 29 - May 31, 2020.
  • We are delighted to have confirmed objective tumour responses in a Phase Ib study in advanced liver cancer patients who are poorly served by existing treatments, commented Robert Habib, CEO of MiNA Therapeutics.
  • At the data cut-off of February 1, 2020, 36 patients with advanced HCC had been treated with MTLCEBPA in combination with sorafenib in the Phase Ib study.

KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Demonstrated Clinically Meaningful Tumor Response Rates in Unresectable Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma

Retrieved on: 
Thursday, May 28, 2020

In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates (ORR) in patients with unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed following immune checkpoint inhibitor therapy, respectively.

Key Points: 
  • In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates (ORR) in patients with unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed following immune checkpoint inhibitor therapy, respectively.
  • The tumor response rates demonstrated with KEYTRUDA plus LENVIMA in these studies underscore the potential of this combination regimen in certain types of hepatocellular and renal cell carcinoma, said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories.
  • KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

ACADIA Pharmaceuticals to Combine CLARITY-2 and CLARITY-3 Phase 3 Studies Evaluating Pimavanserin for the Adjunctive Treatment of Major Depressive Disorder

Retrieved on: 
Tuesday, May 26, 2020

The primary endpoint in both studies is the change from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.

Key Points: 
  • The primary endpoint in both studies is the change from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.
  • Patients who completed the Phase 3 studies were eligible to participate in the ongoing 52-week open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in MDD.
  • On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004).
  • ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, adjunctive major depressive disorder, and the negative symptoms of schizophrenia.

ACADIA Pharmaceuticals to Present Pimavanserin Clinical Data at the 2020 American Society of Clinical Psychopharmacology Virtual Annual Meeting

Retrieved on: 
Thursday, May 21, 2020

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting on May 29-30, 2020.

Key Points: 
  • ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting on May 29-30, 2020.
  • Our research presentations at ASCP underscore the potential clinical utility of pimavanserin in serious CNS disorders, said Serge Stankovic, M.D., M.S.P.H., ACADIA's President.
  • Poster Presentation: Pimavanserin for the Treatment of Comorbid Depression in Patients with Parkinsons Disease on Friday, May 29, 2020, 12:30 p.m. - 2:00 p.m. Eastern Time.
  • Poster Presentation: Long-Term Evaluation of Open-Label Pimavanserin Safety and Tolerability in Parkinsons Disease Psychosis on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.

Ipsen Announces Publication of First Matching-Adjusted Indirect Comparison of Cabometyx® (cabozantinib) Versus regorafenib in Advanced Hepatocellular Carcinoma in Advances in Therapy

Retrieved on: 
Tuesday, May 19, 2020

CABOMETYX (cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points: 
  • CABOMETYX (cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • Matching-adjusted indirect comparison of cabozantinib versus regorafenib in advanced hepatocellular carcinoma.
  • Cost of treatment-related adverse events (TRAES) in second-line (2l) advanced hepatocellular carcinoma (AHCC): match adjusted indirect comparison (MAIC) of nivolumab and regorafenib.
  • Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomized, double-blind, placebo-controlled, phase 3 trial.

Tiziana Lifesciences Announces Online Publication of Two Abstracts at the American Society of Clinical Oncology (ASCO) Reporting Clinical Activity and Safety of Milciclib in Patients with Advanced Hepatocellular Carcinoma

Retrieved on: 
Thursday, May 14, 2020

Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.

Key Points: 
  • Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.
  • Positive demonstrated clinical activity included:
    50% (14 out of 28) evaluable patients completed 6-month duration of the trial.
  • Abstract #307309: Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence.
  • The American Society of Clinical Oncology (ASCO) was established in 1964 with the sole purpose of improving the care of people with cancer.

AVEO Oncology Reports First Quarter 2020 Financial Results and Provides Business Update

Retrieved on: 
Thursday, April 30, 2020

AVEO Oncology (NASDAQ: AVEO) today reported financial results for the first quarter ended March 31, 2020 and provided a business update.

Key Points: 
  • AVEO Oncology (NASDAQ: AVEO) today reported financial results for the first quarter ended March 31, 2020 and provided a business update.
  • AVEO expects to report results from the final OS analysis by June 2020.
  • In February 2020, AVEO announced the publication of results from a monotherapy trial of tivozanib in patients with advanced, inoperable HCC in the British Journal of Cancer.
  • The results were presented during a poster session at the 2020 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium.