Valganciclovir

Viracta Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 7, 2024
SAN, Research, Investment, FDA, Food, PTCL, SDD, ODD, Valganciclovir, Completeness, Therapy, Food and Drug Administration, NPC, Patient, PTLD, G&A, DLBCL, Pharmaceutical industry

SAN DIEGO, March 07, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported financial results for the fourth quarter and full-year of 2023 and provided a business update.

Key Points: 
  • “Nana-val is a first-in-class, all-oral combination treatment regimen that has entered late-stage development to target and treat EBV-associated cancers.
  • Completed enrollment of Stage 2 in the R/R EBV+ PTCL cohort of patients treated with Nana-val (n=21, Stage 1 + Stage 2 patients) in the first quarter of 2024.
  • Amended protocol to additionally enable enrollment of second-line R/R EBV+ DLBCL patients and R/R EBV+ PTLD patients, including pediatric EBV+ PTLD patients ≥ 12 years of age.
  • Present Stage 1 + Stage 2 data (n=21) in the R/R EBV+ PTCL cohort in patients treated with Nana-val in the third quarter of 2024.

Viracta Therapeutics Announces Completion of Second-Stage Enrollment into the Peripheral T-Cell Lymphoma Cohort of the NAVAL-1 Trial

Retrieved on: 
Thursday, February 29, 2024
SAN, FDA, Food, Stage 2, PTCL, Epstein–Barr virus, Valganciclovir, EBV, Therapy, Patient, Peripheral T-cell lymphoma, Pharmaceutical industry

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that its lead development program, Nana-val (nanatinostat in combination with valganciclovir), a first-in-class, all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, has completed Stage 2 enrollment into the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort of the NAVAL-1 trial.

Key Points: 
  • “The completion of Stage 2 enrollment of the PTCL cohort in NAVAL-1 is a major milestone for the Nana-val clinical development program.
  • We would like to acknowledge the dedication of our study execution team and the commitment of our investigators for this achievement.
  • Present Stage 1 + Stage 2 data (n=21) from the R/R EBV+ PTCL cohort in patients treated with Nana-val in the third quarter of 2024.
  • Engage with the U.S. Food and Drug Administration (FDA) in mid-2024, to align on requirements for accelerated approval.

EQS-News: AiCuris Received 15 Million Euros Milestone Payment from Licensing Partner MSD Following EMA Approval of PREVYMIS® for Prevention of CMV Infection in High-Risk Adult Kidney Transplant Recipients

Retrieved on: 
Saturday, January 13, 2024
MSD, HSCT, Patient, Research, Kidney, Incidence, CMV, Merck & Co., Valganciclovir, EMA, Risk, Infection, Immunodeficiency, Food, Disease, EUR, FDA, Merck, MRK, Pharmaceutical industry

“Following the U.S. approval mid-2023, we are excited that our partner MSD now also received European approval for PREVYMIS® (letermovir) in its second indication, the prophylaxis of CMV infection in adult kidney transplanted patients at high risk.

Key Points: 
  • “Following the U.S. approval mid-2023, we are excited that our partner MSD now also received European approval for PREVYMIS® (letermovir) in its second indication, the prophylaxis of CMV infection in adult kidney transplanted patients at high risk.
  • In June 2023, the FDA and in December 2023 the EMA approved PREVYMIS® for prophylaxis of CMV disease in adult kidney transplant recipients at high risk.
  • Moreover, extended 200-day dosing for PREVYMIS® for CMV prophylaxis in adult HSCT recipients at risk for late CMV infection and disease was approved by the FDA in August 2023.
  • Approvals by national authorities was supported by a Phase 3, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869) in 589 adult kidney transplant recipients at high risk (CMV D+/R-).

Viracta Therapeutics Announces Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Tuesday, December 12, 2023
NPC, Food, Nasopharyngeal carcinoma, Post-transplant lymphoproliferative disorder, Drug development, FDA, Disease, Plasmablastic lymphoma, ODD, Therapy, T-cell lymphoma, B-cell lymphoma, EBV, Valganciclovir, Patient, Lymphoma, Pharmaceutical industry

SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Nana-val (nanatinostat in combination with valganciclovir), the company's all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, for the treatment of nasopharyngeal carcinoma (NPC). This represents the first ODD granted for Nana-val in Epstein-Barr virus-positive (EBV+) solid tumors and outside of EBV-associated lymphomas. The FDA previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and EBV+ diffuse large B-cell lymphoma, not otherwise specified.

Key Points: 
  • This represents the first ODD granted for Nana-val in Epstein-Barr virus-positive (EBV+) solid tumors and outside of EBV-associated lymphomas.
  • The FDA previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and EBV+ diffuse large B-cell lymphoma, not otherwise specified.
  • "This orphan drug designation highlights the urgent need for new targeted treatment options for patients with rare diseases such as nasopharyngeal carcinoma, which is highly associated with EBV," said Mark Rothera, President and Chief Executive Officer of Viracta.
  • With sites open and enrolling the sixth dose cohort of the study, we are on track to expand into the Phase 2 portion in 2024.

Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies

Retrieved on: 
Thursday, December 21, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Transplant, SOT, CDE, CMV, Cidofovir, Incidence, Hospital, Week, NMPA, Ganciclovir, Infection, European, National Medical Products Administration, Cytomegalovirus, Valganciclovir, Patient, Safety, Foscarnet

Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
  • LIVTENCITY is the first and only inhibitor of CMV-specific UL97 protein kinase in China for this indication.
  • LIVTENCITY was granted Breakthrough Therapy Designation by China Center for Drug Evaluation (CDE) in 2021.
  • “This approval will help redefine the CMV treatment landscape for transplant patients in China and is a positive step forward toward addressing an unmet need for this community.”
    The NMPA approval is based on the results of the Phase 3 SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies – ganciclovir, valganciclovir, cidofovir or foscarnet – for the treatment of patients with CMV infection/disease refractory* to prior therapies.

Viracta Therapeutics to Host R&D Day Highlighting Nana-val in Epstein-Barr Virus (EBV)-Associated Cancers

Retrieved on: 
Wednesday, October 4, 2023
Lymphoma, PTCL, Peripheral T-cell lymphoma, Hematopoietic stem cell transplantation, Initiation, Creatinine, DLBCL, Thomas Jefferson University, Valganciclovir, Oncology, EDT, B-cell lymphoma, Stage 2, Nasopharyngeal carcinoma, Bone marrow, CRR, 2009 Tour de France, Stage 1 to Stage 11, SDD, Dor, Patient, Division, CR, Toxic leukoencephalopathy, NPC, R, FDA, Therapy, Stomach, Engagement, ORR, EBV, Pharmaceutical industry, Fine chemical, Medical device, Medical imaging, Leiomyosarcoma, Lymphoepithelioma

SAN DIEGO, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that it plans to highlight new preliminary clinical and preclinical data from studies of nanatinostat and valganciclovir (Nana-val), its all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, during an R&D Day today, Wednesday, October 4, 2023, at 8:00 a.m. EDT.

Key Points: 
  • “The clinical responses and favorable safety profile observed in multiple relapsed or refractory EBV-positive lymphoma patient populations continue to be encouraging.
  • In addition, the R&D Day will feature presentations by expert key opinion leaders who will discuss the high unmet medical needs of EBV-associated lymphomas.
  • Enrollment completed through the fifth dose level of the Phase 1b dose escalation portion of the trial without any dose-limiting toxicities reported.
  • A live video webcast of the presentation will be available here and on the Investors section of the Viracta website under " Events and Webcasts ".

EQS-News: AiCuris Received 30 Million Euros Milestone Payment from Licensing Partner MSD Following U.S. FDA Approval of PREVYMIS® (letermovir) in Second Indication

Retrieved on: 
Wednesday, August 23, 2023
MSD, HSV, Cytomegalovirus, Infection, Food and Drug Administration, Valganciclovir, MRK, Food, Research, U.S. FDA, Incidence, EUR, Patient, CMV, Merck, Merck & Co., Immunodeficiency, FDA, NYSE, Pharmaceutical industry, Pritelivir

AiCuris Received 30 Million Euros Milestone Payment from Licensing Partner MSD Following U.S. FDA Approval of PREVYMIS® (letermovir) in Second Indication

Key Points: 
  • AiCuris Received 30 Million Euros Milestone Payment from Licensing Partner MSD Following U.S. FDA Approval of PREVYMIS® (letermovir) in Second Indication
    The issuer is solely responsible for the content of this announcement.
  • “We are excited that our partner MSD received FDA approval for PREVYMIS® (letermovir) for the prophylaxis of CMV infection in kidney transplanted patients.
  • Since 2017, the drug has already protected thousands of allogeneic stem cell transplanted patients from CMV disease.
  • With this label expansion, CMV-seropositive kidney transplant patients now have a novel, safe and effective treatment option,” said Larry Edwards, CEO of AiCuris Anti-infective Cures AG.

Viracta Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 14, 2023
Lymphoma, PTCL, Patent, Peripheral T-cell lymphoma, Extranodal NK/T-cell lymphoma, nasal type, Probability, Drug development, Hematology, Creatinine, DLBCL, Crizotinib, Valganciclovir, United States patent law, G&A, CMO, B-cell lymphoma, Stage 2, Transplant, Journal, American Society of Hematology, State, Patient, Investment, Cytopenia, EBV, Bone marrow, T-cell lymphoma, Financial toxicity, R, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patent and Trademark Office, Stomach, Society, Food, Pharmaceutical industry, Vaccine, Platinum, Fine chemical, Leiomyosarcoma, Lymphoepithelioma

“In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication.

Key Points: 
  • “In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication.
  • Prioritization also enables the allocation of resources to those indications with the greatest probability of success and market opportunity in key geographies.
  • Patients with extranodal NK/T-cell lymphoma (ENKTL) and other ultra-rare subtypes of EBV+ lymphoma will continue to be enrolled.
  • In July 2023, Viracta received a Notice of Allowance from the US Patent and Trademark Office on Viracta’s patent claims directed to a next-generation formulation of nanatinostat.

Viracta Therapeutics Announces Publication in Blood Advances Demonstrating Promising and Durable Signal of Nana-val Efficacy in Patients with Relapsed or Refractory (R/R) Epstein-Barr Virus-Positive (EBV+) Lymphoma

Retrieved on: 
Tuesday, August 8, 2023
Lymphoma, PTCL, Peripheral T-cell lymphoma, Hematopoietic stem cell transplantation, ASH, Angioimmunoblastic T-cell lymphoma, Lymphoproliferative disorders, Creatinine, DLBCL, Thomas Jefferson University, Aes, Valganciclovir, Constipation, Oncology, Histone deacetylase inhibitor, B-cell lymphoma, Bone marrow, Patient, Division, American Society of Hematology, Data, SAN, PTLD, PTCL-NOS, Cytopenia, Nausea, Paper, CRS, Therapy, Society, ORR, Disease, Vaccine, Pharmaceutical industry, Hematology

SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced the publication of clinical data from an open-label, multicenter, Phase 1b/2 study of Nana-val in 55 patients with R/R EBV+ lymphoma in Blood Advances. Results showed complete responses (CRs) achieved and ongoing durable responses observed out to approximately 36 months across multiple EBV+ lymphoma subtypes, including some of the most aggressive cancers: peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL), and post-transplant lymphoproliferative disease (PTLD). This paper titled, “Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study,” can be found here.

Key Points: 
  • This paper titled, “Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study,” can be found here .
  • The published paper includes an additional 10-month follow-up period, which demonstrated durable response durations across multiple EBV+ lymphoma subtypes.
  • Overall, trial participants received a median of two prior therapies before entering the trial, with 75% (41/55) being refractory to their last therapy.
  • Initial data from the Nana-val Phase 1b/2 clinical trial were previously presented at the 2021 American Society of Hematology (ASH) Annual Meeting .

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

Retrieved on: 
Tuesday, June 6, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, MSD, Cytomegalovirus, Neutropenia, Male, Pimozide, Aciclovir, IV, AE, Culture, Alkaloid, Simvastatin, Aes, Myopathy, Valganciclovir, MRK, HSCT, Immunotherapy, Merck & Co., Hypertension, Incidence, Ergotism, Diarrhea, Drug, Patient, Leukopenia, Blood, CMV, Kidney, Ciclosporin, ALT, Transplant, Rhabdomyolysis, AST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, NYSE, Food, Safety, Disease, Medical device, Vaccine, Pharmaceutical industry, Merck

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Key Points: 
  • PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
  • Increased pimozide concentrations due to concomitant administration of PREVYMIS may lead to QT prolongation and torsades de pointes.
  • Study drug was initiated between Day 0 and Day 7 post-kidney transplant and continued through Week 28 (~200 days) post-transplant.
  • The most common primary reasons for transplant were congenital cystic kidney disease (17%), hypertension (16%), and diabetes/diabetic nephropathy (14%).