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CellVax Therapeutics Announces FDA Clearance of IND Application for FK-PC101, a Novel Personalized Cancer Immunotherapy
Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, has announced that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for FK-PC101. Patient recruitment for the randomized Phase II trial will begin in March of 2024, with first patient treatments expected in Q2 2024

SUO-CTC and AngioDynamics Complete Enrollment for PRESERVE Clinical Study
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients, today announced the completion of enrollment and final treatment in its Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE). The PRESERVE study was initiated by AngioDynamics, Inc. in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC).

AngioDynamics Announces a Partnerships in Clinical Trial Engagements (PCTE) Initiative
AngioDynamics introduces a new grant opportunity that encourages clinical trial sites to build partnerships within underserved communities to increase patient participation.

Gene Therapy for Non-Muscle-Invasive Bladder Cancer: A New Era of Treatment
In December 2022, the Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg), a nonreplicating, adenoviral, vector-based gene therapy for the treatment of adult patients with high-risk bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It was the first gene therapy approved by the FDA for high-risk NMIBC.

Ferring Receives Approval from U.S. FDA for Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
The U.S. FDA has approved Adstiladrin® (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial
The standard of care for locoregional renal cell carcinoma is surgery, but many patients experience recurrence. The objective of the current study was to determine if adjuvant atezolizumab (vs placebo) delayed recurrence in patients with an increased risk of recurrence after resection.

First Patient Treated in PRESERVE Clinical Study
Study Will Assess Use of NanoKnife System in Prostate Tissue Ablation

AngioDynamics Receives FDA Approval for PRESERVE Study
Study Will Assess Use of NanoKnife System in Prostate Tissue Ablation

Results from Late Stage Bladder Cancer Clinical Trial Conducted by SUO-CTC Are Published in the Lancet Oncology
Investigational Treatment Option May Offer New Hope for Patients

Discovery Brings Bladder Cancer Patients Hope
Medical Breakthrough Tested in Phase 2 and 3 Trials from Society of Urologic Oncology Clinical Trials Consortium

Novel Gene Therapy Shows Three-Fold Improvement in Recurrence-Free Survival in High-Risk, Early-Stage Bladder Cancer Patients Where Current Gold-Standard Treatment Fails
Durable responses in 35 percent of patients reported in Phase II data published in the Journal of Clinical Oncology

Sites of Interest

Society of Urologic Oncology
The SUO's mission is to enable qualified members primarily interested in the care of patients with malignant GU diseases to meet for the purpose of discussion, development and implementation of ideas to improve care.

American Urological Association
The AUA is a premier urologic association, providing invaluable support to the urologic community. Our mission is to promote the highest standards of urological clinical care through education, research and the formulation of health care policy.

ClinicalTrials.gov
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more about clinical studies and about this site, including relevant history, policies, and laws.

National Cancer Institute at the National Institutes of Health
Cancer.gov is the central website for the National Cancer Institute (NCI), the U.S. government’s principal agency for cancer research. NCI is mandated by U.S. law to disseminate information about cancer and cancer research.

National Institutes of Health
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.