Tengion (TNGN) Updates on Its Neo-Urinary Conduit
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Tengion, Inc. (Nasdaq: TNGN), has made significant advances in its two lead programs. A fourth patient was implanted in the last several weeks in the ongoing initial clinical trial of the Company's lead product candidate, the Neo-Urinary Conduit. The Company also submitted a pre-Investigational New Drug (IND) filing to the U.S. Food and Drug Administration (FDA) for its lead preclinical program, the Neo-Kidney Augment.
From the release:
"Neo-Urinary Conduit Clinical Program Update: Tengion has now enrolled a fourth patient in the ongoing initial clinical trial of its lead product candidate, the Neo-Urinary Conduit, which is being evaluated in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. The ongoing initial trial is being conducted at the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland.
The goal set by the clinical investigators in this trial has been to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patient into the surgical approach for subsequent patients, as necessary. Data from the first three patients have allowed clinical investigators to make surgical modifications for the trial moving forward in an effort to address conduit patency and vascular supply. Complications that arose in the first three patients were resolved successfully and, following new surgeries to construct a urinary diversion using bowel tissue, all three patients have recovered well.
Upon implanting the fourth patient in the ongoing trial, Tengion and its clinical investigators believe they have translated the surgical technique, including the procedure to provide greater blood supply to the Neo-Urinary Conduit supporting regeneration of urinary tissue; the ureteral attachment to the Neo-Urinary Conduit using an established surgical procedure used in the current standard of care; and the procedure for the stoma incision and passage of the Neo-Urinary Conduit with its blood supply through the abdominal wall. The Company is also collaborating with post-operative care staff at the two trial sites to optimize stoma management for rapid patient recovery.
The Company plans to discuss with the Data Safety Monitoring Board a reduction in the timelines between future patient implants, which is currently 12 weeks. If granted and assuming appropriate safety data, the Company anticipates that it will complete implantation of up to 10 patients by the end of 2012.
Neo-Kidney Augment Preclinical Program Update: Tengion submitted a pre-IND filing to the FDA for its lead preclinical program, the Neo-Kidney Augment, one quarter ahead of schedule. The Neo-Kidney Augment is intended to prevent or delay the need for dialysis or kidney transplant by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). Following the early submission of the pre-IND, Tengion's Board of Directors has authorized the Company to aggressively pursue the development of its Neo-Kidney Augment program and will retain the full team of employees involved in the Neo-Kidney Augment program.
Tengion has scheduled a meeting with the FDA to discuss the Company's proposed GLP animal study program to support an IND filing. Tengion is also exploring moving forward using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies. The Company expects to provide an update on its expectations for the clinical trial program in its first quarter 2012 financial results announcement in May."
From the release:
"Neo-Urinary Conduit Clinical Program Update: Tengion has now enrolled a fourth patient in the ongoing initial clinical trial of its lead product candidate, the Neo-Urinary Conduit, which is being evaluated in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. The ongoing initial trial is being conducted at the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland.
The goal set by the clinical investigators in this trial has been to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patient into the surgical approach for subsequent patients, as necessary. Data from the first three patients have allowed clinical investigators to make surgical modifications for the trial moving forward in an effort to address conduit patency and vascular supply. Complications that arose in the first three patients were resolved successfully and, following new surgeries to construct a urinary diversion using bowel tissue, all three patients have recovered well.
Upon implanting the fourth patient in the ongoing trial, Tengion and its clinical investigators believe they have translated the surgical technique, including the procedure to provide greater blood supply to the Neo-Urinary Conduit supporting regeneration of urinary tissue; the ureteral attachment to the Neo-Urinary Conduit using an established surgical procedure used in the current standard of care; and the procedure for the stoma incision and passage of the Neo-Urinary Conduit with its blood supply through the abdominal wall. The Company is also collaborating with post-operative care staff at the two trial sites to optimize stoma management for rapid patient recovery.
The Company plans to discuss with the Data Safety Monitoring Board a reduction in the timelines between future patient implants, which is currently 12 weeks. If granted and assuming appropriate safety data, the Company anticipates that it will complete implantation of up to 10 patients by the end of 2012.
Neo-Kidney Augment Preclinical Program Update: Tengion submitted a pre-IND filing to the FDA for its lead preclinical program, the Neo-Kidney Augment, one quarter ahead of schedule. The Neo-Kidney Augment is intended to prevent or delay the need for dialysis or kidney transplant by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). Following the early submission of the pre-IND, Tengion's Board of Directors has authorized the Company to aggressively pursue the development of its Neo-Kidney Augment program and will retain the full team of employees involved in the Neo-Kidney Augment program.
Tengion has scheduled a meeting with the FDA to discuss the Company's proposed GLP animal study program to support an IND filing. Tengion is also exploring moving forward using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies. The Company expects to provide an update on its expectations for the clinical trial program in its first quarter 2012 financial results announcement in May."
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