Titoli Biotech ! Tengion (TNGN) – Grafico
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Tengion, Inc. (Tengion), incorporated on July 10, 2003, is a regenerative medicine company focused on discovering, developing, manufacturing and commercializing a range of replacement organs and tissues, or neo-organs and neo-tissues. The Company focuses on creating these functional neo-organs and neo-tissues using a patient’s own cells, or autologous cells, in conjunction with its Organ Regeneration Platform. Tengion manufactures product candidates in its facilities using processes and it has implanted its neo-organs in clinical trials. The Company focuses on developing its technology to address medical needs in urologic, renal, gastrointestinal and vascular diseases.
Tengion’s product candidate, the Neo-Urinary Conduit, is an autologous implant that catalyzes regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal, or cystectomy. This tubular conduit passively transports urine from the ureters, through a hole in the abdomen, or stoma, into a removable, disposable bag, or ostomy bag. It has also applied the technology in two Phase II clinical trials for its Neo-Bladder Augment for the treatment of neurogenic bladder, or dysfunctional bladder due to some form of neurological disease or condition. The Company’s product pipeline includes several candidates in early stage development, such as its Neo-Kidney Augment for patients with advanced chronic kidney disease (CKD).
The Tengion Neo-Urinary Conduit
The Company focusing on using its Neo-Urinary Conduit in replacing the use of bowel tissue in bladder cancer patients requiring a non-continent urinary diversion after bladder removal. The Neo-Urinary Conduit is produced using smooth muscle cells from a routine fat biopsy. Tengion has an effective investigational new drug application (IND). Principal observations of its Neo-Urinary Conduit in preclinical animal models have shown that implantation of the Neo-Urinary Conduit results in the formation of a functional conduit and by three months post-implantation, the scaffold is replaced by native-like bladder tissue consisting of urothelium, submucosa and smooth muscle cells.
The Tengion Neo-Bladder Replacement
The Company has conducted preclinical studies of its Neo-Bladder Replacement in large animals to serve as an autologous urinary reservoir. Animals receiving the Company’s product candidate underwent urethral-sparing bladder removal. The urethra and ureters were attached using bioabsorbable sutures to its Neo-Bladder Replacement. Principal observations of the Neo-Bladder Replacement in large animal models have shown that all animals demonstrate continence upon removal of the urethral catheter 21 days after surgery, and implantation of the Neo-Bladder Replacement created from muscle cells results in the formation of a compliant and functional bladder, with demonstrated nerve growth into the tissue.
The Tengion Neo-Bladder Augment
The Company’s Neo-Bladder Augment is a combination of bioabsorbable materials used to form a scaffold shaped like a bladder, which is seeded with the requisite bladder cells cultured by its scientists from the patient’s bladder. When its Neo-Bladder Augment is implanted into the body, it serves as a template to regenerate native-like bladder tissue. The Company has conducted two open-label, multi-center Phase II clinical trials of its Neo-Bladder Augment for the treatment of neurogenic bladder resulting from spina bifida in pediatric patients and neurogenic bladder resulting from spinal cord injury in adult patients. The primary objective of each of these two Phase II clinical trials was to evaluate the safety and efficacy of the Neo-Bladder Augment.
The Company competes with Cytograft, Tissue Engineering, Inc., Osiris Therapeutics, Inc., Integra Life Sciences, Inc., Pervasis Therapeutics, Inc., Kinetic Concepts, Inc., Genzyme, Allergan, Speywood Biopharma, Medtronic, Detrol and Ditropan.