Skip to main content

Posts

Showing posts with the label Cell-Based Drugs

New Drug Approvals 2011 - Pt. XX azficel-T (laVivTM)

On June 21st 2011, the FDA approved azficel-T (trade name:  laViv ) for the aesthetic treatment of moderate to severe nasolabial fold wrinkles in adults ("smile lines"). laViv is an autologous cell therapeutic , consisting of fibroblasts (cells which can produce  collagen ) which are produced from a biopsy of post- auricular tissue by proliferation in vitro , and re-injected into the nasolabial folds to improve their cosmetic appearance. With increasing age, nasolabial folds can become more pronounced, caused by habitual facial expressions ( i.e. laughing ), and a decline of collagen production. Alternative non-drug treatments include liposuction and facelift . After biopsy, dermal fibroblasts are expanded using standard tissue-culture procedures until a sufficient amount of cells for re-injection is obtained. This process takes 11-22 weeks. laViv is provided in two vials of approximately 18 million fibroblasts in 1.2 mL suspension and should be administere...

2010 New Drug Approvals - part IX - Sipuleucel-T (Provenge)

On April 29th, the FDA approved Sipuleucel-T (Tradename: Provenge, REsearch Code: APC-8015) a highly novel treatment (a cell-based vaccine) for hormone refractory (castration resistant) prostate cancer. Patients with this form of late-stage prostate cancer have refractory metastases after hormonal therapy even though they may have few symptoms. Sipuleucel-T has had a complex development and approval history (as a google search will readily show). Sipuleucel-T is a mixture of white blood cells that are extracted from the patient through a process called Leukapheresis , which is routinely used to isolate white blood cells e.g. for diagnostic purposes. In the 3 days that pass between the extraction of the white blood cells from the patient and the treatment with sipuleucel-T, the mixture is activated by exposing the extracted cells to an engineered protein called PAP- GM-CSF . In this, PAP stands for prostatic acid phosphatase (Uniprot P15309 ), which is produced in high amounts by me...