It was determined that after the first 30 minutes (after IV dose was administered) a rapid decline in concentration occurred, followed by a subsequent plateau once 1.5 hours had been achieved. A decline in concentration was consistently observed once 6 hours post-dose had been reached. It was also noted that with a 4X increase in dose, a 3X increase in AUC was achieved. Half-life values of 4–6 hours were noted; extravascular distribution of the drug was noted as well. Phase II
Study 980231 (Randomized, double-blind, placebo-controlled). Three dose regimens were included: "pre-post", "pre", and placebo Palifermin administration (60 micrograms/kg) by IV for three consecutive days before chemotherapy and after autologous peripheral blood progenitor cell (PBPC). Efficacy was demonstrated in the drug versus the placebo. Phase III
Study 2000162 (Randomized, double-blind, placebo-controlled). Intended to evaluate Palifermin efficacy in reducing oral mucositis in subjects with hematologic malignancy undergoing chemotherapy with autologous peripheral blood progenitor cell transplantation. Patients were administered with 3 daily, consecutive IV doses (or placebo) of Palifermin (60 micrograms/kg) before chemotherapy and Filgrastim (60 micrograms/kg) was administered after transplantation for three days consecutively. Efficacy was demonstrated in the drug versus the placebo. Costs
Palifermin costs approximately 5,000 euros per treatment for a 70 kg patient. Annual sales
The worldwide profits for years the 2008–2011 are provided below. 2008: $5.7 million
2009: $109.9 million
2010: $94.8 million
2011: $77.9 million

References
This article incorporates public domain material from Dictionary of Cancer Terms. U.S. National Cancer Institute. External links
Kepivance homepage
Encephalocraniocutaneous lipomatosis (ECCL), is a rare condition primarily affecting the brain, eyes, and skin of the head and face. It is characterized by unilateral subcutaneous and intracranial lipomas, alopecia, unilateral porencephalic cysts, epibulbar choristoma and other ophthalmic abnormalities. It was named after Haberland and Perou who first described it. Signs and Symptoms
Eighty to ninety percent of those with encephalocraniocutaneous lipomatosis are  unable to produce and keep fat tissue and have multiple lipomas. Other types of growths, including jaw tumours, may also occur.Approximately two thirds of individuals with Encephalocraniocutaneous lipomatosis have intracranial and/or intraspinal lipomas. They also have an increased risk of developing a form of brain cancer known as a glioma. Other neurological issues that can occur include seizures, spasticity and variable intellectual disability. However, approximately one third of effected individuals have typical intelligence.The most common ocular abnormality in encephalocraniocutaneous lipomatosis is a form of benign growth called a choristoma which can occur in one or both eyes. These may effect vision. Other ocular symptoms include  abnormally small eyes, small pupils, iris hypoplasia, sclerocornea, hypertrophic conjunctivae, an absent macular reflex and anterior chamber anomalies. There may be eyelid colobomas and short or abnormal palpebral fissures. Skin tags often grow around the eyelids. Cause
History
This condition was first described in 1970. See also
Nevus psiloliparus

References


== External links ==