Fibrosis File

IPF Medication and Research News

Gilead Sciences Inc. is halting the Phase III clinical trial of Ambrisentan in patients with idiopathic pulmonary fibrosis (IPF) “due to lack of efficacy.” The biopharma- ceutical company said the decision follows an analysis of efficacy and safety data “which did not show evidence of a treatment benefit in the group of patients that received Ambrisentan.”

Eight months after the Food and Drug Administration rejected Pirfenidone as a treatment for IPF, InterMune Inc. said it will undertake a Phase III study of the drug. The company said it would enroll the first patient in a late- stage trial of Pirfenidone (also known as Esbriet) in patients with IPF in the first half of this year. InterMune said it has a March meeting scheduled with the FDA to discuss the new study – that is required for their approval of the drug. There is no current treatment in the United States for IPF. Esbriet last month won a positive recom- mendation from a European advisory group and is expected to be marketed, starting in Germany, in the third quarter.

Another company, FibroGen Inc., based in San Fran- cisco, will also target IPF in a mid-stage study. The 48-pa- tient study will test human monoclonal antibody, FG-3019, which it has developed to combat connective tissue growth factor.

FibroGen hopes to show that blocking connective tissue growth factor, or CTGF, is key to stopping and perhaps even rolling back damage caused after injured lungs heal improperly.

Patients in the study will receive intravenous doses of FG-3019 every three weeks for 45 weeks. The trial will judge safety, tolerability and the effectiveness of the drug on the extent of lung fibrosis, lung function and shortness of breath. FG-3019 also is being studied in two Phase II studies against advanced liver fibrosis due to chronic infection with Hepatitis B virus and in patients with pancreatic cancer.

For more information on this clinical trial, go to www.clinicaltrials.gov and search for NCT01262001. You may also contact Loredie Lugos RN at 415-978-1353.

The new year is a great time to start a new exercise routine! If you do not have access to a pulmonary rehabilitation program, ask your physician which exercises would be appropriate for you. When you begin to exercise at home, start for short periods, even if for only a few minutes. Work toward a goal of exercising once a day, four to five times per week for five to 15 minutes at a time. Increase the duration of your exercise by a few minutes each time with a goal of 20 to 40 minutes of continuous exercise. Aerobic exercise like cycling, swim- ming and walking is best for the lungs, heart and circulatory system.

Resistance or strength training should be performed at light intensity for beginners with one or two repetitions. Examples of chest and shoulder exercises:

Wall Push-Ups

• Stand facing a wall with your feet about 1 to 2 feet back from The farther you stand back, the more difficult the exercise becomes.
• Place your hands on the wall a bit wider than shoulder-width
• Bending only at the elbows, lower yourself forward towards the wall then push yourself away from it, keeping your body
• Exhale while you

Seated Shoulder Presses

• Use something around the house for weight, as canned goods if you do not have one or two pound
• From a seated or standing position, hold the weights just above your
• Push weights up overhead