Amgen says higher death risk seen in Aranesp trial

Amgen Inc. disclosed negative findings in studies of its Aranesp anemia drug and Vectibix colon cancer treatment, including a higher risk of death among cancer patients not undergoing chemotherapy who were treated with Aranesp.

"There was a statistically significant increased risk of death in the Aranesp-treated group," Amgen said in a release, although no specific unexplained safety concerns could be identified in the late-stage trial. It involved patients with anemia and active cancer who were not receiving chemotherapy or radiation.

"These were patients with an especially dire prognosis," said Roger Perlmutter, Amgen's executive vice president of research and development.

The company said that at the end of 16 weeks, the trial showed no statistically significant difference in the frequency of blood transfusions in the population receiving placebo injections as opposed to those receiving Aranesp.

Perlmutter said the data provides "a lot of hypotheses to test," and Amgen is conducting further studies.


AMGN is down over 4% in todays late afternoon trading to $71.62 per share.

What is Aranesp and how does it work?
Patients with anemia often need blood transfusions to restore their levels of hemoglobin, the red component of blood that carries oxygen to the rest of the body. Aranesp is a recombinant human protein made in the laboratory that is very similar to the protein erythropoietin that your body makes. It is a type of growth factor that stimulates red blood cells to be made. It's mechanism of action is the same as natural RBC production: release from the kidney in response to hypoxia and cell release from the bone marrow.

What about Vectibix?
Vectibix is another humanized monoclonal antibody treatment directed towards certain cancers. Panitumumab is the antibody name and is made in the laboratory. It binds specifically to the human Epidermal Growth Factor Receptor (EGFR). Overexpression of EGFR is detected in many human cancers, including those of the colon and rectum. When Vectibix binds to EGFR it competitively inhibits the binding of ligands for EGFR. This results in inhibition of cell growth, induction of apoptosis [cell death], decreased pro-inflammatory cytokine and vascular growth factor production.