Originally published October 3 2005
Avastin's side effects prompt Genentech to close its clinical trial
by Mike Adams, the Health Ranger, NaturalNews Editor
Genentech Inc., developing the ovarian cancer drug Avastin, halted its small trial of the drug because of a high percentage of bowel rupture among study participants.
Genentech Inc. has stopped enrolling women with ovarian cancer in a small clinical trial of its drug Avastin because an unexpectedly high percentage of participants suffered ruptures of the bowel, a known side effect of the treatment.
The trial subjects may have been more vulnerable to gastrointestinal complications because they were at a more advanced stage of the disease than subjects in previous ovarian cancer trials, the South San Francisco biotechnology giant said in an announcement Friday.
Avastin, a humanized monoclonal antibody, battles tumors with a mechanism unique in cancer treatment.
It is designed to prevent the development of new blood vessels to nourish tumor growth.
Since its approval for colon cancer treatment in 2004, it has helped fuel Genentech's revenue growth and its significant share price gains.
Genentech, betting that Avastin's mode of action will make it useful in a wide range of cancers, is conducting trials in kidney, breast, lung and other tumor types.
But Avastin's molecular strategy can also interfere with healthy processes involving the blood vessels, including cardiovascular function and the healing of wounds.
It carries an increased risk of congestive heart failure and stroke -- risks that are balanced against the chance of treating a life-threatening cancer.
Such ruptures often occur in ovarian cancer patients because the disease spreads to the bowel, oncologists say.
The other possibility is that Avastin caused tumors in the bowel to shrink or die, leaving a hole.
Until more is known about the safe use of Avastin, doctors should not prescribe it indiscriminately beyond its FDA-approved uses, said Dr. Alan Venook, a professor of clinical medicine at UCSF who has studied Avastin in trials funded by Genentech and other sponsors.
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