Amgen drug slows bone loss in cancer patients

	Tweet

Amgen Inc. said on Sunday that early results from mid-stage trials of its experimental drug denosumab show that it works at least as well as current therapies to limit bone loss in patients with late-stage cancer.

A study investigator said that the product, seen as one of Amgen’s most promising, was not able to show at this point in time that it is more effective than existing drugs, called bisphosphonates.

“There are hints that this drug is very, very active. We would hope that a phase III trial would show that it works better than bisphosphonates, but we can’t say that now,” said Dr. Allan Lipton, professor of medicine/oncology at Penn State University and an investigator in both Amgen studies.

Each year, more than 400,000 U.S. cancer patients, often those with breast or prostate cancer, have the disease spread to their bones, leading to pain, fractures and the need for surgery.

Currently, they are treated with intravenous bisphosphonates drugs, including Novartis AG’s Zometa and Aredia, which help in about a third of cases, Lipton said.

Denosumab, which is also being developed for treatment of osteoporosis, is an antibody designed to turn off the genetic switch that triggers bone-chewing cells called osteoclasts.

In the first study, which involved different doses of denosumab in breast cancer patients not previously treated with bisphosphonates, researchers saw as much as an 82 percent decrease in a urinary marker that tracks bone loss after 13 weeks.

Bisphosphonate-treated patients saw a 79-percent drop in the marker, said Amgen, which reported the results at a meeting of the American Society of Clinical Oncology in Atlanta

In a separate phase III study of 49 prostate, breast, and multiple myeloma patients already on IV bisphosphonates but not responding to them, twice as many patients achieved normal levels of bone turnover when they were switched to denosumab, the company said.

After 13 weeks, 76 percent of denosumab patients achieved normal levels of bone turnover, compared with 38 percent of patients who remained on the IV bisphosphonate,

Side effects of denosumab included nausea, vomiting, weakness and diarrhea, while side effects for bisphosphonate-treated patients included infection-induced fever, joint pain, and bone pain.

Zometa and Aredia, as well as oral bisphosphonates, have been linked to a serious side effect known as osteonecrosis, or death of areas of bone in the jaw.

Preliminary data on denosumab, which has a different mechanism of action than those drugs, show no indication of a similar problem, said Amgen spokeswoman Kerry Beth Daly.

She added that the company’s clinical program is ongoing and the drug’s safety profile won’t be clear until pivotal phase III data are out.

“The hope in the future is that this class of drugs may be able to prevent bone metastases,” Lipton said.

Amgen is currently conducting several trials of denosumab, including studies of bone cancer prevention. The first phase III results for the drug, in osteoporosis, are expected in 2008.

RELATED STORIES:
Music Therapy Helps Relieve Anxiety of Cancer   Anti-Cancer Agent Stops Metastasis in Its Tracks   New attack on cancer forces cells to grow old & die   New Research Suggests Ways to Improve Cancer Therapy   Team Identifies New Cancer Stem Cell Driving Metastatic Tumors   Study shows gene positions may aid cancer diagnosis   Combining NSAIDs with chemotherapy, radiation may improve cancer treatment   Experts say 40 percent of cancers could be prevented   Custom-made cancer cell attacks   Rate of Secondary Cancers Increases Over Years After Treatment for Childhood Leukemia   Broccoli, cauliflower and cabbage help repair damaged DNA   Green tea extract may boost cancer-fighting enzymes   Moderate activity may reduce ovarian cancer risk   Study Predicts Dramatic Growth in Cancer Rates Among U.S. Elderly, Minorities   Botox Could Help Target Resistant Tumors for Treatment   Study suggests a way to eliminate glioblastoma   Many cancer survivors still smoking and drinking   Most patients want cancer prognosis test   Hepatitis C: a risk factor for lymphoma   Radiation after surgery reduces chance of melanoma returning   Gene test for cancers could mean more effective, tailored-made treatment   Few people are doing it, so why should I? Motivating men to seek cancer screening

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]