Cancer Drug

EntreMed Inc. said yesterday that it has received permission from the Food and Drug Administration to begin testing one of its much anticipated experimental anti-cancer drugs in humans, and expects the small trial to begin in September.The Rockville biotechnology company had not planned to seek FDA approval to test its Endostatin protein until September at the earliest. The experimental drug has shown promise in animal studies by blocking tumor growth.Dr. John W. Holaday, EntreMed's chairman, president and chief executive officer, said the company was able to move up the time frame because of an "aggressive development schedule," which included completing and compiling data from required animal testing earlier than anticipated.

Hospitals across the nation are recruiting women for a large study to determine whether a drug used to prevent osteoporosis is a safer alternative to tamoxifen in preventing breast cancer.The study, involving numerous hospitals in metropolitan Baltimore, should answer the question of whether the drug, raloxifene, prevents breast cancer without increasing the risk of uterine cancer and other ills.About a year ago, doctors concluding a major national trial reported that tamoxifen, long used to treat existing breast cancers, reduced by half the incidence of new cancers in women considered at high risk for the disease.

EntreMed Inc. said yesterday that it expects to begin human trials of its anti-cancer drug Endostatin this fall, launching a process that will answer at last whether the experimental treatment is a breakthrough drug for the illness.EntreMed and the National Cancer Institute, which is assisting EntreMed with the study and development of Endostatin, plan to test the compound on a broad range of cancer patients, as is normally done with promising new cancer treatments. The NCI said it plans to test the drug on patients with advanced solid tumors, including patients diagnosed with cancers of the breast, prostate and colon, as well as lung lymphomas.

EntreMed Inc., the Rockville biotechnology company whose experimental anti-cancer drugs generated widespread news coverage and controversy last year, reported yesterday that its fourth-quarter and annual loss more than doubled as the company stepped up development efforts.For the three months that ended Dec. 31, EntreMed posted a loss of $4.6 million, or 35 cents per share, compared with a $2.1 million loss, or 17 cents per share, a year ago. Revenue was $1.5 million, up from $1.3 million.

Enthused by evidence that the drug tamoxifen prevents breast cancer in some women, physicians nonetheless cautioned yesterday that women must weigh the potential side effects before deciding to take the medication.Doctors agreed that the news could hardly have been better in light of past failures to stem disease rates: A study, reported yesterday, showed that the drug cut the rate of breast cancer by almost half for women at high risk. Tamoxifen is the first drug ever shown to prevent the disease, which kills some 44,000 women in the United States each year.

PHILADELPHIA -- Tamoxifen, a drug widely used to treat breast cancer patients, shows that it can reduce the incidence of the disease by nearly half among healthy women at increased risk, according to a landmark study.Letters announcing the breakthrough have gone out to the 13,000 women in the United States and Canada who kept on with the Breast Cancer Prevention Trial despite controversy over its risks and benefits."Based on the most recent analysis of the data, this is now the first study in the world to show that a drug can reduce the incidence of breast cancer," the letter says.

BETHESDA -- Bristol-Myers Squibb Co. won the support of government medical experts yesterday to expand the approved uses of its $900 million Taxol cancer drug to include advanced, usually fatal, forms of lung and ovarian cancer.A Food and Drug Administration advisory panel recommended use of the drug for lung cancer patients who cannot be cured by radiation or surgery and as a primary weapon in the treatment of advanced ovarian cancer.Panel members said they were impressed by studies for both new uses that show adding the drug into treatment regimens could extend the lives of patients suffering from the usually terminal advanced forms of the diseases.

Cel-Sci Corp., a biotechnology company with research and development offices in Baltimore, said that three more medical institutions have agreed to participate in clinical testing of Multikine, an anti-cancer drug developed by the company.The new institutions are Wayne State University in Detroit; Sir Mortimer B. Davis Jewish General Hospital/Lady Davis Institute for Medical Research in Montreal; and Hamilton Regional Cancer Centre, in Hamilton, Canada.Those institutions join Hotel Dieu de Montreal Hospital in Montreal, which was the first to agree to participate in the study.

A Baltimore biotechnology company yesterday won the next-to-last federal approval needed to commercialize its cancer-fighting brain implant, and Guilford Pharmaceuticals Inc. said it will press for final approval early next year.Guilford said the Food and Drug Administration approved a "treatment investigational new drug" application for thecompany's Gliadel brain implant. The product is a wafer saturated with chemotherapy drugs that surgeons implant in the cavity left in a patient's brain upon removal of a malignant tumor.

Guilford Pharmaceuticals Inc. of Baltimore said yesterday that it has asked the U.S. Food and Drug Administration for limited marketing approval for its Gliadel cancer drug implant, which is designed to fight relapses of brain cancer.The company said it filed an investigational new drug application, which, if approved, would allow the 2-year old firm to give Gliadel to a limited number of patients outside the setting of an organized clinical trial while Guilford pursues full FDA marketing approval.