Celgene Corp. announced Dec. 15 that "its experimental psoriasis treatment, apremilast, met key goals in a midstage clinical trial." Specifically, the drug "reduced the severity of moderate-to-severe psoriasis" in "41 percent of patients receiving the 30-milligram dose...compared with only six percent taking placebo." The company may "advance the drug candidate to late-stage development in 2010. It reported that if apremilast is successful, it will compete against the injectable TNF-inhibitor Enbrel (etanercept). Enbrel is manufactured by Amgen, Inc.
Gilead's hypertension treatment candidate fails to meet main trial goal.
Gilead Sciences, Inc. said that its high blood pressure treatment candidate, darusentan, failed to meet the main goal of a late-stage clinical trial when compared to a placebo." Company executives found the result "disappointing, and...think it would be challenging to define an expedient path forward”.
Bevacizumab plus chemotherapy may modestly improve survival in metastatic breast cancer.
According to findings from two trials reported at the San Antonio Breast Cancer, Bevacizumab (Avastin) only modestly improves progression-free survival for metastatic breast cancer when added to chemotherapy. In both trials, researchers found that "the gain was statistically significant, but averaged only one to two months compared with chemotherapy alone." Furthermore, "neither trial showed a significant survival advantage with the addition of the biologic agent." The researchers noted that "given the drug's expense -- roughly $30,000 to $40,000 a month," bevacizumab is "definitely not a home run."
Tarenflurbil appears to have no effect on cognition, activities of daily living in early Alzheimer's.
According to a study published Dec. 16 in the Journal of the American Medical Association, "tarenflurbil (Flurizan, Myriad Genetics), a gamma-secretase modulator, has no effect on cognition or activities of daily living (ADL)...in patients with mild" Alzheimer's disease. In a "large phase 3, randomized, placebo-controlled trial" of 1,684 patients with mild Alzheimer's disease, Boston University School of Medicine researchers found "virtually no difference between patients receiving active therapy vs. placebo controls at 18 months in either coprimary endpoints of cognition or ADL." They also found "no differences between the two treatment groups on secondary outcome measures."
FDA approves olanzapine for adolescents with schizophrenia, bipolar disorder. Eli Lilly & Co. the FDA approved "its best-selling medication Zyprexa [olanzapine] for adolescents with schizophrenia and" bipolar disorder. Specifically, the agency "approved the drug for adolescents aged 13 to 17 years old, but cautioned that the" medicine "can cause weight gain and high blood sugar in younger patients."
FDA however supposedly recommended doctors consider prescribing it after other medicines because of its side effects," because olanzapine "has been linked to weight gain and metabolic changes in adolescents." In June, "outside advisers to the FDA ruled...that Zyprexa was 'acceptably safe' for teens who don't improve with other treatments."
FDA extends review of Nuvigil for jet lag by three months.
FDA extended its review of Cephalon Inc.'s drug Nuvigil [armodafinil] as a treatment for jet lag by three months. According to Cephalon, after it submitted new information about Nuvigil, "the agency decided it needed more time to review its application." A decision is expected by March 29, 2010.
Shionogi to stick with velneperit despite failed study.
Japanese drugmaker Shionogi & Co. "plans to stick with velneperit, an experimental obesity drug, after one of two key studies failed and Merck & Co., Johnson & Johnson and GlaxoSmithKline Plc abandoned similar treatments." In one clinical test, the company found that "35 percent of patients on a restricted diet who took velneperit for 54 weeks lost more than five percent of their weight, almost three times the proportion for those who were given a dummy pill." But, "in the other test, there was little weight-loss difference between patients taking the drug and those on placebo." The drugmaker said "it is sticking with velneperit because the treatment shows more promise than Merck's MK-0557."
Vitamin E extract may shrink tumors within 24 hours.
A vitamin jab that shrinks tumors in a day is being hailed as a powerful new treatment for cancer. Researchers at the University of Glasgow and the University of Strathclyde found that "injecting an extract of vitamin E," called tocotrienol, "into the bloodstream" shrank tumors "within 24 hours...and after ten days they had almost completely disappeared." The study targeted skin cancers by disguising tocotrienol "inside thousands of microscopic bubbles made from fat," which travelled "through the body without damaging healthy cells."