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Drug-clinical research updates

12/25/2009

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Boehringer to announce trial results of female desire drug.
Boehringer Ingelheim GmbH "is putting the finishing touches on a pill designed to reawaken desire by blunting female inhibitions." The company has been studying the drug compound, called Flibanserin, "for more than a decade and it has yet to publish clinical test results showing the drug is effective." It is said to announce data from trials of more than 5,000 European and US women "at the European Society for Sexual Medicine conference." The main criterion for the clinical trials...was how many 'satisfying sexual events' women said they had experienced after starting treatment."

Pentamidine may combat genetic defects leading to type 1 myotonic dystrophy.
University of Oregon chemist J. Andrew Berglund reported that researchers "tested the drug pentamidine in mice and found that it appears to combat genetic defects that lead to type 1 myotonic dystrophy, one of nine types of muscular dystrophy," and "also known as DM1 and Steinart's disease." Further, the levels used in mice "would be poisonous in humans," but "could be modified." Pentamidine "is approved to treat several conditions, including a severe type of pneumonia in people with compromised immune systems, some yeast infections and sleeping sickness."

Fixed-dose combination of fluticasone reduces serious asthma exacerbations, costs.
According to Richard H. Stanford, PharmD, director of US Health Outcomes at GlaxoSmithKline, and colleagues, "Asthmatic children treated with a fixed-dose combination of fluticasone propionate plus salmeterol [Advair] experienced fewer serious asthma exacerbations and lower costs than those treated with inhaled corticosteroids plus montelukast," Specifically, the "use of fluticasone propionate plus salmeterol was associated with a 96 percent reduced risk of having an asthma related inpatient hospital visit and a 56 percent lower risk of having an inpatient visit or an emergency department visit compared with treatment with inhaled corticosteroids and montelukast."

Leukemia drug may limit growth of ovarian cancer cells.
A study published in British Medical Journal reported, "A drug for people with a form of leukemia holds promise as a possible treatment for ovarian cancer". The drug, dasatinib, is currently "used to treat chronic myeloid leukemia," but researchers found that the treatment "limited the growth and invasive powers of ovarian cancer cells." Dasatinib also "proved to have even more cancer-fighting powers when it was combined with chemotherapy and used to fight certain kinds of ovarian cancer cells known as Src dependent."

Researchers noted that the findings may help "predict response to" dasatinib.
 
Early data for ALS drug candidate shows improved muscle function. Sangamo Biosciences Inc. reported that early data from a clinical trial shows its Lou Gehrig's disease drug candidate," SB-509, "improved patients' muscle function." Patients injected with the drug "were about twice as likely to have improved muscular function," according to Sangamo. Specifically, "32 percent of patients who received SB-509 had improved muscle function, compared to 17 percent of patients who took standard treatments." The company "is also testing SB-509 as a treatment for diabetic neuropathy."

Patients who take statins may not immediately require therapy for CLL.
According to research presented at the American Society of Hematology meeting,patients who are taking statins to reduce cholesterol when they're diagnosed with chronic lymphocytic leukemia (CLL) may be less likely to need treatment for the cancer,". The analysis of data on 254 patients taking statins showed that "therapy for" CLL "was not immediately required in 132 (52 percent) patients." But, researchers noted that "even though patients taking a statin at the time of diagnosis were less likely to ever require therapy, statin use was not associated with a significant improvement in overall or treatment-free survival." Furthermore, "the researchers said they did not find any significant correlation between the need for treatment and total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, or triglyceride levels at diagnosis."

Generic version of Alzheimer's medication receives FDA approval.
Reports from the US Food and Drug Administration "has approved the first generic version of an orally disintegrating tablet containing the Alzheimer's-related dementia drug donepezil (Aricept); the approval of the application by Mutual Pharmaceutical covered 5 and 10 mg dosages."

Drug candidate to treat Peyronie's disease yields mixed results in midstage trial.
Auxilium Pharmaceuticals Inc. Reported that its drug candidate Xiaflex (collagenase clostridium histolyticum) to treat Peyronie's disease , improved the condition in 29.7 percent of patients after 36 weeks, compared with 11 percent of patients taking placebo in a midstage study. Still, the company said there were no statistically significant results in the drug's effectiveness at reducing patients' pain, intercourse coonstraint and discomfort during intercourse." The company expects to meet with the FDA "during the second quarter of 2010 to discuss a proposed late-stage study." 
      
Hepatitis C drug candidate shows positive proof-of-concept results in early study.
Achillion Pharmaceuticals Inc. Reported that its hepatitis C drug candidate showed positive 'proof-of-concept' results, while meeting safety and tolerability goals in an early-stage study." Achillion said the drug candidate, called ACH-1625, "reduced levels of the virus in patients taking the five-day course." The AP adds, "Enrollment in the study is still ongoing and is expected to reach 54 patients." The company also "said it expects to share additional data on the study in early January, with full data set for a presentation in April at the European Association for the Study of Liver Disease meeting in Vienna." 

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