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Drug - clinical research updates

12/31/2009

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JAK inhibitor shows promise for patients with myelofibrosis.
According to data from the largest-ever trial of patients with the incurable bone marrow disease, "Half of patients with myelofibrosis had major clinical responses to an investigational inhibitor of Janus activated kinase (JAK). A Houston oncologist also said during a press briefing at the American Society of Hematology meeting that after "follow-up for at least a year, 48% of 155 patients had greater than a 50% reduction in splenomegaly." The oncologist added, "More than 75% of the patients are still on the study after an average of 16 months, meaning the patients benefit and the drug is safe."

New approach to treating hepatitis C said to look promising.
An experimental antiviral drug that works by a different mechanism than existing drugs has been shown to suppress hepatitis C in chimpanzees," according to a paper in Science. In fact, "preliminary tests suggest that the drug, called SPC3649, has no toxic side effects, does not allow development of resistance -- which plagues other hepatitis drugs -- and has lasting effects after treatment has stopped." Apparently, "the new drug outwits the virus by targeting not the virus itself, but a short piece of RNA in cells" -- miR-122 -- "that is crucial to" replication.  

The "standard treatment is a two-drug cocktail of interferon...and ribavirin, an antiviral, which cures about half of those infected." The side effects, however, "can be grueling," and for "those who don't respond to the two-drug cocktail, there are few options." Enter the team at Southwest Foundation for Biomedical Research.  

The group "studied four chimps chronically infected with HCV genotype 1 and noted two chimps got a low dose of SPC3649, and two got a high dose, given once a week for 12 weeks. The higher-dose treatment was remarkably effective in suppressing HCV." Specifically, "HCV levels drop 350-fold in chimps treated with SPC3649." The team also pointed out that the "lower dose showed a strong but lesser effect in one chimp, but not in the other." Treatment also "made the virus much more sensitive to the antiviral effects of interferon."  

The study further reported, "also showed the technology could prove useful in the treatment of other diseases, including HIV, cancer, and inflammatory diseases." As for its current applications, the treatment, developed by Santaris Pharma A/S, is "undergoing 'human clinical trials and is currently undergoing Phase 1 clinical studies in healthy volunteers."  

Postmenopausal women taking antidepressants may be at higher stroke, death risk.
According to a study published in the J.Archives of Internal Medicine, "postmenopausal women who take anti-depressants face a small -- but statistically significant -- increased risk of a stroke." In a study "based on" data from the Women's Health Initiative Study on "136,293 women aged 50 to 79, who were followed for an average of six years," Harvard Medical School researchers found that "antidepressant users were 45% more likely to have a stroke than women not taking the" medications.  

Further, "women taking antidepressants also had a 32% higher risk of death from all causes." While "the absolute risk of stroke was very small -- 0.43% a year versus 0.3% for women not on antidepressants," the fact that "so many people take the pills" may "have a significant impact at the population level, said the scientists." Moreover, "no difference in stroke risk was found between the two major classes of antidepressant, selective serotonin reuptake inhibitors (SSRIs)...and tricyclic antidepressants." SSRIs, however, "were more associated with bleeding in the brain."  

The investigators, admitted they could not rule out the possibility of underlying depression contributing to stroke risk. Study lead author and psychiatrist Jordan Smoller, MD, stated, "While this study did find an association between antidepressants and cardiovascular events, additional research needs to be done to determine exactly what it signifies." Dr. Smoller added, "Older women taking antidepressants, like everyone else, should also work on modifying their other risk factors for cardiovascular disease, such as maintaining a healthy weight and controlling cholesterol levels and blood pressure."  

The finding underscores what women have come to learn from a wide range of studies, including several that have emerged from the Women's Health Initiative: It's important to know whether you are at high or low risk of something like stroke before allowing a study like this to sway a decision to take medication for depression, and that's a conversation to be had with a physician who knows your medical history." 
 

FDA approves longer-lasting version of Zyprexa.
Eli Lilly & Co. said regulators have approved a longer-lasting version of its top-selling drug, the anti-psychotic Zyprexa [olanzapine]." The FDA "approved Zyprexa Relprevv, an injection that can last up to four weeks, for the treatment of schizophrenia in adults." Lilly spokeswoman Janell Smith said for the new version, patients "will visit their doctors every two or four weeks -- depending on their dosage -- to receive the injection."

The approval "could bring some much-needed profit to Lilly" because the drugmaker "will lose most of the $4.7 billion a year Zyprexa now generates in revenue when cheaper generic versions of the drug hit the market two years from now." In addition, despite some initial concerns from the FDA, Lilly worked with the agency "to develop a mandatory patient care program, which restricts distribution of Zyprexa Realprevv to medical professionals or patients enrolled in the program." 

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