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Starpharma Plans Effectiveness Studies On Herpes-Killing Gel For Women- Pharmaceutical R&D updates.

6/16/2010

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Teva Announces Positive Results from a Study Assessing a New Formulation of Copaxone(R). Significantly less pain and fewer injection site reactions were reported by patients receiving the new lower volume injection. Teva Pharmaceutical Industries Ltd. announced positive results from a study assessing a new lower-volume injection of Copaxone(R) (glatiramer acetate) containing the currently approved dose in half the injection volume.  

The SONG study ('Study of New Glatiramer Acetate Formulation') explored the safety and tolerability of a 20mg/0.5mL injection of Copaxone(R) versus the current formulation of 20 mg/1.0mL. These findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas. 

"Copaxone(R) has proven long-term efficacy, safety and tolerability with more than one million patient years of treatment," said Dr. Ronald Murray, FAAN, a lead study investigator and Director of the MS Clinic of Colorado. "We are encouraged by these data as they suggest that a 0.5mL dose of glatiramer acetate may enhance patients' experience with the most frequently prescribed MS therapy." 


Bevacizumab May Improve Some Outcomes In Advanced Gastric Cancers.MedPage Today  reported that "bevacizumab (Avastin) may improve some outcomes in advanced gastric cancers, but it did not benefit overall survival, according to a major international clinical trial reported" at the American Society of Clinical Oncology annual meeting. Researchers found, "in the phase III AVAGAST clinical trial, conducted among more than 770 patients," that "adding the monoclonal antibody bevacizumab to standard chemotherapy tended to be associated with a 13% reduction in risk of death from any cause, but the two-month survival advantage was not significant compared with chemotherapy alone." But, "bevacizumab produced significant benefits in progression-free survival and response rates," the researchers reported.
http://www.medpagetoday.com/MeetingCoverage/ASCO/20582

 
Erlotinib May Prolong Survival In Older Women With Advanced Non-Small Cell Lung Cancer.
MedPage Today  reported that "the targeted agent erlotinib (Tarceva) prolonged survival by 26% in older women with advanced non-small cell lung cancer, but did not benefit men with the disease," according to research presented at the American Society of Clinical Oncology annual meeting. Investigators found, "in the randomized clinical trial, conducted among 670 patients (median age 77)," that "erlotinib also markedly extended the time before relapse in women." However, "men in the study saw no benefit either in overall survival or progression-free survival."
http://www.medpagetoday.com/MeetingCoverage/ASCO/20581

 
Mapatumumab Fails In Midstage Study.
"Human Genome Sciences's potential cancer drug mapatumumab failed in a midstage study. The company found "no difference in disease response or progression-free survival rates between patients receiving the drug for multiple myeloma and the control group. The drug was studied in combination with bortezomib for the study.


Rosiglitazone, Metformin Low-Dose Combination May Reduce Progression To Type 2 Diabetes.
The Los Angeles Times  reported, "A combination of low doses of the diabetes drugs Avandia [rosiglitazone] and metformin can reduce the progression to type 2 diabetes by two-thirds in people who are at high risk of developing the disease," according to a study published online  in The Lancet. In fact, "the benefit is greater than with either of the drugs used alone, and the combination has fewer side effects." For the study, researchers at the University of Toronto "enrolled 207 patients with impaired glucose tolerance, randomly assigning half to take the combination and half to take a placebo," then followed them for almost four years.  

HealthDay  reported that not only did the study find "that the risk of developing type 2 diabetes was reduced by two-thirds in those taking the drug combo compared to those on placebo," but also that "using half of the maximum dose was extremely effective for preventing type 2 diabetes." Moreover, "the drug combination appeared to counteract the weight gain that's common with Avandia therapy alone," and with relatively few side effects.  

"The dosages used in the study were 2 milligrams of Avandia plus 500 milligrams of metformin. There is no evidence whatsoever that lower doses of [Avandia] are 'safe’. Any suggestion that serious cardiovascular toxicity can be avoided by using a small dose represents pure speculation at best." According to MedPage Today , an accompanying editorial also "cautioned that the 'larger issues that have cast doubt on use of drugs to prevent diabetes are not addressed by the'" study.

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