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Genta's Genasense fails to meet co-primary endpoint of Phase III advanced melanoma trial
What's This?
Genta Inc.'s investigational cancer agent Genasense (oblimersen sodium) failed to meet the co-primary endpoint of progression-free survival in a Phase III study that included patients with advanced melanoma. The double-blind AGENDA trial included treatment-naive individuals with unresectable, progressive melanoma. All of the participants had low-normal baseline levels of the biomarker lactate dehydrogenase, a parameter associated with improved outcomes in a previous trial. The patients...
Genta Inc.'s investigational cancer agent Genasense (oblimersen sodium) failed to meet the co-primary endpoint of progression-free survival in a Phase III study that included patients with advanced melanoma.
The double-blind AGENDA trial included treatment-naive individuals with unresectable, progressive melanoma. All of the participants had low-normal baseline levels of the biomarker lactate dehydrogenase, a parameter associated with improved outcomes in a previous trial. The patients were randomized to receive dacarbazine plus Genasense or placebo.
Treatment with Genasense did not demonstrate statistical significance on the co-primary endpoint of progression-free survival, Genta said, adding that not enough time had passed to evaluate the other primary endpoint of overall survival. However, the company said that the study passed a futility analysis for overall survival.
The drug also failed to meet the secondary endpoints of overall response rate and disease control rate; more data are needed before durable response, also a secondary endpoint, can be assessed, the firm added.
"The prospectively specified analyses for both overall survival and durable response will be conducted when the data are mature," Genta noted.
The company could not predict whether more mature data would demonstrate a benefit in overall survival or durable response but said the findings for progression-free survival would hinder it from submitting an application for marketing approval this year.
Genta is conducting an ongoing evaluation of the AGENDA data and the data's affect on the company's strategic direction. It plans to provide more detailed study findings in Boston at next month's Molecular Targets and Cancer Therapeutics conference, which is jointly sponsored by the American Association for Cancer Research, the National Cancer Institute and the European Organisation for Research and Treatment of Cancer.
Shares of Genta closed at $0.20, down $0.46, or 70 percent, in heavy volume on the OTC Bulletin Board.
This information concerns a use that has not been approved by the Food and Drug Administration.
Psoriatic arthritis linked with clinical, economic burden, data reveal 
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Despite current treatment options, patients with psoriatic arthritis (PsA) exhibit increased rates of comorbidities, reduced quality of life (QoL), heavy medical resource use, decreased work productivity and impaired activity relative to subjects without PsA, new research shows.Investigators used patient-reported data from the 2008 National Health and Wellness Survey to evaluate 413 individuals with PsA and 62,587 individuals with no diagnosis of PsA. Approximately half of the...
Patients with psoriasis use more health care services, incur higher costs as compared with general population, analysis reveals
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Relative to the general population, patients with psoriasis use more medical services and incur greater costs, according to new study findings, and the severity of the condition appears to have a correlation with usage and costs. Investigators compared 2003 claims data for 56,528 patients with psoriasis and a control sample matched 2:1 on baseline demographics.
Results of the analysis revealed significantly higher utilization of health care resources, medical...
High prevalence of other autoimmune diseases found in patients with psoriasis, psoriatic arthritis, research reveals
What's This?
Psoriasis and psoriatic arthritis may be linked to the development of other autoimmune diseases, such as Crohn's disease, new findings suggest. Researchers evaluated the prevalence of other inflammatory autoimmune diseases in nearly 22,500 patients aged 18 years or older with psoriasis, 3,066 patients with psoriatic arthritis and more than 100,000 matching control patients. All the subjects were continuously enrolled in IMS Health Inc.'s Health Integrated Administrative Claims...
Probiotics may reduce risk of eczema among at-risk infants, preliminary study suggests
What's This?
Treatment with certain probiotics prenatally and in the first years of life may offer infants at risk for allergies protection from eczema, a new study suggests.Scientists do not yet have a clear understanding of the role probiotics may play in the prevention of allergic disease. To gain insights, researchers in New Zealand set out to determine whether probiotic supplementation early in life could prevent development of eczema and atopy at 2 years. In their double-blind,...
- Patients with psoriasis use more health care services, incur higher costs as compared with general population, analysis reveals
- Genta's Genasense fails to meet co-primary endpoint of Phase III advanced melanoma trial
- High prevalence of other autoimmune diseases found in patients with psoriasis, psoriatic arthritis, research reveals
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- Psoriatic arthritis linked with clinical, economic burden, data reveal
- Omiganan 2.5% gel shows promise in Phase II rosacea trial
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