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Herpes Drug Acyclovir Does Not Reduce Risk Of HIV Transmission, Does Slow HIV Progression, Study Says
The drug acyclovir, which suppresses herpes simplex virus-2, does not reduce the risk of HIV transmission when taken by HIV-positive people who also have herpes, according to a study conducted by researchers at the University of Washington, United Press International reports. According to United Press International, genital ulcers associated with HSV-2 are known to increase the risk of HIV transmission. The study was conducted among 3,408 discordant couples, in which one member is HIV-positive and the other is not, at 14 sites in seven African countries: Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda and Zambia. The primary results of the study found that 41 new HIV cases occurred in the couples in which the HIV-positive member took acyclovir, compared with 43 new infections among the couples who did not take the drug. The results were not statistically significant, according to the researchers (United Press International, 5/13). However, the study did find that acyclovir can slow progression of HIV by 17% in HIV-positive people who also have HSV-2 and whose CD4+ T cell counts are too high to begin antiretroviral therapy. "Although the primary outcome of reducing HIV transmission was not observed, the study yielded important information that will inform HIV prevention research in a number of ways," Connie Celum, a professor of global health and medicine at the University of Washington"s Division of Allergy and Infectious Diseases, said. She added that the "findings will bear fruit for both the HIV prevention and vaccine fields for years to come." The study, called the Partners in Prevention HSV/HIV Transmission Study, was funded by the Bill & Melinda Gates Foundation (University of Washington release, 5/8).
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Stop Seeing Red By Looking Through Blue-Tinted Lenses, UK
As the UK enters a summer of discontent, one company has a vision to make the outlook decidedly brighter - by looking at life through blue-tinted spectacles.
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UNICEF: Children And Women Displaced By Conflict In Pakistan Need Urgent And Ongoing Support
UNICEF is deeply concerned about the condition of thousands of children who have been displaced by conflict, or who remain in affected areas, in north-western Pakistan. Nearly 50 per cent of the estimated 2 million displaced are children, many of whom are in urgent need of health and educational services, nutritional support, access to clean water and sanitation as well as protection. Their situation has been compounded by the harsh summer temperatures.
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Plexxikon Announces PLX4032 Phase 1 Data Showing Objective Responses In Metastatic Melanoma Patients

Plexxikon Inc. today announced preliminary data from a Phase 1 clinical study investigating PLX4032 (R7204). PLX4032 is a novel, oral and highly selective drug that targets the BRAFV600E cancer-causing mutation that occurs in most melanomas and about eight percent of all solid tumors. In patients whose cancer harbors this mutation and who were treated with therapeutic doses of PLX4032, tumor shrinkage and extended progression-free survival have been observed. Currently, two extension studies are being conducted in mutation-positive melanoma and colorectal cancer patients. Following the initial positive findings announced today, larger clinical trials to support a registration program for product approval are targeted to start later in 2009. Plexxikon and Roche are co-developing PLX4032 under their 2006 license and collaboration agreement. "PLX4032 has shown both tumor shrinkage and delay in tumor progression in patients whose tumors harbor a BRAF mutation as well as reports of clinical symptom improvement in some patients," stated Keith T. Flaherty, M.D., assistant professor at the Abramson Cancer Center of the University of Pennsylvania and principal investigator for the PLX4032 Phase 1 clinical trial. "Seven years after BRAF mutations were first identified, we have validation that this mutation is a cancer driver and therapeutic target. This is a new and important chapter in the story of targeted therapy development in cancer, and we are especially excited for our melanoma patients, for whom there are currently few treatment options." Link to video clip of Dr. Flaherty In the dose escalation phase of the study, 55 cancer patients have been treated, including 24 mutation-positive melanoma patients and 3 mutation-positive thyroid patients, as well as 28 melanoma, rectal and ovarian cancer patients who did not have the mutation or whose mutation status was not known. In 16 BRAF mutation-positive melanoma patients treated with PLX4032 doses at or above 240 mg twice daily (BID), representing targeted drug exposure levels, data show: - PLX4032 is well tolerated at very high doses, with 960 mg BID under evaluation as the maximum tolerated dose - Partial responses in 9 patients showing greater than 30% tumor regression by RECIST (Response Evaluation Criteria in Solid Tumors) criteria, with 7 confirmed - Regression of metastatic lesions in every site to which melanoma commonly spreads, including liver, lung and bone - Minor responses in 4 patients showing tumor regression greater than 10% but less than 30% - Disease control lasting up to 14 months with continuous therapy, with many patients still receiving treatment - Interim median progression-free survival of at least six months, with many responding patients still receiving treatment By contrast, no treatment response was observed in a small group of patients without the mutation, and progression-free survival was less than 2 months, consistent with historical data. Dose-limiting toxicities, primarily rash, fatigue and joint pains, were seen at 1120 mg BID. Drug-related adverse events have been predominantly mild in severity and transient, including rash and photosensitivity. Serious adverse events were observed in some patients after chronic treatment, including possibly drug-related cutaneous squamous cell carcinoma. A risk management plan has been implemented for baseline evaluation of the skin and monitoring of all patients while on study. Cutaneous squamous cell carcinoma is typically excised by a patient"s dermatologist. "This is a significant day for us at Plexxikon. The clinical data for PLX4032 so far support our hypothesis that a truly selective drug can target tumors harboring this cancer-causing mutation, while at the same time, deliver a treatment that is well tolerated by patients," stated K. Peter Hirth, Ph.D., chief executive officer of Plexxikon. "In conjunction with bio-response markers and a companion diagnostic test, PLX4032 has all the hallmarks of an ideal personalized medicine. Plexxikon"s pipeline includes several highly selective kinase inhibitors, including novel therapies for other cancers as well as other chronic diseases such as rheumatoid arthritis where such precision is anticipated to provide a safety advantage." Companion Diagnostic in Parallel Development Along with the development of PLX4032 therapy, a diagnostic test to identify patients with the BRAF mutation is being co-developed by Plexxikon and Roche, under a separate 2005 agreement. This test is already being used to identify mutation-positive patients for ongoing clinical trials. Most importantly, this companion diagnostic enables the identification of mutation-positive cancer patients considered most likely to respond to PLX4032 treatment. Exploring PLX4032 in Colorectal and Other Cancers The prevalence of the BRAF mutation is about eight percent of all solid tumors. Preclinical studies in colorectal cancer models also suggest that PLX4032 causes tumor regression, either as a single agent or in combination. Hence, future clinical trials may evaluate PLX4032 in tumor types beyond melanoma. Currently, one of two extension cohorts is recruiting mutation-positive colorectal cancer patients in order to evaluate PLX4032 in this target population. In a retrospective study of 600 patients with colorectal cancer, including all stages and both genders, tumor tissue was tested for the presence of the BRAF mutation and correlated with outcomes. The data confirmed that approximately 10 percent of colorectal cancer patients carry this mutation, which is independent of the KRAS mutation, and those BRAF mutation-positive patients have a much poorer prognosis than patients with wild-type BRAF (ASCO 2009 Abstract #1103). Additionally, in the Phase 1 dose escalation study which enrolled patients with several different tumor types, one mutation-positive thyroid patient showed a confirmed partial response, while two others showed stable disease with prolonged therapy. Biomarkers Enhance Development of Personalized Medicine The development of PLX4032 has employed a variety of translational tools, including bio-response markers and an in vitro diagnostic test. These tools can potentially enable early detection of targeted pathway modulation and treatment response, as well as identification of the targeted patient population for this treatment. Biomarker data from patient tumor biopsies before and after PLX4032 treatment showed early target modulation and when dosed at higher levels, have shown nearly complete inhibition of the desired target (ASCO 2009 Abstract #9021). About PLX4032 (R7204)-A Personalized Medicine for Cancer Treatment PLX4032 is a novel, oral small molecule for the treatment of melanoma and other cancers harboring the V600E mutation of the BRAF kinase gene. This defect is present in approximately 60 percent of melanoma skin cancers, and occurs in about eight percent of all solid tumors, including melanoma, colorectal, thyroid and other cancers. Preclinical data suggest that Plexxikon"s novel anti-cancer compound selectively targets and inhibits tumor cells which contain this cancer-causing mutation. In contrast to many other kinase inhibitors available, PLX4032 is highly selective for its primary target, and does not have significant activity on other kinase targets. About Melanoma Melanoma is the most serious type of skin cancer. More than 50,000 people in the U.S. are diagnosed with melanoma each year, but the percentage of people in the U.S. who develop melanoma has more than doubled in the past 30 years. Worldwide, about 160,000 new cases of melanoma are diagnosed annually. Melanoma is treatable if caught early but is very deadly when it becomes metastatic. The median progression-free survival for a patient with metastatic melanoma is less than 60 days, and the median overall survival for these patients is less than 12 months. Patients who develop metastatic disease are rarely cured with available treatments. About Roche Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world"s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche"s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.com. Plexxikon


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