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Opposition To Abortion Rights 'Purity Test For Remaining In GOP Inner Circle,' Opinion Piece Says
People "will not be surprised" by the recent Republican "purge" and "un-eulogies" of several conservative abortion-rights supporters -- including retiring Supreme Court Justice David Souter, former Republican Sen. Arlen Specter (D-Penn.) and former Secretary of State Colin Powell -- given that "abortion is the purity test for remaining in the GOP inner circle," syndicated columnist Ellen Goodman writes in a Memphis Commercial Appeal opinion piece. The U.S. is "in for another battle centered, again, on Roe v. Wade" as President Obama nominates a replacement for Souter, she writes, adding that the "purge has led me to wonder what would have happened if the first abortion case to arrive at the Supreme Court" were Struck v. Secretary of Defense, rather than Roe. "What if it had been brought by the woman who did not want an abortion?" Goodman writes, noting that Justice Ruth Bader Ginsberg has recently "mused out loud about the case that got away -- the one she would have liked to argue before the court back when she was a women"s rights litigator."According to Goodman, Susan Struck was a captain in the Air Force who became pregnant in 1970 and was told by her commanding officer that she could either resign or have an abortion. "Struck picked a third choice: a lawsuit," and Ginsberg -- a lawyer with the American Civil Liberties Union -- "argued that the regulation prohibiting pregnant women from military service was sex discrimination," Goodman writes. Ginsberg also argued that Struck"s choice to carry her pregnancy to term was a personal one and that government intervention was a violation of her liberty. However, as the case was heading to the Supreme Court, the defending lawyer "figured that he was going to lose. So the savvy solicitor advised the armed services to change the rules and the case became moot," Goodman writes."It is mind-bending to think about how different the whole debate might have been if the first Supreme Court case arguing for the right to decide had been brought by a woman wanting to have a baby," Goodman continues. She asks if the U.S. would "have better understood this reality: a government that can force a woman to have an abortion is the same government that can force a woman to continue the pregnancy? Would it have changed a Republican Party that was traditionally so wary of government power-grabs?" (Goodman, Memphis Commercial Appeal, 5/14).
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UPMC Senior Living Community To Host Health Fair And Blood Drive
Weatherwood Manor, a UPMC Senior Living Community, will host a health fair from 1:30 to 3:30 p.m. and a blood drive from 12 to 5 p.m., Thursday, June 11. Weatherwood Manor is located at 896 Weatherwood Lane in Greensburg.
News of the day
IAS Conference Begins, Report Says Economic Crisis Forcing Africans Living With HIV/AIDS Off Life-Saving Medications
At a news conference opening the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention on Sunday in Cape Town, South Africa, Julio Montaner, president of the International AIDS Society, expressed disappointment that the "G8 ignored the HIV-AIDS issue at its annual summit this month," which was "just four years after pledging at the 2005 Gleneagles [G8] summit to fight for universal access to AIDS treatment by 2010," the Globe and Mail reports. "The silence of the G8 leaders is not just pathetic, it is criminal," Montaner said. The Global and Mail writes, "Cutting back on HIV-AIDS treatment programs during the recession will mean billions or even trillions of dollars in additional costs over the long term, especially because of growing scientific evidence that anti-retroviral medicine for AIDS patients can be crucial in preventing the transmission of the AIDS virus, Dr. Montaner said" (York, 7/20).
Public Health

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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