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Elekta Provides VMAT And Radiosurgery Solutions For New Jersey Health System
CentraState Medical Center (Freehold, New Jersey) has purchased two new state-of-the-art Elekta radiation therapy treatment systems, both with Volumetric Modulated Arc Therapy (VMAT). The first site in the world to have both Elekta Axesse and Elekta Infinity, CentraState will offer the most advanced cancer care available to its patients.
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Health Care Reform Debate Renews Focus On Insurance Coverage Of Abortion Care
The issue of whether government-subsidized health care programs should include coverage for abortion procedures is gaining attention as Congress continues drafting health care reform legislation, Time reports. Currently, the Hyde Amendment -- a legislative provision attached annually to major spending bills since 1976 -- prohibits states from using federal Medicaid funds to pay for abortion. All but 17 states have similar restrictions on their own funds. Although current versions of health reform legislation do not yet address the issue of abortion, congressional s involved in the process say that an explicit ban on abortion coverage could have "much further-reaching implications" than the Hyde Amendment. According to Time, the restrictions could deny abortion coverage to women whose private insurance plans currently cover the procedure. A 2002 Guttmacher Institute survey found that nearly 90% of private insurers cover abortion procedures. Under the legislation being worked on in three House committees, U.S. residents with incomes up to 400% of the poverty level -- about $88,000 annually for a family of four, or $43,000 for an individual -- would be eligible for government subsidies to help purchase coverage. However, antiabortion-rights lawmakers are pushing to prohibit those subsidies from being used to purchase health insurance policies that include abortion coverage, Time reports. Such restrictions would mean that women who currently have abortion coverage in their private plans would have to give up the benefit. According to Time, such a provision also "would raise all sorts of other questions if insurers were allowed to discriminate among their customers based on whether or not they are using federal dollars to pay for their policies."Pelosi Negotiating With House Dems Over ConcernsLast week, 19 House Democrats sent a letter to House Speaker Nancy Pelosi (D-Calif.) stating that they "cannot support any health care reform proposal unless it explicitly excludes abortion from the scope of any government-defined or subsidized health insurance plan." They also said that abortion "must be addressed clearly in the bill text" of the legislation. The signers of the letter include Reps. Bart Stupak (Mich.) and Charlie Melancon (La.), both members of the House Energy and Commerce Committee, one of the three panels with jurisdiction over health care reform. According to Time, Pelosi"s office is attempting to address the concerns through negotiations.Poll Shows Support for Reproductive Health CoverageMeanwhile, abortion-rights advocates are "pushing back" against those seeking to specifically exclude abortion coverage in health care reform legislation, Time reports. The National Women"s Law Center on Monday released results of a nationwide poll of 1,000 likely voters showing that 71% of respondents favor including reproductive services like birth control and abortion in health care reform (Tumulty, Time, 7/8). The poll also found that 72% would oppose exclusion of abortion coverage from any national health care plan (Eaton, Plain Dealer, 7/7). In addition, 75% of respondents said that an independent commission, not Congress, should determine what medical services are included in the basic benefits offered under health reform. Congress also is weighing giving that power to HHS Secretary Kathleen Sebelius (Time, 7/8).Judy Waxman, NWLC vice president, said that 80% of employer-based insurance plans provide coverage for abortion services, adding that "people will be angry if they don"t get to keep what they already have" under any public insurance option (Cleveland Plain Dealer, 7/7). Waxman said Congress should "refrain from practicing medicine and instead let medical professionals determine what health care services will be included in a benefits package" (Time, 7/8).
News of the day
Senate Judiciary Committee Vote On Sotomayor Reset For July 28
The Senate Judiciary Committee on Tuesday postponed its vote on Supreme Court nominee Sonia Sotomayor until July 28 at the request of Republican members who said they need one more week to review written answers she recently submitted to the panel, CongressDaily reports. Both Republicans and Democrats expect Sotomayor to be approved by the committee and confirmed by the Senate, CongressDaily reports (CongressDaily, 7/21).The delay came as Senate Republicans continued to weigh whether they would vote to confirm Sotomayor, the Wall Street Journal reports. Sen. Susan Collins (R-Maine) announced plans to vote for Sotomayor and issued a statement calling the judge "committed to applying the law impartially without bias or favoritism." Four other moderate Republicans have said they will support Sotomayor, and Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) indicated that more might follow suit. "There are a number of Republicans who have announced they plan to vote for her," Leahy said, adding, "There are a number of others who"ve not made that announcement yet, but plan to vote for her" (Peterson, Wall Street Journal, 7/21). Leahy said he is confident that Sotomayor will be confirmed in time for the Supreme Court"s first meeting on Sept. 9.Some strong conservatives, including Senate Minority Leader Mitch McConnell (Ky.), have said they will oppose Sotomayor (Hirschfeld Davis, AP/Denver Post, 7/22). Among the Senate Republicans who have not announced their intentions are Sens. John Cornyn (Texas), who serves on the Judiciary Committee, and Judd Gregg (N.H.) (Wall Street Journal, 7/21).NARAL Endorses Sotomayor NARAL ProChoice America recently said that it will endorse Sotomayor, the AP/Seattle Times reports. The group said that Sotomayor"s testimony shows that she is a stronger supporter of privacy rights than the last two Supreme Court nominees -- Chief Justice John Roberts and Justice Samuel Alito. Sotomayor said several times during her confirmation hearings that privacy rights include a woman"s right to have an abortion, NARAL said. According to the AP/Times, NARAL did not endorse Sotomayor until now because of uncertainty over her views on abortion rights (Hirschfeld Davis, AP/Seattle Times, 7/21).
Diagnostics

ARIAD Announces Preliminary Results From Ongoing Clinical Trial Of Its Investigational, Bcr-Abl Inhibitor In Drug-Resistant Chronic Myeloid Leukemia

ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced preliminary clinical data from an ongoing Phase 1 clinical trial of its investigational, multi-targeted kinase inhibitor, AP24534, in patients with advanced hematological cancers. The study results provide initial clinical evidence of hematologic, cytogenetic and molecular anti-cancer activity of AP24534 in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML), including those with the T315I mutant variant of the target protein, Bcr-Abl. An abstract describing these data is being submitted for presentation at a major hematology meeting to be held later this year. Treatment of CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) with Bcr-Abl inhibitors is effective in most patients but frequently results in the emergence of Bcr-Abl mutations that confer drug resistance over time. The T315I mutant of Bcr-Abl currently accounts for approximately 15 to 20 percent of all drug-resistant cases of CML and Ph+ ALL. First-generation therapies, such as imatinib (Gleevec®), and second-generation therapies, such as dasatinib (Sprycel®) and nilotinib (Tasigna®), are not able to inhibit this mutated protein and, therefore, are not effective against all forms of CML and Ph+ ALL. Clinical Proof-of Concept in Patients with CML and Ph+ ALL Thirty-two patients have been enrolled to date in this trial in six dosing groups (once daily oral dosing) at five medical centers in the United States; 28 of the patients have resistant and refractory CML or Ph+ ALL. All patients have previously been treated with the currently available first- and second-generation targeted therapies for CML and in most instances, other investigational agents as well. The patients with CML and Ph+ALL enrolled in this study only had very limited treatment options available to them: stem cell transplants, conventional palliative chemotherapy or investigational agents. The study commenced patient enrollment in the second quarter of 2008 and will continue enrolling patients until approximately 50 patients have been enrolled. Dose-escalation will continue until dose-limiting toxicity is observed. Key preliminary findings to date include: - In patients with a variety of Bcr-Abl mutations, hematologic responses, cytogenetic responses, and molecular responses have been observed with AP24534 treatment. Hematologic and cytogenetic responses have also been seen in patients with the T315I mutation, which is resistant to all approved Bcr-Abl inhibitors. Collectively, these data suggest a significant degree of anti-tumor activity of AP24534 in highly resistant CML patients. - In addition, of 23 CML patients in the four highest dosing groups, 19 patients remain on study without disease progression, evidence of control of their disease. Most importantly, of 12 CML patients with the T315I mutation, nine patients remain on study without disease progression, providing further evidence of control of their disease. - For many of the patients in the highest dosing groups, the duration of treatment with AP24534 has been relatively short. In these patients, it is still early for complete-response assessment. Even in spite of this, evidence of significant improvement in multiple blood-cell lineages has been observed. - Preliminary safety assessment shows that AP24534 is well tolerated without dose-limiting toxicity at doses studied to date. The most common drug-related adverse events have been thrombocytopenia (low platelet count) and neutropenia (low white blood cell count), which the Company believes reflects the underlying disease and the extensive pre-treatment of the patients in the trial. - To date, pharmacokinetic data indicate that blood levels predicted preclinically to be associated with complete inhibition of Bcr-Abl mutations have been surpassed. Pharmacodynamic data show evidence that AP24534 is acting mechanistically as designed. "Especially given that we have not yet reached a maximally tolerated dose, we believe that these preliminary results provide promising evidence of clinical proof-of-concept of AP24534 in patients with drug-resistant and refractory CML and Ph+ ALL, including those with the T315I mutation," said Frank G. Haluska, M.D., Ph.D., vice president, clinical affairs at ARIAD. Dr. Haluska added, "Many of the patients assessed to date have already had objective evidence of anti-tumor activity - hematologic, cytogenetic and molecular responses to AP24534. It is important to underscore the lack of therapeutic options available to the patients included in this study. We expect to complete enrollment in the study and to undertake additional evaluation of the safety and efficacy data in the coming months, leading to a presentation at one of the major hematology meetings later this year. Pending completion of the trial and evaluation of the final results, we believe that the results of this trial could form the basis for a pivotal registration trial of AP24534 starting next year." About CML and Ph+ ALL CML is characterized by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the Bcr-Abl protein. After a chronic phase of production of too many white blood cells, CML typically evolves to more aggressive phases such as accelerated or blast crisis. Ph+ ALL is a subtype of acute lymphoblastic leukemia that also carries the Ph+ chromosome that produces Bcr-Abl. It has a more aggressive course than CML and is often treated with chemotherapy. Because both of these diseases express the Bcr-Abl protein, this would render them potentially susceptible to treatment with AP24534. ARIAD Pharmaceuticals, Inc


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