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The Lives Of Pancreatic Cancer Patients Prolonged By New Drug Candidate
Every year, 42,000 Americans are diagnosed with pancreatic cancer. Few live very long, and less than 5% are still alive five years after diagnosis.
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Medicare Reimbursement Issues Enter Health Reform Debate
New legislation introduced yesterday would attempt to shift Medicare reimbursement policy to reward patient health outcomes, rather than the volume of services provided, MinnPost, a nonprofit online news organization, reports. "We need to be sure to keep score," said Sen. Amy Klobuchar, D-Minn., who introduced the bill, according to MinnPost. "That means measuring outcomes and rewarding providers that deliver quality results."
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Columnists Discuss HIV Statistics, National Testing Day
"It"s getting harder to convince people of the urgency, that knowing your HIV status is better than not knowing, that this is still a serious problem," columnist Wendi Thomas writes in the Memphis Commercial Appeal. She writes that some people "assume being HIV positive is no big deal" because former National Basketball Association player Earvin "Magic" Johnson has lived with HIV since 1991 and appears to be healthy. "But if you are HIV positive and delay finding out, the virus could progress" to a point where it becomes "much more difficult to treat," Thomas adds (Thomas, Memphis Commercial Appeal, 6/25). Philadelphia Inquirer columnist George Curry today discussed HIV statistics and findings from a recent Kaiser Family Foundation survey that looked at U.S. residents" views on HIV/AIDS. He said, "It"s time to refocus our attention on HIV and AIDS. And a good way to do that is by getting tested tomorrow" on National HIV Testing Day (Curry, Philadelphia Inquirer, 6/26).
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Apthera Receives Special Protocol Assessment (SPA) From FDA For Pivotal Phase III Trial Of NeuVax In Early-Stage Breast Cancer

Apthera, Inc. announced that it reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase III clinical trial of the Company"s lead drug, NeuVax. The SPA is a written agreement between the trial"s sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase III trial to be used in support of a Biologics License Application (BLA). The SPA approval letter was received from the FDA on June 19, 2009, concluding a 21-month reiterative process between Apthera, the breast oncology community in the U.S. and the Agency. Chief Medical Officer, William E. Gannon, M.D., said, "We would like to thank FDA reviewers for their input and guidance during the SPA approval process and are pleased that the Agency has indicated an agreement to proceed with the Phase III protocol." The multicenter, double-blind, randomized pivotal trial is expected to enroll 700 women diagnosed with HER2/neu-expressing tumors and who have completed standard of care consisting of surgery, chemotherapy and radiotherapy. Women must have a common HLA haplotype (HLA-A2 or -A3) and must agree to be followed for 5-10 years. The primary endpoint of the study is disease-free survival (DFS) as determined by disease recurrence or death from any cause, and the first analysis of the data will occur after 70 recurrence events or approximately 3 years from the start of the study. Alton C. Morgan, Ph.D., President and CEO, added, "The positive outcome of the SPA process means Apthera has reached a major developmental milestone for NeuVax. With regulatory approval of the design of the pivotal trial, this achievement has created a value inflection milestone for both the product and the Company." Apthera


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