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Savient Pharmaceuticals Receives Complete Response Letter From U.S. Food And Drug Administration For KRYSTEXXA(TM)
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) stating that the FDA can not at this time approve the Company"s Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.
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New Support For A Controversial Mechanism Underlying An Irregular Heart Beat
The most common form of human heart beat irregularity (atrial fibrillation) can be fatal if left untreated. It has been suggested that it is caused, in part, by calcium leaking from a cellular store in heart cells, potentially through the RyR2 channel, although this mechanism remains controversial. However, a team of researchers at Baylor College of Medicine, Houston, and Dresden University of Technology, Germany, has provided support for this hypothesis by showing that the protein CaMKII can enhance RyR2-mediated calcium leak, promoting atrial fibrillation in mice.
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Surgeon General Nominee Backs Obama's Positions On Reproductive Health, White House Says
The Washington Post reports that Regina Benjamin -- President Obama"s nominee for U.S. surgeon general -- shares Obama"s position on reproductive health issues, a position that could put her "at odds" with the Catholic Church"s positions on reproductive rights, according to s familiar with her selection. White House spokesperson Reid Cherlin said, "Like [Obama], she believes that this is an issue where it is important to try and seek common ground and come together to try and reduce the number of unintended pregnancies." Cherlin added, "As a physician, she is deeply committed to the philosophy of putting her patients" needs first when it comes to providing care." The White House would not specifically comment on her views on abortion rights, and an HHS spokesperson says Benjamin is not permitted to speak publicly until she is confirmed. s close to Benjamin, who is Catholic, say that she does support abortion rights, the Post reports. However, several individuals who know Benjamin said her views would not affect her role as surgeon general. David Satcher -- a surgeon general in the Clinton administration who taught community health to Benjamin at the Morehouse School of Medicine -- said, "We all have our religions, but when you speak as the surgeon general to the American people, it"s not about your religion." He added, "I don"t see why the surgeon general has to get involved in a discussion about abortion." Jorge Alsip -- president of the Medical Association of the State of Alabama -- said abortion-related issues occasionally arose when he and Benjamin served on the Alabama State Committee on Public Health. Alsip, who is Catholic, said he does not know her position on the issue, adding, "You kind of have to park your personal beliefs at the door when they conflict with what your role is."Sister Carol Keehan, president and CEO of the Catholic Health Association, said, "This is not pivotal to the surgeon general"s job." She added, "From the perspective of being a practicing Catholic, you can certainly say that it matters. I think being willing to work to reduce (abortion) is a good thing."Robert Lawrence, a director at Johns Hopkins University"s Bloomberg School of Public Health and chair of the board of Physicians for Human Rights, served with Benjamin on the group"s board from 1996 until 2002. He said, "I would think that as surgeon general she would uphold the law of the land, and the law of the land guarantees women a choice for reproductive health." He added, "The charge of the surgeon general is to be the people"s doctor and ensure that all those health services guaranteed under federal law are available to the people" (Thompson, Washington Post, 7/19).
Sexual Health

Personalized Anti-Cancer Vaccine Pivotal Phase III Results To Be Presented At ASCO Plenary Session

Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), announced that BiovaxID®, Biovest"s personalized anti-cancer vaccine targeting B-cell blood cancers, will be featured in an oral presentation during the Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31st, 2009 in Orlando, Florida. Stephen J. Schuster, M.D., Associate Professor of Medicine at the Abramson Cancer Center of the University of Pennsylvania, will deliver the BiovaxID presentation titled, "Idiotype Vaccine Therapy (BiovaxID®) in Follicular Lymphoma in First Complete Remission: Phase III Clinical Trial Results." Note to editors: Pursuant to ASCO policy, this abstract is embargoed until 10:30 a.m. (EDT) on Sunday, May 31st, when it will be highlighted during ASCO"s official Press Program to the media. Dr. Schuster"s oral presentation is scheduled to be the second of four clinical trial results presentations at the ASCO Plenary Session on Sunday, which begins at 1:00 p.m. (EDT) at the Orlando Convention Center location Level 2, West Hall D2. In addition to the Plenary Session, BiovaxID will also be featured in a presentation to be delivered at ASCO by Larry Kwak, M.D., Ph.D., Chairman of the Department of Lymphoma and Myeloma and Associate Director of the Center for Cancer Immunology Research at the University of Texas M.D. Anderson Cancer Center. Dr. Kwak"s presentation will be part of a Panel Education Session titled, "Cancer Vaccines: Where do we go from here?" This presentation is scheduled for Sunday, May 31st at 4:45 p.m. (EDT) at location Level 2, West Hall F1. About BiovaxID® BiovaxID is a personalized, patient-specific therapeutic vaccine designed to stimulate the patient"s own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non-Hodgkin"s lymphoma, BiovaxID is designed to kill only cancerous B-cells, with the initial indication of follicular Non-Hodgkin"s lymphoma. Additionally, it is anticipated that BiovaxID could be used to treat other types of B-cell cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma. A Unique Approach to Immunotherapy Targeting B-Cell Blood Cancers B-cells (a type of white blood cell or lymphocyte) are a vital part of the human immune system, as they produce antibodies that seek out and bind to foreign substances in the body. In lymphoma, as cancerous B-cells grow and multiply unrestrained, each malignant B-cell expresses a unique idiotype or biomarker on the cell"s surface, specific to each patient. Research at Stanford University and the National Cancer Institute led to the development of BiovaxID as a personalized, therapeutic vaccine capable of selectively targeting only cancerous B-cells, while sparing healthy cells. This is achieved by using the idiotype obtained from a sample of the patient"s tumor by biopsy, and through proprietary bioengineering techniques in a patented cell line, a patient-specific vaccine is created that stimulates the immune system by recruiting a patient"s T-cells (immune cells that kill cancerous cells) to seek out and destroy only the diseased B-cells. Unlike other failed cancer vaccine therapies that attempted to target lymphoma, BiovaxID is the only hybridoma (fusion of human lymphocyte with cancer cell) anti-cancer vaccine that consists of a high-fidelity copy of the complete idiotype, believed to be critical in mounting a full and complete immune response against the cancer, as well as "training" the immune system to maintain continuous response if cancerous cells were to return. Biovest International, Inc.


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