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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.
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Race Has Role In Incidence, Survival Of Rare Brain Tumor, Mayo Researchers Find
The incidence of a rare and deadly tumor called primary central nervous system lymphoma (PCNSL) is two times higher in black Americans, ages 20 to 49, than in white Americans, according to a Mayo Clinic study published in the June issue of Journal of Neuro-Oncology. In patients older than 49, the results were reversed. White Americans were twice as likely as black Americans to be diagnosed with PCNSL.
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Ohio Supreme Court Restricts Mifepristone Use In State To Scope Of FDA's Approval Letter
In answering two certified questions from the U.S. Court of Appeals for the 6th Circuit, the Ohio State Supreme Court on July 1 declared that a state law regulating the use of mifepristone -- which is used in medication abortion -- bars physicians from prescribing it for off-label use, BNA reports. The court confirmed that doctors who use the drug to induce abortion must do so in compliance with the 49-day gestational limit included in FDA"s 2000 drug approval letter. Doctors also must prescribe the drug in accordance with the protocols and dosage indications included in its FDA-approved labeling.Interpretation of State Law in ContentionThe Ohio General Assembly in 2004 passed a law (Section 2919.123 (A)) that required any health care professional prescribing or dispensing mifepristone to comply with "all provisions of federal law that govern the use" of the drug. The law defines "federal law" as "any law, rule or regulation of the United States or any drug approval letter" from FDA "that governs or regulates the use of" mifepristone for inducing abortion. FDA"s approval letter states that the drug "is indicated for use in the termination of pregnancy (through 49 days" pregnancy) and has no other approved indication for use during pregnancy." In addition, the drug"s label states the recommended dosage and that its use requires three office visits by the patient. Planned Parenthood Southwest Ohio Region challenged the law in district court, arguing that neither FDA"s approval letter nor any other federal provision bans the off-label use of mifespristone to induce abortion beyond 49 days" gestation. The group also argued that the state law was unconstitutionally vague because it did not notify abortion providers in advance regarding which FDA documents were included in the state"s criminal law. In addition, Planned Parenthood said that prohibiting the evidence-based use of the drug would infringe on the rights of women, requiring them to take higher-than-necessary dosages of the drug or to undergo surgical abortions when a noninvasive alternative is available. The district court ruled in favor of Planned Parenthood, saying that the law was void because of vagueness. The state appealed the decision to the 6th Circuit, which then submitted two questions to the state Supreme Court seeking its interpretation of the law.The state Supreme Court ruled that FDA"s drug approval letter is included in the definition of "federal law" and that the state law is not ambiguous, according to BNA. The court said that because the drug approval letter incorporated FDA"s labeling text, Ohio physicians cannot prescribe or provide mifepristone to induce abortion outside of the stipulations of the drug approval letter and approved label. According to BNA, product liability law experts say the ruling will not have an impact outside of mifepristone or the state of Ohio.Case Returns to Appeals CourtRoger Evans of Planned Parenthood Federation of America said that he is not sure if the court"s decision helps or hurts the group"s case. Evans said that the district court declared the law unconstitutional based on an interpretation that the statute operates in the same way the state Supreme Court ruled it does. He noted that there are other possible interpretations of the law that would have solved the constitutional issues at the center of the litigation. However, because those issues were not resolved, the case now returns to the 6th Circuit, which will decide if the statute is constitutional based on the state Supreme Court"s interpretation. If the circuit court agrees with the district court that the statute is unconstitutionally vague, the state of Ohio could seek a U.S. Supreme Court review. If the circuit court finds that the statute is constitutional, the case likely will be sent back to the district court for resolution of some other issues in the case, according to BNA (BNA, 7/6).
Sexual Health

Sexually Transmitted HPV Linked To Certain Head & Neck Cancers; Roswell Park Cancer Institute Researchers Say Boys Need To Be Vaccinated Too

Researchers at Roswell Park Cancer Institute (RPCI) in Buffalo, New York, are strongly advocating a national discussion about the need to vaccinate both young men and women against HPV 16 to prevent head & neck cancers. The call comes amid growing evidence that certain cancers of the head and neck are strongly linked to HPV 16, a specific strain of the human papillomavirus (HPV) that is one of the most common sexually transmitted diseases in the United States. It is estimated that approximately 70% of Americans, both men and women, will be infected with HPV at some point in their lives. The types of cancer associated with HPV 16 occur mostly at the back (base) of the tongue, in the tonsils, and in the soft palate at the back of the throat, according to Thom Loree, MD , Chair of RPCI"s Department of Head & Neck Surgery . Over the past 10 years, members of RPCI"s Head & Neck Department have seen a threefold increase in the number of throat cancers they treat. In 2007, Roswell Park researchers began testing all head and neck tumors treated at the Buffalo-based comprehensive cancer center for the presence of HPV DNA, says Saurin Popat, MD, FRCSC, FACS, Attending Surgeon in Head & Neck and Plastic & Reconstructive Surgery, RPCI. RPCI is one of few institutions in the nation to do so. Data from the ongoing testing have been combined with data from archived tumor samples to provide a clearer picture of how many head and neck cancers treated at RPCI test positive for HPV. To date, the total is around 50 to 60 percent. There are more than 100 types of HPV-each identified by number-but only 70 have been described so far, explains Popat. Some HPV viruses, including 16 and 18, are transmitted sexuallyò€"not just through sexual intercourse, but through any skin-to-skin contact involving the mouth, vagina, vulva (the external female genitalia), penis, anus, or fingers. HPV 16 and HPV 18 were previously identified as the cause of most cases of cervical cancer in the U.S. HPV has also been implicated in the development of some cancers of the vulva, vagina, anus, penis, and perineum (the area between the genitals and anus). There is no cure for HPV, just as there is no cure for the common cold. In most people, an HPV infection will clear up on its own, but it can be passed on to other people during the infection period - just as with the common cold. In some cases, the person may continue to be infected for decades without any symptoms. During that time, the infected person can infect others without knowing it. Over time, this "silent," chronic HPV infection increases the risk of developing certain cancers. In 2006, the FDA approved the use of Gardasil, a vaccine that protects against HPV 6, 11, 16 and 18, for females between the ages of 9 and 26, to help prevent cancers of the cervix, vulva, and vagina, as well as genital warts. The FDA has not approved the vaccine for males. The issue of extending approval to males to protect against HPV related cancers is under review, with a decision expected in June 2009. Loree, Popat, and their RPCI colleagues see compelling evidence for extending the vaccine"s protection to boys. Says Popat, "The side effects of the vaccine are so small, and the potential benefits are great." He notes that patients with throat cancer "have to undergo major treatment lasting several months, with an additional four to six months of recovery. Their ability to speak and swallow is affected. Generally, they do very well; however, it is a long, challenging road." Based on the evidence to date, Loree says that "with increased vaccination against HPV, you"ll see a decrease in cervical cancer and in throat cancers." He says if everyone stopped smoking and using tobacco in any form, and also got vaccinated against HPV, "we could eliminate head and neck cancers, and I"d be out of business." The American Cancer Society estimates that 35,310 new cases of oral and oropharyngeal cancer are diagnosed every year-25,310 of those in men-and 7,590 people, including 5,210 men, die of those cancers. Smoking, the use of chewing tobacco, and heavy alcohol use remain the leading causes of cancers of the head and neck. Roswell Park experts discuss the link between HPV and throat cancer. Roswell Park Cancer Institute


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