Advaxis requests orphan drug designation for treatment of HPV-associated head and neck cancer with ADXS-HPV

Source: www.marketwatch.com Author: press release Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has submitted an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated head and neck cancer. There are about 50,000 new cases of head and neck cancer annually, with about 15,000 deaths. HPV infection is estimated to account for 20-50% of current incidence. Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and a seven year market exclusivity period. "HPV-associated head and neck cancer is growing at an epidemic rate in the United States and other regions throughout the world. According to the U.S. Centers for Disease Control and Prevention (CDC), over 80% of new cases occur in men, who are not typically part of HPV vaccination programs," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Data from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this HPV-associated cancer. We believe that ADXS-HPV immunotherapy will show similar activity in HPV-associated head and neck cancer, given the shared causality of the cancers. We have one ongoing Phase 1/2 study in [...]

Why HPV vaccination makes a difference against cancer

Source: www.cbsnews.com Author: Michelle Castillo Michael Douglas' frank discussion about the human papillomavirus (HPV) and oral cancer has put a spotlight on the dangers of the sexually transmitted virus. While using a condom may reduce risk for HPV, doctors are reminding people that the best way to protect oneself from the disease that can potentially lead to cancer is to get vaccinated at an early age and, if possible, go for routine screenings. HPV is a group of more than 100 very common viruses, about 40 of which can be transmitted sexually, according to the U.S. Department of Health and Human Services Office on Women's Health. Approximately 79 million Americans are currently infected with an HPV strain, the Centers for Disease Control and Prevention reports, and nearly all sexually active men and women will get one type of sexually transmitted HPV in their lifetime. Specifically, 20 million people in the U.S. between the ages of 15 to 49 are infected with a genital HPV at any given time, and about half of men and women can expect to be infected with genital HPV in their lifetime. "HPV is ubiquitous in our population," Dr. Lori Wirth, medical director of the Center for Head and Neck Cancers center at Massachusetts General Hospital in Boston, explained to CBSNews.com. "Anyone who has led a normal sex life will get HPV, and develop antibodies to the virus. But, a minority of people who have contact with the virus who don't effectively clear the virus from [...]

Gastric Reflux Is an Independent Risk Factor for Laryngopharyngeal Carcinoma

Source: http://cebp.aacrjournals.orgAuthors: Scott M. Langevin1,2,Dominique S. Michaud1,Carmen J. Marsit4,5,Heather H. Nelson6,7,Ariel E. Birnbaum3,Melissa Eliot1,Brock C. Christensen4,5,Michael D. McClean8, and Karl T. Kelsey1,2  Abstract Background: Gastric reflux can reach into the upper airway, inducing cellular damage in the epithelial lining. This condition is believed to be a risk factor for development of laryngopharyngeal squamous cell carcinoma (LPSCC), although the literature is conflicting. Methods: To better clarify this relationship, we assessed the association of self-reported heartburn history and medication use among 631 patients with LPSCCs and 1234 control subjects (frequency-matched on age, gender, and town of residence) enrolled as part of a population-based case–control study of head and neck squamous cell carcinoma in the greater Boston area. Results: After adjusting for age, gender, race, smoking, alcohol consumption, HPV16 seropositivity, education, and body mass index, subjects reporting a history of frequent heartburn and who were neither a heavy smoker nor heavy drinker had a significantly elevated risk of LPSCCs [OR, 1.78; 95% confidence interval (CI), 1.00–3.16]. Among those with a history of heartburn, there was an inverse association between antacid use and LPSCCs relative to those never taking heartburn medication (OR, 0.59; 95% CI, 0.38–0.93) that remained consistent when analyzed by smoking/drinking status, HPV16 status, or by primary tumor site. Conclusions: Our data show that gastric reflux is an independent risk factor for squamous cancers of the pharynx and larynx. Further studies are needed to clarify the possible chemopreventive role of antacid use for patients with gastric reflux. Impact: Elucidation of additional risk factors for head [...]

2013-06-10T16:27:36-07:00June, 2013|Oral Cancer News|

Enhanced radiation sensitivity in HPV-positive head and neck cancer

Source: http://cancerres.aacrjournals.orgAuthors: Randall J. Kimple1,*,Molly A. Smith1,Grace C Blitzer1,Alexandra D Torres1,Joshua A Martin1,Robert Z. Yang1,Chimera R Peet1,Laurel D. Lorenz2,Kwangok P Nickel3,Aloysius J Klingelhutz4,Paul F Lambert5, andPaul M Harari1  Abstract Patients with human papillomavirus associated (HPV+) head and neck cancer (HNC) demonstrate significantly improved survival outcome compared to those with HPV-negative (HPV-) tumors. Published data examining this difference offers conflicting results to date. We systematically investigated the radiation sensitivity of all available validated HPV+ HNC cell lines and a series of HPV- HNC cell lines using in vitro and in vivo techniques. HPV+ HNCs exhibited greater intrinsic radiation sensitivity (average SF2 HPV- 0.59 vs. HPV+ 0.22, p<0.0001), corresponding with a prolonged G2/M cell cycle arrest and increased apoptosis following radiation exposure (percent change 0% vs. 85%, p=0.002). A genome-wide microarray was used to compare gene-expression 24 hours following radiation between HPV+ and HPV- cell lines. Multiple genes in TP53 pathway were upregulated in HPV+ cells (Z score 4.90), including a 4.6 fold increase in TP53 (p<0.0001). Using immortalized human tonsillar epithelial cells, increased radiation sensitivity was seen in cell expressing HPV-16 E6 despite the effect of E6 to degrade p53. This suggested that low levels of normally functioning p53 in HPV+ HNC cells could be activated by radiation, leading to cell death. Consistent with this, more complete knockdown of TP53 by siRNA resulted in radiation resistance. These results provide clear evidence, and a supporting mechanism, for increased radiation sensitivity in HPV+ HNC relative to HPV- HNC. This issue is under active investigation in [...]

2013-06-10T16:15:32-07:00June, 2013|Oral Cancer News|

Don’t Take Your Vitamins

Source: New York TimesBy PAUL A. OFFITPublished: June 8, 2013       PHILADELPHIA — LAST month, Katy Perry shared her secret to good health with her 37 million followers on Twitter. “I’m all about that supplement & vitamin LYFE!” the pop star wrote, posting a snapshot of herself holding up three large bags of pills. There is one disturbing fact about vitamins, however, that Katy didn’t mention. Derived from “vita,” meaning life in Latin, vitamins are necessary to convert food into energy. When people don’t get enough vitamins, they suffer diseases like scurvy and rickets. The question isn’t whether people need vitamins. They do. The questions are how much do they need, and do they get enough in foods? Nutrition experts argue that people need only the recommended daily allowance — the amount of vitamins found in a routine diet. Vitamin manufacturers argue that a regular diet doesn’t contain enough vitamins, and that more is better. Most people assume that, at the very least, excess vitamins can’t do any harm. It turns out, however, that scientists have known for years that large quantities of supplemental vitamins can be quite harmful indeed. In a study published in The New England Journal of Medicine in 1994, 29,000 Finnish men, all smokers, had been given daily vitamin E, beta carotene, both or a placebo. The study found that those who had taken beta carotene for five to eight years were more likely to die from lung cancer or heart disease. Two years later the [...]

2013-06-10T13:10:46-07:00June, 2013|Oral Cancer News|

The New Face of Oral Cancer

Source: nursing.advanceweb.comBy Jonathan BassettPosted on: April 22, 2013   For decades tobacco was the primary cause of oral cancer but a more insidious culprit has emerged.  Jerry Wilck had no reason to suspect anything. Why would he? He only smoked for a couple of years and gave it up more than 40 years ago. He didn't drink excessively, didn't have a family history of cancer, and took good care of himself. In fact, maybe the only reason the 59-year-old consulted an oral surgeon about the small sore on his tongue - the result of a habit of running this particular spot along his teeth - was that there happened to be such a specialist right there in his office. Wilck was a general practice dentist in Langhorne, Pa., and particularly attuned to anomalies of the soft tissues of the mouth. His oral surgeon took no chances and ordered a biopsy. Wilck was "floored" the night in March 2005 when the lab report arrived by fax from the oral pathology department at Temple University in Philadelphia - squamous cell carcinoma. Wilck immediately consulted with John Ridge, MD, PhD, FACS, chief of head and neck surgery at Temple's Fox Chase Cancer Center. After surgical removal of part of his tongue and lymph nodes from his neck, along with a round of physical and speech therapy, Wilck is now cancer free and has full use of his jaw, throat and voice. "I was lucky," confessed Wilck, who retired from practice in 2009 and now spends a [...]

2013-06-10T12:26:21-07:00June, 2013|OCF In The News, Oral Cancer News|

Health Experts Praise Michael Douglas For His Oral Cancer Revelation

June 3rd, 2013 7:20pm EDTSource: starpulse.com    Health experts have commended Michael Douglas for speaking out about link between throat cancer and oral sex. The 68 year-old actor, who endured a six-month battle with the illness, hit headlines over the weekend when he voiced his belief that his cancer was caused by HPV, the human papillomavirus, which can be contracted through oral sex. The Behind The Candelabra star told Britain's The Guardian newspaper, "Without wanting to get too specific, this particular cancer is caused by HPV, which actually comes about from cunnilingus... I mean, I did worry if the stress caused by my son's incarceration didn't help trigger it. But yeah, it's a sexually transmitted disease that causes cancer. And if you have it, cunnilingus is also the best cure for it." Douglas' frank admission has now won him praise from Brian Hill, executive director of Oral Cancer Foundation, who tells the New York Post, "I'm really quite proud of Michael saying this. This (oral sex) is not an aberrant sexual behavior. But the willingness to talk about this openly can be difficult." The actor recorded a public service announcement for the Oral Cancer Foundation last year.   *This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.  

2013-06-10T11:43:06-07:00June, 2013|OCF In The News|

The Man’s Guide to HPV

Source: Men's HealthBy: Melaina Juntti   What men can do about HPV Michael Douglas caught major flak for saying oral sex gave him throat cancer. But if you're laughing, it's time to grow up. Oral cancers caused by the sexually transmitted human papillomavirus (HPV) have skyrocketed 225 percent in the past 15 years, with men accounting for 75 percent of all cases. The number-one culprit: HPV passed via oral sex. It used to be that cigarettes caused most of these cancers. But since smoking rates have plummeted over the past few decades, and we're having way more oral sex today than even our fathers' generation, HPV has become the most common STD in the U.S. – inevitably leading to more oral cancer cases. It only takes one time going down on someone to contract HPV, and experts estimate that 80 percent of us will be exposed to the virus at some point in our lives. This STD sometimes causes genital warts, but according to the Centers for Disease Control and Prevention, that's not very common. In most cases, HPV has no symptoms. And since no test exists to detect HPV in guys, you won't know you have the virus until years later – if it turns into cancer. "It's very hard to determine when you acquired HPV," says Dr. William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University. "It doesn't usually come from just one sexual episode. That said, every once in a while, cancer develops within [...]

2013-06-10T11:35:49-07:00June, 2013|OCF In The News|

Michael Douglas pleased that oral sex story raised public awareness

By Agence France-PresseTuesday, June 4, 2013 18:40 EDTSource: The Raw Story                  Michael Douglas said he would win a Nobel prize if he knew exactly what caused his throat cancer, in fresh comments Tuesday after a dispute with a British newspaper over an interview he gave. The “Fatal Attraction” star, whose spokesman already denied he blamed his throat cancer specifically on oral sex, also said that, regardless, he was happy to raise awareness about causes of the killer disease. “I never expected to become a poster boy for head and neck cancer,” Douglas said in comments issued by a representative. “But, if after what started out as trying to answer a couple of questions about the suspected sources of this disease results in opening up discussion and furthering public awareness, then I’ll stand by that.” In an interview with Britain’s Guardian newspaper, Douglas, who stars in the just-released biopic of flamboyant entertainer Liberace, “Behind The Candelabra,” said his cancer was caused by the human papillomavirus (HPV). “Without wanting to get too specific, this particular cancer is caused by HPV, which actually comes about from cunnilingus,” he said, in comments the newspaper said amounted to blaming oral sex for his cancer. Douglas’s spokesman Allen Burry said Monday that the 68-year-old actor was talking in general, not personal terms. “This is not the cause of his cancer,” he said. On Tuesday, Douglas himself added: “Head and neck cancer can be caused by many things including [...]

2013-06-05T09:36:15-07:00June, 2013|Oral Cancer News|

Researchers Investigate A Less Toxic Radiation Treatment For HPV-Positive Oropharynx Cancer

Source : BiocomparePosted: June 03, 2013   CHICAGO, IL (May 29, 2013)—Researchers from Fox Chase Cancer Center and other institutions have completed a phase II clinical trial that may help identify those patients with HPV-positive oropharyngeal cancer who do not require the full radiation dose given in a standard regimen of Intensity-Modulated Radiation Therapy (IMRT). Preliminary findings will be presented by Shanthi Marur, first author on the study and an oncologist at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, at the 49th Annual Meeting of the American Society of Clinical Oncology on Sunday, June 2. Patients enrolled in the trial received an initial regimen of chemotherapy followed by treatment with the targeted therapy cetuximab, a monoclonal antibody. In the study, a patient's response to those initial treatments determined the dose during radiation treatment. “Those patients who had a really good response to chemotherapy might also be more responsive to radiation,” says Barbara Burtness, senior author on the study and chief of head and neck medical oncology at Fox Chase. “Therefore, the use of a full dose of radiation for those patients might represent overtreatment.” Burtness is also chair of the Eastern Cooperative Oncology Group (ECOG), which sponsors this ongoing trial. ECOG is a a National Cancer Institute-funded team of researchers who organize and carry out clinical trials. According to the National Cancer Institute, more than 40,000 people will be diagnosed with cancer of the oropharynx—a swath of tissue at the back of the throat—in 2013, and nearly 8,000 will die [...]

2013-06-04T11:49:00-07:00June, 2013|Oral Cancer News|
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