HPV vaccine involving Sanford researcher moving to clinical trials

This is such great progress! -- Dr. Dale

http://www.prairiebizmag.com/event/article/id/15559/

SIOUX FALLS, S.D. - Etubics Corp. has received a $1.03 million grant from the National Institutes of Health to move a vaccine for human papilloma virus (HPV) developed by a Sanford researcher to clinical trials. The vaccine was engineered by Sanford Research’s Dr. John Lee and his team in collaboration with Etubics.

In October, a study led by Lee and published by Cancer Gene Therapy indicated a Etubics drug (Ad5 [E1-, E2b-]), when used in conjunction with chemotherapy and radiation, successfully improved long-term survival of animals expressing HPV.

The grant will support the necessary pre-clinical experiments to allow Etubics’ HPV vaccine, which targets head and neck cancers, to enter into clinical trials.

The Etubics drug delivers E6 and E7 proteins of HPV (HPV-E6/E7) as a safe vaccine, giving it the ability to deliver a long lasting "active" immune response against cancer targets and educating the immune system's T-cells to act as if the cancer is a simple virus.

“While the results of our trials in animal models were exciting, the potential of translating this vaccine to a human application could be a game changer,” said Lee, a Sanford Clinic ear, nose and throat specialist. “The incidence of head and neck cancer is on the rise, and research has indicated that HPV is playing a key role in that.”

HPV is the leading cause of more than 90 percent of cervical cancers and is linked to 60 percent of head and neck cancers, according to the Centers for Disease Control and Prevention. Currently, no HPV therapeutic vaccine is effective at treating established tumors, despite its success with preventing HPV infection.

Etubics is a clinical stage bio-pharmaceutical company with a proprietary platform vaccine technology that delivers a long lasting "active" immune response against diseases.

HPV vaccine effective but grossly underutilized

Friends, this is a really great read. -- Dr. Dale

HPV vaccine effective but grossly underutilized

http://www.post-gazette.com/stories/news/health/hpv-vaccine-effective-but-grossly-underutilized-698118/

August 5, 2013 12:03 am

By Monica Disare / Pittsburgh Post-Gazette

When Kathy Hixenbaugh of South Fayette heard about the HPV vaccine from her son's pediatrician, she thought about it, talked to her 13-year-old son and together they decided to have him vaccinated.

But a recent report from the federal Centers for Disease Control and Prevention titled, "HPV vaccine: Safe, effective, and grossly underutilized" claims that not enough parents are making the same decision.

"There is no doubt in my mind that the vaccine is underutilized," said Jonathan Pletcher, clinical director for the division of adolescent medicine at Children's Hospital of Pittsburgh of UPMC, "I think there's generally a lack of understanding about HPV."

Human papillomavirus or HPV is one of the most common sexually transmitted diseases in the country. The vaccine, approved by the Food and Drug Administration in 2006 for females ages 9 to 26 and administered in three shots over six months, protects against four strains of HPV; two of these strains account for about 70 percent of all cervical cancers, as well as cancer to the vagina and vulva. The two others cause 90 percent of genital warts. HPV also is linked to anal cancer.

In 2009, the FDA recommended that males ages 9 to 26 also receive the three-shot vaccination. Men can develop genital warts or cancer of the penis, anus or oropharynx (the back of the throat) from HPV. Males also help spread HPV to their female partners

"Boys are at risk, boys are carriers, [so] it's a no-brainer," Dr. Pletcher said.

Children are encouraged to get the vaccine starting at ages 11 or 12 before they become sexually active to protect against infection.

According to the new study, HPV vaccination rates in girls ages 13-17 years failed to increase between 2011 and 2012, and three-dose coverage declined slightly from 2011 to 2012.

HPV is present in 79 million Americans, although not all cases develop into cancer. In 2009, the most recent year for which statistics are available, according to the CDC's website, 12,357 women in the United States were told they had cervical cancer, and 3,909 died from the disease.

According to the CDC, for each year that the three-dose HPV vaccine series coverage remains near the current level of 33 percent, an additional 4,400 women will be diagnosed with cervical cancer and 1,400 cervical cancer-attributable deaths will occur in the future.

Some experts believe that parents aren't receptive to the vaccine because they are just uncomfortable thinking about their young children becoming sexually active.

When Mrs. Hixenbaugh talked to another parent about the HPV vaccine, the parent said her son would not receive the shot because he was not going to have sex until he was married, she said.

"Parents don't want to talk about sex and their kids," she added. "Honestly, to think that kids aren't going to have sex is ridiculous."

Doctors also need to debunk the belief by some parents that the HPV vaccine encourages promiscuous sex while at the same time they explain the potential health benefits, said Thomas Krivak, director of the clinical research division of gynecological oncology at the Allegheny Health Network.

"HPV is associated with sex, and I think that that gets polarizing," Dr. Krivak said. "I don't think that anyone says after you finish her three-shot course it's OK for you to go have sex, [so] go have sex with 15 different people."

He added that while there are both benefits and risks to any type of medical procedure, vaccines play an important role in public health. According to the CDC's report, in the seven years that the HPV vaccine has gone through safety monitoring and evaluation, no serious safety concerns have been identified. The number of adverse events following the vaccine has decreased from 2008-12.

Others feel that a pediatrician's relationship with the family is the missing link in improving the HPV vaccination rate. The problem is that only about 60 percent of teenagers see their pediatrician annually, said Joseph Aradri, a doctor of osteopathic medicine and president of Pediatric Alliance in Green Tree.

While most pediatricians support the use of the HPV vaccine, some underplay the importance of the three-shot course, Dr. Pletcher said.

The CDC's 2012 National Immunization Survey-Teen data show that not receiving a health care provider's recommendation for HPV vaccine was one of the five main reasons parents reported they did not vaccinate their daughters.

Mrs. Hixenbaugh also pointed out that, from a practical standpoint, the vaccination requires three trips to the doctor's office, which makes it inconvenient.

The trend to have fewer HPV vaccinations has been observed in some, but not all, quarters of Pittsburgh. The number of people who received the HPV vaccination at the Allegheny County Health Department has decreased. In 2010, 758 vaccinations were administered, in 2011 that number increased to 923 and then in 2012 it dropped to 465, said Ronald Voorhees, acting director of the health department.

He added that this number does not necessarily reflect whether Allegheny County as a whole is getting fewer vaccines because residents may be vaccinated at private practices.

There also is a segment in the Pennsylvania population that is anti-vaccine, said Dr. Krivak, which may be driving some of these trends.

However, the number of people who were vaccinated at the Pediatrics Alliance Arcadia office in McCandless is on track to increase this year. The number of HPV vaccinations given in 2011 was 122. It shot up to 243 in 2012 and is currently at 159 in 2013 with five months left to go. This means that the office will likely give more HPV shots than in 2012, said Bill Coppula, a physician at the Arcadia office. Dr. Coppula added that he is encouraged by the progress in HPV vaccination but that he hopes the number of people receiving the vaccine will continue to increase.

As an additional boon, the shot is usually covered by insurance. According to the CDC report, because of the Affordable Care Act, most private health insurance plans must cover the full cost of HPV vaccine without a co-pay or deductible.

But for those who have decided to vaccinate their children, the matter boils down to a simple calculation.

"If there's something out there that I can do to protect my child from the potential for cancer, I feel like I need to do that as a parent," said Paula Krivak of Ohio Township, who is Dr. Krivak's wife and decided to have both her son and daughter vaccinated.

Monica Disare: mdisare@post-gazette.com.

Save a life.

Your life! Just a quick post to share yet another journal article explaining the importance of getting a colonoscopy.

You can literally save your life just by getting checked.

I got you.

-- Dr. Dale

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Colorectal cancer screening cuts long-term mortality

By: MARY ANN MOON, Frontline Medical Communications

The long-term incidence of colorectal cancer was lower in patients who underwent screening by either endoscopy or fecal occult-blood testing than in those who did not, even if that screening took place decades earlier, according to two separate reports published online Sept. 19 in the New England Journal of Medicine.

Importantly, colorectal cancer–related mortality also was correspondingly lower in screened patients.

Identifying and removing colorectal polyps yields far-reaching benefits, saving lives for up to 30 years afterward, researchers involved in both studies said.

Dr. Aasma Shaukat

In the first study, Reiko Nishihara, Ph.D., of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, and her associates assessed lower-GI endoscopy’s effect on the long-term risk of incident colorectal cancer in two large U.S. cohorts that were prospectively followed for 22 years. The Nurses’ Health Study involved 121,700 female nurses aged 30-55 years at baseline in 1976, and the Health Professionals Follow-Up Study involved 51,529 male health professionals aged 40-75 years at baseline in 1986.

For their secondary analysis of data from these cohorts, Dr. Nishihara and her colleagues examined the records of 57,166 female subjects and 31,736 male subjects who developed 1,815 incident colorectal cancers during 22 years of follow-up. "We were able to directly compare actual incidences of cancer among persons after polypectomy with the incidences among persons from the same background population who did not undergo endoscopy, while adjusting for potential confounders."

At their own discretion, 14,287 of the men and 31,423 of the women had undergone no lower endoscopy at all by 1998, the midpoint of follow-up; 3,578 men and 3,957 women had undergone colonoscopy with negative results; 8,091 men and 16,748 women had undergone sigmoidoscopy with negative results; and 1,259 men and 1,481 women had undergone lower endoscopy with polypectomy.

At the end of follow-up, the incidence of colorectal cancer was significantly lower among the men and women who had undergone any of these screening methods than among those who had not had any screening. The multivariate hazard ratios for colorectal cancer were 0.57 after endoscopy plus removal of adenomatous polyps (polypectomy), 0.60 after negative sigmoidoscopy, and 0.44 after negative colonoscopy.

"We estimated that 40% of colorectal cancers (including 61% of distal colorectal cancers and 22% of proximal colon cancers) that developed during follow-up would have been prevented if all the participants in our study had undergone colonoscopy," the investigators said (N. Engl. J. Med. 2013 Sept. 19 [doi:10.1056/NEJMoa1301969]).

This decrease in colorectal cancer occurred in both men and women, across all stages of disease at presentation, and regardless of subject age, body mass index, smoking status, or use of aspirin prophylaxis.

"Negative colonoscopy was associated with a lower incidence of both distal colorectal cancer and proximal colon cancer, whereas negative sigmoidoscopy and colonoscopy with polypectomy were associated primarily with a lower incidence of distal colorectal cancer," they said.

Notably, screening sigmoidoscopy and screening colonoscopy were associated with lower colorectal cancer–specific mortality, compared with no endoscopy.

The association between a negative colonoscopy and a significantly reduced incidence of colorectal cancer persisted for up to 15 years after the procedure. Thus, "our findings support the 10-year examination interval recommended by existing guidelines for persons at average risk who have a negative colonoscopy. Our study suggests that even a single negative colonoscopy is associated with a very low long-term risk of colorectal cancer," Dr. Nishihara and her associates said.

Among study subjects who were found to have adenomas, the reduced incidence of colorectal cancer persisted for up to 5 years after the procedure. Thus, "our data support screening at more frequent intervals for persons with a family history of colorectal cancer, which [also] supports current surveillance guidelines."

The researchers also examined DNA from stored specimens of tumors from 62 patients who developed colorectal cancer within 5 years of "passing" an endoscopy. Compared with other cancers, these interval cancers were much more likely to have CpG island methylator phenotype (CIMP), microsatellite instability, and high levels of LINE-1 methylation – all indicators of increased tumor aggressiveness.

It is possible that such lesions are particularly difficult to detect endoscopically or to remove adequately. "It remains unclear whether any of the challenges posed by these biological differences can be addressed by improvements in colonoscopic technique, including more meticulous inspection or improved bowel cleaning," the researchers said.

In the second study, a different research group found that adults who were screened for colorectal cancer using fecal occult blood testing (FOBT) had a 32% decrease in colorectal cancer–related mortality for up to 30 years afterward.

This association appeared to be stronger for men than for women, said Dr. Aasma Shaukat of the Minneapolis Veterans Affairs Health Care System and the University of Minnesota, Minneapolis, and her associates.

They performed a secondary analysis of data from the Minnesota Colon Cancer Control Study, in which 46,551 healthy men and women aged 50-80 years at baseline in 1975 through 1978 were randomly assigned to undergo annual, biennial, or no FOBT screening until 1993. Dr. Shaukat and her colleagues attempted to identify the mortality status and cause of death for as many of these study subjects as possible in 2011.

They identified 33,020 deaths, which represents 71% of the entire study population. A total of 732 deaths were from colorectal cancer.

Both annual and biennial FOBT screening reduced colorectal-cancer-specific mortality by approximately one-third for up to 30 years. The relative risk of death from colorectal cancer was 0.68 with annual FOBT and 0.78 with biennial FOBT, compared with no FOBT. Overall, the relative risk of death with any FOBT screening was 0.73, compared with no FOBT.

This reduction "is consistent with the effect of removing adenomas that would have progressed to cancer and death," Dr. Shaukat and her associates said (N. Engl. J. Med. 2013 [doi:10.1056/NEJMoa1300720]).

The decline in colorectal cancer-specific mortality was greater for men than for women.

"The high accessibility and acceptability of stool-based tests have major public health implications for improving screening rates, although this approach to screening involves more frequent testing than does screening with flexible sigmoidoscopy or colonoscopy," the investigators noted.

Dr. Nishihara’s study was supported by the National Institutes of Health, the Bennett Family Foundation, and the Entertainment Industry Foundation. Dr. Nishihara reported no ties to industry sources; one of her associates reported ties to Bayer Healthcare, Pfizer, Millenium Pharmaceuticals, and Pozen. Dr. Shaukat’s study was supported by the Veterans Affairs Merit Review Reward Program, the National Institutes of Health, and the National Cancer Institute. Dr. Shaukat and her associates reported no financial conflicts of interest.

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