Category Archives: Case Studies

Explosive Data: Fireworks Injuries Skyrocket on July 4th

It’s as predictable as taxes in April. Every year, the Fourth of July brings patriotic displays of color, smoke, and sound — and a slew of emergency room visits from burns and blast wounds.

Federal researchers track data on those injuries year-round using the National Electronic Injury Surveillance System, a national probability sample of about 100 hospitals in the U.S. and its territories. Fireworks injuries don’t only happen in July, but they are, unsurprisingly, far more common in that month versus the rest of the year.

Even when fireworks are sold legally, they are still prone to safety recalls. 36,100 units of TNT Red, White & Blue smoke fireworks were recalled because the fireworks may explode unexpectedly.

Fireworks law varies widely
Where fireworks laws do exist, they vary wildly from state to state, or even from county to county. In Massachusetts and New Jersey, it’s illegal to buy or sell fireworks at all. In Ohio, fireworks are available for purchase, but consumers have to sign a document stating they’ll take them out of the state within 48 hours. And in spite of known hazards here’s a surprising fun fact: Four states (Arkansas, Mississippi, North Dakota, and Oklahoma) allow residents to legally purchase fireworks at age 12.

So who gets hurt?
Legal fireworks or not, children are much more likely than adults to get hurt — 12-year-olds sustain more fireworks injuries than any other age group. But age isn’t the only factor playing into fireworks injuries: Men are more likely to be hurt than women.  So what about trends in the data? If you look at injury rates over the last two decades, you see that injuries to teenagers and children have dropped since 2005, but injuries among 20-40-year-olds are creeping up.  And what goes wrong most often? The most common type of injury is thermal burns. Sparklers are an unassuming culprit in the hands of any child.

The injuries span a wide range — from a 2-year-old boy who sustained a burn to his eye after his brother accidentally hit him with a sparkler to a 23-year-old who had a bottle rocket explode in his hands and needed a finger amputated.  Some of the data points are indirect injuries: One patient suffered bites after fireworks spooked a nearby dog. And a 10-year-old girl put two pieces of bathroom tissue in her ear to drown out the noise of fireworks.

See a full set of data graphs for this article at: STAT NEWS

Source: By Natalia Bronshtein, Displayed with permission courtesy of STAT News via Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Adding Friendly Bacteria to Skin Lotion Wards Off Bad Germs

Customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin.

Bacteria live on everyone’s skin, and new research shows some friendly germs produce natural antibiotics that ward off their disease-causing cousins. Now scientists are mixing the good bugs into lotions in hopes of spreading protection. In one early test, those customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin, researchers reported.

Image courtesy of Shutterstock

“It’s boosting the body’s overall immune defenses,” said Dr. Richard Gallo, dermatology chairman at the University of California, San Diego, who is leading the work.

We share our bodies with trillions of microbes that live on our skin, in our noses, in the gut. This community  – what scientists call the microbiome  – plays critical roles in whether we stay healthy or become more vulnerable to various diseases. Learning what makes a healthy microbiome is a huge field of research, and already scientists are altering gut bacteria to fight diarrhea-causing infections.  The research sheds new light on the skin’s microbiome, suggesting that one day it may be possible to restore the right balance of good bugs to treat skin disorders, too.

Healthy skin harbors a different mix of bacteria than skin damaged by disorders such as atopic dermatitis, the most common form of eczema. Those patches of dry, red, itchy skin are at increased risk of infections, particularly from a worrisome germ known as Staphylococcus aureus.

Gallo’s team took a closer look at how microbes in healthy skin might be keeping that bad staph in check.  They discovered certain strains of some protective bacteria secrete two “antimicrobial peptides,” a type of natural antibiotic. In lab tests and on the surface of animal skin, those substances could selectively kill Staph aureus, and even a drug-resistant strain known as MRSA, without killing neighboring bacteria like regular antibiotics do, the team reported in the journal Science Translational Medicine.

But those good bugs are rare in the skin of people with atopic dermatitis, Gallo said.  “People with this type of eczema, for some reason that’s not quite known yet, have a lot of bacteria on the skin but it’s the wrong type of bacteria. They’re not producing the antimicrobials they need,” he explained. Would replenishing the good bugs help? “They’re normal skin bacteria, so we knew they would be safe,” Gallo noted.

His team tested five volunteers with atopic dermatitis who had Staph aureus growing on their skin’s surface  – what’s called colonization, but didn’t have an infection. Researchers culled some of the rare protective bacteria from the volunteers’ skin, grew a larger supply and mixed a dose into an over-the-counter moisturizer. Volunteers had the doctored lotion slathered onto one arm and regular moisturizer on the other.

A day later, much of the staph on the treated arms was killed – and in two cases, it was wiped out, compared to the untreated arms, Gallo said.  “We’re encouraged that we see the Staph aureus, which we know makes the disease worse, go away,” he said.

The study couldn’t address the bigger question of whether exposure to the right mix of protective bacteria might improve atopic dermatitis itself, cautioned Mount Sinai’s Guttman-Yassky. Next-step clinical trials are underway to start testing effects of longer-term use.

Source: By Lauran Neergaard, AP, Displayed with permission from STAT via RePubHub

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Ingredient In Red Bull Helps Treat Psychotic Episodes

Many of us have relied on energy drinks like Red Bull or Monster to pull all-nighters in college, alleviate hangovers, or as a pick-me-up before hitting the gym. These 20-ounce sugar-laden drinks are not the healthiest beverages to consume, but researchers now suggest they may possess medicinal properties. A study presented at the annual meeting of the International Early Psychosis Association found taurine, an additive in energy drinks, can significantly help with psychosis.

angel-wings-305131_640 FREE USE CC00 PIXABAY

Image courtesy PIXABAY CC00 Lic

“Although taurine supplementation did not improve cognition, it appears to improve core symptoms and depression in patients with FEP,” concluded the authors. (FEP is an individual’s first episode of psychosis.)

Taurine is a naturally occurring amino acid in the body that aids a variety of functions. It helps control cardiovascular function, and has been found to both protect the paths of neurons in the brain, and help stimulate the creation of new neurons via neurogenesis. The amino acid is also known to have a calming effect on the brain.

Keeping this in mind, the team of researchers sought to observe if taurine could be utilized to stabilize the neurological activity occurring in people experiencing their first episode of psychosis. A total of 86 participants, aged 18 to 25, who had been previously diagnosed as suffering from a mental disorder with psychosis as a symptom, were recruited for the study. Every day for 12 weeks, half of the participants got four grams of taurine along with their antipsychotic medication, while the other half got a placebo.

Signs of early or FEP include hearing, seeing, tasting or believing things that others don’t; sudden decline in self-care; and trouble thinking clearly or concentrating, according to the National Alliance on Mental Illness. These warning signs often point to a person’s deteriorating health, requiring a physical and neurological evaluation to help identify the problem. The severity of the participants’ symptoms was measured using the Brief Psychiatric Rating Scale (BPRS) and the Calgary Depression Scale for Schizophrenia (CDSS). The researchers also used a scale called the MATRICS consensus cognitive battery (MCCB) to measure changes in cognition.

After 12 weeks, those who received taurine has significantly improved scores on the BPRS, indicating a reduction in psychotic symptoms. They also experienced a significant decrease in depression, although there were no notable changes in cognition. The researchers suggest taurine could potentially act as an effective nutritional therapy in treating FEP.  However, they caution: “The use of taurine warrants further investigation in larger randomised studies, particularly early in the course of psychosis.”  Previous research supports taurine’s ability to aid symptoms in mental disorders. Its been used as an alternative to lithium, by blocking the effects of excess acetylcholine that contributes to bipolar disorder.

Researchers are still a long ways away from prescribing taurine to help with psychosis. It clear that the substance could potentially play an influential role in treating mental illness. But the dose used in the experiment is equivalent to drinking about four 250-millimeter cans of Red Bull in one sitting every day: This is not recommended, and for most people, it’s likely to lead to more problems than it would solve.

Source: Trial finds Red Bull additive taurine improves symptoms of young people suffering first episode psychosis. International Early Psychosis Association Meeting in Milan, Italy. 2016.

By Lizette Borreli, Displayed with permission from Medical Daily
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Clinical Trials Monthly Case Study Analysis: Cost Reductions / Hematology

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question – this time it’s a look at an orphan indication in HEMATOLOGY, and significant cost reductions for the sponsor:

We asked ourselves:

Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug. The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.

•    Criterium offered an integrated technology-enhanced solution that allowed the sites to register ePRO Patient Diaries Input-Output Diagrampatients and allowed the patients to record their event data directly into our remote systems.
•    Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.

What If:  If the client had used traditional methods, the cost would have soared for a product that has modest revenue and it would have taken much longer to provide the data to the FDA and the prescribing community.

Results:  Criterium’s centralized real-time data accession utilizing Automated CRFs and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were satisfactory for rapid submission to the FDA for conditional approval, were provided to the medical community to support the indication for which the drug was approved and numerous publications resulted from this fairly large body of data for this orphan indication.

Read more of our successful case studies: http://www.criteriuminc.com/case_studies.php

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For Cancer Patients, The Possibility Of DNA-Tailored Care

Holly Boehle looked at the expression on the face of her radiologist and knew something was wrong. Boehle had felt a lump just before the holidays and had decided to schedule a mammogram, even though she wasn’t due to start standard screening for another eight years. The mammogram was followed up with an ultrasound, and then a biopsy. Finally, she was given the formal diagnosis: invasive ductal carcinoma, the most common type of breast cancer.

The next week she traveled to Mayo Clinic’s oncology office in Rochester, Minn., where she met with clinical breast surgeon Dr. Judy Boughey who suggested Boehle consider participating in a new, ongoing study. She quickly agreed and became one of 140 women to take part in the Breast Cancer Genome-Guided Therapy Study, affectionately called “BEAUTY.”

By the end of the month, the first phase of the study was underway. Tumor tissue was taken from Boehle, and promptly brought into a lab where the sample was injected into mice with compromised immune systems. With her tumor tissue growing inside of them, the avatar mice are given different chemotherapy drugs in order to test the efficacy of treatment before they try it out on human Boehle.

BEAUTY’s Beginnings

Each patient in BEAUTY was given a biopsy, imaging, and chemotherapy treatment, followed by a second round of biopsy and imaging before they headed into the operating room. This gave researchers information on each patient’s blood and genetic makeup, and the sequencing information for their tumor before, during, and after chemotherapy treatment. The mouse avatars, known as patient xenografts, took up the patient’s individualized tumor 40 percent of the time, ultimately serving as a preview into the patient’s treatment outcome.

DNA Strand Free CCLicenseA class of chemo drug called taxanes are the standard of treatment for breast cancer, but doctors currently don’t have a genetic marker to indicate who will respond to taxane therapy and who won’t. That’s why anthracyclines and cyclophosphamide, a separate chemotherapy drug regimen, are typically given in conjunction as the first step in treatment followed by taxane therapy. However, Boughey’s team reversed the sequence for BEAUTY patients whose mice reacted well to the taxane treatment first. It turned out that those patients who responded best to the flipped treatment sequence also shared the same gene in their genetic makeup.

Based on how her mice reacted to treatment, Boehle was one of those patients who were treated with a reverse chemotherapy schedule than what the typical patient with invasive ductal carcinoma is treated with. Within six months of her diagnosis, Boehle’s tumor shrank considerably as a reaction to the chemotherapy.

Being part of the trial has long-term implications for Boehle, too. If the cancer were to recur, she says, “we would already know…what works for me and what doesn’t. It really opens up a whole new world for me and other breast cancer patients in terms of individualized medicine and knowing that I don’t need to be the person who they experiment on and say, ‘Let’s try this medication or chemotherapy and see if it works and we hope that it does.’”

Four years ago, when Boughey and her team began setting up the BEAUTY study, they wanted to be able to design a treatment plan with a relatively accessible patient population. Because breast cancer is so common among women, the research team chose to start work on individualized medicine with those patients with plans to eventually work their way to other solid tumor cancers such as prostate.

By sequencing the genome for both the tumor and the patient’s inheritable DNA, researchers are able to pull the curtain back and see what’s driving the tumor to grow, why it’s different from another tumor, and how the tumor might react to drug treatments. Harnessing the genetic sequence of a tumor in conjunction with a person’s DNA will allow doctors to expand personalized cancer treatments beyond breast cancer.

Standard of Care Tumor Sequencing

Sequencing a tumor for its complete genetic information can take as little as a few days, and as long as several weeks, depending upon the stage of cancer. Once they have the results, researchers then compare them to a patient’s individual germline cells, which contain hereditary mutations that occur during conception. Patients born with germline mutations can pass on to future generations. Somatic mutations can be caused by a number of different environmental factors and can occur spontaneously. As researchers unravel which gene mutations are responsible for causing each corresponding disease, it sets the foundation for creating individualized treatments through trial-and-error.

“From there potential drugs can be identified that act on genes and/or pathways,” Boughey and her colleague Dr. Matthew Goetz, a clinical oncologist at the Mayo Clinic, told Medical Daily in an email. “One novel aspect of the BEAUTY clinical trial is our ability to link drug response in the patients with both germline and somatic genomic information and validate using the patient derived xenografts [mouse avatars].”

Mayo Clinic’s research team is currently writing the protocol for BEAUTY 2 based on the types of tumors they identified, and the drug resistance and successes discovered in BEAUTY 1. Because they were able to prove mouse avatars, when administered the same drug that patients were treated with, mirror the drug response seen in patients, pharmaceutical companies will be involved with this next stage by designing medications based on study participants’ response to treatment.

BEAUTY, Boughey says, will “drive forward breast cancer treatments for the future.”

By Samantha Olson Displayed with permission from Medical DailyRePubHub Banner

 

 

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HIV Uses Immune System’s Own Tools to Suppress Itself

Canadian scientists make a significant discovery on HIV persistence

A Canadian research team at the IRCM in Montréal, led by molecular virologist Éric A. Cohen, PhD, made a significant discovery on how HIV escapes the body’s antiviral responses. The team uncovered how an HIV viral protein known as Vpu tricks the immune system by using its own regulatory process to evade the host’s first line of defense. The findings pave the way for future HIV prevention or cure strategies.

The study’s goal was to determine how HIV manages to compromise antiviral responses in the initial period of infection, also called the acute infection stage, during which the virus establishes itself in the body. The acute infection is considered a critical period in determining the complexity, extent and progression of the disease. It is also during this stage that HIV establishes latent infection in long-lasting cellular reservoirs. These viral reservoirs, which harbor the virus out of sight from the immune system and antiviral drugs, represent the primary barrier to a cure.

“An important component in this process is a group of proteins collectively called type 1 Interferons, which are the immune system’s first line of defense against viral infections and are known to have a beneficial role in the early stages of HIV infection,” says Dr. Cohen, Director of the Human Retrovirology research unit at the IRCM. “The problem is that HIV has developed mechanisms to suppress the Interferon response and, until now, little was known about how this was achieved.”

PHIL-18143 PubDomLic SEM HIV Particles courtesy NIAID

SEM HIV Particles courtesy NIAID PHIL-18143

Most of the Interferon is produced by a very small population of immune cells called pDCs (plasmacytoid dendritic cells), responsible for providing immediate defense against infections. PDCs patrol the body to detect invaders and, when they recognize the presence of a pathogen, they secrete Interferon. The Interferon then triggers a large array of defense mechanisms in nearby cells, creating an antiviral state that prevents the dissemination and, ultimately, the expansion of the virus.

“When pDCs encounter HIV-infected cells, the production of Interferon is regulated by a protein located on the infected cell’s surface called BST2,” explains Mariana Bego, PhD, first author of the study and research associate in Dr. Cohen’s laboratory. “BST2 has the ability to bind to and activate a receptor called ILT7, found on the surface of pDCs, which, in turns, sends a signal that suppresses the production of Interferon and halts its defensive functions. Interestingly, BST2 is also responsible for restricting HIV production by trapping the virus at the cell surface before it can exit infected cells and disseminate. However, HIV uses the viral protein Vpu to counteract BST2 antiviral activity.”

“With this study, we uncovered a unique mechanism whereby HIV exploits the regulatory process between BST2 and ILT7 to limit the body’s antiviral response, which allows the virus to spread and leads to persistent infection,” adds Dr. Bego. “We found that HIV, through Vpu, takes advantage of the role played by BST2 by maintaining its ability to activate ILT7 and limit the production of Interferon, all the while counteracting its direct antiviral activity on HIV production.”

“The hope for a definitive cure and an effective vaccine has been frustrated by HIV’s endless propensity to subvert the host’s defenses and persist in small populations of long-lasting reservoirs despite antiretroviral therapy,” describes Dr. Cohen, who also leads CanCURE, a team of leading Canadian researchers working towards an HIV cure. “Our findings can provide tools to enhance antiviral responses during the early stages of infection. By blocking Vpu’s action, we could prevent early viral expansion and dissemination, while also allowing pDCs to trigger effective antiviral responses. We believe that such interventions during primary infection have the potential to limit the establishment and complexity of viral reservoirs, a condition that seems required to achieve a sustained HIV remission.”

“The discovery by Drs. Bego and Cohen, which explains how the virus can’t be held down or wiped out during early periods of infection, will bring us closer to ending HIV/AIDS,” says Robert Reinhard, CanCURE Community Liaison. “By filling an important gap in knowledge, this new study will advance research for an HIV cure.”

About the study
The research project was funded by the Canadian Institutes of Health Research (CIHR), the Canadian HIV Cure Enterprise (CanCURE) through a partnership between CIHR, the Canadian Foundation for AIDS Research (CANFAR) and the International AIDS Society (IAS), as well as by a pilot project from the FRQS AIDS and Infectious Disease Network. The study’s authors also include Édouard Côté and Johanne Mercier from the IRCM, as well as Nick Aschman and Winfried Weissenhorn from the Université Grenoble Alpes in France. For more information on the study, please refer to the article published online by PLoS Pathogens

Findings from this study presented by Dr. Cohen on July 21 at the Vancouver Convention Centre as part of the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention.

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2015: Lung Cancer Research Outside the USA

Female Lung Cancer Deaths to Surpass Breast Cancer in Europe

In January 2015, a study by researchers from Switzerland and Italy revealed that lung cancer deaths among women in Europe would overtake those from breast cancer in 2015.[1] Lung cancer is the most common type of cancer, accounting for 13% of all cancer deaths worldwide. That represents a death toll of 1.6 million people, over 80% of who are tobacco users.[2]  While European men have been more afflicted by the disease due to higher smoking rates, the rates among men have been on the decline in the recent past. Meanwhile, the rates among women have been on an upward trend. This year, the prevalence of lung cancer among women in Europe is expected to rise by 9% over 2009 levels to reach 14.24 per 100,000 of population. Meanwhile, the death rate from breast cancer over the same period will fall by 10.2% to 14.22 deaths per 100,000 of population.[3]

The rise is attributed to the delayed effect of the surge in smoking among European women during the period after the 2nd World War and extending to the late 1960s.[4] The UK is one of the main drivers of this trend. Of all the countries surveyed independently, the UK had the highest level of lung cancer deaths, 21 per 100,000 of population.[5] Professor Carlo La Vecchia of the University of Milan, who is also the lead researcher attributed this to the fact that, “…British women started smoking during the second world war, while in most other EU countries women started after 1968.”

Research Shows Personalized Treatments are Underutilized

An international survey conducted between December and January 2015 revealed that the rates of patients receiving personalized treatment for advanced non-small cell lung cancer (NSCLC) remains low despite a large proportion of them (81%) having been tested for EGFR mutations. The results of the study were released in April in Ingelheim Germany, the seat of the Boehringer Ingelheim Pharmaceutical group which is the main sponsor of the study. The results were collected from 562 oncologists from 10 developed countries across Asia, Europe and North America. In Europe, 30% of advanced NSCLC patients were put on first-line treatment before their test results were ready, displaying a huge disparity with Asia (12%). The average global rates were 25%. The main reasons cited by oncologists for non-testing were insufficient tissue, poor patient fitness and protracted process of acquiring results once samples had been taken. Additionally 51% of all oncologists involved in the study stated that their treatment decisions were not dependent on EGFR mutation subtype of their patients. EGFR mutations are present in 40% of East Asian and 10-15% of white NSCLC patients.[6] ESMO clinical practice guidelines[7] recommend the use of EFGR mutation testing results to guide treatment decisions according to each patient’s specific cancer type as this has been shown to improve survival rates at least with the Del 19 mutation[8], the most common type of mutation.[9]

Sources:
[1] http://annonc.oxfordjournals.org/content/early/2015/01/24/annonc.mdv001.full
[2] http://www.cancerresearchuk.org/about-cancer/causes-of-cancer/smoking-and-cancer/smoking-facts-and-evidence#smoking_facts0
[3] http://annonc.oxfordjournals.org/content/early/2015/01/24/annonc.mdv001.full
[4] http://www.theguardian.com/society/2014/oct/07/smoking-falls-lowest-level-uk-recording-started-1940s
[5] http://annonc.oxfordjournals.org/content/early/2015/01/24/annonc.mdv001.full
[6] https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/17_april_2015_oncology.html

[7] http://annonc.oxfordjournals.org/content/early/2014/08/11/annonc.mdu199.full.pdf+html
[8] Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials
    Yang, James Chih-Hsin et al., The Lancet Oncology , Volume 16 , Issue 2 , 141 – 151
[9] http://link.springer.com/article/10.1007/s00330-015-3697-0/fulltext.html

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IUDs safe in population at high risk for STIs

  1.  In a study population at high-risk for sexually transmitted infections, the rate of pelvic inflammatory disease following intrauterine device placement was low.
  2. The IUD continuation rate at one year was greater than 85 percent.

Evidence Rating Level: 3 (Average)       

IUD Diagram Jun15 Blog

 

 

 

 

 

 

Image: CC/Wikimedia Commons/Blausen.com used with license/permission

Study Rundown: Intrauterine devices (IUDs) are some of the most effective forms of birth control, with a failure rate of less than one percent, and have been demonstrated to be safe for a wide range of women, including teenagers and young adults. Despite their high efficacy and safety record, many practitioners and patients still have misconceptions regarding the risk of pelvic inflammatory disease (PID) after IUD placement. PID is an infection of the upper genital tract (endometrium, tubes and ovaries) that commonly occurs when a sexually transmitted infection (STI), such as Chlamydia, gonorrhea, or trhichomonas ascends from the lower genital tract. Complications from PID include infertility and PID as well as an increased risk of ectopic pregnancy. If a woman has an STI at the time of IUD placement, she is at higher risk of contracting PID, but after about 20 days, the risk of PID decreases to the baseline risk among women who use a non-barrier form of contraception. Because of the concern for risk of PID with IUD insertion among women at high risk for STIs, most large studies exclude this population and limited data exists to guide their use in this population. In the present work, researchers retrospectively assessed rates of PID after IUD placement in an urban teaching hospital that did not restrict IUD eligibility based on STI risk factors.

Rates of PID following IUD placement were low and comparable to previous studies. The study population was at high-risk for STIs with a high incidence (nearly 50%) of personal history of STIs, 50% of participants were under the age of 26, and participants identified as being single. Lack of control group limited this study. Replication of findings using an age-matched control cohort would lend credence to the results presented herein.

Click to read the study in Contraception

Relevant Reading: Does insertion and use of an intrauterine device increase the risk of pelvic inflammatory disease among women with sexually transmitted infection? A systematic review

In-Depth [retrospective cohort]: Researchers reviewed charts of all patients undergoing hormonal IUD placement in the resident clinic of a large, urban, academic medical center from July 2007-June 2008 (n = 283). IUD candidates were not restricted by age, parity or STI risk. The primary outcome was diagnosis of PID within twelve months of IUD placement. Secondary outcomes included continuation and adverse outcomes: expulsion, perforation, pregnancy, pain and heavy bleeding.

Prior to IUD placement, 140 patients (49.5%) reported a history of STI and eight (3.02%) tested positive for gonorrhea or chlamydia at the time of placement in this high-risk population. In the 12 months following placement, only two patients (0.7%) were diagnosed with PID, one of which had a positive gonorrheal test at the time of placement. The continuation rate at one year was 85.2%, expulsion rate was low (5.3%) and a minority of women (17.7%) reported adverse effects.

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Halozyme: Update Following Type B FDA Meeting

Recent FDA meeting allows for potential marketing application based on progression free survival in pivotal Phase 3 pancreatic cancer study

Halozyme Therapeutics, Inc.,a biotechnology company developing novel oncology and drug-delivery therapies, today announced it plans to proceed with a Phase 3 clinical study (Study 301) of its investigational new drug PEGPH20 in patients with metastatic pancreatic cancer, using a design allowing for potential marketing application based on either progression free survival (PFS) or overall survival. The use of PFS as the basis for marketing approval will be subject to the overall benefit and risk associated with PEGPH20 combined with nab-paclitaxel (ABRAXANE ®) and gemcitabine therapy, including the:

  • Magnitude of the PFS treatment effect observed;
  • Toxicity profile; and
  • Interim overall survival data.

The study will enroll patients whose tumors accumulate high levels of hyaluronan (HA) – a sugar that is sometimes more prevalent in the areas surrounding cancer cells. Halozyme recently discussed the study as part of a planned Type B meeting with the U.S. Food and Drug Administration (FDA).

bullseyeData discussed at the meeting focused on interim results from the company’s randomized Phase 2 study in pancreatic cancer, Study 202, which showed a doubling in median PFS in metastatic pancreatic cancer patients with high levels of HA who were treated with Halozyme’s investigational new drug PEGPH20 combined with nab-paclitaxel (ABRAXANE ®) and gemcitabine (9.2 months vs. 4.3 months in patients treated with nab-paclitaxel ABRAXANE ® and gemcitabine alone). The potential risk profile, including rate of thromboembolic events, was also discussed.  Additional takeaways from the meeting include:

  • Halozyme affirmed plans to enroll and evaluate high-HA patients using a companion diagnostic test; and
  • FDA provided feedback on the current companion diagnostic approach and confirmed that an approved companion diagnostic strategy is required prior to Phase 3 study initiation.

“We are encouraged by the FDA’s feedback and their willingness to consider a novel primary endpoint such as PFS given the high unmet medical need in high-HA metastatic pancreatic cancer,” said Dr. Helen Torley, President and Chief Executive Officer. “We are committed to rapidly finalizing the Phase 3 protocol and developing the companion diagnostic regulatory filings required to initiate Study 301.” Based on this FDA feedback, the company is targeting the end of first quarter 2016 to initiate the Phase 3 study.

About Study 202 & PEGPH20microscope in laboratory
Study 202 (Halo 109-202) is a Phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for treatment of patients with stage 4 metastatic pancreatic cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint will assess the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival. More information may be found at: http://oncologytrials.halozyme.com/pancreatic/.

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the systemic treatment of tumors that accumulate hyaluronan. FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.

About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor.  PEGPH20 is currently in development for metastatic pancreatic cancer and non-small cell lung cancer and has potential across additional cancers in combination with different types of cancer therapies. For more information, visit www.halozyme.com.

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FDA Approves Pulmozyme with eRapid Nebulizer

CF Patients See 2 – 3 Minute Treatment Times

The eRapid Nebulizer System (eRapid) from PARI has been approved as the first electronic nebulizer by the Food and Drug Administration to deliver Genentech’s Pulmozyme for cystic fibrosis treatment.  A huge improvement for cystic fibrosis patients, eRapid is able to reduce average treatment times with Pulmozyme from 6-8 minutes down to 2-3 minutes.  Both adult and pediatric patients showed a strong preference for eRapid over conventional nebulizers in a clinical study. FDA-Logo

“We have been pleased with eRapid’s fast treatment times in the lab and are excited that patients now have access to a much faster Pulmozyme therapy.  As the first electronic nebulizer to deliver Pulmozyme, eRapid is a true breakthrough for cystic fibrosis patients who take the therapy daily, often for years,” said Lisa Cambridge, director of Medical Science and Pharmaceutical Alliances at PARI Respiratory Equipment, Inc.

“PARI was motivated to introduce eRapid to the US market based on encouragement from the Cystic Fibrosis Foundation and their input to have a general-use, electronic nebulizer that could improve therapy adherence. For many years, eRapid has been successfully distributed in Europe (as eFlow Rapid) with favorable feedback from patients with CF. In the Pulmozyme clinical trial, there was a 10:1 preference for eRapid in the pediatric group and a 20:1 preference in the adult group.  That confirmed our decision to bring eRapid to the US,” added Geoff A. Hunziker, president of PARI USA.

“After the successful results of a Phase IV study, we are confident that physicians will see that both pediatric and adult patients favor eRapid based on reduced treatment times, quiet operation, and its small, portable size.  We were also happy to see that patients were more satisfied with treatment and eRapid had a positive influence on adherence – good for their overall cystic fibrosis management,” added Lisa Cambridge.  eRapid is available today by prescription through a select group of specialty pharmacies.  Visit www.pari.com or call 1-800-FAST-NEB to learn more.

Pulmozyme is indicated for daily administration along with standard therapies for the management of cystic fibrosis to improve pulmonary function.  For more information, visit http://www.pulmozyme.com/.

About eRapid Nebulizer System eRapid is an electronic nebulizer that enables quick and efficient inhalation that can greatly reduce a patient’s treatment burden.  For more information on eRapid, please visit http://www.pari.com/.

About Cystic Fibrosis Cystic fibrosis, a life-threatening disease affecting 30,000 American patients, involves a genetic mutation that results in poorly hydrated, thickened mucus secretions in the lungs, as well as severely impaired mucociliary clearance.  Get more information about Cystic Fibrosis, visit http://www.cff.org

About PARI Respiratory Equipment, Inc. PARI is a leading, worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, cystic fibrosis, RSV, VAP, and HAP.  PARI’s worldwide vision is to improve the lives of those affected by respiratory diseases and those who care for them. PARI is considered the gold standard for aerosol delivery for nebulizer therapies.  Featured products include the PARI LC PLUS Reusable Nebulizer, Vortex Holding Chamber, and the drug-specific eFlow Technology platform.

SOURCE: PARI Respiratory Equipment, Inc., Displayed with permission from PR Newswire via RePubHub