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Injectable, radioactive gel synergizes with chemotherapy to shrink pancreatic tumors

Pancreatic cancer is one of the deadliest types of cancer—in the U.S., it is estimated that over 88 percent of people will die from the disease within five years of their diagnosis.

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Preclinical study led to unprecedented results in mouse models
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Credit: Chilkoti lab
The preclinical treatment regimen evaluated in this study. The radioactive biopolymer (131I-ELP, where ELP stands for elastin-like polypeptide) is injected into the pancreatic tumor, and the radiosensitizing chemotherapeutic drug paclitaxel is delivered systemically.
« Injectable, radioactive gel synergizes with chemotherapy to shrink pancreatic tumors

Newswise — Pancreatic cancer is one of the deadliest types of cancer—in the U.S., it is estimated that over 88 percent of people will die from the disease within five years of their diagnosis. One reason for this bleak prognosis is that the majority of pancreatic cancers are diagnosed after the disease has already spread, or metastasized, to other parts of the body. Another reason is that pancreatic cancers are particularly challenging to treat, as these tumors are often resistant to standard anti-cancer drugs.

NIBIB-funded researchers are developing a new method to treat this lethal disease. Their study, recently published in Nature Biomedical Engineering, combined an injectable radioactive gel with systemic chemotherapy in multiple mouse models of pancreatic cancer. The treatment resulted in tumor regression in all their evaluated models, an unprecedented result for this genetically diverse and aggressive type of cancer.

“Radiation treatments are typically delivered externally, which exposes healthy tissue to radiation and limits the dose that a tumor receives, ultimately limiting its effectiveness,” said David Rampulla, Ph.D., director of the division of Discovery Science & Technology at NIBIB. “The radioactive biomaterial investigated in this preclinical study can be injected directly into the tumor, allowing for a localized approach. What’s more, this biodegradable biomaterial allows for higher cumulative radiation doses than other implantable radiation treatments.”

Brachytherapy—where a radiation source is placed inside the body—can be used to treat several different types of cancer. Early-stage prostate cancer, for example, can be treated with ‘seed’ brachytherapy, where many tiny metal seeds that contain a radioactive substance are implanted into the prostate. While these seeds can limit healthy tissues’ exposure to radiation, their metal casing prevents the use of potent radiation particles, known as alpha and beta emitters, which are more effective at killing cancer cells. Additionally, due to their small size, around 100 seeds are typically needed for prostate cancer treatment (with each individual seed requiring an injection). To date, brachytherapy approaches have not improved clinical outcomes among patients with pancreatic cancer.

The current study is investigating a new type of brachytherapy. Instead of delivering radiation using a metal seed or a catheter, the study authors are investigating the use of a radioactive biopolymer that is injected directly into the tumor. In addition to being biodegradable, the biopolymer has a unique property—it has been engineered to transition from a liquid at room temperature to a gel-like state when warmed to body temperature. As the biopolymer solidifies, it stays within the tumor, and can’t easily spread into surrounding healthy tissues.

“Our biopolymer is derived from elastin, an abundant protein that it is found in the connective tissues throughout our bodies,” explained first author Jeff Schaal, Ph.D., who conducted this work at Duke University. “By tinkering with the composition of this biopolymer, we can control the exact temperature where it transitions from a liquid to a gel. And because we’re not encasing the radioactive polymer within a protective metal seed, we can use different—and more potent—isotopes, allowing us to deliver a higher radiation dose than conventional seed brachytherapy.”

The radioactive isotope used in this proof-of-concept treatment is iodine-131 (or I-131), which releases high-energy particles known as beta particles. Beta particles cause DNA damage and kill irradiated cells, but they can’t travel very far—only a few millimeters (so off-target toxicity is limited). I-131 has been used to treat thyroid cancer for decades and has a well-established safety profile, said Schaal.

Pancreatic cancer is sometimes treated with a combination of radiation and specific chemotherapeutic agents that make the radiation more effective. These ‘radiosensitizing’ drugs work by prolonging the cell’s replication process—specifically when its DNA is exposed, Schaal explained. The exposed DNA is more sensitive to radiation and is more likely to be irreparably damaged by it, which ultimately results in cell death.

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In combination with a radiosensitizing chemotherapeutic known as paclitaxel, the study authors evaluated their radioactive biopolymer in several different pancreatic cancer models, carefully selected to reflect different aspects of pancreatic cancer (e.g., common mutations, tumor characteristics,  tumor density, or treatment resistance). Among all the models tested, nearly every mouse responded, meaning the tumors either shrunk or completely vanished. “The response rates that we saw in our models were unprecedented,” said Schaal. “After a thorough review of the literature, we have yet to find another treatment regimen that demonstrates such a robust response in multiple and genetically diverse models of pancreatic cancer.” Further, in some mice, the tumors never returned during the course of the study.

When the study authors evaluated a current clinical treatment regimen—paclitaxel plus external beam radiation—the response rates weren’t nearly as impressive: Tumor growth rate was only inhibited, instead of tumors shrinking or vanishing. “Unlike external beam radiation, which is given in short bursts, our brachytherapy approach delivers radiation continuously,” explained Schaal. “We found that this continuous beta-particle radiation altered the microenvironment of the tumor and allowed paclitaxel to better penetrate into the tumor core, allowing for a synergistic therapeutic effect.”

Importantly, the researchers did not observe any acute toxicity issues during the course of their study, with negligible amounts of radioactivity accumulating in critical organs in the mice. They have previously reported that their radioactive biopolymer safely biodegrades—with the half-life of the gel (roughly 95 days) far outlasting the half-life of I-131 (roughly eight days).

The authors did not evaluate their treatment in metastatic disease, but the nature of their approach would allow for biopolymer injections in multiple locations, such as tumor masses in other organs. And while this study remains in the preclinical stage, the study authors are working to move this treatment forward. “Our group has been partnering with clinical researchers to develop and optimize our system for endoscope-guided delivery in a larger animal model,” said senior author Ashutosh Chilkoti, Ph.D., a professor in the Department of Biomedical Engineering at Duke University. “The challenge however of taking this—or any new treatment—to patients is finding the support to take it through clinical trials.”

This study was supported by a grant from NIBIB (R01EB000188) and a grant from the National Cancer Institute (NCI; grant R35CA197616).

This Science Highlight describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process—each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research.

Link: https://pubmed.ncbi.nlm.nih.gov/36261625/

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Source: National Institute of Biomedical Imaging and Bioengineering

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Important Recall Notice: Certain Ulker Brand Products Due to Undeclared Allergens

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dough in a tray. Ulker
Photo by Felicity Tai on Pexels.com

Attention Consumers in Ontario and Quebec!

We want to ensure that you stay informed and safe, especially when it comes to food products. Recently, a recall was issued for specific Ulker brand snacks due to undeclared allergens, which can pose serious health risks for those with allergies or intolerances. Here’s what you need to know.

The Affected Products

The following Ulker products have been recalled:

  • Kekstra Mini (Strawberry)
  • Biskrem Cocoa
  • Rulokat


The Issue

The recall is a response to the discovery that these products contain undeclared egg, milk, and wheat. For individuals with allergies or sensitivities to these ingredients, consuming these products can potentially lead to serious or even life-threatening reactions.

Distribution

These products are specifically distributed in the provinces of Ontario and Quebec. If you reside in these areas, it is crucial to check your pantry and ensure that you do not have any of the affected items.

What You Should Do

  1. Check Your Inventory: Look for the Kekstra Mini (strawberry), Biskrem cocoa, and Rulokat products in your home. If you have them, examine the packaging for any allergen warnings.
  2. Do Not Consume: If you have allergies or sensitivities to egg, milk, or wheat, please do not eat these recalled products. The presence of these allergens could trigger a serious reaction.
  3. Celiac Disease Awareness: For those who have celiac disease or other gluten-related disorders, it is essential to avoid these products entirely, as hidden gluten could be harmful.
  4. Proper Disposal or Returns: If you find any of these products, do not serve, use, or distribute them. We recommend throwing them out or returning them to the place of purchase for a full refund.

Stay Safe!

The safety and well-being of consumers are of utmost importance. By taking a moment to assess your pantry and ensuring that you’re not inadvertently consuming these recalled products, you can help protect yourself and your loved ones.

For additional updates and information on recalls, staying informed is key. Regulatory bodies and health organizations often release updates and safety information, so keeping an eye on these resources will help you stay safe.

If you have any questions or need further assistance, please feel free to reach out! Your health and safety are our priority, and we’re here to help you navigate any concerns you may have.

Stay informed and stay safe! 🥳

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Learn more:

Important links:

https://recalls-rappels.canada.ca/en/alert-recall/certain-ulker-brand-products-recalled-due-undeclared-egg-milk-and-wheat

https://prnmedia.prnewswire.com/news-releases/certain-ulker-brand-products-recalled-due-to-undeclared-egg-milk-and-wheat-879269964.html

SOURCE Canadian Food Inspection Agency (CFIA)

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Lifestyle

Clinical Trials Expand Patients’ Treatment Options

Clinical trials play a crucial role in developing effective treatments for chronic health conditions. They evaluate safety and efficacy, but low enrollment delays drug approvals, limiting patient options.

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Clinical Trials

(Family Features) For health conditions with no cure, effective treatments are the next best option. However, in order to make medical interventions including new drugs, devices, vaccines and lifestyle modifications available, they must undergo a thorough evaluation process to demonstrate their benefits.

Clinical trials are an important part of this process because they provide data for researchers on the effectiveness of various treatments and interventions. However, many myths about clinical trials deter people from enrolling. In fact, more than 70% of clinical trials are delayed at least one month due to unfulfilled enrollment, according to the “Journal of Medical Internet Research.”

Delays create barriers to the drug approval process and result in fewer available treatments for chronic conditions like Crohn’s disease and ulcerative colitis. The experts at the Crohn’s & Colitis Foundation offer these facts about the importance of clinical trials:

  1. More patients can benefit from clinical trials While hundreds of participants may take part in a trial, the results can lead to new care and treatment options for an entire patient community.
     
  2. Clinical trials lead to better and improved medications. For a new treatment to be approved, it needs to demonstrate a meaningful benefit to patients, such as improved outcomes, treating a wider range of symptoms, fewer side effects or more convenience for patients.
     
  3. They provide information. Clinical trials provide evidence of a treatment’s effectiveness and safety that can be used to guide patient care.
     
  4. Trials test safety and efficacy. Clinical trials are conducted in four phases. During the first phase, the main objective is to assess the safety of a new treatment. Experimental treatments only advance to the next stages if they pass certain safety and efficacy standards
    .
  5. They help prevent bias. In a randomized controlled trial, the effects of treatment with a new drug are compared with that of a control group – either a placebo (a treatment that looks identical to the new drug but contains no active medicine) or the current standard of care. Treatment assignments are “randomized,” which means neither the trial doctors nor the participants choose which treatment each participant will receive.

How Clinical Trials Work
Before a clinical trial begins, a research team develops a clinical trial protocol. This is the research plan that describes who can join the trial, which treatments the participants will receive, what questions the researchers will try to answer, how long the trial will last and how participant privacy and safety will be protected.

Conducting clinical research relies on volunteer trial participants. Those interested in joining a clinical trial meet with clinical research professionals to discuss the trial, treatments, eligibility requirements and expectations.

Joining a Trial
If you are interested in participating in a clinical trial, do some research. Your doctor may not be aware of or proactively tell you about trials you may be eligible to join. If you find a clinical trial you may be interested in joining, discuss the trial with your doctor and other health care professionals on your research team.

Foundations supporting chronic conditions can be a good source of information. For example, you can learn more about trials affecting individuals with inflammatory bowel disease by exploring the Clinical Trials Community at crohnscolitisfoundation.org.

Photo courtesy of Shutterstock

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SOURCE:
Crohn’s & Colitis Foundation


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Why community pharmacies are closing – and what to do if your neighborhood location shutters

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Lucas A. Berenbrok, University of Pittsburgh; Michael Murphy, The Ohio State University, and Sophia Herbert, University of Pittsburgh

Neighborhood pharmacies are rapidly shuttering.

Not long ago, Walgreens, one of the nation’s biggest pharmacy chains, announced plans to close 1,200 stores over the next three years. That’s part of a larger trend that has seen nearly 7,000 pharmacy locations close since 2019, with more expected in the coming years.

Many community pharmacies are struggling to stay open due to an overburdened workforce, shrinking reimbursement rates for prescription drugs and limited opportunities to bill insurers for services beyond dispensing medications.

As trained pharmacists who advocate for and take care of patients in community settings, we’ve witnessed this decline firsthand. The loss of local pharmacies threatens individual and community access to medications, pharmacist expertise and essential public health resources.

The changing role of pharmacies

Community pharmacies – which include independently owned, corporate-chain and other retail pharmacies in neighborhood settings – have changed a lot over the past decades. What once were simple medication pickup points have evolved into hubs for health and wellness. Beyond dispensing prescriptions, pharmacists today provide vaccinations, testing and treatment for infectious diseases, access to hormonal birth control and other clinical services they’re empowered to provide by federal and state laws.

Given their importance, then, why have so many community pharmacies been closing?

There are many reasons, but the most important is reduced reimbursement for prescription drugs. Most community pharmacies operate under a business model centered on dispensing medications that relies on insurer reimbursements and cash payments from patients. Minor revenue comes from front-end sales of over-the-counter products and other items.

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However, pharmacy benefit managers – companies that manage prescription drug benefits for insurers and employers – have aggressively cut reimbursement rates in an effort to lower drug costs in recent years. As a result, pharmacists often have to dispense prescription drugs at very low margins or even at a loss. In some cases, pharmacists are forced to transfer prescriptions to other pharmacies willing to absorb the financial hit. Other times, pharmacists choose not to stock these drugs at all.

And it’s not just mom-and-pop operations feeling the pinch. Over the past four years, the three largest pharmacy chains have announced plans to close hundreds of stores nationwide. CVS kicked off the trend in 2021 by announcing plans to close 900 pharmacy locations. In late 2023, Rite Aid said that thousands of its stores would be at risk for closure due to bankruptcy. And late in 2024, Walgreens announced its plans to close 1,200 stores over the next three years.

To make matters worse, pharmacists, like many other health care providers, have been facing burnout due to high stress and the lasting effects of the COVID-19 pandemic. At the same time, pharmacy school enrollment has declined, worsening the workforce shortage just as an impending shortfall of primary care physicians looms.

Why pharmacy accessibility matters

The increasing closure of community pharmacies has far-reaching consequences for millions of Americans. That’s because neighborhood pharmacies are one of the most accessible health care locations in the country, with an estimated 90% of Americans living within 5 miles of one.

However, research shows that “pharmacy deserts” are more common in marginalized communities, where people need accessible health care the most. For example, people who live in pharmacy deserts are also more likely to have a disability that makes it hard or impossible to walk. Many of these areas are also classified as medically underserved areas or health professional shortage areas. As pharmacy closures accelerate, America’s health disparities could get even worse.

So if your neighborhood pharmacy closes, what should you do?

While convenience and location matter, you might want to consider other factors that can help you meet your health care needs. For example, some pharmacies have staff who speak your native language, independent pharmacy business owners may be active in your community, and many locations offer over-the-counter products like hormonal contraception, the overdose-reversal drug naloxone and hearing aids.

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You may also consider locations – especially corporate-owned pharmacies – that also offer urgent care or primary care services. In addition, most pharmacies offer vaccinations, and some offer test-and-treat services for infectious diseases, diabetes education and help with quitting smoking.

What to ask if your pharmacy closes

If your preferred pharmacy closes and you need to find another one, keep the following questions in mind:

What will happen to your old prescriptions? When a pharmacy closes, another pharmacy may buy its prescriptions. Ask your pharmacist if your prescriptions will be automatically transferred to a nearby pharmacy, and when this will occur.

What’s the staffing situation like at other pharmacies? This is an important factor in choosing a new pharmacy. What are the wait times? Can the team accommodate special situations like emergency refills or early refills before vacations? Does the pharmacist have a relationship with your primary care physician and your other prescribers?

Which pharmacies accept your insurance? A simple call to your insurer can help you understand where your prescriptions are covered at the lowest cost. And if you take a medication that’s not covered by insurance, or if you’re uninsured, you should ask if the pharmacy can help you by offering member pricing or manufacturer coupons and discounts.

What are your accessibility needs? Pharmacies often offer services to make your care more accessible and convenient. These may include medication packaging services, drive-thru windows and home delivery. And if you’re considering switching to a mail-order pharmacy, you should ask if it has a pharmacist to answer questions by phone or during telehealth visits.

Remember that it’s best to have all your prescriptions filled at the same pharmacy chain or location so that your pharmacist can perform a safety check with your complete medication list. Drug interactions can be dangerous.

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Community pharmacies have been staples of neighborhoods for more than a century. Unfortunately, current trends in pharmacy closures pose real threats to public health. We hope lawmakers address the underlying systemic issues so more Americans don’t lose access to their medications, health services and pharmacists.

Lucas A. Berenbrok, Associate Professor of Pharmacy and Therapeutics, University of Pittsburgh; Michael Murphy, Assistant Professor of Pharmacy Practice and Science, The Ohio State University, and Sophia Herbert, Assistant Professor of Pharmacy, University of Pittsburgh

This article is republished from The Conversation under a Creative Commons license. Read the original article.


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