Johns Hopkins Kimmel Cancer Center Completed Phase I Trial of Intravenous Mistletoe

February 23, 2023 BelieveBig Press Release Comments Off

Non-profit Believe Big funded research shows mistletoe treatment safe and improves quality of life for cancer patients.

Hunt Valley, Maryland — February 23, 2023 — The first mistletoe therapy clinical trial in the United States utilizing intravenous Mistletoe has been completed by oncologists at the Johns Hopkins Kimmel Cancer Center. Spearheaded by Believe Big, a non-profit cancer assistance organization founded by cancer survivor and mistletoe advocate Ivelisse Page, the Phase I trial began in 2015 with the goal of evaluating the safety of Mistletoe use for cancer patients and determining the recommended dosing for Phase II.

In the trial, Helixor M Mistletoe was administered intravenously three times a week to 21 participants. The results indicate improvement in quality of life.

Trial results were published in February 2023 by the American Association for Cancer Research.

Download the Mistletoe clinical trial results here >

Mistletoe Prescribed Widely in Europe

Mistletoe, one of the most widely studied CAM (Complementary and Alternative Medicine) therapies for cancer treatment, has been in common use in Europe for over a century, using extracts of the mistletoe plant. According to the National Cancer Institute, preparations made from European mistletoe (Viscum album) are among the most prescribed drugs offered to cancer patients in some European countries. However, its use has not been widely explored in the United States, where almost 1 in 2 people will be diagnosed with cancer in their lifetime.

Although Mistletoe is listed as an FDA approved substance in the homeopathic pharmacopeia and can be prescribed off label, oncologists cannot offer this treatment as standard of care in America until all phases of the trial are completed.

Currently, only the European species of the mistletoe plant is used for cancer treatment. Mistletoe is one of the most prescribed complementary and/or alternative cancer treatments in Europe. Research in Germany finds it can reduce side-effects and toxicity during chemotherapy and radiotherapy, boost immune response, reduce pain, and increase survival times when used with orthodox medicine. Physicians in Europe are known to administer Mistletoe for treatment in malignant and non-malignant tumors to stimulate bone marrow activity alongside conventional treatments and to offset the side effects of chemotherapy/radiation such as nausea, vomiting, and lack of appetite. It can also be used to diminish tumor-related pain and to reduce the risk of tumor recurrence.

Since 1975, Helixor has been one of the leading international pharmaceutical companies in the field of integrative oncology and a respected manufacturer of various Mistletoe products used intravenously as well as for self-injections.

A Cancer Survivor’s Mistletoe Story

“We are at a monumental time in history that will be forever marked by the teamwork and belief by the team at Johns Hopkins, Believe Big supporters and the hand of God,” said Ivelisse Page, founder of Believe Big and a stage IV colon cancer survivor of 14 years. “I know how well mistletoe worked for me and my hope is that is becomes available to all patients.”

Page developed colon cancer at age 37, facing the same cancer that took her father’s life, her grandmother’s life, and half of her siblings. Discovering that the survivorship of stage IV colon cancer with metastasis to the liver was less than 8 percent, she made the decision to forgo chemotherapy and radiation, as it would not have increased her chances of survival. Instead, she pursued an integrative approach. After two surgeries, Page was monitored by her oncologist with scans and blood work and began her complementary treatments prescribed by her integrative physician which included mistletoe injections, a plant-based diet, homeopathy, cancer fighting supplements and more. She beat the 8 percent survival rate and has been cancer free since December 2008.

Additional Funding Needed for Phase II

Now that the maximum tolerated dose has been determined and its safety verified, it is possible to begin Phase II clinical trials, pending additional funding.

The road to a clinical trial is long, often arduous, and quite expensive. Traditionally in the United States, large pharmaceutical companies will spend hundreds of millions of dollars to begin the process and see a new drug through to a conclusion. Ivelisse Page and her Believe Big organization raised over $400,000 to kickstart this Mistletoe trial. Work has already begun to raise the funds needed for Phase II.

“This is an exciting development in the world of cancer treatment,” offers Page. “The more tools available in the medical arsenal, the more options the patient has. We are immensely grateful to the incredible staff at Johns Hopkins who have devoted their time and talents to this effort. Our gratitude also goes to Helixor for making their Mistletoe products available for this study.”

About Believe Big

Established in 2011, Believe Big is a 501 (c) 3 non-profit founded by Ivelisse and Jimmy Page after her battle with Stage IV colon cancer. Believe Big serves those with cancer in the United States and beyond. Believe Big offers a wide array of support mechanisms for cancer patients, ranging from nutrition therapy to Mistletoe education and patient advocacy. The organization helps cancer patients move through the overwhelming process of treatment by bridging the gap between conventional and complementary medicine to heal in all aspects of life: physically, emotionally, and spiritually.

To learn more, visit www.BelieveBig.org

For Immediate Release
Contact: Jeff Davis
410- 372-0827

Donate towards Phase II of the mistletoe clinical trial >

First U.S. Study of Mistletoe Extract to Treat Cancer – Johns Hopkins Kimmel Cancer Center – Press Release

February 22, 2023 BelieveBig Press Release Comments Off

First U.S. Study of Mistletoe Extract to Treat Cancer

Mistletoe extract has been widely used to support cancer therapy and improve quality of life, but questions remain due to a lack of clinical trials and data to support its use. Researchers at the Johns Hopkins Kimmel Cancer Center completed the first Phase I intravenous trial in the U.S. aimed at determining dosing for subsequent clinical trials and to evaluate safety.

The findings from the small study were reported online Feb. 9 in Cancer Research Communications.

The trial’s purpose was to evaluate the drug’s safety, but the researchers, led by Channing Paller, M.D., associate professor of oncology, also documented improved quality of life and some disease control.

The mistletoe extract (ME), known as Helixor M, was studied in 21 patients with advanced and treatment-resistant cancers of various types. The Phase I trial used dose escalation, exploring multiple dose levels delivered intravenously three times per week until disease progression or until toxicity. The study concluded the maximum tolerated dose to be 600 mg of ME.

The median follow-up duration on mistletoe was 15.3 weeks, however, the range among patients varied from two weeks to 101.1 weeks. Stable disease was observed in five patients and lasted, on average, for 15 weeks. Tumors in three participants decreased in size, and remained stable for two to five months, however, it did not meet official criteria for partial response. Patients also reported overall improved quality of life via a questionnaire. The most common side effects reported were fatigue, nausea, and chills and were manageable.

“Intravenous mistletoe demonstrated manageable toxicities with disease control and improved quality of life in this heavily pretreated group of patients,” says Paller, adding that additional Phase II studies in combination with chemotherapy are the next step, pending additional funding.

In addition, Paller says, laboratory research to better decipher ME’s mechanisms are needed, as the cytokines (cell-signaling proteins) measured in this study are preliminary and hypothesis generating.

Mistletoe extract is a semi-parasitic plant with several active ingredients that, in preclinical studies, appear to directly cause the death of tumor cells and stimulate an immune response. It has been used in Europe for several decades as a complementary medicine approach to cancer treatment alone or in combination with chemotherapy and radiation therapy but has not been evaluated in clinical trials. ME is not currently FDA approved for cancer treatment in the U.S. but is listed in the Homeopathic Pharmacopoeia and is offered in integrative care clinics.

In addition to Paller, other researchers included Lin Wang, Rajendra Kumar, Jennifer N. Durham, Nilofer S. Azad, Daniel A. Laheru, Ilene Browner, Sushant K. Kachhap, Kavya Boyapati, Thomas Odeny, Deborah K. Armstrong, Christian F. Meyer, Stephanie Gaillard, Julie R. Brahmer, Ivelisse Page, Hao Wang, and Luis A. Diaz

The research was supported by the National Institutes of Health P30CA006973, and Believe Big, Inc. Study drug was provided by Helixor Heilmittel GMBH.

To interview Dr. Paller about the study, email Amy Mone, amone@jhmi.edu, or Valerie Mehl, mehlva@jhmi.edu.

Download the Mistletoe clinical trial results here >

Donate towards Phase II of the mistletoe clinical trial >

Link to original press release source >

Mistletoe: The holiday plant is making headlines as an alternative cancer treatment

January 7, 2015 BelieveBig Press Release Comments Off

Mistletoe’s big season may have just ended, but its role as an anticancer agent could be just getting started. An oncologist at Johns Hopkins successfully treated a patient who had advanced colon cancer with an extract of the seasonal botanical, sparking interest in the plant’s anticancer properties.

The Smithsonian Institution describes mistletoe as a semiparasitic plant in the order of flowering plants known as Santalales. There are approximately 1,300 species that grow mostly in temperate or tropical areas throughout the world. The two types that are commonly sold during the Christmas season are Phoradendron serotinum, the North American mistletoe, and Viscum album, the European variety.¹ Scientists are interested in the latter type for medical applications.

THERAPEUTIC USE

Europe and Asia Although mistletoe is poisonous when ingested, doctors outside the United States have been processing it into an injectable extract to treat patients with cancer for a number of years; and with increasingly positive results.² In fact, German physicians recently published a paper demonstrating how treatment with mistletoe apparently led to the complete regression of an adenoma in the colon of a 78-year-old man who had refused chemotherapy for a cancer relapse 5 years after surgery.³

United States Physicians in the United States, however, have not been so eager to use the substance, and the National Institutes of Health (NIH) discourages its use outside of clinical trials, despite citing some success. According to the National Center for Complementary and Alternative Medicine (NCCAM) Clearinghouse

“Laboratory studies have found that mistletoe kills cancer cells and stimulates the immune system.

“The use of mistletoe to treat cancer has been studied in Europe in more than 30 clinical trials. Although improvements in survival or quality of life have been reported, almost all of the trials had major weaknesses in their design that raise doubts about the findings. For example, many of the studies had a small number of participants or did not have a control group.”⁴

Studies from Europe have shown benefits for patients with cancer of the colon, breast, pancreas, and even for those with melanoma, but the results of treating other types of cancer with mistletoe have not been so positive. Now, researchers at Johns Hopkins will study mistletoe as a cancer treatment thanks to one patient’s success story, her open-minded oncologist, and his colleague, a physician specializing in alternative and complimentary medicine.

SOMETHING WORKED

In 2008, Luis Diaz, MD, an associate professor of oncology at the Johns Hopkins School of Medicine, treated Ivelisse Page, a 37-year-old woman with stage IV cancer of the colon. Despite resection of 15 inches of colon and 28 lymph nodes, the cancer progressed to her liver. After a second surgery in which 20% of her liver was removed, Peter Hinderberger, MD, a physician on Page’s health care team, suggested trying mistletoe. A specialist in using complementary therapies, Hinderberger had seen patients respond favorably to injections of the substance. Diaz, also the director of translational medicine at the Ludwig Center for Cancer Genetics and Therapeutics at the Johns Hopkins Kimmel Cancer Center, reviewed the literature on mistletoe studies from Europe, and decided to initiate the therapy. He noted, “… as soon as she went on it, she started feeling better. That’s a universal feature I’ve seen in all patients who get mistletoe.”⁵

Whether it was the surgery, diet and exercise, or the mistletoe therapy, Page has been free of cancer since her liver surgery.⁶ She and her husband formed a nonprofit organization, Believe Big, to bring the mistletoe extract from Europe, where it is manufactured, to the United States for clinical trials. They also hope to use their organization to connect cancer patients with doctors who use nonconventional therapies.⁶ Channing Paller, MD, is principal investigator for the Johns Hopkins research on the use of mistletoe in cancer. An assistant professor of oncology at the School of Medicine, she theorizes that the effectiveness of mistletoe could lie in its apparent ability to boost the immune system and increase patients’ tolerance of traditional chemotherapy. That would mean that patients could receive higher doses of chemotherapy, enhancing the effect but with fewer consequences.

Germany and other countries have approved prescribing mistletoe for palliation, but not for chemotherapy.⁷ Studies have shown the plant’s derivatives have led to enhanced quality of life, concentration, and mood. Patients on chemotherapy report that they have more energy, and they experience less nausea and discomfort while taking mistletoe. Researchers in the United States are hoping to achieve similar positive effects while proving the extract’s anticancer activity.

REFERENCES

1. Mistletoe facts from a Smithsonian Botanist. Smithsonian Science Web site. http://smithsonianscience.org/2011/12/mistletoe-facts-from-a-smithsonian-botanist/. Accessed January 7, 2015.

2. Wrotek S, Skawiński R, Kozak W. Immunostimulatory properties of mistletoe extracts and their application in oncology [in Polish]. Postepy Hig Med Dosw (Online). 2014;68:1216-1224.

3. von Schoen-Angerer T, Goyert A, Vagedes J, et al. Disappearance of an advanced adenomatous colon polyp after intratumoural injection with Viscum album (European mistletoe) extract: a case report. J Gastrointestin Liver Dis. 2014;23(4):449-452.

4. European mistletoe. Side effects and cautions. NIH National Center for Complementary and Alternative Medicine (NCCAM) Web site. http://nccam.nih.gov/health/mistletoe#cautions. Accessed January 7, 2015

5. Sugarman J. Are mistletoe extract injections the next big thing in cancer therapy? Johns Hopkins Magazine. http://hub.jhu.edu/magazine/2014/spring/mistletoe-therapy-cancer. Published Spring 2014. Accessed January 7, 2015

6. Ivelisse’s Story. Believe Big Web site. https://believebig.org/WhoWeAre.html. January 7, 2015.

7. Handwerk B. Medical mistletoe: Can the holiday plant really fight cancer? Smithosonian.com Web site. http://www.smithsonianmag.com/science-nature/medical-mistletoe-can-holiday-plant-really-fight-cancer-180953551/?no-ist. Published December 8, 2014. Accessed January 7, 2015.

original story source: https://www.oncologynurseadvisor.com/home/departments/issues-in-cancer-survivorship/mistletoe-the-holiday-plant-is-making-headlines-as-an-alternative-cancer-treatment/

Cancer survivor drives Hopkins mistletoe therapy trials

September 11, 2013 BelieveBig Press Release Comments Off

Cancer survivor drives Hopkins mistletoe therapy trials

By BY BARBARA PASH

SEP 11, 2013 8:02 AM

Iveliesse Page is the founder of Believe Big, an anti-cancer non profit in Reisterstown. Believe Big is raising funds for a clinical trial at Johns Hopkins Medicine’s Kimmel Cancer Center. (Photo by Karen Jackson)

Ivelisse Page is on a mission.

In 2011, Page launched Believe Big, a nonprofit foundation that helps cancer patients and their families through this traumatic, life-changing diagnosis. Based on her own experience as a colon cancer survivor, Page aims to educate the cancer community about the importance of combining conventional and complementary approaches to treatment.

To that end, Believe Big is the primary backer of a clinical trial of mistletoe extract, an alternative therapy Page underwent, slated to begin at Johns Hopkins Medicine’s Sidney Kimmel Comprehensive Cancer Center within the next six months.

Page attributes her current health condition to conventional surgery and complementary mistletoe extract, a therapy widely used in Europe as an alternative cancer treatment.

Through dinners, fees from walking/running events and donations, Believe Big has raised $100,000 of the $300,000 needed for the first phase of the three-phase trial, even though nonprofits don’t usually initiate clinical trials. The treatment, using mistletoe extract, is barely known in the United States.

However, her doctor, Peter Hinderberger, of the Ruscombe Mansion Community Health Center near Sinai Hospital, though, is well versed in the treatment.

Through her own research and through the recommendations of friends, Page became acquainted with Hinderberger’s work in complementary medicine.

He’s one of two physicians in Baltimore — and 50 total in the U.S. — allowed to prescribe mistletoe for certain cases. Hinderberger, now a board member of Believe Big, first learned about the treatment in the 1970s when he worked at a cancer clinic in Switzerland that specialized in alternative treatment.

Hinderberger describes mistletoe extract as the “backbone” of his cancer protocol, the specifics depending on the patient’s kind of cancer, current stage and treatment — surgery, chemotherapy or radiation.

While mistletoe is not approved by the federal Food and Drug Administration (FDA). It falls under the category of homeopathy and is paid for out-of-pocket, at a cost of $100 to $150 per month, depending on the extract intensity and number of injections.

Page, a slim, vibrant woman who runs Believe Big out of her home in Reisterstown, has had an equally improbable journey.

Five years ago, the 37-year-old mother of four, was found to have Stage 4 colon cancer that eventually spread to her liver, dropping her survival rate chances after two years to just 8 percent.

That’s why after her surgery, Page searched for an alternative to standard chemotherapy treatment.

“As I was going through this process, I saw people who were in such a hopeless state. I wanted to help them, to let them know about treatments other than the traditional ones,” said Page, who added that she is now cancer-free.

At first blush, Page was taken aback by the thought of being cured by mistletoe extract, which is sold under the brand names Iscador, Helixor and a handful of others, in liquid form in injectable vials.

“I’m like, ‘mistletoe, what’s that? That’s what I see at Christmastime,’ she said. ‘Why haven’t I been told about this before?'”

According to the institute, several trials of mistletoe have been undertaken and are under way in Europe for those countries’ official approval. In the U.S., the institute lists two mistletoe trials besides Hopkins, although the sites are not given and the results not yet published.

Still, after Hinderberger explained that mistletoe contains viscotoxin, a poisonous substance that actively and directly kills cancer cells and boosts patients’ cancer-fighting immune system via special proteins called lectins, Page became very interested. Once he added that the substance also prevents new blood-vessel formation in cancers and promotes natural cell death, she was all in.

“When I found out from my oncologist that I only had a 10 percent better chance of survival by taking chemo(therapy), I decided to burn the boats and not look back,” she said. “Why would I want to destroy everything in my body for just a 10 percent chance?”

From clinical studies and his personal experience, “mistletoe prolongs survival time and improves the quality of life,” Hinderberger said.

Page is the link between Hinderberger and Dr. Luis Diaz, an associate professor of oncology at Hopkins’ Kimmel Cancer Center, who is conducting the mistletoe trial. Diaz is also a board member of Believe Big.

“Dr. Diaz followed my progress” on mistletoe therapy, Page said. “Once I hit the one-year mark, I told him, ‘We need to make this available.’ At the three-year mark, he was willing to do the trial. He told me that being cancer-free three years after surgery is unbelievable.”

Apparently, she and the mistletoe also made a big believer of Diaz.

“She showed me research on mistletoe. I saw other patients through her who seemed to be thriving,” said Diaz, who also researched the topic. “It sounds like it’s very common in Europe, but hasn’t hit the mainstream in the U.S.”

The mistletoe trial’s three phases will take between five to eight years and involve patients with different kinds of cancers and ultimately cost in the millions. Diaz expects that once the trial begins, it will attract other funding. Weleda Group, the Swiss manufacturer of Iscador, is providing the extract free for the trial.

“At the end, if we improve outcomes, if mistletoe becomes one of the ingredients in that cocktail, we’ll be pleased,” Diaz said.

To Page, the ultimate goal of the Hopkins’ trial is FDA approval, which would make mistletoe an acceptable “standard of care.”

“As of now, mistletoe is considered alternative medicine, even though it is used all over the world,” she said, noting that she met with representatives of European mistletoe extract developers Sept. 5 and will continue to promote the treatment through Believe Big. “FDA approval would allow it to be used by cancer institutes, and that’s why we’re working through the process now with the FDA.”

original story source: https://www.baltimoresun.com/maryland/baltimore-county/ph-om-believe-big-0905-20130911-story.html

Johns Hopkins Kimmel Cancer Center Completed Phase I Trial of Intravenous Mistletoe

Download the Mistletoe clinical trial results here >

First U.S. Study of Mistletoe Extract to Treat Cancer – Johns Hopkins Kimmel Cancer Center – Press Release

Download the Mistletoe clinical trial results here >

Mistletoe: The holiday plant is making headlines as an alternative cancer treatment

THERAPEUTIC USE

SOMETHING WORKED

Cancer survivor drives Hopkins mistletoe therapy trials

Cancer survivor drives Hopkins mistletoe therapy trials

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