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Cleveland Clinic Launches First-of-its Kind Preventive Breast Cancer Vaccine Study

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#October 30, 2021 – Cleveland Clinic researchers have opened a novel study for a vaccine aimed at eventually preventing triple-negative breast cancer, the most aggressive and lethal form of the disease.

This phase I trial is designed to determine the maximum tolerated dose of the vaccine in patients with early-stage triple-negative breast cancer and to characterize and optimize the body’s immune response. The U.S. Food and Drug Administration recently approved an investigational new drug application for the vaccine, which permits Cleveland Clinic and partner Anixa Biosciences, Inc. (ANIX:NASDAQ) to start the study.

“We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,” said G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study. “Long term, we are hoping that this can be a true preventive vaccine that would be administered to healthy women to prevent them from developing triple-negative breast cancer, the form of breast cancer for which we have the least effective treatments.”

There is a great need for improved treatments for triple-negative breast cancer, which does not have biological characteristics that typically respond to hormonal or targeted therapies. Despite representing only about 12-15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

“This vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, Ph.D., the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute. “The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women.” Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences, Inc. He will receive a portion of commercialization revenues received by Cleveland Clinic for this technology and also holds personal equity in the company.

The investigational vaccine targets a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in the majority of triple-negative breast cancers. Activating the immune system against this “retired” protein provides pre-emptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response that allows the immune system to mount a response against emerging tumors to prevent them from growing.

The study is based on pre-clinical research led by Dr. Tuohy that showed that activating the immune system against the α-lactalbumin protein was safe and effective in preventing breast tumors in mice. The research also found that a single vaccination could prevent breast tumors from occurring in mouse models, while also inhibiting the growth of already existing breast tumors. The research, originally published in Nature Medicine, was funded in part by philanthropic gifts from more than 20,000 people over the last 12 years.

Funded by the U.S. Department of Defense, the new study at Cleveland Clinic will include 18 to 24 patients who have completed treatment for early-stage triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence. During the course of the study, participants will receive three vaccinations, each two weeks apart and will be closely monitored for side effects and immune response. The study is estimated to be completed in September 2022.

Researchers anticipate that a subsequent trial will involve healthy, cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. Typically, those women carry mutations in either the BRCA1 or BRCA2 gene and are therefore at risk of developing triple-negative breast cancer or have high familial risk for any form of breast cancer.

“This vaccine strategy has the potential to be applied to other tumor types,” added Dr. Tuohy. “Our translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers. If successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had.”

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Guys, Have 2 Minutes? Here’s How to Check Yourself for Testicular Cancer

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Testicular cancer is a rare form of cancer for men in The Bahamas.  It is highly curable — if you know it’s there!

 

November 30, 2021 – Men…how often do you perform a self-exam to check yourselves for testicular cancer?

While it’s a relatively rare form of cancer, young men aren’t exempt – in fact, testicular cancer occurs most often in young and middle-aged men. The good news is, it can usually be treated successfully.

The most common symptom of testicular cancer is a lump on your testicle. But that’s not the only sign of this disease.

Men who have testicular cancer may experience several different kinds of symptoms, says oncologist Timothy Gilligan, MD, a Medical Oncologist at Cleveland Clinic who specializes in treating testicular cancer.

Testicular cancer most frequently strikes men younger than age 44, and is the most commonly diagnosed cancer for men ages 15 to 34. It is almost always curable if found early, Dr. Gilligan says, and it is usually curable even when at a later stage. So it’s important to know signs and symptoms.

Here, Dr. Gilligan says, are five possible signs of testicular cancer you might not know about:

5 Testicular Cancer Symptoms That Aren’t a Lump  – Know what to look for and catch it early

  1. A feeling of heaviness or pressure in your scrotum.
  2. Change in testicle size or firmness.Certain types of testicular tumors can reduce testosterone or increase estrogen in the body, which can result in a change in testicle size or firmness.
  3. Swollen legs.When a tumor spreads to the lymph node, it can constrict blood flow in the veins and result in a blood clot. The clots often occur in the legs, which causes them to swell. You might even experience blood clot symptoms such as pain and difficulty breathing.
  4. Lower back pain and shortness of breath.These are symptoms of advanced testicular cancer, meaning the cancer has spread to lymph nodes behind your stomach. Shortness of breath also may signal that the cancer has spread to your lungs, which may make it harder for air to move in and out.
  5. Breast growth or tenderness.In rare cases, hormone changes also can cause breast tenderness or growth of breast tissue. Some tumors can secrete high levels of a hormone called human chorionic gonadotropin (HCG), which stimulates breast development.

If you experience any of these symptoms, make an appointment with your doctor right away, Dr. Gilligan says. If your physician diagnoses you with epididymitis or orchitis and the symptoms do not resolve quickly with antibiotics, request an ultrasound to evaluate for a testicular tumor.

“While up to 95 percent of men with testicular cancer are cured, it’s important to get care quickly if you’re experiencing symptoms because testicular cancers usually grow fast,” Dr. Gilligan says. “If there is disease, the earlier it is treated, the greater than chance for success.”

 

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Signs of Recovery in East Grand Bahama Habitats Scarred by Hurricane Dorian

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#TheBahamas, November 30, 2021 – In the pinelands and mangroves that make East Grand Bahama so distinctly unique, nature is replenishing itself from the massive destruction of Hurricane Dorian. The restoration slowly taking shape is evidence that the death and devastation that the massive storm left behind is giving way to new life, according to biodiversity experts and scientists who recently conducted field assessments.

The biodiversity consultants with the Implementing Land, Water and Ecosystems Management (IWEco) in The Bahamas project have concluded a new phase of field surveys in East Grand Bahama. The team assessed pinelands and wetlands, collecting detailed information on the habitats and the life forms they support for a biodiversity inventory that will be published as part of the project.

“We have yet to see a standing pine tree that remains alive. In different types of pine habitats, however, you’re seeing different rates of recovery, with seedlings beginning to be established and these seedlings are typically anywhere from eight to 12 inches tall, and some we’ve seen are two to three feet tall,” Mark Daniels, biodiversity consultant with BRON Ltd. said.

The biodiversity team spent more than a week conducting point counts, walking transects and vegetation plots to better understand the recovery process of pine and wetland areas in East Grand Bahama since Hurricane Dorian in 2019.

“The external fringes of those mangrove systems remain dead. However, in the more protected interior regions of these mangrove patches you are seeing mangroves returning and those creek systems where you have mangrove habitats that are inland and protected from the full force of the sea, are also recovering and looking very healthy,” Daniels said.

The biodiversity team also saw several species of wetland and forest birds as well as endemics like the Bahama Yellowthroat and Bahama Woodstar as well as pine saplings that are growing in areas where the trees were dead. Information on the wildlife in East Grand Bahama will also be included in the biodiversity inventory that will be made public.

“We are seeing a lot more birds in the area but most of them are winter migrants from North America coming to The Bahamas and their presence increases our avian fauna by over 50 per cent,” said Scott Johnson, biodiversity consultant with BRON Ltd. “What’s also interesting is that some of the highest diversity of birds we are seeing is in patches of coppice areas in East Grand Bahama. These birds are occupying sites that have a variety of plant species that are producing flowers and some fruits so they have food resources.”

Although the Bahama Yellowthroat and Bahama Woodstar have been observed in the area, other pineland species of birds have not been seen since Hurricane Dorian in 2019, he added.

“I fear that they may have been extirpated from the East Grand Bahama area. Until that pineland ecosystem comes back which may allow for new immigration of birds in that area, chances are that we may not see Bahama Warblers, Olive-Capped Warblers, or Cuban Emeralds in that area for a while,” Johnson said.

The IWEco The Bahamas project is part of a larger, regional undertaking for the Caribbean funded by the Global Environment Facility (GEF) and implemented by the United Nations Environment Programme (UNEP). For The Bahamas, the Department of Environmental Planning and Protection (DEPP), the Forestry Unit, the Ministry of Public Works and Bonefish & Tarpon Trust are the leading partners.

The work that is being done towards creating a biodiversity inventory is pivotal as it will not only benefit the natural environment but involve citizens more closely in sustaining it. East Grand Bahama has a diverse ecosystem in its plant and animal life as well as its habitats. Investigating and gathering a record of all these life forms is a key part of developing the systems and driving the adaptation to make the environment stronger.

“The Biodiversity Inventory conducted under the IWEco project and its respective findings show significant signs of ecosystem regeneration, and therefore signs of hope as it relates to Hurricane Dorian recovery,” said IWEco The Bahamas National Project Coordinator Melissa Ingraham. “The inventory, amongst other project aspects, such as the development of an ecotourism sector and capacity building opportunities will be incorporated into a watershed management plan to sustainably guide resource use and management at a community based level.”

The project aims to develop and implement of integrated systems that support ecosystem health and strengthen national monitoring and evaluation systems. Other goals include policy, legislative and institutional reforms to increase capacity for sustainable natural resource management and deepening the knowledge that is key for effective stakeholder involvement.

 

Header: Gathering information for the biodiversity inventory from the pineland forest near West Gap Creek.

1st Insert: These dead mangroves at Ridge Creek are among the lingering signs of Hurricane Dorian’s trek across East Grand Bahama.

2nd insert: Members of the IWEco The Bahamas biodiversity team visit the mangroves at Ridge Creek where there are signs of recovery.

 

Press Release: IWECO

 

 

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MOSSUD to adopt ‘You are Somebody’ Programme in early 2022

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#TheBahamas, November 30, 2021 – Minister of Social Services and Urban Development, the Hon. Obadiah Wilchcombe said his Ministry will adopt the “You are Somebody” Programme within the first quarter of the year 2022 as a means of ensuring that the community of persons with disabilities are included in all aspects of society.

Minister Wilchcombe was addressing the Church Service held (Sunday, November 28 at Living Waters Kingdom Ministries) to officially launch Disability Awareness Week in The Bahamas. The Week runs November 27 to December 4 under the theme: ‘Inclusion for All.’

Inclusion, Minister Wilchcombe said, has been more of a word, than an action.

“The Bible tells us that our gifts open doors,” Minister Wilchcombe told his inhouse and virtual audience. “The Bible didn’t say that you have to be able or living with a disability; the Bible says that all of us have gifts and that we should all utilize our gifts, and leadership must do what it can to lift those gifts and make them useful for communities, for societies, for our country.

“My purpose here today is to tell you that over the next several months, all of the things you thought were left, were gathering dust, will be lifted, will become part of the dialogue in this country and will become a part of the action taken by the Ministry responsible for Social Services and Urban Development (to ensure inclusion). I thank you. I appreciate you. You are somebody.”

Speaking formally for the very first time (outside of the House of Assembly) as Minister regarding one of the units that fall under his remit, Minister Wilchcombe told members of the community that the “You are Somebody” Programme (the name is adopted from the words of U.S Civil Rights icon, the Reverend Jesse Jackson) will help to address some of the many issues still facing the community of persons with disabilities in The Bahamas.

“I have a difficulty with the fact that so many of you, in general, feel marginalized; I have a difficulty because you are not to be considered separate and different in our communities; I have  a difficulty because inclusion has been more of a word than action, that there is still discrimination, that we have not done some of the things that we were supposed to do legislatively; that you still do not have transportation that you ought to have.

“We still have not created the Foundation that was intended to raise funding. The truth is we have not fulfilled the agenda, we have not done what we ought to have done, and so I have come to tell you that my Ministry will be adopting, in the first quarter of next year, a simple programme for the disabled and the programme will be titled –  and I borrow the words of Jesse Jackson – ‘You are Somebody’ and we will do all we must to ensure that you are included.”

Minister Wilchcombe said the Ministry will “lead by example.”

“I am going to ensure that at the Ministry itself, that we lead by example. Those who wish to discriminate and do not wish to provide jobs and employment, well I don’t see why you can’t be receptionists; I don’t see why you can’t be working throughout the Ministry; I don’t see why the Ministry cannot set the example and cause others to follow. And so, we shall lead. My purpose is to ensure that you have an appreciation that you are loved, and that you are appreciated,”

Minister Wilchcombe also shared the stories of his brother, Richard, whom he said is autistic, and his best friend, a female, who spent most of her life in a wheelchair.

“What I found most interesting about both is that they have never been excluded, always included, always individuals who were present with incredible capacity, talent – in fact my brother always teases me that he can do things I can’t,” Minister Wilchcombe added.

 

By Matt Maura

BIS

 

 Photo Captions: 

Header: Minister of Social Services and Urban Development, the Hon. Obadiah Wilchcombe addressing Sunday’s Church Service that officially launched Disability Awareness Week in The Bahamas. The Church Service was held at Living Waters Kindom Ministries. The Week runs November 27 – December 4.

1st insert: Bahamas Ambassador to CARICOM, Her Excellency Leslie Miller-Brice (third left), joined the community of persons with disabilities for Sunday’s Church Service launching Disability Awareness Week in The Bahamas.  Her Excellency is pictured with (from left): Mr. Kendrick Rolle, Disability Affairs Division; Miss Christina Fernander, Secretariat, National Commission for Persons with Disabilities; Mrs. Desire Clarke, Deputy Secretary, Secretariat, National Commission for Persons with Disabilities (to Her Excellency’s left); Mrs. Annette Lunn, Sign Language Interpreter/Community of Persons who are Deaf or Hard of Hearing; Mr. Kelvin Lunn and Miss Tamera Lunn.

2nd insert: Mrs. Annette Lunn provides Sign Language Interpretation for the community of persons who are Deaf and Hard of Hearing during Sunday’s Church Service. Sign Language Interpreters help to bridge the communication gap for the community. Sign Languages are an extremely important communications tool for members of the Deaf and Hard of Hearing community.

(BIS Photo/Ulric Woodside)

 

 

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