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Vaxart Receives BARDA-Funded Project NextGen Award Valued Up to $453 Million to Conduct a Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine…

Posted: June 14, 2024 at 2:45 am

— 10,000-subject Phase 2b study will evaluate Vaxart’s next generation oral pill COVID-19 vaccine against an approved mRNA vaccine comparator —

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Enzo Biochem Reports Third Quarter Fiscal 2024 Results and Provides Business Update

Posted: June 14, 2024 at 2:45 am

FARMINGDALE, N.Y., June 13, 2024 (GLOBE NEWSWIRE) -- Enzo Biochem, Inc. (NYSE: ENZ) (“Enzo” or the “Company”) today announced financial results for the fiscal third quarter ended April 30, 2024.

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Dyne Therapeutics Presents New Preclinical Data for its Facioscapulohumeral Muscular Dystrophy Program During the FSHD Society International Research…

Posted: June 14, 2024 at 2:45 am

- Leveraging the FORCE™ Platform, DYNE-302 Achieved Robust and Durable DUX4 Suppression and Functional Benefit in FSHD Preclinical Models -

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Vaxart Announces $40 Million Underwritten Offering of Common Stock

Posted: June 14, 2024 at 2:45 am

SOUTH SAN FRANCISCO, Calif., June 13, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (“Vaxart”) (Nasdaq: VXRT) today announced an underwritten offering of 50,000,000 shares of its common stock at an offering price of $0.80 per share, which is a premium to the last closing price of $0.75 per share. Gross proceeds to Vaxart from the offering are expected to be $40 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Vaxart. The offering is expected to close on or about June 17, 2024, subject to customary closing conditions.

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Opthea Successfully Completes Placement and Institutional Component of Entitlement Offer Raising A$171.5 million (US$113.2m¹)

Posted: June 14, 2024 at 2:45 am

Fully underwritten Retail Entitlement Offer to raise a further approximately A$55.9m (US$36.9m1) will open on 19 June 2024 and close at 5:00 pm (Melbourne time) on 10 July 2024

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Opthea Successfully Completes Placement and Institutional Component of Entitlement Offer Raising A$171.5 million (US$113.2m¹)

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The Enterprise Court of Nivelles approves the BioSenic restructuring plan  

Posted: June 14, 2024 at 2:45 am

PRESS RELEASE – PRIVILEGED INFORMATION

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Cabaletta Bio Reports Positive Initial Clinical Data from Phase 1/2 RESET-Myositis™ and RESET-SLE™ Trials of CABA-201

Posted: June 14, 2024 at 2:45 am

– No CRS, ICANS, infections or serious adverse events observed in either of the first two patients through data cut-off of May 28, 2024 –

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Providing Patients With Multidisciplinary, Preventative Care in the Management of Albinism – Dermatology Times

Posted: June 14, 2024 at 2:44 am

Image Credit: alfa27 - stock.adobe.com

June 13 is recognized annually as International Albinism Awareness Day (IAAD). Since 2014 when the United Nations' General Assembly first signed a resolution establishing the commemorative day, IAAD has served as a source of awareness, advocacy, and empowerment for patients with albinism.1

Albinism typically refers to oculocutaneous albinism (OCA), or a series of 8 main types of the inherited disorders. Individuals typically present with OCA1 (the most severe type), OCA2 (the most common type), OCA3, and OCA7. Other types include OCA4, OCA5, and OCA8, and some types may be divided into subtypes.2

Though albinism impacts pigmentation of the skin, as well as the nails and eyes, dermatologists cannot "treat" patients with albinism. There is no way to treat or prevent the lack of skin pigmentation.3

However, it is crucial that dermatology clinicians engage in preventative and multidisciplinary care.

The care team for an individual with vitiligo typically includes a primary care provider, an ophthalmologist for eye issues, and a dermatologist for skin concerns. A genetic specialist may help determine the specific type of albinism, which can guide care and identify potential complications.3

Treatment generally involves regular eye exams by an ophthalmologist, usually requiring prescription lenses, and possibly surgery for eye muscle issues or strabismus. Skin care includes annual exams to monitor for skin cancer, particularly melanoma.3

Clinicians should provide patients with practical guidance on managing low vision and protecting their skin and eyes from sun damage. For patients with low vision, recommending the use of various aids can significantly enhance their quality of life. Hand-held magnifiers, telescopes, or magnifiers that attach to glasses can make daily tasks easier.3

Emphasize the importance of sun protection to your patients with albinism, even more than is typical with otherwise healthy individuals. Advise them to use sunscreen with a sun protection factor of at least 30, ensuring it offers broad-spectrum protection against both UVA and UVB rays. Alongside sunscreen, patients should be cautioned against prolonged sun exposure, particularly during peak UV radiation times, such as midday, and in high-risk environments like high altitudes or areas near water.3

Encouraging patients to wear protective clothing is another essential aspect of sun safety. Recommend garments that cover the skin, such as long-sleeved shirts, long pants, socks, and broad-brimmed hats. Clothes with built-in UV protection can offer additional security against harmful rays.3

Lastly, stress the importance of eye protection by suggesting dark, UV-blocking sunglasses or photochromic lenses, which adjust to varying light conditions, to shield their eyes from potential sun damage.3

Health care professionals, such as dermatologists, are trained to recognize and understand the components that can create internal and external conflicts. We are able to connect and provide resources to better aid in ones health care journey, according to Albert Zhou, MD, PhD, resident physician, PGY-1, Department of Medicine, Mercy Medical Center, University of Maryland School of Medicine, Baltimore.4

By sharing these comprehensive measures, clinicians can help their patients adopt effective strategies to safeguard their vision and overall health.

Do you have patients with albinism? What steps do you take to ensure your patients receive preventative and multidisciplinary care? Share your experiences and/or patient cases with us by emailing our team at DTEditor@mmhgroup.com.

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Nava Health Begins Construction on First Boston-Area Location; New Center in Chestnut Hill Will Provide Personalized … – AccessWire

Posted: June 14, 2024 at 2:44 am

CHESTNUT HILL, MA / ACCESSWIRE / June 12, 2024 / Nava Health, a leader in longevity, integrative, and functional medicine, is pleased to announce it has begun construction on its first center in the Boston area, to be located in Chestnut Hill, at the popular luxury shopping destination, The Street at Chestnut Hill. The 4,252 square foot space will occupy 33 Boylston Street, offering residents of Chestnut Hill and surrounding areas access to Nava Health's innovative approach to personalized healthcare. The store is expected to open later in 2024.

Nava Health isn't just about treating illness; the Company views healthcare as a proactive journey toward optimal well-being. Recognizing the growing emphasis and effectiveness of preventative and longevity-focused medicine, Nava Health offers a comprehensive suite of services tailored to empower individuals. Offerings include functional medicine, focused on the root causes of health issues, regenerative medicine, which aims to restore cellular and tissue function, and personalized wellness plans that provide a roadmap for long-term health.

"Our first location in the Boston area marks a milestone achievement in Nava Health's expansion in the Northeast. Chestnut Hill is a vibrant community known for its active lifestyle and commitment to well-being," says Bernie Dancel, CEO of Nava Health. "We at Nava Health understand the value residents here place on preventive care and achieving optimal health. Our personalized, data-driven approach to medicine perfectly complements this focus. We look forward to supporting their journey to a longer, healthier life."

A Perfect Fit for Chestnut Hill's Focus on Well-Being

Located just six miles outside of Boston, Chestnut Hill village is unique in that it crosses three counties, Middlesex, Norfolk, and Suffolk. The home of Boston College, Chestnut Hill is known for the beautiful campus, historic architecture and a community that thrives in a culturally rich environment.

About Nava Health

Nava Health is a vertically integrated, tech-enabled healthcare practice specializing in integrative, functional, preventive, and regenerative medicine. Their innovative approach utilizes a data-driven, personalized model to optimize health and increase longevity. Each client receives a customized wellness roadmap developed through their proprietary "Nava Method," which leverages data and specialized software to create optimal patient outcomes.

Media Contact Suzanne Coblentz [emailprotected]

Investor Contact John Nesbett/Jen Belodeau IMS Investor Relations [emailprotected]

SOURCE: Nava Health

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Nava Health Begins Construction on First Boston-Area Location; New Center in Chestnut Hill Will Provide Personalized ... - AccessWire

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Lifestyle Changes Significantly Improve Cognition and Function in Early Alzheimer’s Disease for the First Time in a … – PR Newswire

Posted: June 14, 2024 at 2:44 am

SAN FRANCISCO, June 7, 2024 /PRNewswire/ --For the first time, a randomized controlled clinical trial has demonstrated that an intensive lifestyle intervention, without drugs, significantly improved cognition and function after 20 weeks in many patients with mild cognitive impairment or early dementia due to Alzheimer's disease. Themultisite clinical study was published today in the leading peer-reviewed Alzheimer's translational research journal, Alzheimer's Research and Therapy.

This peer-reviewed study was directed by lifestyle medicine pioneer Dean Ornish, M.D., founder and president of the nonprofit Preventive Medicine Research Institute and clinical professor of medicine at the University of California, San Francisco, in collaboration with other renowned scientists and neurologists from leading academic medical centers. These include:

"I'm cautiously optimistic and very encouraged by these findings, which may empower many people with new hope and new choices," said Dr. Ornish. "We do not yet have a cure for Alzheimer's, but as the scientific community continues to pursue all avenues to identify potential treatments, we are now able to offer an improved quality of life to many people suffering from this terrible disease."

The research team recruited 51 participants with a diagnosis of mild cognitive impairment or early dementia due to Alzheimer's disease and randomly assigned them to either an intensive lifestyle intervention group (no drugs added) or a usual-care control (comparison) group. Members of the control group were instructed not to make any lifestyle changes during the 20-week trial.

The intervention group participated in an intensive lifestyle program with four components: (1) a whole-foods, minimally processed plant-based diet low in harmful fats, refined carbohydrates, alcohol and sweeteners predominantly fruits, vegetables, whole grains and legumes, plus selected supplements with all meals sent to each patient's home to maximize adherence; (2) moderate aerobic exercise and strength training for at least 30 minutes per day; (3) stress management, including meditation, stretching, breathing and imagery, for one hour per day; and (4) support groups for patients and their spouses or study partners, for one hour three times per week.

Improvements in patients with early Alzheimer's diseaseTo measure pre- and post-trial cognitive function, the researchers utilized four standard tests used in Food and Drug Administrationdrug trials: the Alzheimer's Disease Assessment ScaleCognitive Subscale (ADAS-Cog), Clinical Global Impression of Change (CGIC), Clinical Dementia RatingSum of Boxes (CDR-SB) and Clinical Dementia Rating Global (CDR-G).

Results after 20 weeks showed overall statistically significant differences between the intervention group and the randomized control group in cognition and function in three of these measures (CGIC, p = 0.001; CDR-SB, p = 0.032; CDR-G, p= 0.037), and differences of borderline significance in the fourth test (ADAS-Cog, p =0.053). When a mathematical outlier was excluded, all four measures showed significant differences in cognition and function in the experimental group. Three of these measures showed improvement in cognition and function in the intervention group and one test showed significantly less disease progression. In contrast, the randomized control group worsened in all four of these measures.

Not all patients in the intervention group improved; in the CGIC test, 71% improved or were unchanged. In contrast, none of the patients in the control group improved, eight were unchanged and 17 (68%) worsened.

Many patients who experienced improvement reported regaining lost cognition and function. For example, several patients in the intervention group reported that they had been unable to read a book or watch a movie because they kept forgetting what they had just read or viewed and had to keep starting over, but now they were able to do so and retain most of this information. One individual reported that it used to take him weeks to finish reading a book, but after participating in the study he was able to do so in only three or four days and was able to remember most of what he read.

A former business executive reported regaining the ability to manage his own finances and investments. "It was so much a part of my life who I am, and who I was it was hard saying that part of me was just gone," he said. "I'm back to reconciling our finances monthly; I keep up to date on our investments. A lot of self-worth comes back."

A woman said that for five years she had been unable to prepare their family business financial reports, but now she is able to do so accurately. "A deep sense of identity is returning. It's given me a new lease on life, and yet it's a familiarity and something I've always prided myself on. I'm coming back like I was prior to the disease being diagnosed. I feel like I'm me again an older but better version of me."

There was a statistically significant dose-response correlation between the degree of lifestyle changes in both groups and the degree of change in most measures of cognition and function testing. In short, the more these patients changed their lifestyle in the prescribed ways, the greater was the beneficial impact on their cognition and function.

This dose-response correlation adds to the biological plausibility of these findings and may help to explain, in part, why some patients in the intervention group improved and others did not (although other mechanisms may also play a role). Other studies have shown that more moderate lifestyle changes such as adopting the Mediterranean diet may slow the rate of progression (worsening) of Alzheimer's disease but may not go far enough to improve cognition and function.

In addition to improvements in cognition and function, the intervention group also demonstrated significant improvements in several key blood-based biomarkers. One of the most clinically relevant biomarkers is called the A42/40ratio, which is a measure of amyloid, thought to be an important mechanism in Alzheimer's disease. This measure improved in the lifestyle intervention group (with the presumption that this improvement reflected amyloid moving out of the brain and into the blood), but it worsened in the randomized control group, and these differences were statistically significant (p = 0.003).

There was also a statistically significant dose-response correlation between the degree of lifestyle change and the degree of improvement in this amyloid ratio (p = 0.035). This direction of change in amyloid was also a major finding with lecanemab, a drug approved for treating Alzheimer's disease last year.

Also, the gut microbiome in the intervention group showed a significant decrease in organisms that raise the risk of Alzheimer's disease and an increase in organisms that are protective against Alzheimer's disease. These biomarker and gut microbiome results also add to the biological plausibility of the overall findings.

According to renowned Alzheimer's scientist Miia Kivipelto, M.D., Ph.D., "These findings add to the growing body of evidence that moderate multimodal lifestyle changes may help prevent Alzheimer's disease or slow its progression, and also suggest that more intensive multimodal lifestyle changes may have additional benefits for improving cognition in patients with early Alzheimer's disease."

New hope in tackling a devastating and costly diseaseAlzheimer's disease, the fifth-leading cause of death among Americans aged 65 and older, is not only physically and emotionally devastating; it's also extremely costly. The disease currently affects more than six million people in the U.S., at an annual cost of more than $345 billion. By 2050, the number affected is expected to reach 13 million, with costs projected to skyrocket to $1.1 trillion annually.

"There's a desperate need for Alzheimer's treatments," said study co-author Rudolph E.Tanzi, Ph.D., an acclaimed professorof neurology atHarvard Medical School and director of the McCance Center for Brain Health at Massachusetts General Hospital, one of the study's clinical sites. "Biopharma companies have invested billions of dollars in the effort to find medications to treat the disease, but only two Alzheimer's drugs have been approved in the past 20 years one of which was recently taken off the market, and the other is minimally effective and extremely expensive and often has serious side effects such as brain swelling or bleeding into the brain. In contrast, the intensive lifestyle changes implemented in this study have been shown here to improve cognition and function, at a fraction of the cost and the only side effects are positive ones."

"I am delighted and honored to be a part of this groundbreaking study showing for the first time in a controlled clinical trial what the epidemiology has told us all along: Lifestyle factors are critically important in our efforts to address Alzheimer's. While efforts to develop drugs to treat this disease will continue, this study provides a blueprint for practical, easily implemented steps that can significantly alter the progression to full Alzheimer's disease,"said study co-author Eric Verdin, M.D., president and CEO of the Buck Institute for Research on Aging.

This study has implications for preventing Alzheimer's disease as well. New technologies such as artificial intelligence now make it possible to predict an individual's likelihood of developing this disease years before it becomes clinically apparent, but many people ask, "Why would I want to know if I'm likely to get Alzheimer's disease if I can't do anything about it? It will just make me worry." Although further research is needed, it is reasonable to believe that the same intensive lifestyle changes that often improve cognition and function in those with mild cognitive impairment or early dementia due to Alzheimer's may help prevent the disease as well.

"This study finally gives us scientific data to support what many of us in this field have believed instinctively for years, that lifestyle interventions may determine the trajectory of people's Alzheimer's journeys," said Maria Shriver, founder of the Women's Alzheimer's Movement (WAM) at Cleveland Clinic, which provided early seed funding for this study. "We opened the WAM Prevention and Research Clinic at Lou Ruvo Center for Brain Health in Las Vegas for women 30 to 60 years of age who are at higher risk than average for developing Alzheimer's. The protocols we use involve adopting many of the lifestyle interventions employed in this study. So, showing success in improving the health trajectories of those already diagnosed with Alzheimer's clearly offers hope to those who want to delay or prevent developing the disease altogether. This is a study to give us hope."

A growing body of lifestyle medicine researchDr. Ornish has directed peer-reviewed research at the nonprofit Preventive Medicine Research Institute for over four decades. He is often referred to as "the father of lifestyle medicine."

The Institute's studies, published in leading peer-reviewed medical and scientific journals, focus on the power of lifestyle medicine to help prevent and often reverse the progression of many of the most common and costly chronic diseases. These include coronary heart disease, Type 2 diabetes, early-stage prostate cancer, hypertension, hypercholesterolemia, and now, early-stage Alzheimer's disease.

Dr. Ornish's most recent bestselling book, "Undo It!," co-authored with Anne Ornish, puts forth his unifying theory: the reason that the same lifestyle changes may beneficially affect so many different chronic diseases is that these share common biological mechanisms that are directly affected by what people eat, how much they exercise, how they respond to stress, and how much love and support they enjoy. Alzheimer's is the latest example of why "what's good for your heart is also good for your brain."

In 2010, the Centers for Medicare & Medicaid Services (CMS) began providing nationwide Medicare coverage for Dr. Ornish's program, which has been shown to often reverse the progression of coronary heart disease, as "intensive cardiac rehabilitation." This nine-week program is offered online, so individuals can join classes from the comfort of their own homes, enabling participation by those who cannot afford to take time off work, who live far from a hospital or who cannot afford childcare, thereby reducing health disparities and inequities."I'm very grateful to CMS for providing Medicare coverage. Having seen what a powerful difference this program of lifestyle changes can make, I appreciate very much that it is now available to all eligible Medicare beneficiaries with heart disease who can benefit from it," Dr. Ornish said.

About the Preventive Medicine Research InstituteThe Preventive Medicine Research Institute (PMRI), a 501(c)(3) nonprofit organization, was founded in 1984 by Dean Ornish, M.D., to conduct pioneering research evaluating the power of lifestyle medicine and to make healthy lifestyle changes more widely available to those who can benefit from them. PMRI's research uses the latest in high-tech medical and scientific technologies to assess the benefits of these low-tech and low-cost lifestyle changes. For more information about PMRI's four decades of peer-reviewed lifestyle medicine research, please visit https://pmri.org.

Media Contact:Laurie Masonson [emailprotected] 917-459-6164

SOURCE Preventative Medicine Research Institute

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