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Roche has had a good week, sharing positive two-year data from Genentech's study on Vabysmo for age-related macular degeneration and eight-year data in its trial for combination therapy for HER2-positive early breast cancer.

2-Year Data On Vabysmo Demonstrates Reliability & Safety

Genentech, a part of the Roche Group, shared positive two years' worth of data from its ongoing LUCERNE and TENAYA trials, which are looking into Vabysmo's (faricimab-svoa) long-term safety, efficacy and durability in wet or neovascular AMD.

In both the TENAYA and LUCERNE studies, over 60% of the participants were able to be treated every four months, up 15% from where they were in the first year. Almost 80% were able to treat at least every three months. No new safety signals came up, and the drug continued to be well tolerated and demonstrate a favorable risk profile.

"These longer-term results reinforce confidence in Vabysmo and support its continued use in people with wet AMD. With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden," Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Genentech, said in a statement.

The disorder, a leading cause of vision loss, affects around 1.1 million people in the United States alone. Treatment usually involves eye injections administered every one or two months. Vabysmo is evaluated for its potential to reduce the frequency of injections.

Vabysmo is the first bispecific antibody for the eye and the only injectable eye medicine approved by the U.S. Food and Drug Administration. It is currently under review by the European Medicines Agency and other regulatory agencies worldwide.

Combination Breast Cancer Therapy Delivers Positive 8-Year Data

Meanwhile, Roche announced positive eight-year data from its long-term evaluation of Perjeta (pertuzumab) combined with Herceptin (trastuzumab) and chemotherapy (Perjeta-based) in HER2-positive early breast cancer, versus Herceptin, chemotherapy and a placebo.

Results at 8.4 years, with a median follow-up of 101 months, showed that patients with lymph node-positive disease saw a 28% reduction in the risk of recurrence or death. The combination's safety profile also remained consistent with previous trials. There were fewer deaths at 168 versus 202 in the placebo group, and around 88.4% of those who received the treatment post-surgery had remained disease-free compared to the 85.8% of the placebo takers.

"The eight-year APHINITY results show the great progress made in treating this aggressive form of early breast cancer. HER2-positive breast cancers are more likely than other subtypes to recur following surgery, so targeted treatment is critical to provide the best chance for a cure," Garraway said, who is also Roches chief medical officer and head of global product development.

Details were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary.

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Roche Wraps Week with a Bang, Touting Long-Term Breast Cancer, AMD Data - BioSpace

Do you see small mosquitoes and flies in front of your eyes, but you cannot drive them away no matter how you try? This is commonly known as eye floater syndrome or eye floaters and also known as muscae volitantes. Especially when looking at a white wall or the blue sky, floaters, which are dark shadows, are quite obvious. Some of these shadows are not shaped like bugs, but rather spots, filaments, and rings. In severe cases, the condition will affect the vision, causing inconvenience in daily life. In some cases, eye floaters may be a sign of serious eye disease.

What are the symptoms of eye floaters, and under what circumstances is there risk of blindness? What are the causes of eye floaters and treatments? We will explain below with infographics.

Eye floaters usually appear as follows:

Eye floaters have subjective symptoms, and the condition is closely associated with the vitreous humor in the eye. In medical terms, it is also known as vitreous clouding or vitreous degeneration.

What is vitreous humor (aka. vitreous body)?

It is a colorless, transparent colloid inside the eye, covered with a vitreous membrane. It is located between the lens and the retina and fills four-fifths of the eye, and its role is to support the retina, so that it can fittingly line the back wall of the eye.

The formation of eye floaters is generally due to the natural aging process of the vitreous humor, which liquefies and condenses, thus producing some cellular debris and adhesives. When these floating impurities in the vitreous humor are projected on the retina by light, the patient will see insects that cannot be driven away.

Most eye floaters are physiological and develop after the age of 40 due to the natural aging of the eyeball.

However, some can also be caused by eye diseases. Trauma to the eye, intraocular inflammation, retinal detachment, and vitreous hemorrhage are all pathological causes of muscae volitantes.

In ancient times, Chinese medicine practitioners called eye floaters fluttering and drifting cloud-like dark shadows or dark flowers and fly wings.

According to traditional Chinese medicine, the causes of the eye floater syndrome are related to the visceral disorders of the body, mainly damp turbidity, liver-kidney deficiency, and the deficiency of qi and blood. This can still be observed today, as many of the other symptoms of these deficiencies may accompany the appearance of floaters.

Damp turbidity: When the bodys dampness becomes too heavy, infringing on the vitreous humor in the eyes, the patient may also experience dizziness, chest congestion, poor digestion, and other symptoms. If you observe the patients tongue, you may see the phenomenon of thick and greasy tongue coating.

Liver-kidney deficiency: The deficiency of essence and blood in the liver and kidney will impede the supplying of nutrients to the eyes, thus causing cloudiness in the vitreous humor. Such patients may also experience tinnitus and back pain.

Qi and blood deficiency: Due to prolonged illness or blood loss, qi and blood deficiency may occur, and as the eyeballs cannot get sufficient nourishment from the blood, eye floaters may form. The patient may also experience dry eyes and photophobia. These patients are prone to having a pallid complexion and experiencing dizziness and palpitations.

Traditional Chinese medicine has a well-known prescription for eye treatment called water honeyed pill (lycii and chrysanthemi and rehmanniae bolus), which can also improve eye floater symptoms.

It includes rehmanniae, which can nourish the liver and kidneys, and goji berries and chrysanthemums, which can help improve eyesight. However, it is not suitable for patients with a cold or flu. If a patient has chronic diseases, such as high blood pressure, heart diseases, liver diseases, and diabetes, the medication should be taken under the instruction of a doctor.

When many patients first discover that they have eye floaters, they are particularly worried, fearing it is a symptom of a major or looming problem. In fact, eye floaters formed due to age are a normal phenomenon, and these people dont need to worry much.

However, the following conditions can cause serious eye floater syndrome, and even have the risk of blindness, so we must pay special attention to them:

Retinal detachment: The vitreous humor supports the retina at the back of the eyeball and is attached to the retina. If the vitreous liquefaction is too severe, the vitreous humor will gradually separate from the retina. And in the separation process, retinal tears and breaks develop when the vitreous pulls on the retina; if the liquefied vitreous humor pours in through the holes, it will cause retinal detachment.

When the vitreous humor pulls on the retina, flashes will appear in the vision; if the vitreous humor and retina are detached, flashes may occur frequently. If the retinal blood vessels are torn, blood will enter the vitreous body and form a black fog of flies that blocks the vision.

Vitreous hemorrhage: The vitreous body itself has no blood vessels, but if its surrounding tissues bleed, the blood will flow into it, which can lead to eye floaters. For instance, bleeding can be caused by uveitis, optic nerve papillitis, tumors, and blows to the eye.

People with high myopia, previous eye trauma, and diabetes are more likely to have retinal detachment and vitreous hemorrhage, and they should be more alert than the general population.

If the following four signs appear, it may mean theres a serious problem such as retinal detachment, and you should seek medical attention as soon as possible:

We can check for eye floaters by ourselves at home. Just cover one eye and stare at a white wall with the other eye to see if any floaters can be spotted.

After you find floating objects in front of your eyes for the first time, you can see an ophthalmologist for a fundus examination. If it is confirmed to be a physiological form of floaters, then there is no need to worry too much, just keep observing the symptoms and follow up with the ophthalmologist regularly.

It is also very convenient to go to a hospital or clinic to check for eye floaters. The procedure is to dilate the pupils with some eye drops (dilating agent) first, wait for about half an hour, and then perform a fundus examination. It should be noted that the dilating agent will cause temporary blurred vision and photophobia, so it is recommended to wear sunglasses after the examination. In addition, it is best to have a family member or friend accompany you after the examination, as you should not drive with dilated pupils.

Eye floaters caused by vitreous degeneration alone will not go away, and there is no specific medicine to treat the condition. Therefore, it is not recommended to treat floaters if they only pose a general nuisance. When the dark shadows affect your vision, you can try to rotate your eyeballs, so that the floating objects in the vitreous bodies will leave the center of your vision.

In a small number of cases, the eye floaters are so dense that they seriously affect the vision. For such patients, there are two treatment options to consider:

Surgically, the vitreous fluid and floaters can be removed from the eye, and the old vitreous fluid is replaced with a salt solution. Since vitreous humor is mainly aqueous, there is no significant difference after the replacement. However, this procedure carries a high risk of complications, such as retinal detachment, retinal tears, and cataracts.

Laser therapy uses lasers to target the floating objects in the vitreous humor to break them down and shatter them, so as to improve the symptoms of eye floaters. However, this method is rarely used, as its effect varies from person to person. If theres an error when aiming the lasers, it may damage the retina.

If the condition of the patients eyes is relatively severe, such as having a fissure in the peripheral retina, a retinal laser surgery can be used to utilize the lasers coagulation effect to fix the retina around the fissure to the wall of the eyeball to prevent further deterioration into retinal detachment. If it is a vitreous hemorrhage, the patient can take hemostatic medication for about 3 to 6 months to allow the oozed blood to be absorbed gradually, and then undergo more complicated treatments, if the condition hasnt improved by then.

The first and foremost task in caring for eyes with floaters is to slow down the aging of the vitreous humor. Therefore, an eye floater patient should avoid staying up late and using electronic devices, such as cell phones and tablets, excessively, and should use desk lamps with soft light.

In addition, we should avoid strenuous and rapid head-turning exercises, such as bungee jumping and riding roller coasters, and excessive eyeball movements.

Furthermore, we can also take appropriate nutritional supplements, such as lutein, vitamin C, and foods rich in collagen (e.g. beef tendons). We can drink goji berry and chrysanthemum tea to slow down the aging of the vitreous humor.

References:

National Eye Institute, Kaohsiung Veterans General Hospital, Kuo General Hospital, and Lin Hsin Hospital

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What Are These Things Floating in Front of My Eyes? - The Epoch Times

Data reinforces strong safety and efficacy for EYP-1901 as a potential six-month maintenance treatment for previously treated wet AMD

No dose limiting toxicities, no ocular serious adverse events (SAEs) and no drug-related systemic SAEs observed

Stable visual acuity and optical coherence tomography observed from a single treatment

Phase 2 clinical trial (DAVIO2) in wet AMD patient dosing anticipated in Q3 2022

WATERTOWN, Mass., July 15, 2022 /PRNewswire/ -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced 12-month data from the Phase 1 "Durasert and Vorolanib in Ophthalmology" (DAVIO) clinical trial evaluating EYP-1901, a sustained delivery anti-vascular endothelial growth factor (anti-VEGF) therapy targeting wet age-related macular degeneration (wet AMD) as a potential every six-month treatment. These data are being presented today at the American Society of Retina Specialists (ASRS) 2022 Annual Meeting by Rishi Singh, M.D., Staff Physician, Cleveland Clinic Florida, President Cleveland Clinic Martin Hospitals.

EyePoint Pharmaceuticals, Inc. logo

"The final 12-month results from the DAVIO clinical trial highlight EYP-1901's continued positive safety and efficacy profile with promising durability as a potential every six-month maintenance therapy for previously treated wet AMD," said Rishi Singh, M.D., a member of EyePoint's Scientific Advisory Board. "We are grateful to the patients, investigators and site staff who participated in the Phase 1 DAVIO trial."

"We are extremely pleased with the excellent safety and efficacy results from our Phase 1 DAVIO trial. There remains a significant opportunity for a safe and effective sustained delivery maintenance treatment in wet AMD, and the DAVIO trial demonstrates that EYP-1901 has the potential to maintain a majority of patients for up to six months with no supplemental anti-VEGF therapy," saidNancy Lurker, Chief Executive Officer ofEyePoint Pharmaceuticals. "We look forward to beginning to dose patients in the Phase 2 DAVIO2 clinical trial for EYP-1901 in wet AMD and anticipate top line data in the second half of 2023."

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The final twelve-month data presented from the Phase 1 DAVIO clinical trial showed no reports of ocular SAEs or drug-related systemic SAEs. There were no reported events of vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, posterior segment inflammation, or retinal vascular occlusive events. Additionally, updated data from the twelve-month follow-up confirm stable best corrected visual acuity (BCVA) (-4.12 ETDRS letters), stable central subfield thickness (CST) on optical coherence tomography (OCT) (-2.76 m), and an expected late increase in supplemental anti-VEGF therapy given the insert's expected drug depletion, with 35% of eyes supplement free up to twelve months versus 53% supplement free up to six months. Additionally, there continued to be positive treatment burden reduction of 74% at twelve months versus 79% at six-months.

EyePoint anticipates that the first patient in the twelve-month, randomized, controlled Phase 2 clinical trial (DAVIO2) of EYP-1901 for wet AMD will be dosed in Q3 2022. The trial is expected to enroll approximately 150 wet AMD patients previously treated with a standard-of-care anti-VEGF therapy and randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) versus an on-label aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO2 trial is non-inferiority to the aflibercept control, as measured by change in BCVA six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplemental anti-VEGF, and safety. More information about the study is available at clinicaltrials.gov (identifier: NCT05381948).

About EYP-1901

EYP-1901 is being developed as an investigational sustained delivery treatment, initially in wet age-related macular degeneration (wet AMD)combining a bioerodible formulation of EyePoint's proprietary Durasert delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive twelve-month safety and efficacy data from the Phase 1 DAVIO clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse eventsand no dose limiting toxicities with stable visual acuity and OCT. Further, 53% of eyes did not require supplemental anti-VEGF injections up to six months following a single dose of EYP-1901. A Phase 2 trial for wet AMD (DAVIO2) is expected in Q3 2022 and Phase 2 studies are planned for non-proliferative diabetic retinopathy and diabetic macular edema in 2H 2022 and 2023, respectively. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.

About Wet AMD

Age-related macular degeneration (AMD) impacts as many as 11 million Americans. About 15% of those affected have neovascular or wet AMD - the hallmark of which is fluid and bleeding in the center of the retina, which may lead to irreversible vision loss. The majority of patients with wet AMD require intravitreal injections every month or two to control the disease. This intense treatment regimen represents an ongoing challenge for patients, caregivers, and physicians.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

Forward Looking Statements

EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint's actual results to be materially different than those expressed in or implied by EyePoint's forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a sustained delivery intravitreal anti-VEGF treatment for serious eye diseases, including wet age-related macular degeneration; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ and DEXYCU; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy; and the impact of general business and economic conditions. More detailed information on these and additional factors that could affect EyePoint's actual results are described in EyePoint's filings with theSEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investors:

Christina TartagliaStern IRDirect: 212-698-8700christina.tartaglia@sternir.com

Media Contact

Amy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com

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EyePoint Pharmaceuticals Announces Positive 12-Month Safety and Efficacy Data from Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment...

Adverum Biotechnologies, Inc.

- Study participants had an 81%-98% reduction in annualized anti-VEGF injections and demonstrated continuous aflibercept expression levels through three years

- Mean best-corrected visual acuity and central subfield thickness were maintained or improved in subjects treated with ADVM-022

-The Phase 2 LUNA trial is expected to dose the first subject in the third quarter of 2022 and preliminary data anticipated throughout 2023

REDWOOD CITY, Calif., July 15, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced new data from the OPTIC study treating wet age-related macular degeneration (wet AMD) during the American Society of Retina Specialists (ASRS) 2022 Annual Meeting. New data presented are as of February 24, 2022 and include best-corrected visual acuity (BCVA) and central subfield thickness (CST) maintenance, as well as reduction in CST fluctuation after a single, in-office intravitreal (IVT) injection of ADVM-022, ixoberogene soroparvovec (Ixo-vec), in subjects requiring frequent anti-VEGF injections for their wet AMD.

We are pleased to present our findings on BCVA and CST from the OPTIC trial, establishing that maintenance in both BCVA and CST, as well as a reduction in CST fluctuations, were sustained through at least two years, suggesting the long-term durability of Ixo-vec after a single IVT injection, stated Richard Beckman, M.D., chief medical officer at Adverum Biotechnologies. As several publications have recently highlighted, retinal CST fluctuations over time are associated with poor long-term visual outcomes for patients. The combination of durable maintenance of BCVA and reduced CST fluctuations in subjects who previously required frequent IVT injections further support our belief that Ixo-vec can provide better long-term benefit for wet AMD patients. We are excited by the possibility of extending the treatment benefit for this lifelong disease from the order of months to the order of years.

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Data Highlights as of February 24, 2022

OPTIC trial participants had an 81%-98% reduction in annualized anti-VEGF injections and demonstrated continuous therapeutic aflibercept protein expression levels through three years following a single, in-office intravitreal injection of ADVM-022.

Mean BCVA (ETDRS) change from baseline to last visit was maintained or improved for two years post-treatment with ADVM-022 across both the 6x10^11 vg/eye (6E11) and 2x10^11 vg/eye (2E11) dose levels.

Mean CST was reduced by 55.7 m at the 6E11 dose (p=0.014) and by 95.9 m at the 2E11 dose (p=0.015) and maintained for two years following treatment across both ADVM-022 dose levels.

In the 2E11 dose in subjects with neutralizing antibodies (NAb) titers <1:125, subjects demonstrated a mean BCVA improvement of 5.2 letters for two years following treatment with ADVM-022.

ADVM-022 was well tolerated, with no participants in the 2E11 dose group requiring any topical corticosteroids to treat inflammation at most recent follow-up.

No evidence of correlation between baseline NAbs and occurrence of inflammation or other safety events has been observed.

We are excited to present these encouraging data, showing continuous and stable aflibercept expression for over three years in our OPTIC trial in subjects with wet AMD, commented Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. As we recently announced, we completed our IND amendment with the U.S. Food and Drug Administration, received European Medicines Agency PRIME designation, and are preparing to initiate the Phase 2 LUNA trial of Ixo-vec in wet AMD. The LUNA trial was designed after a detailed data review from all 55 participants treated to date with a single ADVM-022 injection. Four new enhanced prophylactic steroid regimens will be evaluated in LUNA with the aim of providing steroid coverage during the period of peak immunogenicity. Our goal is to enhance the safety profile of ADVM-022 while building upon the impressive efficacy profile we continue to see in the OPTIC trial. We plan to dose the first subjects in the third quarter of 2022 and anticipate preliminary data from LUNA throughout 2023 and look forward to providing more detail on the expected timeline once we can assess the pace of enrollment.

The LUNA trial is a multicenter, double-masked, randomized, parallel-group Phase 2 trial evaluating two doses of Ixo-vec, including 2E11 and a new, lower 6x10^10 vg/eye (6E10) dose, in up to 72 patients with wet AMD. The LUNA trial will assess four new enhanced prophylactic steroid regimens, including local steroids and combinations of local and systemic steroids to test the relative contribution of local versus systemic AAV exposure on ocular inflammation. Specific regimens include topical difluprednate (Durezol), IVT Ozurdex, or a combination of either topical Durezol or IVT Ozurdex with oral prednisone.

The trial will randomize the participants equally between the 2E11 and 6E10 Ixo-vec doses across four prophylactic steroid regimens and will be conducted at approximately 40 sites in the U.S. and Europe. The primary endpoints will be similar to the OPTIC trial and focus on mean change in BCVA and CST from baseline to one year, and incidence and severity of adverse events. Other data points will include protein expression of aflibercept starting at 10 weeks and an interim analysis at 26 weeks. The study will also evaluate the effectiveness and tolerability of the prophylactic steroid regimens.

As an investigator in OPTIC, I have observed the potential of ADVM-022 to significantly reduce the treatment burden for my patients with neovascular age-relatedmacular degeneration. In the latest data from the OPTIC trial, we have seen a manageable safety profile, robust aflibercept expression, and sustained anatomical improvements after two years following a single 2E11 dose of ADVM-022, said Dante Pieramici, M.D., partner, California Retina Consultants, and presenter of the data at ASRS. I look forward to participating as a LUNA investigator and building on the efficacy and safety profile in OPTIC with a new, lower 6E10 dose and to determine an optimal prophylactic steroid regimen for patients.

About Wet Age-Related Macular Degeneration

Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD. Wet AMD is a leading cause of blindness in patients over 65 years of age, with a prevalence of approximately 20 million individuals worldwide living with this condition. The incidence of new cases of wet AMD is expected to grow significantly worldwide as populations age. AMD is expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.

About OPTIC Trial of ADVM-022 in Wet AMD

ADVM-022 is Adverums clinical-stage gene therapy product candidate being developed for the treatment of wet AMD. ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require a surgery to administer the gene therapy under the retina (sub-retinal approach), ADVM-022 has the advantage of being administered as a one-time IVT injection in the office and is designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance, and improve vision outcomes for patients with wet AMD.

The OPTIC trial is designed as a multi-center, open-label, dose-ranging, safety and efficacy trial of ADVM-022 in patients with wet AMD who have demonstrated responsiveness to anti-VEGF treatment. Patients in OPTIC are treatment-experienced, and previously required frequent anti-VEGF injections to manage their wet AMD and to maintain functional vision.

About Adverum Biotechnologies

Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for a number of highly prevalent ocular diseases with the aspiration of developing functional cures for these diseases to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary, intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, ixoberogene soroparvovec (Ixo-vec), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. For more information, please visit http://www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding Adverums plans to initiate a Phase 2 study in wet AMD to investigate the 2x10^11 vg/eye dose and a lower 6x10^10 vg/eye dose of ADVM-022, as well as new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids, planned for the third quarter of 2022, as well as the benefits Adverum expects from this trial, and the timing of preliminary data from the LUNA trial. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverums novel technology, which makes it difficult to predict the timing of commencement and completion of clinical trials; regulatory uncertainties; enrollment uncertainties the results of early clinical trials not always being predictive of future clinical trials and results; and the potential for future complications or side effects in connection with use of ADVM-022. Additional risks and uncertainties facing Adverum are set forth under the caption Risk Factors and elsewhere in Adverums Securities and Exchange Commission (SEC) filings and reports, including Adverums Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 12, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Corporate & Investor Inquiries

Anand ReddiVice President, Head of Corporate Strategy and External Affairs & EngagementAdverum Biotechnologies, Inc.T: 650-649-1358E: areddi@adverum.com

Media

Megan TalonAssociate Director, Corporate CommunicationsAdverum Biotechnologies, Inc.T: 650-649-1006E: mtalon@adverum.com

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Adverum Biotechnologies Presents Best-Corrected Visual Acuity and Central Subfield Thickness Analyses After a Single IVT Injection of ADVM-022...

Diabetes causes a persons blood sugar levels to become too high, which must be handled carefully to prevent further complications. Unfortunately, the condition doesn't always produce obvious symptoms. Excessive sweating at night, however, could be a sign that high blood sugar has damaged the nerves.

Excessive can both be a sign of low blood sugar levels and blood sugar damage to nerves.

The most common reason for unusual sweating in people with the condition, however, is diabetes-related nervous system damage.

According to the American Diabetes Association, approximately half of people with diabetes experience some level of nerve damage.

When nerve damage occurs, known as autonomic neuropathy, it occasionally affects the sweat glands.

READ MORE:Diabetes: Summer foods that could spike blood sugar

High blood sugar and high levels of fat, such as triglycerides, can damage the nerves or the blood vessels that nourish the nerves.

This may produce several different symptoms depending on which of the bodys functions are affected.

The National Institute of Diabetes and Digestive and Kidney Diseases says: Damage to the nerves that control your sweat glands may cause you to sweat a lot at night or while eating.

Your sweat glands may not work at all, or certain parts of your body may sweat while other parts are dry.

DON'T MISS:

If your sweat glands do not work properly, your body may not be able to control its temperature.

Sometimes nerve damage prevents signals from being sent to different parts of the body, which can result in numbness.

Other types of discomfort may occur, such as sharp pains, cramps, muscle weakness or sensitivity to touch.

Depending on the nerves affected, neuropathy can cause these sensations in the hands, feet, and legs.

READ MORE:Diabetes warning: Do not 'overindulge' in a particular type of fruit

The Centers for Disease Control and Prevention says: Nerve damage can cause health problems ranging from mild numbness to pain that makes it hard to do normal activities."

There are several steps that can help prevent diabetes, but the most logical starting point is diet.

It is advisable to choose whole grain products over refined grained ones and other highly processed carbohydrates.

This is because refined carbohydrates can increase blood triglycerides, and blood sugar levels and cause insulin resistance, which are major risk factors for diabetes.

There are also many benefits to regular physical activity for blood sugar control, as it can help keep them within a healthy range for up to 48 hours.

Plants, which provide a wealth of vitamins, minerals and carbohydrates, are good energy sources for the body.

Dietary fibre can also slow the absorption of sugars and interfere with the absorption of dietary cholesterol.

These food sources also promote weight loss, which in turn may lower the risk of diabetes.

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Diabetes symptoms: The sign of nerve damage that often strikes at night - severe - Express

What is Diabetes?

Diabetes is the seventh-leading cause of death in the United States.

Diabetes is a long-lasting health condition that affects how your body turns food into energy. With diabetes, your body either doesnt make enough insulin or cant use it as well as it should.

Most of the food you eat is broken down into sugar (also called glucose) and released into your bloodstream. When your blood sugar goes up, it signals your pancreas to release insulin. Insulin acts like a key to let the blood sugar into your bodys cells for use as energy.

If you have diabetes, your body either doesnt make enough insulin or cant use the insulin it makes as well as it should. When there isnt enough insulin or cells stop responding to insulin, too much blood sugar stays in your bloodstream.

Over time, that can cause serious health problems, such as heart disease, vision loss, and kidney disease.

Types & symptoms

Type 1 diabetes is thought to be caused by an autoimmune reaction (the body attacks itself by mistake) that stops your body from making insulin. Approximately 5-10% of the people who have diabetes have type 1.

Symptoms of type 1 diabetes often develop quickly. Its usually diagnosed in children, teens, and young adults. Currently, no one knows how to prevent type 1 diabetes.

People who have type 1 diabetes may also have nausea, vomiting, or stomach pains. Type 1 diabetes symptoms can develop in just a few weeks or months and can be severe.

Type 2 diabetes occurs when your body doesnt use insulin well and cant keep blood sugar at normal levels. About 90-95% of people with diabetes have type 2. It develops over many years and is usually diagnosed in adults; however more children, teens, and young adults are developing type 2 diabetes.

With healthy lifestyle changes, such as eating healthy food, losing weight, and being active Type 2 diabetes can be prevented or delayed.

Some people dont notice any symptoms at all. Because symptoms are hard to spot, its important to know the risk factors for type 2 diabetes. Make sure to visit your doctor if you have any of them.

Gestational diabetes develops in pregnant women who have never had diabetes. If you have gestational diabetes, your baby could be at higher risk for health problems.

Gestational diabetes usually goes away after your baby is born but increases your risk for type 2 diabetes later in life. Your baby is more likely to develop type 2 diabetes later in life too. Gestational diabetes (diabetes during pregnancy) usually doesnt have any symptoms.

If youre pregnant, your doctor will test you for gestational diabetes between 24 and 28 weeks of pregnancy.

Symptoms & risk factors

Diabetes symptoms may include an increase in thirst, urinating a lot, lose of weight without trying, increased hunger, blurry vision, dry skin, feeling tired, numbness or tingling in your hands or feet, sores or wounds that heal slowly. If you have any of the following diabetes symptoms, see your doctor.

Risk factors for developing type 2 diabetes can include a history of prediabetes, being over the age of 45, overweight, having a parent or sibling with type 2 diabetes, or ever had gestational diabetes, are physically active less than 3 times a week.

There isnt a cure yet for diabetes, but losing weight, eating healthy food, and being active can help. Knowing diabetes risk factors and taking medicine as directed, you can prevent or delay type 2 diabetes with lifestyle changes.

Diabetes self-management education, support, and keeping your health care appointments can reduce the impact of diabetes on your Life! Please see the American Diabetes Association https://www.diabetes.org/, for further information .

Source: Centers for Disease Control Prevention.

Michaella Quallen is with the Clinton County Health District.

Read the rest here:
Diabetes: Symptoms, risks, and prevention - Wilmington News Journal, OH

While most of us are familiar with type 1 and type 2 diabetes, you may not have come across the term type 3 diabetes before. First things first, this is not to be confused with type 3c diabetes, which is something else entirely. It is, however, related to insulin resistance in the brain.

Being diagnosed as insulin resistant generally means that someone is either prebiabetic or has type 2 diabetes. But scientists have proposed that it can also result in the brains neurons lacking glucose, which is needed for proper function, and this can lead to symptoms of Alzheimer's disease.

While type 3 diabetes is not an officially recognised health condition, in 2008 Dr Suzanne de la Monte and Dr Jack Wands of Brown University put forward a proposal that Alzheimers disease could be termed type 3 diabetes due to its strong links with insulin resistance. Insulin resistance may be a leading cause of dementia, as this glucose deficiency in the brain leads to symptoms such as loss of memory, decrease in judgment and reasoning skills.

Type 3 diabetes is not a medically recognised term and is not something doctors use for diagnostic purposes. However, insulin resistance and decreased insulin signaling in the brain may play a role in the development of Alzheimer's disease. Not to mention, the risk of developing Alzheimer's disease is significantly higher in those with type 2 diabetes. As such, the term type 3 diabetes has been colloquially used by some in the field to illustrate these links.

A study in the Lancet journal of Neurology (opens in new tab) links diabetes with declining brain health and indicates that treatments that restore cerebral insulin function may offer therapeutic benefits to those with Alzheimer's disease.

Dr. William H Frey II, an Alzheimer's specialist at the Health Partners Center for Memory and Aging (opens in new tab), also explains that the disease causes cognitive decline in patients. Alzheimer's is a degenerative brain disease that accounts for more than 60% of the cases of dementia, he tells Live Science. It is characterized by memory loss, especially short-term or recent memories, cognitive decline and changes in behavior, all of which get progressively worse over time.

Dr Tariq Mahmood, a doctor and medical director at Concepto Diagnostics (opens in new tab), adds: Type 3 diabetes isnt an officially recognised health condition and isnt used for diagnostic purposes. It differs from type 1 diabetes and type 2 diabetes, which cause blood sugar levels to become too high due to issues with a hormone called insulin. Some scientists hypothesize that insulin dysregulation in the brain causes dementia and use type 3 diabetes as a term to describe Alzheimers disease a progressive neurological condition which is the most common cause of dementia.

Mahmood explains that while type 3 diabetes is not an official diagnosis, doctors can diagnose Alzheimers disease, which affects multiple brain functions gradually over the course of many years. Minor memory problems are usually the first sign, he says. More specific symptoms can include confusion, difficulty planning, disorientation, getting lost and personality changes.

Early to moderate symptoms of Alzeimers include:

These symptoms usually develop to a point that patients cannot swallow, lose bowel control and eventually pass away. Often people with Alzeimers die from aspiration pneumonia. This develops when food or liquids pass into the lungs instead of air due to problems with swallowing, as is stated by the National Institute of Aging (opens in new tab).

Dr Frey tells us that Alzheimers is best diagnosed by a neurologist who is familiar with neurodegenerative memory disorders. Diagnostic procedures may involve taking a complete history, blood tests, brain imaging, neuropsychological testing, etc. to help rule out other disorders that may produce somewhat similar symptoms, he says.

A review on insulin resistance in the Frontiers in Neuroscience (opens in new tab) journal indicates that insulin links multiple conditions together, such as obesity, dementia and diabetes, and recommends the potential use of antidiabetic medication to treat dementia. Additionally, the review explores the link between dementia and a high allostatic load, which is the burden created by stress, life events and other environmental challenges.

Mahmood tells us that while the science is unclear on the specific cause of Alzeimers disease, a combination of factors may be at play. Its widely believed that age-related neurological changes combined with genetic, environmental, and lifestyle factors can contribute toward it, he says. Age is the most important known risk factor for Alzheimers disease due to, among other things, atrophy in parts of the brain. Atrophy is the wasting of a muscle, meaning it can shrink, thin or be outright lost.

But Dr Frey explains that general aging is not the only risk factor associated with the development of Alziemers disease. Aging is the major risk factor for Alzheimer's disease, but Alzheimer's is not a normal part of aging, he says. Family history of Alzheimer's and genetic changes can also increase the risk, but individuals without a family history of the disease can still get Alzheimer's disease. A history of moderate traumatic brain injury can also significantly increase the risk for developing Alzheimer's disease.

Finally, type 2 diabetes doubles the risk for developing Alzheimer's disease. This is likely due to the fact that in both diabetes and Alzheimer's disease, there is a deficiency of insulin signaling.

He goes on to explain that In Alzheimer's disease, this insulin signaling deficiency occurs in the brain and leads to a loss of brain cell energy. Without sufficient insulin signaling, blood sugar is not taken into brain cells and metabolized normally.

Loss of brain cell energy means that the brain can no longer carry out memory and cognitive functions normally and also can not produce the parts of brain cells needed to replace those that wear out over time leading to degeneration of the brain itself.

Unhealthy lifestyles, including lack of exercise, poor diet and lack of sleep, likely also increase the risk for Alzheimer's disease, he says.

Dr Freys research has been pioneering in the area of insulin resistance and Alzheimer's. In 2022, he released a study in the Pharmaceuticals (opens in new tab) journal indicating that intranasal insulin (insulin administered up the nose) can help with cerebral glucose hypometabolism, which is a characteristic that is commonly found in those with degenerative cognitive disorders, as well as type 2 diabetes.

Because insufficient insulin signaling contributes to loss of brain cell energy in individuals with Alzheimer's disease, [we] first proposed intranasal insulin as a treatment for Alzheimer's disease about 22 years ago, he says. Intranasal insulin delivers and targets insulin to the brain along the nerves involved in smell without altering the blood levels of insulin or blood sugar.

But while clinical trials have shown that non-invasive intranasal insulin increases brain cell energy and improves memory in normal healthy adults, as well as those with mild cognitive impairment or Alzheimer's disease, it needs further development and testing to sufficiently demonstrate its safety and efficacy before it can be considered for regulatory approval and made available.

Dr Mahmood tells us that while there is regrettably no cure for Alzheimer's disease, treatments for those with the condition are available. There are medicines and treatments that can reduce symptoms on a temporary basis, he says. The two main medicines right now are acetylcholinesterase (AChE) inhibitors, which help nerve cells communicate with each other, and memantine, which blocks the effects of excessive glutamate this is a neurotransmitter released by nerve cells which plays a major role in learning and memory.

For people who begin to show aggression or distress, antipsychotic medicines can also be prescribed. For treatments, cognitive rehabilitation and cognitive stimulation therapy can help maintain memory and problem-solving skills.

A review in the Journal of Alzheimer's Disease (opens in new tab) indicates meditation may help with the prevention of Alzheimers disease, as it reduces allostatic load, which has been linked to the development of several cognitive disorders. Just 12 minutes of Kirtan Kriya meditation per day was shown to improve sleep, decrease depression, reduce anxiety, down regulate inflammatory genes, upregulate immune system genes, and improve insulin and glucose regulatory genes.

Dr Mahmood tells us that general healthy living is recommended to reduce your risk too, although other risk factors are uncontrollable. Unfortunately, theres no way to prevent Alzheimers disease at the moment, he says. Living a healthy lifestyle might lessen your risk, but age-related neurological changes and genetic factors are impossible to work around. Cardiovascular disease has been linked with an increased risk of Alzheimer's disease, so eating a balanced diet, making sure you get 150 minutes of exercise per week, limiting alcohol consumption and stopping smoking are all worthwhile.

Our easy Mediterranean diet plan and 7-day plant-based diet meal plan have lots of ideas to help you to eat a more balanced diet.

Dr Frey agrees that general healthy living is a wise course of action in working to avoid Alzheimer's disease. He also recommends protecting your head. Maintaining a healthy lifestyle including regular physical activity, avoiding head injury by wearing your seatbelt while in vehicles and a helmet during sports, consuming a healthy diet and remaining socially active can all help to reduce your risk for Alzheimer's disease, he says.

This article is for informational purposes only and is not meant to offer medical advice.

Original post:
Type 3 diabetes: symptoms, causes and treatments - Livescience.com

Alexandra drops TD1 kits off to a Yonkers school (Photo by Jason Malkin)

An Ardsley teen is working to make life with type 1 diabetes easier on local kids. Alexandra Malkin, a rising senior at Ardsley High School, started T1D Kits for Kids to provide free essential health supplies (along with a few small treats) to elementary-aged children. And people are taking notice she was recently named Hero of the Day by Good Day New York for her work.

Malkin saw firsthand what kind of hardships kids face with juvenile diabetes after her childhood friend was diagnosed with the condition at age 9. As I watched her life change extremely quickly, I began to understand the true impact that diabetes can have on someones life especially at a very young age, she told River Journal.

The experience stayed with her. Malkin decided to focus on diabetes once she was accepted into her schools science research program, a 3-year elective that allows students to dive into specific research areas. After reading various articles on past diabetic studies during the year, I was sure I wanted it to be what I would study for the remainder of my time in the program influencing the two summer research projects I have been a part of involving diabetes.

While immersing herself in the science, Malkin also discovered that the high costs associated with type 1 diabetes can be especially detrimental to children. More recently, I found out from a friend that their cousin who works at an elementary school in Michigan has seen a lot of diabetic students who arent able to afford the basic diabetic technology, she said. As I looked into this issue more, I noticed extremely high prices of diabetic kits sold by large diabetes companies more than any underprivileged family could afford.

This sparked the idea to provide children with the devices and medical supplies needed for free. Her kits include glucose monitors, lancets, Band-Aids, batteries, and glucose tabs, basic and necessary tools to stay healthy throughout the day. While those items will make many parents happy, Malkin doesnt forget her main focus: kids with juvenile diabetes. She tucks a few treats inside each basket to make them smile. I also wanted to address the desire for comfort from young type-1 diabetics by including teddy bears, sugar-free candy, and bracelets, pins, that help them embrace their T1D identity.

Since kicking off in January, Malkin has donated batches of kits to three different elementary schools, where she works with nurses to identify those who would benefit from them most. The greatest amount of newly-diagnosed type 1 diabetics usually are found within that age group (kindergarten 4th grade), she noted. The kits have been specialized to appeal to this

age group as well. Shes working to keep relationships with the schools, and has been sent photos of the recipients holding the kits and smiling ear-to-ear.

Malkin hopes to expand the program outside Westchester in the future and has applied for grants to continue funding and upgrading her kits. And she wants to help connect children with juvenile diabetes through their stories. I also have an idea to create a diabetes advice book that would include advice from experienced type 1 diabetics to help the younger diabetics make a smoother transition and feel like they arent alone.

To help keep the program going, Malkin said sharing her work with others and making a donation would go a long way. The only way to truly make my organization grow is to promote necessary funding and recognition for the work of T1D Kits for Kids and the concept behind it, she said. With these contributions, I can achieve the goals I have for the non-profit and expand my impact to the larger diabetic community.

Visit t1dkitsforkids.org to learn more or to make a donation.

Read more:
Local Teen Brings Smiles and Health Kits to Kids with Diabetes - River Journal Staff

When you are traveling by vehicle to your destination, you should:

Once you reach your destination:

One of the most important aspects of managing Type 2 diabetes is for the patient to test their blood glucose level, usually twice a day. This could be more for some patients, depending on the care plan from their physician.

In an article in Healthline, Lisa Harris, CDE, RN at Rush University Medical Center in Chicago said that many patients with type 2 diabetes would likely benefit from testing more frequently. "Testing your blood sugar can be extremely informative for people when they're trying to prevent the need for further medication, like insulin," Harris said. "Even if they're only taking metformin, seeing for themselves how certain types of foods affect their blood sugar can have the biggest impact on motivating them to make changes in their diet."

In addition, when traveling, healthy eating tends to become more difficult to regularly sustain. People will usually eat out more and have less time to plan healthy meals or have fewer healthy options from which to choose. There's also less time to ensure proper nutrition and exercise which is important for managing diabetes.

"For people with diabetes, having their blood glucose readings sent to a provider is even more important when they travel because their diet might not be as healthy, eating times and patterns may shift, and other metabolic stressors related to traveling," said Dr. Bill Lewis, a leading telehealth consultant. "The iGlucose is the perfect traveling companion for people with diabetes so their test results are still being transmitted seamlessly to their provider."

Many of today's devices for at-home remote patient monitoring (RPM) rely on Bluetooth technology or Wi-fi paired to an app on a smartphone. These connections especially low-energy Bluetooth, can fail and may not reliably or securely deliver health data to providers.

The iGlucose from Smart Meter has proprietary cellular technology that utilizes the fast and secure 4/5G AT&T IoT network for reliable transmissions every time. With the cellular-enabled iGlucose, the measurement is sent immediately to the patient's provider with no extra steps required by the patient.

About Smart Meter, LLC

Now serving more than 100,000 patients, Smart Meter is the leading supplier of cellular-enabled virtual care technologies that include the iGlucose, iBloodPressure, iPulseOx, iScale, and SmartRPMcloud platform, as well as data, and services. Smart Meter's remote patient monitoring solutions are recognized as the standard for the RPM industry and are regarded for their high patient retention and satisfaction. The unique combination of reliable health data, patient-friendly devices, and platform integrations enable and enhance RPM, CCM, Employee Wellness, Population Health, and Telehealth programs for more than 300 RPM distribution partners across the United States. For more information, visitSmartMeterRPM.com

Smart Meter, LLC

Media Contact

5501 W. Waters Ave., Suite 401

Keith Tolbert

Tampa, FL 33602

[emailprotected]

813-773-4080

336-509-8024

SOURCE Smart Meter, LLC

The rest is here:
Diabetes Travel Essentials and Tips for the Approximately 21 Million Americans that Must Manage Their Diabetes While on Vacation - PR Newswire

News Release

Thursday, July 14, 2022

NIH-funded clinical trial finds that starting with a cheaper drug and switching to a more expensive drug as needed leads to good vision outcomes in diabetic macular edema.

Clinical trial results from the DRCR Retina Network suggest that a specific step strategy, in which patients with diabetic macular edema start with a less expensive medicine and switch to a more expensive medicine if vision does not improve sufficiently, gives results similar to starting off with the higher-priced drug. The main complication of diabetic macular edema, fluid build-up in the retina that causes vision loss, is commonly treated with anti-vascular endothelial growth factor (VEGF) drugs.

The trial was funded by the National Eye Institute (NEI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both part of National Institutes of Health. Results of the trial, which examined a stepped regimen of anti-VEFG drugs Avastin (bevacizumab) and Eylea (aflibercept), were published today in the New England Journal of Medicine.

Our study showed that switching treatments when needed is a reasonable strategy, said Chirag Jhaveri, M.D., Austin Research Center for Retina, Texas, the lead study author. Insurance companies often require clinicians to start with the less expensive treatment, so we really wanted to see how a specific treatment strategy using this approach would affect patient care.

Diabetic macular edema is caused by diabetes-related alterations to retinal blood vessels. Symptoms include blurred vision. If untreated, vision loss can become permanent and progress to blindness. Retinal injections of anti-VEGF drugs can restore vision. The DRCR Retina Network previously showed that Avastin and Eylea improve visual acuity in people with diabetic macular edema. However, while Eylea is approved by the U.S. Food and Drug Administration to treat diabetic macular edema and results in better visual outcomes on average, off-label Avastin is much less expensive and is sometimes required by insurers as a first-line treatment.

The study enrolled 270 participants with diabetic macular edema, some of whom received treatments in both eyes. At enrollment, all had best-corrected visual acuity between 20/50 and 20/320. Half the study eyes were assigned to Eylea from the start, and half were assigned to start with Avastin. For participants who needed treatment in both eyes, each eye started treatment with a different drug. Participants received either Avastin or Eylea injections every four weeks for 24 weeks. If eyes assigned Avastin failed to reach the pre-set improvement benchmarks starting at 12 weeks, the eye was switched to Eylea.

After 24 weeks, physicians could taper down the frequency of injections as appropriate to maintain visual acuity. The study collected information about participants retinal structure and visual acuity for two years.

After two years, eyes in both groups had similar visual acuity outcomes, improving on average approximately three lines on an eye chart, compared to the trials start. In the Avastin group, 70% of eyes switched to Eylea during the study.

While most participants on Avastin eventually switched to Eylea, they still had improvement during those initial weeks, even if they didnt hit our pre-set benchmarks, said Adam Glassman of the Jaeb Center for Health Research and director of the DRCR Retina Network coordinating center. There are large cost disparities between these drugs, so differences in treatment strategies may have substantial cost implications.

Weve demonstrated here one method to managing a step treatment, where the outcomes are similar to the best existing treatment protocol with Eylea, said Jennifer Sun, M.D., M.P.H., of Joslin Diabetes Center and Harvard Medical School, Boston, and chair of diabetes initiatives for the DRCR Retina Network. Any time we can add to a clinicians toolbox, whether its a new medication or a new approach to using existing medications, as in this study, its a benefit for patients.

The study was supported by NEI (EY014231) and NIDDK through the Special Diabetes Program for Type 1 Diabetes Research. Clinical trial number NCT03321513.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Jhaveri CD, Glassman AR, Ferris FL, Liu D, Maguire MG, Allen JB, Baker CW, Browning D, Cunningham MA, Friedman SM, Jampol LM, Marcus DM, Martin DF, Preston CM, Stockdale CR, Sun JK, DRCR Retina Network. Aflibercept monotherapy versus bevacizumab first followed by aflibercept if needed for treatment of center-involved diabetic macular edema. NEJM. July 14, 2022.

###

Continued here:
A type of 'step therapy' is an effective strategy for diabetic eye disease - National Institutes of Health (.gov)

International Diabetes Federation (IDF) reports one in five Google searches for terms related to diabetes reveal inaccurate information about the condition and how to manage its complications, showing the lack of reliable diabetes education available for those who have or may have the condition.

The number of people living with diabetes continues to rise around the world, with the latest IDF estimatesindicating that one in nine adults will be affected by 2030. The necessity for reliable, accessible and accurate data on the condition can be a matter of life or death for people with serious cases of diabetes.

When diabetes is undetected and inadequately treated especially treated through home remedies which are reliant on misinformed articles on diabetes education people with diabetes are at higher risk of serious and life-threatening complications.

This is putting added strain on healthcare systems that, following two years of a global pandemic, are already struggling.

Out of 30 search results (the first results page for each search term), six links directed users to unverified information for different diabetes terms.

Terms including diabetes, how to manage diabetes and diabetes symptoms featured results and answers to questions from non-medical sources including Wikipedia, Amazon and Facty the last of which showed an article on home remedies for diabetes.

In one case, when searching for the term diabetes, users were shown an advert from an organisation that aims to wean people living with diabetes from insulin this can be extremely dangerous for those with type 1 diabetes, because if they experience an interruption in their supply of insulin, it can be potentially fatal.

Researchers of this data strongly advocate that decisions to reduce insulin treatment should be taken in close consultation with a qualified healthcare professional, preferably a specialist in diabetes.

According to IDF figures, an estimated 44.7% of adults living with diabetes (240 million people) across the world are undiagnosed with the overwhelming majority having type 2 diabetes.

Professor Andrew Boulton, IDF President, says: Many people now turn to Google and the internet for advice, so its worrying that misinformation about diabetes is still rife online.

With the prevalence of diabetes showing no signs of declining, ensuring that healthcare professionals are equipped to provide the best possible care and that people with diabetes can make informed decisions about their self-care is more important than ever. We need quality education today to help protect tomorrow.

IDF is committed to facilitating learning opportunities for all people concerned by diabetes, so their newonline platformhas been launched providing free interactive courses to help people with diabetes and their carers to understand and manage their condition.

The first course available provides an introduction to diabetes, explaining what it is, how it works and the common warning signs and risk factors.

For healthcare professionals, theIDF School of Diabetesoffers a selection of free and premium online courses that help them to keep up-to-date with various aspects of diabetes education, management and treatment.

Editor's Recommended Articles

Read more:
Diabetes education: one in five search results for diabetes lack reliable information - Open Access Government

Since 2005, talented performers ages 8-18 from across the St. Louis region come together every summer to form the Arch City Kids Theater Troupe (ACTT), producing a Broadway-style musical revue to raise money and awareness for JDRF (formerly the Juvenile Diabetes Research Foundation) in hopes of finding a cure for Type 1 diabetes.

As always, this year's production, Don't Stop Believin', is run entirely by kids, who cast, direct, choreograph and perform the show, donating all proceeds to JDRF. Don't Stop Believin' is directed this year by 18-year-old 2022 Lutheran South graduate, Gracie Maurer.

"ACTT is my favorite part of the summer," she says. "I've met lifelong friends and grown as a leader. I'm so excited to be directing the show this year!"

In 2021, ACTT's production Something About This Night raised $25,000, and over the years, with participation of more than 200 area kids, ACTT has given nearly $300,000 to JDRF.

Being a part of ACTT has become a fun and meaningful summer tradition for many young St. Louis performers, but for Assistant Director Natalie McAtee, singing and dancing in the show is only part of the appeal.

"Being able to raise money doing what I love for a disease that affects my friends is the highlight of my summer," said Natalie.

Gracie agrees.

"I am looking forward to raising money to turn Type 1 into Type None."

Don't Stop Believin', featuring songs from Broadway favorites like Rock of Ages, Hairspray, Legally Blonde, A Chorus Line, and Mamma Mia, runs August 5-7 at Ladue Horton Watkins High School. Tickets are free but donations are encouraged. Raffles and concessions are available at each show, and all proceeds go to JDRF.

For more information on ACTT: https://cloud.broadwayworld.com/rec/ticketclick.cfm?fromlink=2186141id=81&articlelink=http%3A%2F%2Fwww.archcitykids.org%2F?utm_source=BWW2022&utm_medium=referral&utm_campaign=article&utm_content=bottombuybutton1

Read more from the original source:
Arch City Kids Theater Troupe Fights Type 1 Diabetes With Its Annual Revue - Broadway World

DUBLIN--(BUSINESS WIRE)--The "Nutrigenomics Testing Market - Growth, Trends, and Forecasts (2022 - 2027)" report has been added to ResearchAndMarkets.com's offering.

The Global Nutrigenomics Testing market is expected to register a 13.3% of CAGR over the forecast period. The major factors for the market growth are increasing burden of lifestyle disorders and gaining popularity of personalized diet. Some of the lifestyle diseases include heart disease, and stroke, obesity and diabetes.

According to the World Health organization, cardiovascular diseases are one of the leading causes of death and around three-quarter of the deaths occur in low- and middle-income countries. Moreover, diet plays an influential role on the health with respect to the prevention of diseases and the overall quality of life. Thus, the nutrigenomics testing market growth is expected to propel.

Key Market Trends

Obesity Segment Expected to Exhibit Significant Market Growth

According to the factsheet of National Health Service, as of May 2020, about 20% of the children aged 6 years were obese in the United Kingdom. Childhood obesity is often associated with higher risk of premature death, disability in adulthood, and other risks such as difficulty in breathing, increased risk of fractures, hypertension, early markers of cardiovascular disease, insulin resistance and psychological effects.

Furthermore, obesity has been a major issue in high-income countries, however in recent years it has seen an upsurge in low- and middle-income countries. In 2018, approximately 40 million children that were under the age of five were obese worldwide, nearly half of this population was found to in Asia. Thus, the rising burden of obesity is expected to have a positive impact on the nutrigenomics testing market.

North America Expected to Hold a Significant Share in the Market

North America is expected to be a dominant region in the Nutrigenomics Testing market owing to rising burden of diseases due to sedentary lifestyle adoption. According to the Centre for Disease Control and Prevention, in 2017-18, the prevalence of obesity in the United States was found to be around 42.4% in adults. The prevalence of obesity was found to be more in women as compared to men. Furthermore, as per the data of Diabetes Research Institute, 2018, 34.2 million people in the United States had diabetes. Hence, a personalised dietary approach is gaining popularity for prevention and treatment of such diseases. Therefore, the aforementioned factors are expected to rise the demand for nutrigenomics testing market growth.

Competitive Landscape

Companies are taking initiatives to grow their presence in the market. In 2019, PT Kalbe Farma Tbk. launched Nutrigen-me panel that includes hormones, methylation, inflammation and antioxidants, plus sleep and lifestyle. Key players that are expected to be dominant in Nutrigenomics Testing market are Orig3n, DNA Life, Genus Health, LLC, Sanger Genomics Pvt. Ltd., The Gene Box, GX Sciences,Inc., Nutrigenomix, Cura Integrative Medicine and Holistic Health

Key Topics Covered

1 INTRODUCTION 1.1 Study Assumptions1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS 4.1 Market Overview4.2 Market Drivers4.2.1 Increasing Prevalence of Lifestyle Disorders4.2.2 Increasing Popularity for Personalized Diet4.3 Market Restraints4.3.1 Stringent Regulatory Framework4.4 Porter's Five Force Analysis4.4.1 Threat of New Entrants4.4.2 Bargaining Power of Buyers/Consumers4.4.3 Bargaining Power of Suppliers4.4.4 Threat of Substitute Products4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION 5.1 By Application5.1.1 Obesity5.1.2 Diabetes5.1.3 Cancer5.1.4 Cardiovascular Disease5.2 Geography5.2.1 North America5.2.2 Europe5.2.3 Asia-Pacific5.2.4 Rest of the World

6 COMPETITIVE LANDSCAPE 6.1 Company Profiles6.1.1 Cura Integrative Medicine6.1.2 DNA Life6.1.3 Genus Health, LLC6.1.4 GX Sciences, Inc.6.1.5 Holistic Health6.1.6 Nutrigenomix6.1.7 Orig3n6.1.8 Sanger Genomics Pvt. Ltd.6.1.9 The Gene Box

For more information about this report visit https://www.researchandmarkets.com/r/gp59f9

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Nutrigenomics Testing Industry Forecast to 2027 - Insights Into Obesity, Diabetes, Cancer, and Cardiovascular Disease Applications -...

Preclinical evaluation of FasT CAR-T cellsFasT CAR-T (F-CAR-T) proliferation in vitro

To characterize the in vitro proliferative capacity of F-CAR-T cells, F-CAR-T and C-CAR-T cells were manufactured in parallel (Supplementary Methods, and Fig. S1) using T-cells from 6 B-ALL patients. To investigate the ex vivo proliferation of F-CAR-T, frozen CD19 F-CAR-T and C-CAR-T cells from each patient were thawed and stimulated with irradiated CD19-expressing K562 cells. The number of CD19-targeting CAR-T cells was then determined during the course of cell expansion in vitro. As shown in Fig. 1A, upon CD19 antigen stimulation, F-CAR-T proliferation was much more robust compared to C-CAR-T proliferation. On day 17 post co-culture, F-CAR-T expanded 1205.61226.3 fold (MeanSD), while C-CAR-T expanded only 116.437.2 fold (MeanSD), (p=0.001). To characterize the mechanism underlying the superior proliferative ability of F-CAR-T, we purified CD19+ CAR-T cells from both F-CAR-T and C-CAR-T. The expression of genes involved in cell proliferation, cell cycle, and apoptosis was analyzed using Nanostring (detailed gene sets are in Table S2). Gene expression profiles showed higher F-CAR-T expression scores for genes associated with cell cycle regulation (F-CAR-T vs. C-CAR-T, p<0.01) and lower expression scores for apoptosis-related genes (F-CAR-T vs. C-CAR-T, p<0.05) in F-CAR-T cells (Fig. S2A).

A Ex vivo cell proliferation of F-CAR-T and C-CAR-T derived from B-ALL patients (n=6) (***P=0.001, F-CAR-T vs. C-CAR-T, d17, unpaired student two-tailed t-test). B Tscm, Tcm, and Tem were characterized by surface staining of CD45RO and CD62L and analyzed with flow cytometry (***P<0.001 comparing F-CAR-T and C-CAR-T). C T-cell exhaustion was characterized by PD-1, LAG3, and TIM-3 staining; Statistical analyses of the percentage of PD1+ LAG3+ Tim3+ (***P<0.001, comparing F-CAR-T and C-CAR-T), unpaired student two-tailed t-test). D RTCA assay was used to examine the specific killing of HeLa-CD19 cells. Growth of target HeLa-CD19 or HeLa cells were monitored dynamically. E CD19+ target Nalm6-Luc cells or F Raji-Luc cells were co-cultured with either F-CAR-T or C-CAR-T for 6h. Target cell killing efficacy was calculated by luciferase activity. NS, P>0.05 F-CAR-T vs. C-CAR-T (unpaired student t-test, two-tailed). F-CAR-T FasT CAR-T, C-CAR-T conventional CAR-T, Tcm (CD45RO+CD62L+) T central memory cells, Tem (CD45RO+CD62L) T effector memory cells, Tscm (CD45ROCD62L+) T stem cell memory, PD1 programmed cell death protein 1, TIM-3 T cell immunoglobulin and mucin domain containing-3, LAG3 lymphocyte-activation gene 3, RTCA real-time cell analyzer, E:T effector cells: target cells, NT normal T-cell.

Phenotypes of unstimulated F-CAR-T from three healthy donors were analyzed by flow cytometry. The CD45ROCD62L+ population was 45.7%2.2% which was comparable to the un-transduced T-cells (data not shown). Upon stimulation with CD19+ tumor cells for 9 days, C-CAR-T central memory cells (Tcm, CD45RO+CD62L+ and effector memory cells (Tem, CD45RO+CD62L) were 56.62%11.97% and 40.48%9.70%, respectively, among the C-CAR-T cells (Fig. 1B and Figs. S2B and S2). In contrast, Tcm cells (87.92%4.36%) was predominant in F-CAR-T, with only a small fraction of Tem (7.84%3.79%). In addition, F-CAR-T cells demonstrated more abundant T stem cell memory (Tscm) (3.841.22% vs 2.342.48%, p<0.05) than C-CAR-T cells. We also examined the exhaustion status of the stimulated CAR-T cells. A higher percentage of PD-1+LAG3+Tim3+T-cells were detected in the C-CAR-T (11.19%2.54%) compared to F-CAR-T (3.59%2.51%, p<0.001) (Fig. 1C). Together these data indicated that the F-CAR-T exhibited a younger phenotype and was less exhausted compared to C-CAR-T.

We used a real-time cell analyzer (RTCA) assay to measure the cytotoxicity of F-CAR-T and C-CAR-T against CD19+ cells in vitro. F-CAR-T and C-CAR-T killing of Hela-CD19 target cells were comparable using this assay (Fig. 1D). Similar levels of IFN- and IL-2 production were also observed (Fig. S2D). In a luciferase-based cytotoxicity assay, CD19+ B leukemia cell lines, Raji and Nalm6, were both effectively killed to similar or better levels at different E:T ratios (Fig. 1E, F).

To compare the in vivo cytotoxicity of F-CAR-T and C-CAR-T, severe immunodeficient NOG mice were engrafted with Raji-luciferase cells. One week after the tumor grafts were established, F-CAR-T and C-CAR-T were intravenously injected at various doses. The engrafted tumors progressed aggressively in control groups with either vehicle alone or control T-cells (Fig. 2A). In contrast, F-CAR-T or C-CAR-T treatment greatly suppressed tumor growth in a dose-dependent manner (Fig. 2A). In the high dose group (2106/mice), both F-CAR-T and C-CAR-T eliminated the tumor rapidly. However, in the low dose group (5105/mice), F-CAR-T showed more effective tumor-killing compared to C-CAR-T. On day 20, mice in the low dose F-CAR-T group became tumor-free, while C-CAR-T treated mice exhibited tumor relapse (Fig. 2A). We examined the CAR-T cell expansion in vivo after infusion. As shown in Fig. 2B, both F-CAR-T and C-CAR-T began to expand in the peripheral blood 7 days after infusion. C-CAR-T cell numbers reached their peak on day 14 and receded on day 21. In contrast, the F-CAR-T cell number peaked on day 21 and declined to a baseline level on day 28. F-CAR-T not only persisted longer but also underwent 26 folds greater expansion than C-CAR-T (Fig. 2B).

A Raji-Luc cell engraftment NOG mice were given high dose (2106/mice, n=3) and low dose (5105/mice, n=3) F-CAR-T/C-CAR-T along with control groups. Tumor growth was monitored with IVIS scan once every 3 days; B CAR-T expansion in peripheral blood of mice was analyzed by flow cytometry (n=6). ***P<0.001 for F-CAR-T HD vs. C-CAR-T HD; F-CAR-T LD vs. C-CAR-T LD; F-CAR-T HD vs. F-CAR-T LD; C-CAR-T HD vs. C-CAR-T LD (two-way ANOVA statistical analysis); C Schematic of the Nalm6 (1106) xenograft model, CAR-T (2106) infused 1 day after cyclophosphamide (20mg/kg) treatment. Bone marrow infiltration of F-CAR-T was analyzed 10 days after CAR-T infusion (n=3); D CD45+CD2 F-CAR-T vs. C-CAR-T in peripheral blood of mice were analyzed by flow cytometry; *P<0.05 (unpaired student two-tailed t-test). IVIS in vivo imaging system, PB peripheral blood, i.v. intravenous, HD high dose, LD low dose, Cy cyclophosphamide; *p<0.05; #: number.

We examined the BM infiltration of F-CAR-T cells after infusion into Nalm6-bearing mice (Fig. 2C). A larger population of CAR-T cells was observed 10 days after infusion in BM in F-CAR-T infused group than that in the C-CAR-T group (p<0.05) (Fig. 2D), suggesting F-CAR-T cells possessed a better BM homing capability than C-CAR-T.

The chemokine receptor CXCR4 is known to be critical for BM homing of T-cells [25, 26]. Indeed, a higher percentage of CXCR4+ T cells were detected in F-CAR-T than in the C-CAR-T. Interestingly, this phenotype was more pronounced for CD4+ T cells than CD8+ T cells (Fig. S3A). In a two-chamber system, more F-CAR-T cells could be detected in the lower chamber than their C-CAR-T counterparts (Fig. S3B).

Between Jan. 2019 and Oct. 2019, 25 pediatric and adult patients with CD19+R/R B-ALL were enrolled onto our phase 1 trial, including two patients who had relapsed following a prior allo-HSCT. Patient characteristics are detailed in Table 1. The median age of patients was 20 (range: 344) years old. Twenty patients were >14 years old, and five were 14 years old. The median percentage of pre-treatment BM blasts was 9.05% (range: 0.1982.9%). As our pre-clinical studies demonstrated that F-CAR-T cells had a superior expansion capability as compared to C-CAR-T, we infused a relatively low doses of F-CAR-T cells, ranging from 104105 cells/kg: 3.0104 cells/kg (n=2), 6.5 (5.867.43)104 cells/kg (n=9), 1.01 (1.01.16)105 cells/kg (n=12), 1.52(1.471.56)105 cells/kg (n=2), (Fig. S4). The median time from apheresis to the infusion of CD19+F-CAR-T cells was 14 days (range: 1220). Although the manufacturing time of F-CAR-T was next day, the quality control time and detailed final product releases including sterility testing require a minimum of 710 days to complete. In addition, transportation of cell products requires approximately two days. Of the 25 patients who received CD19 F-CAR-T infusion, 22 (88%) received bridging chemotherapy between apheresis and lymphodepleting chemotherapy to control rapid disease progression (Table S3).

F-CAR-T cells were manufactured successfully for all patients. The mean transduction efficiency of F-CAR-T was 35.4% (range: 13.170.3%) (Fig. S5A). Both CD4+/CAR+ (mean, 49.6%; range: 13.673.2%) and CD8+/CAR+ (mean, 41.5%; range: 20.677.7%) subsets were present in the CD3+CAR+ T cell subsets of all products. The mean proportion of Tscm, Tem, and Tcm cells in the CD3+CAR+ T cell subsets of all products was 23.3% (range: 3.5545.3%), 33.2% (range: 17.267.9%), and 36.1% (range: 20.758.1%), respectively (Fig. S5B). F-CAR-T products exerted significant IFN- release and cytotoxic effects against the CD19+ cell line HELA-CD19 (Fig. S5, C, D).

All 25 infused patients experienced adverse events (AEs) of any grade, with 25 (100%) experiencing grade 3 or higher adverse events. No grade 5 events related to F-CAR-T treatment were observed (Table 2).

CRS occurred in 24 (96%) patients with 18 (72%) grade 12 CRS,6 (24%) of grade 3, and no grade 4 or higher CRS (Fig. S6). In the >14 years old group, 16/20 (80%) patients developed mild CRS, and only 2/20 (10%) developed grade 3 CRS. For 14 years old patients, 2/5 (40%) had mild CRS, yet 3/5 (60%) experienced grade 3 CRS (Table S4). ICANS was observed in 7 (28%) patients, with 2 (8%) grade 3 ICANS occurring in patients >14 years old and 5 (20%) grade 4 ICANS all occurring in patients 14 years old. No grade 5 ICANS was developed (Fig. S7 and Table S4). The most frequent presentation of CRS was fever, particularly a high fever of >39C. The first onset of CRS symptoms occurred between day 3 and 8 post-CAR-T infusion with a median onset at day 4 (range: 110 days). The most common symptoms of ICANS were seizure (5/7) and depressed consciousness (5/7). The median time to ICANS onset from CAR-T cell infusion was 7 days (range: 58), and the median time to resolution was 2 days (Fig. S7). All CRS and ICANS events were managed including early intervention when fever of 39C persisted for 24h. Sixteen (64%) patients received tocilizumab with a median total dose of 160mg (range: 160320mg). Twenty-one (84%) patients received corticosteroids including dexamethasone (median total dose, 43mg; range: 4127mg) and or methylprednisolone (median total dose, 190mg; range: 401070mg). The vast majority of these patients discontinued corticosteroids within 2 weeks. The change in IL-6, IFN-, IL-10, and GM-CSF levels after infusion are selectively shown in Fig. S8. The peak levels of these four cytokines were observed between day 710. Among all 21 cytokines examined, only post-infusion IL-6 levels were associated with moderate to severe CRS and/or ICANS (Figs. S9 and S10).

Superior in vivo proliferation and persistence of F-CAR-T compared to C-CAR-T cells were observed regardless of dose levels. The median peak level was reached on day 10 (range: 714 days) with 1.9105 transgene copies/g of genomic DNA (range: 0.225.2105 transgene copies/g of genomic DNA) by qPCR and 83 F-CAR-T cells per l blood (range: 42102 F-CAR-T cells per l blood) by FCM (Fig. 3A, B). No significant differences were observed among the different dose groups in the mean F-CAR-T copies peak (Fig. 3C). Importantly, there was no significant difference in the mean F-CAR-T copies peak between patients who received corticosteroids compared to those who did not (Fig. 3D).

A F-CAR-T cells in peripheral blood by qPCR. Purple, dose level 1; black, dose level 2; blue, dose level 3; red, dose level 4; B F-CAR-T cells in peripheral blood by flow cytometry. Purple, dose level 1; black, dose level 2; blue, dose level 3; red, dose level 4; C Comparison of the mean peak copy number of F-CAR-T cells in peripheral blood at each dose level. Statistical significance was determined by the MannWhitney test. D Comparison of the mean peak copy number of F-CAR-T cells in peripheral blood with or without steroids. Statistical significance was determined by the MannWhitney test.

Fourteen days after F-CAR-T cell infusion, all patients achieved morphologic CR including 2/25 with CR and 23/25 CR with incomplete hematologic recovery (CRi), which further improved to 11/25 CR and 14/25 CRi 28 days post F-CAR-T (Table 1 and Fig. 4). More importantly, 23/25 (92%) had the minimal residual disease (MRD)-negative remission on day 14 and day 28 after F-CAR-T treatment. Patients achieving remission through CAR-T were given the option to proceed to allo-HSCT. With a median time of 54 days (range: 4581 days) post F-CAR-T infusion, 20 of 23 patients with MRD-negative status decided to pursue consolidative allo-HSCT including one patient who received a 2nd transplant. As of 18 October 2021, with a median follow-up duration of 693 days (range: 84973 days) among the 20 patients who had received allo-HSCT, one patient relapsed on day 172 and died 3 months after relapse, and four patients died from transplant-related mortality (TRM) including infection (n=3) and chronic GVHD (n=1) on day 84, day 215, day 220, and day 312, respectively. The other 15 patients remained in MRD-negative CR with a median remission duration of 734 days (range: 208973) except for one who became MRD-positive on day 294 with CD19+ disease. Among the other three patients (F05, F06, F16), one remained in MRD-negative CR on day 304, one remained in MRD-negative CR until day 303, received allo-HSCT but died from an infection on day 505, and one was lost to follow-up after day 114. Two patients who had MRD-positive CR after infusion withdrew from the study on day 42 and day 44, respectively, to seek other studies.

Clinical outcomes and consolidative allo-HSCT for the 25 patients who were treated with F-CAR-T therapy are shown. On day 28, 23/25 patients achieved MRD-negative CR/CRi. With a median time of 54 days (range: 4581) post F-CAR-T infusion, 20 of 23 patients with MRD-negative status received consolidative allo-HSCT. Among the 20 patients, 1 patient (F23) relapsed on day 172 and died 3 months after relapse. Four patients (F04, F09, F11, F12) died from transplant-related mortality (TRM) including infection (n=3) and chronic GVHD (n=1) on day 84, day 215, day 220, and day 312, respectively. The remaining 15 patients were in MRD-negative CR except for one (F18) who became MRD-positive on day 294. Among the other 3 patients (F05, F06, F16), 1 remained MRD-negative CR on day 304, 1 remained in MRD-negative CR until day 303, received allo-HSCT, and subsequently died from an infection on day 505. One patient was lost to follow-up after day 114. MRD minimal residual disease, CR complete remission, Allo-HSCT allogeneic hematopoietic stem cell transplantation.

F-CAR-T/T ratio in cerebrospinal fluid (CSF) was evaluated by FCM in 13/25 patients with available samples (Table S5). Between days 10 and 32, 9 patients were found to have considerable F-CAR-T penetration in their CSF, ranging from 40.65 to 79.2%, including 4 who developed severe ICANS. Among the other 4 patients, F-CAR-T cell abundance in the CSF ranged from 1.29% to 3.57%, and none experienced severe ICANS. Patients with higher levels of CAR-T in PB on day 10 consistently had higher levels of CAR-T in CSF with the exception of patient F15. Notably, CAR-T cells were still detectable in the CSF on day 101 with a 2.36% CAR-T/T ratio in patient F06, who also had undetectable circulating CAR-T cells at the same time.

In addition, concentrations of seven cytokines (IL-1b, IL-6, IL-10, IFN-, TNF-, MCP-1, and GM-CSF) in CSF samples from the above 10 of 13 patients were measured. Specifically, IL-1b was not detected in any of the 10 patients, and only one patient had detectable GM-CSF. For the other five cytokines, patients with severe ICANS had higher IL-6 levels in contrast to patients without severe ICANS, and the difference between the median level of IL-6 among these two groups of patients was statistically significant (Fig. S11). We did not observe significant differences among the other 4 cytokines between the two groups of patients. No clear relation between the CSF cytokine levels and the F-CAR-T/T % was observed.

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Next-day manufacture of a novel anti-CD19 CAR-T therapy for B-cell acute lymphoblastic leukemia: first-in-human clinical study | Blood Cancer Journal...

Could a brain ever exist on its own, divorced from or independent of a body? For a long time, philosophers have pondered such "brain-in-a-vat" scenarios, asking whether isolated brains could maintain consciousness when separated from their bodies and senses.

Typically, a person's experiences are characterized by a web of interactions between the human brain, body and environment.

But recent developments in neuroscience mean this conversation has moved from the realm of hypothetical speculation and science fiction, to isolated examples where consciousness could be sealed off from the rest of the world.

In a 2020 study, detailed in the journal Trends in Neuroscience (opens in new tab), philosopher Tim Bayne, of Monash University in Melbourne, and neuroscientists Anil Seth, of the University of Sussex in England, and Marcello Massimini, of the University of Milan in Italy, describe contexts in which such "islands of awareness" could exist.

Related: What happens in our brains when we 'hear' our own thoughts?

In one possible situation, a brain that has been removed from its host is able to sustain consciousness using the oxygen and nutrients necessary for function delivered via some kind of apparatus. This is called the ex cranio brain.

In a study that sounds like something out of a horror movie (opens in new tab), researchers were able to successfully restore blood flow to brain cells, cellular functions of neurons, and spontaneous synaptic activity in pigs' brains that were removed after death and connected to a system called BrainEx. The system, which is designed to slow the degeneration of brain tissue after death, can be connected to the base of a postmortem brain, delivering warm artificial oxygenated blood.

In people who suffer from severe refractory epilepsy, one treatment called a hemispherotomy (opens in new tab) involves completely disconnecting the damaged half of the brain from the other hemisphere, brainstem and thalamus. In these cases, the damaged half remains inside the skull, and connected to the vascular system. While the disconnected hemisphere continues to receive the nutrients and oxygen needed for function, some have wondered whether this isolated hemisphere supports an adjacent consciousness to the opposing, connected hemisphere.

And scientists have created lab-based mini-brains, 3D structures developed from stem cells that display various features of the developing human brain. Some of these brains-in-a-dish have brainwaves similar to those seen in preterm babies.

But do any of these "brains" actually possess consciousness?

Scientists can't deduce consciousness from behavior in these cases, nor can they ask these brains if they are experiencing consciousness. This conundrum has led neuroscientists to devise a potential "objective" measure of consciousness.

For instance, scientists could use the so-called perturbational complexity index (PCI), which is based on the level of interactions between neurons within these "brains." Using this index, scientists would electrically stimulate a part of the brain and then measure the resulting patterns of neural activity to gauge the complexity of brain-cell interactions. If the resulting measurement of these interactions carries lots of information, then the system can be said to be more conscious.

It's kind of like tossing a rock into a pond and measuring the resulting ripples. If the ripples interact with other objects in the pond, setting off more ripples, then the more conscious the system.

In states where people have not been fully conscious, PCI has been a reliable indicator of their level of consciousness. For instance, being in a coma, or sleeping, would be considered a "lower" level of consciousness or awareness.

"PCI has proven effective in detecting disconnected awareness during dreaming, ketamine anesthesia (opens in new tab), and has also been fruitfully applied to patients who are non-responsive following severe brain injury (opens in new tab)," Bayne told Live Science.

It could be the case that consciousness is tightly coupled to dynamics of the brain that are relatively easy to measure, such as the case with the PCI.

But even if consciousness doesn't turn out to be reducible to any neural signal in the brain, Bayne believes the task of developing an "objective" measure of consciousness is still a valid one.

While these techniques might not be able to definitively answer the question of whether consciousness is present in these contexts, they will provide answers to some fundamental questions, such as whether islands of awareness have the same levels of neural complexity as the brains of conscious subjects. Or do these brains slowly go offline once disconnected from the external world?

Understanding what the contents of consciousness could look like in such cases offers an even trickier problem.

Originally published on Live Science.

Originally posted here:
Can minds persist when they are cut off from the world? - Livescience.com

Black adolescent young adult patients with acute myeloid leukemia appeared to have inferior outcomes compared with White patients.

Adolescent and young adult patients who are Black with acute myeloid leukemia (AML) between 18 and 29 years old reportedly have worse survival than White patients receiving similar therapy, according to a study published in Blood Advances.

A higher rate of early death was observed in Black patients between the ages of 18 to 29 (16%) vs 3% the White population (3%; P = .002). Moreover, Black patients had a lower complete remission (CR) rate at 66% vs 83% (P = .01) in White patients, as well as a lower 5-year overall survival (OS) rate at 22% vs 51% (P <.001), respectively. Disparities were also observed across different cytogenetic subgroups, including worse 5-year OS rates among Black patients with non-core binding factor AML (12% vs 44%; P <.001) and cytogenetically normal AML (13% vs 50%; P = .003) compared with White patients.

Patients who were Black compared with White had a higher rates of early death at 11% vs 2% (P <.001), lower CR rates at 73% vs 82% (P = .06), and shorter 5-year OS rates at 32% vs 46% (P = .002). However, the 5-year disease-free survival (DFS) rate was in 32% in Black patients vs 40% in White patients (P = .25).

Patient characteristics were almost the same in regard to age and sex, while there were no differences in clinical features were apparent at diagnosis. A total of 327 samples were collected from 50 Black patients and 277 White patients. At diagnosis, 40% of White patients were cytogenetically normal vs 19% of Black patients (P <.001), and 22% vs 37% of patients, respectively, had abnormal karyotypes with chromosome rearrangement that were associated with core-binding factor AML (P = .005).

Mutations of t(8;21)(q22;q22)/RUNX1::RUNX1T1 were observed in 22% of patients who were Black vs 10% of those who were White (P = .002), while there were similar rates of inv(16)(p13.1q22)/CBFB::MYH11 or t(16;16)(p13.1;q22)/CBFB::MYH11 mutationsincluding 15% in Black patients vs 12% in White patients (P = .49).

Gene variants including ASXL1 (12% vs 1%; P <.001), KRAS (16% vs 5%; P = .01), ZRSR2 (6% vs 0.4%; P = .01), BCOR (8% vs 2%; P = .05), and CALR (8% vs 2%; P = .05) were more prevalent in Black patients vs White patients. However, more White patients had gene alterations in NPM1 (29% vs 4%; P <.001) and bi-allelic CEBPA (17% vs 3%; P = .02) compared with Black patients.

Overall patients who were Black had higher early death rates in 16% vs 3% (P = .002). The median OS for patients who were Black and between the ages of 18 to 29 years was 1.3 years vs 10.2 years for patients who were White (P <.001). Investigators did not find any significant differences in survival between patients who were Black or White between the ages of 30 to 39.

A total of 15% of patients who were White and 4.5% of those who were Black received allogeneic hematopoietic stem cell transplantation (HSCT) during first CR. Of those who underwent allogeneic HSCT, a longer DFS was observed among White patients vs Black patients and did not undergo the treatment. There were no significant differences in OS between treatment groups (P = .21).

Patients who were Black and had core-binding factor AML had higher rates of early death at 12% vs 3% of patients who were White (P = .06), lower CR rates at 85% vs 95% (P = .06), and shorter 5-year OS rates in 54% vs 70% (P = .05), respectively. No differences in DFS and OS were observed between patient subgroups with non-core binding factor AML with t(8;21) alterations. However, OS but not DFS was shorter for patients who were Black between 18 to 29 years of age with inv(16)/t(16;16) vs 18 to 29 and 30 to 39 year-olds who were White.

Larkin K, Nicolet D, Kelly BJ, et al. High early death rates, treatment resistance, and short survival of Black adolescents and young adults with AML.Blood Adv. Published Online July 5, 2022. doi:10.1182/bloodadvances.2022007544

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Black Adolescent Young Adults With AML Have Worse Outcomes Vs White Population - Cancer Network

Akari Therapeutics Plc

NEW YORK and LONDON, July 07, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on developing advanced therapies for autoimmune and inflammatory diseases, today announced that a patient has completed the course of investigational nomacopan treatmentin the open-label, multi-center Phase IIIPart Aclinical trial in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4).

Three patients with severe (nephrotic range proteinuria and elevated soluble C5b-9) HSCT-TMA have been enrolled in the clinical trial. One patient completed more than 60 days of nomacopan treatment and subsequently was discharged from the hospital. Another patient died from multi-organ failureunrelated to nomacopan treatment.Dosing has begun in the third patient.

This is promising news for children and families facing hematopoietic stem cell transplant-related TMAs who have unmet needs that are significant and urgent because there are no approved treatment options, said Rachelle Jacques, President and CEO of Akari Therapeutics. Recruitment into a study of treatment for a rare and emergent complication of stem cell transplants in children has inherent challenges, and it is testament to the passion and commitment of everyone involved that this important Phase III clinical trial is progressing on behalf of patients and their families.

Nomacopan was granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for pediatric HSCT-TMA. Data from the Phase III Part A study of nomacopan in HSCT-TMA will inform the pivotal Phase III Part B study that will be the basis for potential regulatory submissions in the U.S. and Europe.

The six-year-old patient who was discharged wastreated at a clinical trial site in Manchester, England by investigator Rob Wynn, M.D. Thrombotic microangiopathy following a stem cell transplant procedure is a rare but devastating complication made even more tragic because there are currently no approved treatments, said Professor Rob Wynn, of Royal Manchester Childrens Hospital, part of Manchester University NHS Foundation Trust. As we advance this important clinical trial and offer treatment to children in Manchester where formerly there was none, we are bringing new hope to families who are in desperate need, and to other clinicians who very much want to offer a treatment option.

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Thrombotic microangiopathy following a stem cell transplant procedure is a rare but serious complication of HSCT that appears to involve complement activation, inflammation, tissue hypoxia and blood clots, leading to progressive organ damage and death. The mortality rate in patients who develop severe transplant-related TMAs is 80%.1 Currently, there are no approved treatment options in the U.S. or Europe.

Sites are open and recruiting in the U.S, U.K., and Poland for the Phase III Part A clinical trial of investigational nomacopan in pediatric patients who have undergone allogeneic or autologous HSCT and develop HSCT-TMA within a year of transplant. Patient dosing is underway in the multi-center, open-label study that has a recruitment goal of seven pediatric patients over six months old.

The primary study endpoints are either independence of red blood cell transfusion or urine protein creatinine ratio of 2 mg/mg maintained over 28 days immediately prior to any scheduled clinical visit up to Week 24. According to the study protocol, patients may discontinue therapy sooner than 24 weeks, if one, or both, of the primary endpoint components has been met and the treating clinician determines there is no longer a need for continued treatment with nomacopan. Patients who have achieved the primary endpoint and are no longer receiving nomacopan will have a follow-up clinic visit 30 days after the last dose, at 24 weeks and for long-term follow-up at one and two years.

References

Rosenthal J. Hematopoietic cell transplantation-associated thrombotic microangiopathy: a review of pathophysiology, diagnosis, and treatment.J Blood Med. 2016;7:181-186. Published 2016 Sep 2. doi:10.2147/JBM.S102235

About Akari Therapeutics

Akari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company focused on developing advanced therapies for autoimmune and inflammatory diseases. Akari's lead asset, investigational nomacopan, is a bispecific recombinant inhibitor of C5 complement activation and leukotriene B4 (LTB4) activity. The Akaripipeline includes two late-stage programs for bullous pemphigoid (BP) and thrombotic microangiopathy (TMA), as well as earlier stage research and development programs in eye and lung diseases with significant unmet need. For more information about Akari, please visit akaritx.com.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward- looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward- looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result there; difficulties enrolling patients in our clinical trials; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected risks associated with the impact of the COVID-19 pandemic; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third- party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

For more information

Investor Contact:Mike MoyerLifeSci Advisors(617) 308-4306mmoyer@lifesciadvisors.com

Media Contact:Eliza SchleifsteinSchleifstein PR (917) 763-8106eliza@schleifsteinpr.com

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Akari Therapeutics Announces First Patient to Complete Course of Treatment in the Phase III Part A Clinical Trial of Investigational Nomacopan in...

The U.S. Supreme Court's June 24 ruling ending federal abortion rights under Roe v. Wade could inspire groups that seek to protect embryos to urge greater restrictions on in vitro fertilization (IVF) and embryonic stem cell research, according to Henry T. (Hank) Greely, director of the Stanford Law School Center for Biomedical Ethics.

Assisted reproductive technologies such as IVF aren't constitutionally protected and neither is preimplantation genetic testing, which screens for certain traits and DNA-caused conditions in embryos that haven't yet been implanted in the uterus, he said in a recent interview prior to the landmark ruling.

The court's ruling doesn't ban these technologies, which assist people seeking to have children, but it is likely to inspire some groups and states to seek to preserve unused embryos or ban embryonic stem cell research, Greely said.

His paper about the potential short- and long-term impacts of the decision is in preprint publication and is expected to be published in the Journal of Law and Biosciences in the coming weeks. In the short term, the technologies that embryo-protection groups might seek to ban or limit might be an alternative for women who can no longer receive an abortion in their home state.

Prenatal testing currently can determine if the fetus has a serious DNA defect that would cause disease or disability; a woman can then decide whether to continue with or terminate the pregnancy. That choice would likely disappear in states that restrict abortions, Greely said.

But a genetic testing technique that is used during in vitro fertilization could be utilized to prevent IVF pregnancies with fetal abnormalities. Preimplantation genetic testing, or PGT, screens out embryos with DNA-causing birth defects before the embryos are transferred to the uterus. The procedure can determine with a high degree of accuracy whether an embryo would develop into a baby who might have one of a large number of conditions. The decision not to transfer an embryo with genes that could cause a disability, condition or trait isn't illegal in the U.S., he said.

In states where abortion is illegal, it's likely there would be an increased interest in using PGT. The embryos are screened while outside the womb and prior to implantation and pregnancy.

"I think some people, some couples will say, well, if we have an embryo for the pregnancy that would have a severe disability as a child, our state wouldn't allow us to abort it. So let's go through preimplantation," he said.

But Greely doesn't think using PGT will skyrocket after the court's abortion decision. The technique requires that prospective parents use IVF, which is unpleasant and risky due to egg harvesting, he said.

IVF is also expensive. Most couples seeking the technique do so due to infertility and the decision isn't made lightly. Anyone with enough money to afford IVF would likely be able to afford to travel to another state for an abortion, he said.

Greely thinks it is unlikely embryo-protection groups would advocate for any kind of legislation that has a negative effect on IVF, however.

"Americans like IVF; almost everybody knows somebody or will know somebody who's either gone through IVF or who's actually the product of IVF. Two percent of the babies born every year in the U.S. with the product of IVF, and particularly the wealthier people are, the more likely they are to have either used IVF or know somebody who uses IVF, and also, the more likely they are to be politically powerful," he said.

There's a certain sort of law Greely thinks might be politically viable: limiting the selection or deselection of an embryo for IVF for a specific reason such as race, gender or disability.

"We've already seen it in abortion state statutes. A lot of abortion laws ban abortion for the purpose of discriminating on race, sex or disability status. And some of them explicitly say Down syndrome status.

"I can imagine the disability community coming together with protection groups to try to pass laws banning using PGT to select against embryos based on race, sex or disability. The important part of that would probably be disability and maybe even with the focus just on Down syndrome, which has a very strong support group and has some political sympathy," he said.

There isn't much political support for eliminating embryos that would have a fatal disease, however, he said.

"There's a more attractive case for protecting embryos that might become people with Down syndrome compared to protecting embryos that might become babies who would die within a year from Tay-Sachs disease," he said.

The court's decision on Roe v. Wade could invigorate efforts to pass new legislation to protect embryos outside the uterus among people who believe embryos are viable far earlier than at the 15 weeks in the Mississippi case that challenged Roe v. Wade. Some groups have claimed that human life starts far earlier and even at fertilization, which would make, in their view, all embryos for IVF "viable" regardless of whether they are implanted in the womb.

In the normal medical standard of care, no more than two embryos should be transferred into a woman's uterus at a time to minimize the chances of multiple pregnancies, Greely noted in his paper.

Most IVF cycles produce more than two eggs. Prospective parents can choose to have the extra embryos frozen for possible later use, donated to other couples, designated for research or destroyed and discarded.

Some legislation advocated by embryo-protection groups could limit or change the practice, he said. With the exception of Louisiana, there are no limitations on destroying embryos that aren't implanted, he said, though some other states have considered the legislation.

"The only limitation that I know of is the Louisiana law where you're not allowed to destroy embryos. So leftover embryos are kept frozen indefinitely in IVF clinics there," he said.

Legislation could lead clinics to build facilities to freeze and store unused embryos in perpetuity, he said, adding that the Louisiana law hasn't caused IVF clinics to close.

Embryo-protection groups might also try to get a law passed that's similar to a 2004 Italian law, which was subsequently limited by a court decision, Greely noted.

"They said you have to transfer for possible implantation every viable embryo you make, which means in Italy they typically only make one or two embryos at a time.

The embryo-protection groups "might try that, but all that would do is make IVF more difficult or expensive, and I don't think there's going to be political support for it. I don't think there'll be enough political support for it for people to adopt it," he said.

Greely noted that there could potentially be a significant change in embryo research as opposed to clinical treatments in an IVF clinic.

"Actually, embryo research in particular has really nothing to do with Roe v. Wade. As a matter of law, Roe v. Wade never protected embryo research, but I think it's connected in terms of the political dynamics after the death of Roe v. Wade," Greely said.

There's a good chance that at some stage, states will pass laws that eliminate human embryo research, in part because it is a huge issue, he said. Embryonic stem cells are taken from embryos created and then not used for pregnancy at IVF clinics.

"Twenty years ago, a number of states banned it; a number of states like California encouraged that research. But research into Type 1 diabetes and other major diseases has been disappointing.

"I think it has been useful, but there have been no miracles from it so far," he said.

The discovery in 2007 of a method to turn regular body cells into cells that can become any cell type in the human body makes the argument for using embryonic stem cells less compelling, he noted in his paper. Called induced pluripotent stem cells or iPSCs, these cells take away some of the urgency about using embryonic stem cells.

But iPSCs aren't exactly like human embryonic stem cells, Greely noted. Researchers would likely argue that human embryos are still required for research on embryonic development that would lead to ways for couples to succeed in having babies.

iPSCs might also play a role in the same types of research, since scientists have been creating "embryo-like things" or "embryo models" that provide more information about human embryonic development, he wrote.

How these laws might affect funding for embryonic research is also unknown.

The federal government has had little appetite for funding embryonic research and has refused to fund research that "destroys, discards, or knowingly subject(s) to risk of injury of death" embryos, Greely noted in his paper.

Yet, the federal government doesn't limit or ban the research itself; its actions have solely been about research it funds. Federal funds can be used for research on cells created from embryos that were destroyed somewhere else, he noted.

At least 11 states, however, have banned (or effectively banned) human embryo research on cells created from destroyed embryos that came from somewhere else, he wrote.

Some states allow such research, including California, Connecticut, Michigan, Montana and New York, Greely noted. California in particular continues to support stem cell research without a ban on the use of embryonic cells. In 2020, the state's voters passed Proposition 14 for $5.5 billion in bonds to advance the research.

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How abortion ruling could affect IVF and embryonic research - The Almanac Online

News Photo by Julie RiddleDetective Sgt. Steve Davis works at his computer at the Alpena Police Department on Wednesday.

ALPENA Police work hinges on relationships, said Detective Sgt. Steve Davis, retiring on Friday from the Alpena Police Department.

In 14 years of responding to complaints in Alpena and another 11 years as Alpena detective, Davis has met some of the strongest people he knows.

Those resilient people often encountered as they reeled from the devastation of a recent trauma gave him strength to do the job he now leaves after 32 years, Davis said, reflecting on his career in an Alpena Police Department conference room on Wednesday.

Davis stepped into law enforcement in 1990, moving to Montmorency County in 1991.

Six years later, he joined the Alpena Police Department as a road patrol officer, from which he was promoted to road sergeant in 2001.

Since 2011, Davis has served as detective, chasing leads and digging deep into Alpenas most serious crimes.

That transition meant learning to slow down, looking over things not once, not twice, but three times, Davis said.

Unlike road patrol work which often involves hustling from complaint to complaint a detective has to step back and examine the big picture surrounding stabbings, suicides, rapes, assaults, and other major crimes, following leads and studying patterns and interviewing residents.

Last summer, during what Davis called one of the most complex cases of his career, he had to call in the help of the Michigan State Police during a months-long investigation into the disappearance of missing Alpena teenager Brynn Bills.

Police later found Bills body buried in a back yard in Alpena Township. No charges have been filed related to her death.

That investigation, now turned into a death investigation by the State Police, required pursuing numerous angles and talking to hundreds of people, Davis said.

Since his young days as a patrol officer, Davis has noted an alarming loss of communication skills within multiple age groups, a change he chalks up to social medias enabling of faceless retorts and insults without consequences.

When I was a kid, if you wanted to talk to someone, you rode your bike over to their house and talked to them, face to face, he said. As a society, weve lost a lot of that. And thats pretty unfortunate.

Society feels the brunt of that loss when people with differing viewpoints dont know how to listen to one another and resort to violence and then police have to step in, Davis said.

Since his career started, inpatient mental health facilities have closed and budget-strapped mental health agencies have struggled to keep up with a seeming increase in mental health struggles and police not trained as mental health workers have to pick up the pieces, Davis said.

Untreated mental illness paired with the inability to deal with an opposing viewpoint puts everyone in danger when people burst into schools or churches or parades ready to kill, he said.

Like many police officers, Davis mourns a changed public perception of police work that makes hiring officers harder and wears out officers who have to work overtime.

News reports of police doing wrong do not reflect the attitude or actions of most police officers, Davis said.

Then again, he added, neither do depictions of people hating and distrusting police reflect the way Alpena treats its police force.

In a community largely supportive of its public safety workers, he cant walk into a sandwich shop without someone offering to buy him lunch.

As a young officer, he sometimes took a cynical view of the community. Age and time have made him less judgemental and more ready to see positives, even while embroiled in the citys worst crimes.

Theres a lot of good people out there, he said. Weve just got to remember that.

Several years ago, Davis donated stem cells to save a woman from another country, someone whose name he will never know.

Asked if he was willing to undergo the procedure to help the woman, Davis assented readily.

Thats kinda why I got into law enforcement, he said.

His wife is making him celebrate his retirement with a party, Davis said, waving off a suggestion that a police retirement deserves special recognition.

We all put our part into this community, he said. Im just one little piece.

Julie Riddle can be reached at 989-358-5693 or jriddle@thealpenanews.com. Follow her on Twitter @jriddleX.

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Viewers of today's This Morning programme have been left 'in tears' after a boy had the chance to meet the donor who saved his life. Jose flew all the way from Brazil to meet 10-year-old Finley Hill who was searching for a life-saving donor to cure a rare immune disease.

Finley and his family appeared on the show to share the news that he has now been cured. A pre-recorded message from Jose was then shown, before Phillip revealed he had been flown from Brazil to meet them in the studio.

And viewers were loving the sweet moment, taking to Twitter to share their reaction. @jmclean514 said: "What a beautiful story in real time. Brought tears to my eyes. This just goes to show that there's kindness in humankind" and @RachelWalker35 said: "I was in tears! Beautiful. Well done."

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@debbuecoates65 also added: "Awww well done this morning you made me cry." and @BushraA89302368 said: "So adorable! What a truly extraordinary story"

Finley Hill first appeared on This Morning in summer 2019 as he searched for a stem cell donor to cure a rare immune disease.

Following his appearance, Finley had a transplant in the November and since then has gone from strength-to-strength with the This Morning team following his journey all the way.

Talking on the programme about Jose saving her son's life, mum Jo said: "Thank you is never going to be enough. How do you thank the person that has saved your world? So thankfully, he's sent messages back and he's the most humble, beautiful man."

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This Morning viewers 'in tears' after boy meets donor who saved his life - Devon Live