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Ulcer Index
Unraveling the Ulcer Index: A Comprehensive Guide to Understanding and Utilizing Market Volatility Introduction: In the fast-paced world of investing, understanding market volatility is paramount to success. One tool that aids investors in this endeavor is the Ulcer Index. This comprehensive guide aims to demystify the Ulcer Index, shedding light on its significance, calculation, and practical…
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Innovation Pharmaceuticals Receives Pre-IND Response from FDA on COVID-19 Trial
November 02, 2020 09:25 ET | Source: Innovation Pharmaceuticals Inc.
WAKEFIELD, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today receipt of written feedback from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company’s planned clinical trial for Brilacidin, a defensin-mimetic drug candidate, for the treatment of COVID-19. The FDA response completes the Pre-Investigational New Drug (Pre-IND) process.
The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19. The Company is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-national study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment for the trial is 120 patients. Contract Research Organizations have been secured to expedite trial enrollment with many clinical sites expressing interest in participating in the study. The Company anticipates commencing the Brilacidin for COVID-19 clinical trial in 4Q2020.
“Getting to the point of being able to advance Brilacidin as a potential treatment for COVID-19 required an enormous amount of time, resources, and team effort,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “From the manufacturing of drug supply, to researching Brilacidin’s mechanisms of action in vitro against SARS-CoV-2 in infected cells, to now preparing and planning for the COVID-19 clinical study—was an extraordinary effort.”
Ehrlich added: “We are extremely grateful for the hard work of our employees, consultants and affiliated researchers. While no one can predict with certainty how Brilacidin will perform in clinical testing against COVID-19, we are optimistic based on the compelling preclinical antiviral data we have released and Brilacidin’s consistently successful results in other clinical trials. Our hope is Brilacidin for COVID-19 can be an important part of the solution to help rid the world of this deadly coronavirus.”
Brilacidin COVID-19 Preprint
The Company, based on pre-clinical research conducted in collaboration with George Mason University, has released a preprint, prior to formal peer review submission, demonstrating Brilacidin’s COVID-19 treatment potential. The preprint can now be downloaded on bioRxiv.org at the link below.
Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2 https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website (http://www.ipharminc.com), and at the following link: https://ipixcovid19tracker.com/
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1β, TNF-α and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate.
Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses, as well as obtaining government regulatory approvals to commence clinical testing. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking IND regulatory approval for Brilacidin and Kevetrin; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS Innovation Pharmaceuticals Inc. Leo Ehrlich [email protected]
https://www.covid19snews.com/2020/11/02/innovation-pharmaceuticals-receives-pre-ind-response-from-fda-on-covid-19-trial/
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Art is a lie that makes us realize truth.
New Post has been published on http://type2diabetestreatment.net/diabetes-research/art-is-a-lie-that-makes-us-realize-truth/
Art is a lie that makes us realize truth.
Study looks at effect of daytime, nocturnal hypoglycemia on ECG in diabetes UK researchers found a longer median duration of hypoglycemia during the night, compared with during the daytime, among young adults with type 1 diabetes. The findings in Diabetes Care, based on 37 individuals who underwent simultaneous electrocardiogram and continuous glucose monitoring, revealed that bradycardia was more frequent during nocturnal hypoglycemia and atrial ectopics was more frequent during daytime hypoglycemia. Physician's Briefing/HealthDay News (2/28) Study: Complications more common in youths with type 2 versus type 1 diabetes Adolescents and young adults with type 2 diabetes were more likely to have diabetic kidney disease, arterial stiffness, hypertension, peripheral neuropathy and retinopathy, compared with type 1 diabetes patients, according to a study in the Journal of the American Medical Association. Researchers used a cohort of 2,018 type 1 and type 2 diabetes patients and found that most type 1 diabetes patients were normal weight or overweight and were white, compared with type 2 diabetes patients, most of whom were obese or overweight and tended to be black. Medscape (free registration) (2/28) Study examines low-cost interventions to prevent diabetic foot ulcers A study in the Journal of Diabetes Complications said such low-cost interventions as mobile-phone reminders, written brochures and self-identification of risk factors were useful in reducing foot ulcers in patients with diabetes and extending the number of ulcer-free days in those who have had diabetic foot ulcers. Podiatry Today magazine (2/2017)
11 cancers associated with obesity, study finds
(Theo Rouby/AFP/Getty Images)
A study in The BMJ found an association between obesity and 11 cancers, including multiple myeloma, colon cancer, biliary tract system cancer, breast cancer and kidney cancer. UK researchers evaluated 95 meta-analyses and found that the increase in cancer risk for every 5-kg/m2 increase in body mass index ranged from 9% for rectal cancer in male patients to 56% for biliary tract system cancer. Medscape (free registration) (2/28) Healthy weight, exercise may reduce risk of HFpEF, study says Exercise and maintaining a healthy weight may reduce the risk of heart failure with preserved ejection fraction, a type of heart failure that is difficult to treat, researchers reported in the Journal of the American College of Cardiology. The study found people who exceeded recommended amounts of exercise had a 19% lower risk of HFpEF, while those who carried excess weight had a significantly higher incidence of HFpEF. HealthDay News (2/27) Exercise may help protect older adults from chronic pain A study in the journal Pain found light physical activity and more vigorous exercise among older adults were associated with lower scores on pain modulation tests. Researchers said the data suggest exercise may have a protective effect against chronic pain. United Press International (2/24)
Stakeholders propose advanced payment models Five organizations have proposed advanced payment models to the Physician-Focused Payment Model Technical Advisory Committee suggesting approaches for incentives to provide high-quality, cost-effective, collaborative health care. The committee will review the proposals and make recommendations to HHS regarding whether to include them in the Medicare quality payment program. Bloomberg BNA (free content) (2/24) Primary care practices adapt to fit in more Medicaid patients Primary care practices were able to provide care for many new Medicaid patients coming in through the Affordable Care Act, according to a study in JAMA Internal Medicine. Data showed an increase of 5.4 percentage points in the availability of primary care appointments for this group from 2012 to 2016, while appointment availability for patients with private insurance remained stable. HealthDay News (2/27)
Governors split on proposed health care changes At the National Governors Association meeting Monday, the Trump administration pledged to cooperate with states in an attempt to assuage concerns about what repeal would mean for people covered through the Affordable Care Act. Republican-led states that expanded Medicaid under the ACA expressed concerns about loss of funding, while those in non-expansion states indicated support for funding caps and flexibility. The Washington Post (tiered subscription model)/Associated Press (2/28)
Apply now: Pathway to Stop Diabetes The call for nominations is now open for ADA's Pathway to Stop Diabetes initiative. Pathway provides substantial support to exceptional scientists who are early in their diabetes research careers or who are established in other disciplines, but are interested in applying their expertise to diabetes research. Applications are by institutional nomination only and are due July 3. Learn more and apply. Register for Scientific Sessions Registration and housing are now open for ADA's Scientific Sessions in San Diego, Calif., June 9-13, 2017. Register and reserve your room today.
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Art is a lie that makes us realize truth. Pablo Picasso, artist
Type 2 Diabetes Treatment Type 2 Diabetes Diet Diabetes Destroyer Reviews Original Article
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In our society ... those who are in reality superior in intelligence can be accepted by their fellows only if they pretend they are not.
New Post has been published on http://type2diabetestreatment.net/diabetes-research/in-our-society-those-who-are-in-reality-superior-in-intelligence-can-be-accepted-by-their-fellows-only-if-they-pretend-they-are-not/
In our society ... those who are in reality superior in intelligence can be accepted by their fellows only if they pretend they are not.
Study links insulin resistance to circulating extracellular RNAs Eighteen circulating extracellular RNAs were associated with insulin resistance in body mass index-, age- and sex-adjusted models across 391 ex-RNAs, according to a study in Diabetes Care. Researchers evaluated 2,317 participants without diabetes in the Framingham Heart Study Offspring Cohort and found a correlation between miR-122 and IR in children, as well as between miR-122 and both IR and regional adiposity in adults, independent of metabolites. Physician's Briefing/HealthDay News (2/14) Abdominal adiposity tied to diabetes, cardiometabolic risks, study finds UK researchers found that a 1-standard deviation increase in the waist-to-hip ratio, adjusted for body mass index, was correlated with a 6.0 increased risk for developing type 2 diabetes per 1,000 participant-years and a 1.8 increased risk for coronary heart disease. The findings in the Journal of the American Medical Association also revealed an association between a 1-SD increase in WHR and higher two-hour glucose levels, log-transformed fasting insulin, LDL cholesterol and systolic blood pressure. MedPage Today (free registration) (2/14) Wound-care dressing gains FDA approval British wound-care product developer Crawford Healthcare received FDA approval for KerraCel AG, a medical dressing that soaks up fluid and bacteria in chronic wounds such as diabetic ulcers and pressure sores. The dressing contains silver to kill antibiotic-resistant bacteria. The Telegraph (London) (tiered subscription model) (2/14)
San Francisco is healthiest city in US, report claims
(Justin Sullivan/Getty Images)
A WalletHub analysis ranked San Francisco as the healthiest US city and Detroit as the least healthiest. The analysis compared 150 of the biggest cities in the areas of health care, food, fitness and green space. BeckersHospitalReview.com (2/13) Study: Mediterranean diet improves HDL function
(Louisa Gouliamaki/AFP/Getty Images)
A Mediterranean diet that included nuts or virgin olive oil improved the function of high-density lipoprotein cholesterol, compared with a control diet that restricted red meat, processed food, high-fat dairy and sugar, researchers reported in the journal Circulation. The study found the Mediterranean diet enriched with virgin olive oil was associated with the biggest increase in HDL function, and while the control diet reduced total and low-density-lipoprotein cholesterol levels, none of the diets increased HDL levels. HealthDay News (2/13)
Pilot project tests cost effectiveness of palliative care A community-based multidisciplinary palliative care model used by Four Seasons Compassion for Life in the Carolinas and funded by the Center for Medicare & Medicaid Innovation will examine the project's cost effectiveness and could offer a new payment model for palliative care, according to experts in health care policy and patient care. The authors said that increases in palliative care spending in Medicare Part B may lead to overall lower spending only by reducing hospitalization and emergency department costs paid for by Part A Medicare. Health Affairs Blog (2/13)
Lawmakers support Medicare home-care pilot project Two US senators support legislation to allow CMS to conduct a pilot project that would provide home-based and community-based care to some Medicare beneficiaries in Medicare Advantage plans. The goal would be to save money by providing some nonmedical care to these patients to reduce hospitalizations and skilled nursing facility admissions, and to keep them from needing Medicaid coverage. The Hill (2/13) ACA creates health jobs for Native Americans, Alaska Natives The Affordable Care Act has helped millions of uninsured in the US gain coverage, including more than half a million Native Americans and Alaska Natives, which has led to an increase in health care jobs. Montana schools, including tribal colleges, are offering more classes in health care fields to meet local demand, and it is estimated the state could lose 3,000 health care jobs if the ACA is repealed. Kaiser Health News/Montana Public Radio (2/13)
In our society ... those who are in reality superior in intelligence can be accepted by their fellows only if they pretend they are not. Marya Mannes, writer and broadcast commentator
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DiabetesPro Home | Professional Education | Journals Research Grants | Recognition Programs | Membership
Type 2 Diabetes Treatment Type 2 Diabetes Diet Diabetes Destroyer Reviews Original Article
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