StemCell Therapy

According to news articles published in early December, Veritas Genetics, a Massachusetts-based company that hoped to lower the cost of whole-genome sequencing, is suspending its U.S. operations because of a lack of investment. Articles theorize that the decreased funding was driven mainly by new CFIUS regulations and heightened CFIUS scrutiny.

Early in December 2019, Veritas announced that its adverse financing situation had forced the suspension of its U.S. business. Veritas has stated that it is assessing potential paths forward, and there are rumors that one such path is the sale of the company. Veritas will no longer sell its tests, which include genetic testing for diseases and cancers (such as the BRCA test), in the United States. Veritas will continue to operate and sell its tests outside the United States.

Veritas first launched in 2014, and since 2015 it had raised $50 million in financing. Major investors included Chinese companies, such as Lilly Asia Ventures, which invested $10 million into the company, and Simcere Pharmaceutical. However, there has been increased scrutiny in the past two years for transactions that involve Chinese investors, especially when sensitive personal information, such as genetic information, is at stake. This year, for example, CFIUS forced iCarbonX, the Chinese, majority owner of U.S. company PatientsLikeMe, to divest its stake in the U.S. company.

According to news reports, recent CFIUS activity may have scared away not only Chinese investors but also non-Chinese investors reluctant to invest in a company with Chinese ownership. Non-Chinese investors may fear that Veritass Chinese ownership will lead to increased CFIUS scrutiny of any investment into Veritas, regardless of the investors nationality. Investors may also worry that CFIUS scrutiny could delay their return on investment if their firms are forced to stall business to address CFIUSs concerns.

No doubt the proposed CFIUS regulations from September also concern foreign investors: the proposed regulations explicitly target U.S. companies that maintain or collect sensitive personal data of U.S. citizens. While most sensitive personal data only triggers the proposed regulations if the U.S. business maintains or collects such data on greater than one million individuals, companies with genetic data are considered to be covered businesses no matter how many individuals are involved. Thus, companies like Veritas will always fall under CFIUS jurisdiction if a foreign person would acquire certain rights in the company. These rights include:

Several genetic and biopharmaceutical companies expressed concern in public comments to the regulations that the proposed regulations, specifically including all genetic data in the definition of sensitive personal data, would stymie foreign investment in these companies. Several companies argued that the Department of the Treasury should revise the proposed CFIUS regulations to require that genetic data be identifiable. Companies often are in possession of anonymized genetic information, which these companies argued does not pose a risk to national security. We await publication of the final regulations and whether CFIUS will make any changes to the definition of sensitive personal data, particularly as it pertains to genetic information. It is to be seen whether U.S. companies in other industries will face similar funding obstacles as foreign investors grow more wary of CFIUS.

Original post:
Veritas, a US Genetic Sequencing Company, Suspends US Operations Due to Decreased Funding; CFIUS Thought to be Leading Cause - Lexology

VANCOUVER, Washington, Dec. 23, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today continued promising clinical responses from its metastatic triple-negative breast (mTNBC) Phase1b/2 trial and its trial investigating leronlimab for the treatment of metastatic breast cancer (MBC).

Further data from the first mTNBC cancer patient continues to show no detectable circulating tumor cells (CTC) or putative metastatic tumor cells in the peripheral blood and additional reductions in CCR5 expression on cancer-associated cells at 11 weeks of treatment with leronlimab. Additional data in an emergency IND protocol involving one MBC patient demonstrated shrinkage of tumor (via MRI) after three weeks of treatment with leronlimab.

In the first patient, were encouraged to see that after 11 weeks these additional data provide further preliminary evidence of efficacy, as demonstrated by sustained undetectable levels of CTCs and a reduction of cancer-associated macrophage like cells (CAMLs), said Bruce Patterson, M.D., Chief Executive Officer of IncellDx. Thus far, the data have been consistent with previous studies evaluating leronlimab as a long-term therapy for HIV+ patients, with no serious adverse effects reported in the mTNBC trial.

CytoDyns second patient enrolled is a stage 4 MBC patient. The metastasis progressed to the liver, lung and brain. This patient was enrolled through an emergency IND. The patient was on Herceptin and Perjita for over 1.5 years. Herceptin is known to stop working after about 12 months, while Perjita is effective for approximately 1.5 years. This patient received her first injection of leronlimab on November 25, with one 700 mg dose each week.

Regarding the second patient, Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated: It is very exciting to see ongoing results that demonstrate leronlimabs potential as a therapeutic option to treat patients with mTNBC and MBC with HER2+ condition. This second patient was enrolled in an emergency IND.

Added Dr. Patterson, The results from two subsequent scans of the metastatic lesions for this second patient demonstrated shrinkage of the tumors at both timepoints following the first leronlimab injection, reduction in brain edema, and remarkably, disappearance of several metastatic tumors.

Dr. Pourhassan continued, Due to these very promising clinical data, we feel that the 98% inhibition of metastasis shown by our animal studies may soon become a reality for many cancer patients throughout the world. We are cautiously optimistic and believe we have enough results in an unmet medical need population to justify filing for Breakthrough Therapy Designation in January 2020.

About Triple-Negative Breast CancerTriple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growthestrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene.1TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur.2,3Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.4Currently, there are no targeted therapies approved to treat triple-negative breast cancer.5About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH. Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98 percent in a murine xenograft model. CytoDyn is therefore conducting aPhase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additionalclinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of graft-versus-host disease (GvHD).

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as graft-vs.-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTS

Media:Grace FotiadesLifeSci Public Relationsgfotiades@lifescipublicrelations.com(646) 876-502

Investors: ir@cytodyn.com

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CytoDyn Reports Early, But Strong Positive Clinical Responses for Two Patients, One in Metastatic Breast Cancer and One in Metastatic Triple-Negative...

BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for REVLIMID (lenalidomide), in combination with rituximab, for the treatment of patients with relapsed or refractory indolent lymphoma (follicular lymphoma or marginal zone lymphoma). REVLIMID was first approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy, and the label for the combination was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma (NDMM) who are not eligible for transplant. It is currently marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.

This milestone for REVLIMID marks another step in the expansion of our hematology franchise into non-Hodgkins lymphoma (NHL) in China, where significant unmet medical needs remain. Together with the pending approvals of tislelizumab for Hodgkins lymphoma and zanubrutinib for mantle cell lymphoma and chronic lymphocytic leukemia as well as Revlimid for multiple myeloma, Vidaza for myelodysplastic syndromes and acute myeloid leukemia and additional products from the collaboration we have announced with Amgen, we are working to build a market-leading presence in the treatment of hematological cancers in China, said Dr. Xiaobin Wu, General Manager of China and President of BeiGene. We are excited about this opportunity and look forward to working closely with Bristol-Myers Squibb and the NMPA to bring this chemotherapy-free treatment option to patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma in China as soon as possible.

The sNDA is supported by a clinical, non-clinical, and chemistry, manufacturing and control (CMC) data package, including the results from the pivotal Phase 3 AUGMENT study (NCT01938001) sponsored and conducted by Bristol-Myers Squibb. AUGMENT is a randomized, double-blind, multicenter trial in which a total of 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomized 1:1 to receive REVLIMID and rituximab (R2) or rituximab and placebo. With a median follow-up of 28.3 months (range: 0.1 to 51.3 months), R2 demonstrated clinically meaningful and statistically significant improvement in progression-free survival (PFS), evaluated by an independent review committee (IRC), relative to the control arm with a 54% reduction in the risk of progression or death (hazard ratio [HR] = 0.46; 95% confidence interval [CI]: 0.34, 0.62; p < 0.0001). The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm with an improvement by more than 2 years. Overall response rate (ORR), a secondary endpoint, was 78% in the R2 arm vs. 53% in the control arm, as assessed by the IRC. Duration of response (DoR) was significantly improved for R2 vs. control with median DoR of 37 vs. 22 months, respectively (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79). The most frequent adverse event (AE) in the R2 arm was neutropenia (58%), vs. 22% in the control arm. Additional commonly observed AEs in more than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in the control arm), constipation (26% vs. 14%), cough (23% vs. 17%), and fatigue (22% vs. 18%). Adverse events that were reported at a higher rate (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare.

About follicular lymphoma (FL) and marginal zone lymphoma (MZL)

FL and MZL are two major types of indolent lymphomas;1 FL is the most common subtype, constituting approximately 20% to 25% of all NHL,2 followed by MZL (approximately 5% to 17% of all NHLs).3 NHL incidence in China is 88,090 according to the World Health Organizations Globocan 2018 database.4 Given the incurable nature of relapsed or refractory FL/MZL, the efficacy and safety limitations of current treatment options, and the fact that patients are typically older and with comorbidities, a high unmet medical need exists for the development of novel treatment options with new differentiated mechanisms of action and a more tolerable safety profile that can improve the quality of response and PFS in the setting of previously treated FL/MZL.

About REVLIMID

In China, REVLIMID was approved in combination with dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are not eligible for transplant in 2018. It received approval in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone in adult patients who have received at least one prior therapy.

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation. REVLIMID as combination therapy is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMID is approved in Europe for the treatment of patients with mantle cell lymphoma (MCL) and in the United States for the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

U.S. Indications for REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

REVLIMID is only available through a restricted distribution program, REVLIMID REMS.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus.

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS.

REVLIMID REMS Program: See Boxed WARNINGS. Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. Patients may require a dose interruption and/or dose reduction. MM: Monitor complete blood counts (CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as maintenance therapy, every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on therapy for del 5q MDS, weekly for the first 8 weeks of therapy and at least monthly thereafter. See Boxed WARNINGS for further information. MCL: Monitor CBC in patients taking REVLIMID for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. FL/MZL: Monitor CBC in patients taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2-4, and then monthly thereafter.

Venous and Arterial Thromboembolism: See Boxed WARNINGS. Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on the patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision.

Increased Mortality in Patients With CLL: In a clinical trial in the first-line treatment of patients with CLL, single-agent REVLIMID therapy increased the risk of death as compared to single-agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials.

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID and in patients with FL or MZL receiving REVLIMID + rituximab therapy, an increase of hematologic plus solid tumor SPM, notably AML, have been observed. In patients with MM, MDS was also observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment.

Increased Mortality With Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID + dexamethasone. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with REVLIMID. The patients at risk of TLS are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches.

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion.

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection.

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before starting REVLIMID treatment and during therapy.

Early Mortality in Patients With MCL: In another MCL study, there was an increase in early deaths (within 20 weeks); 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L).

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

Follicular Lymphoma/Marginal Zone Lymphoma

DRUG INTERACTIONS

Periodically monitor digoxin plasma levels due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

Please see the rituximab full Prescribing Information for Important Safety Information at http://www.rituxan.com.

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in the United States, China, Australia, and Europe; BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA (zanubrutinib) and in China, the Company markets ABRAXANE (paclitaxel for injection [albumin bound]), REVLIMID (lenalidomide), and VIDAZA (azacitidine) under a license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.5

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGenes plans and expectations for further development and commercialization of REVLIMID in China and the potential implications for patients. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

______________________1 Bello C, Zhang L, Naghashpour M. Follicular lymphoma: current management and future directions. Cancer Control. 2012;19:187-95.

2 Sousou T, Friedberg J. Rituximab in indolent lymphomas. Semin Hematol. 2010; 47(2):133-42.

3 Zinzani, P. L. (2012). The many faces of marginal zone lymphoma. Hematology, 2012(1), 426432.

4 https://gco.iarc.fr/

5 ABRAXANE is registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb company; REVLIMID and VIDAZA are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb company.

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BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma - BioSpace

By Hristina ByrnesDecember 23, 2019 3:32 pm

If you are someone who at least tries to stay informed about what is going on in the world, your faith in humanity may be long gone. Daily headlines are predominantly about negative subjects such as ugly politics, crime, and how we are killing the planet. While these important topics need attention, there is plenty of good news to share as well.

24/7 Tempo reviewed dozens of articles from multiple online sources on various topics to compile a list of 20 things that have improved in the United States and around the world since 2010.

Many people may react with incredulity at the possibility that things could be getting better. For example, according to Pew Research Center, Americans believe crime is up, but thats not true. In 18 of 22 Gallup polls conducted between 1993 and 2018, at least 60% of Americans said there was more crime than the previous year even though the national violent and property crime rates during most of that period were trending down.

The 2010s will go down in history as a decade of many newsworthy stories and, fortunately, many of them were good news albeit less talked about than the grimmer headlines. And for even more positive news, take a look at the 15 best health news over the last decade.

Click here to see 20 things that have changed for the better since 2010.

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20 Things That Have Changed for the Better Since 2010 - 24/7 Wall St.

It always comes back to haunt you.

Thats what Union County Sheriff Brad Whitehead says of crime in general, after his office helped detectives in Colorado arrest a suspect, at last, in a 40-year-old rape-murder case.

On January 16, 1980, Helene Pruszynski a 21-year-old radio intern was raped and murdered in a vacant field in Douglas County, Colo. Her body was found the next morning.

Finding a suspect would take much longer.

It was a combination of DNA, existing technology that was available, but then the dogged police work, 18th Judicial District Attorney (CO) George Brauchler said at a press conference almost 40 years later, upon the arrest and formal charging of James Curtis Clanton, now 62.

It was an investigation that turned up occasional suspects but just as many dead ends. Clanton, who at the time of Pruszynskis death went by the name Curtis Allen White, had been convicted of rape in Arkansas in 1975 but was paroled less than four years later. He also was arrested in Palm Beach County, Fla. on a domestic battery charge in 1998.

But despite DNA found at the crime scene, investigators couldnt connect Clanton to the crime in Colorado, at least not until some of those dead ends spawned different approaches.

RELATED: Florida man charged with murder, kidnapping in 1980 death of Colorado radio intern

In one key instance, investigators had begun to suspect a man named William White Jr., who had a criminal history. Whites DNA would prove to be an imperfect match with evidence at the Pruszyinski murder scene and he was cleared. But then detectives used a relatively new technique called genetic genealogy, which allows investigators to essentially climb "up" a family tree from an eliminated suspect to ancestors often with the help of online DNA databases to find viablesuspects among common descendants. It would turn out, White and Clanton are brothers.

Eventually, it was determined that Clanton was living in Lake Butler, Fla. and had resided there at least a decade. According to Whitehead, Clanton had no encounters with local law enforcement during those years.

In a town where Whitehead says many people grow up together and know each other, it wasnt difficult to learn that Clanton was a regular at the Full House Lounge on Fourth Avenue.

He was always a laid-back, cool guy," Tom Christakes told First Coast News at a bar. "I dont know him other than just coming here and playing pool.

Christakes added that hed been acquainted with Clanton for about five years.

I actually taught him how to bank playing pool, just a couple weeks ago,: he said. But Im, like, completely shocked.

Investigators in Douglas County, Col. asked the Union County Sheriffs Office to try getting a sample of Clantons DNA. Thats when a deputy who knew the owner of the Full House Lounge arranged a plan to retrieve a beer mug after Clanton used it. The mug was retrieved Nov. 30.

Within days, Whitehead says a DNA match was confirmed. Police arrested Clanton without incident at his home Dec. 11.

He parked his truck where he normally always does, Douglas County Sheriff Tony Spurlock said in a press conference Dec.16. Got out of his truck and was walking away from it, when he was taken in to custody.

Whitehead added, I believe once he saw us, that he felt like he knew his past had caught up with him.

Clanton was extradited to Colorado, where he was formally charged with four murder-related counts and one of kidnapping on Monday, Dec. 16. The District Attorneys office in Colorados 18th judicial district tells First Coast News its still considering whether to pursue the death penalty against Clanton.

Whatever that decision will be, District Attorney Brauchler offered a stern-yet-satisfied summation of Clantons arrest particularly the modern methods that he says solved the cold case.

There are crimes yet unsolved today that I have great optimism because of cases like this, that were going to end up solving, Brauchler told the media. And I think the public ought to feel good about that, and I think murderers ought to be scared to death of it.

In a statement on Facebook, a woman named Janet Johnson, who says Helene Pruszynski was her sister, asked that her familys privacy be respected, offering the following statement:

"I want people to know what a special person Helene was. My sister was my best friend. She was a loving daughter, sister, aunt, & friend. Helene was on track to do great things, she had a bright future ahead of her. There has not been a day that goes by that we haven't missed her. The detectives and everyone else who helped to make this day happen are my heroes. I look forward to justice being served.

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'I think murderers ought to be scared to death of it...' Genetic genealogy leads to arrest of Florida man in 40-year-old cold case murder -...

This article, written byMichael Mackley, Dalhousie University, originally appeared on The Conversation and is republished here with permission:

Youve likely heard about direct-to-consumer DNA testing kits. In the past few years, at-home genetic testing has been featured in the lyrics of chart-topping songs, and has helped police solve decades-old cold cases, including identifying the Golden State Killer in California.

Even if you dont find a DNA testing kit under your own Christmas tree, theres a good chance someone you know will.

Whether youre motivated to learn about your health or where your ancestors came from, it is important to understand how these tests work before you spit in the tube.

While exciting, there are things that these genetic testing kits cannot tell users and important personal implications that consumers should consider.

Health, traits and ancestry kits

My main area of research is around clinical genome sequencing, where we look through all of a persons DNA to help diagnose diseases. With a PhD in genetics, I often get questions from friends and family about which direct-to-consumer genetic test they should buy, or requests to discuss results. Most questions are about two types of products: ancestry and health kits.

The most popular ancestry kit is from AncestryDNA. These kits are aimed at giving users insight into where their ancestors might be from. They can also connect users with family members who have used the service and have opted into having their information shared. Another option is Living DNA, which has a smaller dataset but provides more precise information on the U.K. and Ireland.

The most popular health kit is from 23andMe. Depending on the users preference, results include information on predispositions for diseases such as diabetes and Alzheimers, as well as on the likelihood of having certain traits such as hair colour and taste. This company also offers ancestry analysis, as well as ancestry and trait-only kits that dont provide health information. The kit offered by the newer MyHeritage DNA also provides a combined ancestry and health option.

There are other kits out there claiming to evaluate everything from athletic potential to relationship compatibility. But gift-buyers beware: for most of these, in contrast to those above, the evidence is seriously lacking.

How these tests work

For all of these tests, customers receive a kit in the mail. The kits contain instructions for collecting a saliva sample, which you mail back to the company for analysis.

During this analysis, these popular tests do not look at the entire genome. Instead, they employ single nucleotide polymorphism (SNP) genotyping. As humans we all share 99.9 per cent of our DNA. SNPs are essentially what is left: all of the points at which we can differ from our neighbour, making us unique. SNP genotyping looks at a subset of these sites to survey the users genome.

These SNPs are then compared to reference datasets of individuals with known conditions or ancestry. Most results are based on the SNPs shared with a given group. For example, if your results say that you are 42 per cent Southeast Asian, its because 42 per cent of your SNPs were most likely to have come from a group in the reference dataset labelled Southeast Asian. The same goes for traits and health conditions.

How they differ from clinical tests

Direct-to-consumer genetic tests are not a substitute for clinical assessment. The methods used differ dramatically from what is done to diagnose genetic diseases.

In a clinical setting, when suspicion of a genetic condition is high, entire genes are often analyzed. These are genes where we understand how changes in the DNA cause cellular changes that can cause the disease. Furthermore, clinical assessment includes genetic counselling that is often key to understanding results.

In contrast, findings from direct-to-consumer genetic tests are often just statistical links; there is commonly no direct disease-causing effect from the SNPs.

Users may interpret a result as positive, when the risk increase is only minimal, or entirely false. These tests can also give false reassurance because they do not sequence genes in their entirety and can miss potentially harmful variants.

Before you spit in a tube, stop and think

These tests are exciting: they introduce new audiences to genetics and get people thinking about their health. Theyre also helping to build vast genetic databases from which medical research will be conducted.

But for individual users, there are important caveats to consider. Recent reports have questioned the accuracy of these tests: identical twins can receive different results. Furthermore, a lack of diversity in the reference data has caused particular concern regarding accuracy of results for ethnic minorities.

There are also concerns about the way these tests emphasize racial categories that science considers to be social constructs and biologically meaningless.

A recent paper in the British Medical Journal suggests four helpful questions for users to consider. First, users should ask themselves why they want the test. If it is to answer a medical question, then they should speak with their doctor. Users should also think about how they might feel when they receive results containing information they would rather not know.

Users should also consider issues around security and privacy. It is important to read the fine print of the service youre using, and determine whether youre comfortable sharing personal information, now and in the future.

In Canada, policies around genetics have not always kept up with the science. At present, direct-to-consumer genetic testing is unregulated. And, although Canadians have legislative protections against genetic discrimination, those laws are being challenged in the courts, and could change.

Finally, it may also be worth discussing DNA testing with relatives. We share half of our genome with our immediate family members, and smaller fractions with more distant relatives. Genetic results not only affect us, but our family.

Bottom line: Its all for fun

Some users may feel they learn more about themselves. For others, results may bring people closer together not a bad outcome for the holiday season.

At the end of the day, these genetic testing kits are for entertainment: they should not be used to assess health risk in any meaningful way.

If you have any questions related to your health or a genetic disease, discuss these with your family doctor or a suitable health-care professional.

Michael Mackley, Junior Fellow, MacEachen Institute for Public Policy and Governance; Medical Student, Dalhousie University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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BEYOND LOCAL: DNA tests might be a fun holiday gift, but beware of the hype - TimminsToday

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The submission is based on the results of HER2CLIMB, a randomized pivotal trial comparing tucatinib added to trastuzumab and capecitabine versus trastuzumab and capecitabine alone. HER2CLIMB trial results were presented on December 11, 2019 at the 2019 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine. Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2.

Tucatinib was recently granted Breakthrough Therapy designation by the FDA in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1. This designation was based on data from the HER2CLIMB trial.

Todays submission marks another important milestone for Seattle Genetics and tucatinib, and a potential advance for patients with either locally advanced or metastatic HER2-positive breast cancer, including those with and without brain metastases, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. We look forward to working with the FDA on the review of this application.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. An estimated 271,270 new cases of invasive breast cancer will be diagnosed in the U.S. in 2019.1 Between 15 and 20 percent of breast cancer cases worldwide are HER2-positive.2 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.2, 3, 4 In patients with metastatic breast cancer, the most common site of first metastasis is in bone, followed by lung, brain, and liver.5, 6 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.2, 7 Despite recent treatment advances, there is still a significant need for new therapies that can impact metastatic disease, especially brain metastases. There are currently no approved therapies demonstrating progression-free survival or overall survival benefit for the treatment of patients with HER2-positive metastatic breast cancer after progression on T-DM1.8, 9, 10

About HER2CLIMB

HER2CLIMB is a multinational randomized (2:1), double-blind, placebo-controlled, active comparator, pivotal clinical trial comparing tucatinib in combination with trastuzumab and capecitabine compared with trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab, and T-DM1. The primary endpoint of the trial was PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by blinded independent central review (BICR) in the first 480 patients enrolled in the trial. HER2CLIMB enrolled a total of 612 patients to support the analyses of key secondary endpoints, including overall survival, PFS per BICR in patients with brain metastases at baseline, and confirmed objective response rate. Safety data were evaluated throughout the study.

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 targeted agents such as trastuzumab.1, 2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, colorectal, and gastric cancers. HER2 mediates cell growth, differentiation, and survival. Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

In addition to HER2CLIMB, tucatinib is being evaluated in a randomized, double-blind, placebo-controlled, multi-center phase 3 trial of tucatinib in combination with T-DM1 compared to T-DM1 alone, in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab. The primary endpoint is progression-free survival per RECIST criteria. Secondary endpoints include overall survival, objective response rate, and duration of response. The trial is being conducted in North America and is expected to enroll approximately 460 patients. More information about the phase 3 trial, including enrolling centers, is available at http://www.clinicaltrials.gov.

Tucatinib is also being evaluated in a multi-center, open-label, single-arm phase 2 clinical trial known as MOUNTAINEER, which is evaluating tucatinib in combination with trastuzumab in patients with HER2-positive, RAS wildtype metastatic, or unresectable colorectal cancer. The primary endpoint of the trial is objective response rate by RECIST criteria. Progression-free survival, duration of response, overall survival, and safety and tolerability of the combination regimen are secondary objectives. Results for 26 patients were evaluated in an analysis and presented at the European Society for Medical Oncology (ESMO) 2019 Congress. Enrollment is ongoing. More information about the MOUNTAINEER trial, including enrolling centers, is available at http://www.clinicaltrials.gov.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops, and commercializes transformative medicines targeting cancer to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) and PADCEV (enfortumab vedotin-ejfv) use the companys industry-leading antibody-drug conjugate (ADC) technology designed to bring a powerful medicine directly to cancer cells. ADCETRIS is approved for the treatment of several types of CD30-expressing lymphomas, and PADCEV is approved to treat adults with metastatic urothelial cancer. In addition, investigational agent tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer, and in clinical development for metastatic colorectal cancer. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland, and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting; the therapeutic potential of tucatinib, including its possible efficacy, safety and therapeutic uses and anticipated development activities including ongoing and future clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that the New Drug Application submission based on the HER2CLIMB trial may not be accepted for filing by, or ultimately approved by, the FDA in a timely manner or at all or with the requested label; the difficulty and uncertainty of pharmaceutical product development; the risk of adverse events or safety signals; and the possibility of disappointing results in ongoing or future clinical trials despite earlier promising clinical results. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive...

Clinicians should consider mosaic Angelman syndrome in the differential diagnosis of people who show milder symptoms of the disorder, a study suggests.

The study, Preserved expressive language as a phenotypic determinant of Mosaic Angelman Syndrome, was published in Molecular Genetics & Genomic Medicine.

Angelman syndrome (AS) is a genetic neurodevelopmental disorder usually associated with severe intellectual disability, difficulty speaking, loss of movement control (ataxia), and epileptic seizures. It is normally caused by the loss or malfunction of the maternal copy of the ubiquitin protein ligase E3A (UBE3A) gene in neurons from specific regions of the brain.

However, in some people, these genetic defects that affect the normal function of the UBE3A gene are only present in a handful of their cells. This phenomenon, known as mosaicism, can happen if one of the first cells of an embryo acquires a mutation in the UBE3A gene which is then passed on to their daughter cells as the embryo grows.

People with mosaic Angelman syndrome (mAS) typically have milder symptoms than those with Angelman syndrome. For instance, they experience milder expressive language delay with greater ability to attain meaningful words than typical Angelman patients.

In this study, researchers from the Vanderbilt University Medical Center and their collaborators set out to describe the clinical symptoms of mAS in a larger group of individuals to help clinicians with the differential diagnosis of Angelman syndrome.

The study included data from 22 people with mAS, whose caregivers filled out surveys at the medical center. Data from four additional patients was obtained from the Angelman Natural History Study, an observational study that followed the course of the disease in 302 Angelman patients over more than eight years. Clinical data from people with mAS was then compared to historical data from individuals with Angelman.

Findings revealed that nearly all mAS patients (90%) had some form of developmental delay. However, unlike those with Angelman, less than 15% of survey respondents said that mAS children showed signs of severe developmental delays before reaching the age of 1.

Compared with the significant language impairments seen in children with Angelman, 59% of the children with mAS retained the ability to articulate more than 20 words, with a fifth (20%) of them able to speak more than 1,000 words.

Other core features of Angelman, including ataxia, gait abnormalities, and limb tremulousness, were found in less than 33% of mAS children.

Additional clinical features of Angelman syndrome were also evident in patients with mAS: The three most prominent findings included abnormal sleep/wake cycles and decreased sleep in 73% of patients, followed by obesity in 64% of patients and heat sensitivity in 45% of patients, the researchers wrote. Constipation, a common problem in [Angelman syndrome] patients was also noted in the mAS cohort, with 72% of patients endorsing constipation.

Although children with mAS had milder speech impairments and were better able to engage in daily activities, they still faced many behavioral challenges that were typical in Angelman syndrome.

Anxiety was the most frequently endorsed behavior reported in our cohort, present to some degree in 95% of mAS patients and rated as severe in 43% of patients. Hyperactivity was commonly endorsed, reported in 59% of patients, the researchers wrote.

Overall these data encourage specialists to broaden the clinical features of [Angelman syndrome], said the researchers, who added that clinicians should consider tests to rule out mAS in individuals with developmental delay, hyperactivity, anxiety, and an uncharacteristically happy demeanor.

Joana is currently completing her PhD in Biomedicine and Clinical Research at Universidade de Lisboa. She also holds a BSc in Biology and an MSc in Evolutionary and Developmental Biology from Universidade de Lisboa. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells cells that make up the lining of blood vessels found in the umbilical cord of newborns.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Mosaic Angelman Should Be in Differential Diagnosis of AS, Study Says - Angelman Syndrome News

In preclinical experiments, a metabolic inhibitor killed a variety of human cancer cells of the skin, breast, lung, cervix and soft tissues.

In preclinical experiments, a metabolic inhibitor killed a variety of human cancer cells of the skin, breast, lung, cervix and soft tissues.In laboratory experiments, a metabolic inhibitor was able to kill a variety of human cancer cells of the skin, breast, lung, cervix and soft tissues through a non-apoptotic route catastrophic macropinocytosis.

In mouse xenograft studies, the inhibitor acted synergistically with a common chemotherapy drug, cyclophosphamide, to reduce tumor growth. Thus macropinocytosis, a rarely described form of cell death, may aid in the treatment of cancer.

Understanding the signaling pathways underlying macropinocytosis-associated cell death is an important step in developing additional effective strategies to treat neoplasms that are resistant to apoptosis induced by chemotherapy, said Mohammad Athar, Ph.D., professor in the University of Alabama at Birmingham Department of Dermatology.

The inhibitor, OSI-027, affects the mTOR pathway, which plays a critical role in regulation cellular growth and metabolism. Significantly, this potent inhibitor simultaneously targets two distinct protein complexes of the mTOR pathway, mTORC1 and mTORC2. Aberrant activation of these components has been associated with many cancer types.

Macropinocytosis starts with formation of ruffles on the surface of a cell that reach out from the cell membrane. These ruffles then fuse back with the cell membrane, creating a bubble that holds extracellular fluid, and the bubble moves inside the cell to become a vacuole filled with fluid. In catastrophic micropinocytosis, large numbers of these vacuoles form inside the cell and then fuse together, causing cell death.

The UAB researchers showed that dual inhibition of the two mTORC1 and -C2 complexes was necessary for highly effective cell death through macropinocytosis.

In early experiments, the researchers found that OSI-027, and a related dual inhibitor, PP242, induced extensive vacuolization in a wide range of human cancer cell lines, including two subtypes of rhabdomyosarcoma. These vacuoles were then shown to be macropinosomes.

Xenograft mouse experiments with human rhabdomyosarcoma tumors showed that OSI-027 blocked tumor growth by inducing macropinocytosis; furthermore, the addition of the chemotherapy agent cyclophosphamide acted synergistically to enhance efficacy of tumor size reduction.

Mohammad Athar, Ph.D.In mechanistic studies, Athar and colleagues found that macropinocytosis depended on activation of the MAP kinase MKK4, which was induced by the presence of reactive oxygen species. However, the full role of MKK4 is not well understood, they say.

Previous work by others had shown that several specific inducers of macropinocytosis induced macropinocytosis mainly in glioblastomas and colorectal cells. In contrast, Athar said, our study demonstrates that the dual inhibitors we tested induce catastrophic vacuolization in tumor cell lines from a wide range of organs, including skin, breast, cervix, lung and soft tissues.

The effects were much less pronounced in immortalized human keratinocytes.

Our data reveal that therapeutic targeting of mTORC1 and mTORC2, together with standard care treatment, Athar said, may be an effective approach to block the pathogenesis of recurrent rhabdomyosarcoma and perhaps other drug-resistant invasive neoplasms of diverse tissue types as well. The underlying mechanism by which tumors become responsive to treatment involves macropinocytosis, a unique form of cell death.

Co-authors with Athar of the study, Combined mTORC1/mTORC2 inhibition blocks growth and induces catastrophic macropinocytosis in cancer cells, published Proceedings of the National Academy of Sciences, are Ritesh K. Srivastava, Changzhao Li and Jasim Khan, UAB Department of Dermatology; and Louise T. Chow and Nilam Sanjib Banerjee, UAB Department of Biochemistry and Molecular Genetics.

Support came from National Institutes of Health grant ES026219 and funds from the Anderson Family Endowed Chair through UAB.

At UAB, Athar holds the Eric W. Baum, M.D., Endowed Professorship in Dermatology, and Chow holds the Anderson Family Chair in Medical Education, Research and Patient Care in the School of Medicine. Both are senior scientists in the ONeal Comprehensive Cancer Center at UAB.

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Cancer therapy may be aided by induced macropinocytosis, a rarely reported form of cell death - The Mix

A primary project for Garrett Gibbons, a postdoctoral researcher at the Center for Neurodegenerative Disease Research (CNDR), is to develop novel tau antibodies as possibletherapies to treat Alzheimers disease. When in the thick of it, the scientific process becomes a huge, timelyand sometimes redundanttask.

One particular experiment comes to mind: Gibbons and his colleagues were injecting tau into mice models, which the mice developed antibodies against, and when they were harvested, the cells were paired with another cell to make a hybridoma. The problem? After two times running the full experiment, the antibodies still didnt meet certain criteria to be applicable.

Gibbons, quite disheartened, told his adviserVirginia Man-Yee Lee, a Perelman School of Medicine professor and director of CNDR, that the benchmark was too high.

Virginia was like, Well, try again, Gibbons recalled. She pushed back and said how she thought we could do better.

Although admittedly frustrated at the time, Gibbons rethought the project, and, ultimately, underwent a revamped test a third time.

And we got better antibodies, performing better than the previous ones, he said. They are now the candidates that we are evaluating as immunotherapy in mice, as potential treatments for Alzheimers disease.

It is safe to say, noted Gibbons, that without this kind of persistence from Lee, Alzheimers research wouldnt be nearly as developed as it is today. A pioneer in the field of neurodegenerative diseases, Lee was recently recognized for her four decades of work with a $3 million Breakthrough Prize in Life Sciences, an award backed by major technology leaders from companies including Google and Facebook.

Growing up in Hong Kong in a very traditional Chinese family, my mother never wanted me to become a professional, let alone a scientist, Lee said to the crowd, while accepting her Breakthrough Prize at the Oscars of Science in Silicon Valley in early November. Thankfully John Trojanowski, my life partner and collaborator, convinced me to embark on this wonderful journey with him, identifying proteins that are involved in devastating neurological diseases, which affect more and more of us, but have no effective treatment.

Lee, with a background in biochemistry and neuroscience, and Trojanowski, who studied pathology and neuropathology, have toiled alongside each other at Penn since the mid-1980s. They began work in Alzheimers research when it was very uncommon to do soin fact, their mentors urged them to stay far, far away from it.

What [our mentors] saw as a swamp, said Trojanowski, we saw as a huge challenge and opportunity that has led to an engaging career.

Before Lee and Trojanowski, prior studies had determined that an Alzheimers patients brain progressively accumulates plaques, abnormal clusters of protein fragments called beta-amyloid, that build up between nerve cells, and tangles, which form inside dying cells. Using this as a starting point, the duo detected their first major finding in 1991: that tau is the building block protein of the neurofibrillary tangles.

In 1997, Lee and Trojanowski found that Lewy bodies, the hallmark brain pathology of Parkinsons disease, are formed by alpha-synuclein. Knowing what causes Lewy bodies is important to Alzheimers researchers because about 50 percent of Alzheimers patients have Lewy bodies that contribute to cognitive deficits.

Then, in 2006, they discovered the pathological protein deposits in amyotrophic lateral sclerosis, or ALS, and frontotemporal degeneration, or FTD, are formed by TDP-43, a multifunctional DNA- and RNA-binding protein, and these deposits are also present in a large number of Alzheimers patients brains.

Lee was specifically recognized for the Breakthrough Prize for discovering TDP-43 protein aggregates in FTD and ALS, and revealing that different forms of alpha-synuclein, in different cell types, underlie Parkinsons disease and Multiple System Atrophy.

This is exceptionally important work, and we are very proud that it is taking place at Penn. Penn President Amy Gutmann

The discoveries led by Dr. Lee and her team are extraordinary, and absolutely worthy of the prestigious Breakthrough Prize, said Penn President Amy Gutmann, who went to Silicon Valley to support Lee in receiving her honor. Dr. Lee and her team have worked to fully understand the different segments of Alzheimers disease and other related disorders, using that knowledge to develop models that are becoming the foundation for therapies that will, hopefully, stop or reverse these diseases. This is exceptionally important work, and we are very proud that it is taking place at Penn.

Its rewarding, Lee said, to reflect on how researchers are becoming increasingly interested in TDP-43s involvement in neurodegenerative diseases, and the biology that is able to follow, now.

It is gratifying that people can, and people are very interested in, using the system that weve built to identify potential therapies, Lee explained. I am really optimistic that maybe some treatment for Alzheimers and Parkinsons will become available in the next, lets say, one or two decades.

Gibbons, who can distinctly remember being a teenager and watching his grandfather cope with all the stages of Alzheimers, as well as the impact it had on his family, knew rather early it would be a field he would want to pursue. But, it wasnt until he was immersed in the research that he realized how complicated it really was.

When I first got to Penn, I was kind of blown away with the challenge and sort of became cynical and pessimistic, Gibbons said. But I like the way that Dr. Lee continues to forge ahead and isnt overwhelmed as a young investigator, that gives me a lot of inspiration and hope. Of course there will be failures, and of course science is hard. This is worthwhile, and we will get there.

In terms of Lee as a leader, Mike Henderson, a research associate in her lab, said he appreciates the way she guides him in his learning, but also provides him with the independence needed to encourage innovative, out-of-the box thinking.

She really shows you what it takes to be a good scientist in the field, he said, adding how inquisitive Lee always is. Shes very curious and I think thats really what has driven her lab and what has made her so successful.

The main reason Henderson came to Penn, he noted, was to work not only with Lee and Trojanowski, but also with the team theyve assembled through the creation of the CNDR, which celebrated its 25th year in 2018. About 50 people are part of the center today.

From the Maloney Building on Penns campus, where CNDR is housed, Lee and Trojanowski have been able to foster multidisciplinary collaborations between basic and clinical scientists, and provide resources to enable the very best research projects, including a brain and biosample bank, a drug discovery program, data management and biostastic support, and expertise in biochemistry, histology, molecular biology, microscopy, tissue culture, and genetics.

John and I spent a lot of time developing an infrastructure to do this type of work, and Penn has been such a fantastic environment, said Lee, who acknowledged all of her collaboratorsstudents, postdocs, and staff scientistsat the Breakthrough event. I truly want to thank them for their dedication and commitment, she said.

Talking later, Trojanowski added, They have made possible all that we have accomplished.

There is no doubt about it: Talking about his beloved wife of 40-plus years is probably one of Trojanowskis favorite things to do. Shes always pushing herself to be better, and shes always pushing me to be better. She is driven, hardworking, very bright, determinedall of the things that you expect to see and need to see in people that are going to be as successful as she is.

Not only is she passionate about science, he adds, shes determined to solve any problem she ever sets her eyes on. Plus, shes an amazing preceptor, trainer, encourager of science in young people. She is just exceptional, he added.

Trojanowski attended the Breakthrough event with his wife, thrilled to stand by her side on such an exciting day. Its an outstanding recognition, he said.

One might think a $3 million check in the bank could be a ticket out of work, but for Lee, she was back in Philadelphia after just a couple days. As always, she rode her bike to the officeready and willing to take on her next challenge.

What Id like to do in the next 10 to 20 years, Lee said, is really work with companiespharmaceutical companies and biotechnology companiesto come up with treatments.

Virginia Man-Yee Lee is the John H. Ware 3rd Endowed Professor in Alzheimers Research in the Department of Pathology and Laboratory Medicinein the Perelman School of Medicine.

John Q. Trojanowski is the William Maul Measey - Truman G. Schnabel, Jr., M.D. Professor of Geriatric Medicine and Gerontology in the Department of Pathology and Laboratory Medicinein the Perelman School of Medicine.

The Breakthrough Prize in Life Sciences, founded in 2013, honors transformative advances toward understanding living systems and extending human life. It is sponsored by Sergey Brin, Priscilla Chan and Mark Zuckerberg, Pony Ma, Yuri and Julia Milner, and Anne Wojcicki.

Homepage photo: Today, about 50 people make up the Center for Neurodegenerative Disease Research, led by Lee and Trojanowski, who both expressed how thankful they are for such a great team.

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An Alzheimer's research pioneer, right here at Penn - Penn: Office of University Communications

When we have this process thats really convoluted and complicated, its always the families with the least privilege who dont make it through.

Katharine Zuckerman, Oregon Health and Science University, on the challenges of getting an autism diagnosis and treatment in the United States.

If they find something that fits their argument, they emphasize it and make a point about it, and if they find something that doesnt fit their argument, they tend to put it aside.

Arthur Beaudet, Baylor College of Medicine, on researchers tendency to pick and choose what to include in a study.

Thats pretty good evidence when you poke it and it jumps, and you keep poking it and it jumps higher that youre on to a causal relationship.

Joy Hirsch, Yale University, on her teams findings that direct eye contact activates a region of the social brain.

Until we attend to the full diversity of autistic traits in confluence with gender, sexuality, culture, ethnicity, race, class, we will continue to miss people, and they will continue to feel lost.

Rua M. Williams, a nonbinary graduate student at the University of Florida, on the need to recognize the full spectrum of people with autism.

Im thinking of introducing a unicorn as our mascot. Who doesnt like magic and a bit of good luck to go with their science?

Annie Ciernia, University of British Columbia, on the ideal lab mascot.

Sitting in a room for two days thinking of nothing else but these children and their parents and the issues they have, and seeing them firsthand, gives you insight you just cant get any other way.

Stephan Sanders, University of California, San Francisco, on the value of attending meetings with families whose children share a rare genetic diagnosis.

Originally posted here:
Quotes of the year - Spectrum

Do you love your tall, meat and cheeseburger? You may want to think again before grabbing your next greasy treat. According to a latest study, a meal packed with a lot of fat and grease may silence the communication between the intestine and the rest of your body.

The researchers used fish to examine the cells that signal and tell the brain and the rest of the body what's going on inside the gut after a meal. The team discovered that a high-fat meal completely shuts down that communication for a few hours. The study published in 'eLife'.

The scientists were looking at the enteroendocrine cells, which occur sparsely throughout the lining of the gut. They happen to play a key role in signalling the body about the all-important alimentary canal. These cells, also have a recently-discovered direct connection to the nervous system and the brain. They produce up to at least 15 different hormones to send signals to the rest of the body about gut movement, feelings of fullness, digestion, nutrient absorption, insulin sensitivity, and energy storage. Hence their communication with rest of the body is imperative.

"But they fall asleep on the job for a few hours after a high-fat meal, and we don't yet know if that's good or bad," said John Rawls, an associate professor of molecular genetics and microbiology in the Duke School of Medicine.

Since enteroendocrine cells are key players indigestion, the feeling of being full and subsequent feeding behaviour, this silencing may be a mechanism that somehow causes people eating a high-fat diet to eat even more.

"This is a previously unappreciated part of the postprandial (after-meal) cycle," Rawls said.

"If this happens every time we eat an unhealthy, high-fat meal, it might cause a change in insulin signalling, which could, in turn, contribute to the development of insulin resistance and Type 2 diabetes."

To understand the silencing better, the researchers tried to break the process down step by step in zebra-fish, reports the study published in 'eLife'.

Once they sense a meal, these cells trigger a calcium burst within seconds, initiating the signalling process.

However after the initial signal, there's a delayed effect later in the after-meal period. The scientists said that it's during this later response that the silencing takes place.

The silenced cells have to potential change shape and experience stress in their endoplasmic reticulum. These enteroendocrine cells tend to become overstimulated and exhausted for a while, which hinders the action.

(This content including advice provides generic information only. It is in no way a substitute for qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.)

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Greasy Meals May Intervene Gut Action And Hinder Intestinal Activity - NDTV Food

You may associate essential oils with aromatherapy products and fancy day spas. But did you know certain varieties of these fairly inexpensive oils may have legit benefits when it comes to relieving anxiety and stress?

According to Yufang Lin, MD, an integrative medicine specialist at the Cleveland Clinics Center for Integrative Medicine, essential oils work through inhalation or through topical application and have mind-body benefits. For inhalation, essential oils can be easily used as a room spray or via diffuser. A few drops on a pendant worn close to skin also allows for a slow release over time.

Topically, essential oils can be added to a carrier oil and used as perfume, massage oil, cream, or salves. Last but not least, adding an essential oil to your bath is a wonderful way to relax at the end of a busy day, says Dr. Lin.

The quickest way to change ones mood is through smell, thus essential oil is an excellent way to reduce anxiety and support relaxation, says Dr. Lin. However, it takes a lot of herbs to make a small amount of essential oil, which makes it a strong medicine that should be used judiciously.

While research on essential oils for mental health benefits is still expanding, there is some info to suggest that certain oils may work for things like stress relief, better sleep, and more. The thing is, though, even if one study shows that a particular scent is great for, say, reducing anxious feelings, it may not work for every single person. If you don't enjoy a scent, you probably won't feel much better after sniffing it, for instance.

The essential oils below have been shown to reduce anxiety in human studies, says Dr. Lin. Other scents are also commonly used to reduce anxiety and support relaxation, but research beyond animal studies is needed to know if they have real benefits for people.

The essential oils ahead have been shown to help people feel calmer and more relaxed, says Dr. Lin. One potential caveat is that most people have scent memory. So, for instance, if a person has a negative memory associated with a particular scent, they may not feel relaxed when they smell that scent, she explains.

Its important to keep potential side effects in mind, as they can be mild to severe. For one thing, certain essential oils (citrus in particular) can cause photosensitivitymeaning you can get a sunburn more easily after using orange essential oil on the skin, says Dr. Lin. (This is why it's a common recommendation to dilute oils before applying them topically, just to be extra cautious.)

Additionally, some essential oils are safe in small amounts but can dangerous in higher doses. Tea tree and eucalyptus essential oils are commonly used for their antimicrobial benefits, but in excess, can cause nerve and liver damage, says Dr. Lin. Some essential oils are toxic in general and should not be usedarnica, parsley, rue, and tansy are a few that fall into this category.

Finally, do not ingest essential oil without supervision from a trained herbalist, and be extra cautious using essential oils around young children, the elderly, pregnant women, and small pets because they are most at risk for toxicity and side effects, she says.

The bottom line: Research on using essential oils to ease anxiety or for stress reduction is growing, but remains limited. But if you're a healthy adult and are using essential oils safely and at the guidance of your doctor, there is little harm in testing some oils out to see which ones help you feel mentally better.

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Majestic Pure Lavender Oil

$21.50

According to a 2012 study, lavender essential oil has been shown to help treat symptoms of anxiety and depression. This might be due to how it impacts the limbic system of the brain, which controls your emotions.

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Bergamot Essential Oil

Bergamot oil, which comes from bergamot oranges and thus has an energizing citrusy scent, has been shown to improve mood and reduce symptoms of anxiety, according to 2015 research.

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Now Essential Orange Oil

$8.37

If youre pregnant and hoping for a Zen birth experience, a 2015 study suggested that orange essential oil may help to lower feelings of anxiety during labor.

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Plant Therapy Peppermint Organic Essential Oil

$7.95

The menthol content in peppermint oil has been shown to help relieve tension and discomfort, which can in turn help you feel more calm and relaxed.

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Frankincense Essential Oil

$8.99

Frankincense comes from the resin of the Boswellia tree. Within 2008 research, massaging a blend of this oil in combination with bergamot and lavender oils helped to relieve anxiety, depression, and pain in terminal cancer patients.

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Pure Gold Myrrh Essential Oil

Similar to lavender, myrrh essential oil (which has a woodsy scent) may help you to feel relaxed and less stressed in general.

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Majestic Pure Rose Oil

$24.50

Rose essential oil, which has similar effects to those of orange oil, has been shown to reduce anxiety during labor in pregnant women when used in a foot bath, according to 2014 research.

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Plant Therapy Marjoram Sweet Essential Oil

$9.95

Although more research is needed, sweet marjoram (also known as oregano) is believed to help relieve headaches and anxiety, as well as promote calmness.

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Eucalyptus Essential Oil

$5.79

Similar to peppermint oil, eucalyptus oil contains menthol, which has a cooling effect that may help to relieve aches and tension, which can in turn promote relaxation and reduce feelings of anxiety.

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Handcraft TeaTree Essential Oil

$14.95

Although there isnt substantial research on it, tea tree oil is believed to reduce stress and even boost immunity and ward off sickness.

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Roman Chamomile Essential Oil

Chamomile isnt just a relaxing tea that can help you sleep. The oil can also have the same calming effect if added to an aromatherapy diffuser or hot bath.

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Jasmine Essential Oil Aromatherapy

$8.22

You may already love jasmine for its uplifting floral scent, but 2013 research showed that it can also promote feelings of well-being as well as reduce sleepiness and symptoms of anxiety.

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Valerian Essential Oil

If you tend to have trouble falling asleep, valerian oil can help you feel more relaxed and calm your nerves at bedtime.

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Patchouli Essential Oil

$7.49

Although there isnt sufficient research available, patchouli oil is believed to promote calmness and relaxation if youre suffering from anxiety, depression, or stress in general. It can be added to a warm bath or diffuser in combination with lavender oil.

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NOW Foods 100% Pure Clary Sage Essential Oil

According to 2015 research, clary sage can relieve tension and help to maintain optimal levels of the stress hormone cortisol in women. This is beneficial because high cortisol levels have been shown to increase the occurrence of anxiety and depression.

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Pure Gold Holy Basil Essential Oil

Rest assured: This isnt the same basil you put in your pasta sauce. Holy basil (also known as tulsi) has a minty scent and, according to 2014 research, it may help to alleviate mental stress.

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Best Ylang Ylang Essential Oil

$13.01

If youve ever gotten a professional massage, youre likely familiar with ylang ylang and the fact that it promotes relaxation. Additionally, per 2013 research, ylang ylang can help to reduce symptoms of anxiety and promote better sleep.

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Geranium Essential Oil

Similar to rose and orange essential oils, geranium oil has been shown to reduce anxiety for pregnant women in labor, in addition to decreasing blood pressure, according to a 2015 study.

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Cliganic Organic Rosemary Essential Oil

$9.95

Another one that isnt just for cooking, rosemary essential oil has been shown to reduce cortisol (stress hormone) levels, which can then, in turn, relieve anxiety, according to 2007 research.

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Art Naturals Lemongrass Essential Oil

$11.95

While research on lemongrass oil is fairly limited, a 2015 study showed that it can possibly provide a rapid response when used by people who experience anxiety and tension.

See the article here:
The 20 Best Essential Oils For Anxiety And Stress, Per Research - Women's Health

By Deepak Chopra, MD

Reality contains many mysteries, some so impenetrable that even the greatest minds are baffled. Albert Einstein was among them. Even though quantum physics had achieved a huge success, Einstein had doubts about its description of reality. These doubts were crystallized in an anecdote. As related the acclaimed modern physicist Lee Smolin, He once walked back from the Institute for Advanced Study in Princeton with the late Abraham Pais. The moon was out and Einstein asked Pais, Do you really believe the moon is not there when you are not looking at it?

Einstein was defending two of the most basic principles in everyday life, first, that physical objects exist out there as real things, second, that they exist independent of an observer. It would seem impossible that these two propositions arent true. Of course, we say, the moon exists as a real thing, and it was around for billions of years before the first human gazed at it. But this view, technically known as naive realism, is fatally flawed.

Imagine that you have a red light bulb hanging in a room of your house, and every time you walk into the room, the bulb is on. Does that mean that it is on all the time? The possibility exists that it only turns on when you walk into the room. This sounds far-fetched, but in fact you cannot prove that the red light ever turns off. It would have to turn off when you arent looking, and yet the only way to check on it is to walk into the room and look.

Quantum physics has many theoretical arguments that have raged for over a century, but among its greatest pioneers, Niels Bohr and Werner Heisenberg stated that nothing in Nature, not just a red light but all the basic stuff in creation, such as electrons and photons, cannot be proven to exist unless someone looks at them. This is only one of the strange behaviors exhibited in the quantum world, but it is probably the most crucial for figuring out the mystery of reality.

Bohr and Heisenberg were pioneering an idea that came to be known as the participatory universe, which holds that human beings, far from being insignificant compared to the vast operation of cosmic laws, are key players. As Heisenberg put it, electrons and other particles are not real but exist only as ideas or concepts. They become real when someone asks questions about Nature, and depending on which question you ask, Nature obligingly supplies an answer.

What exists outside our questions? That is the core mystery. The quantum revolution did away with the common-sense view that physical objects out there can be taken for granted. Einstein knew this, of course. Having discovered relativity, he understood that time and space are not actually the time and space of everyday perception. He wanted the moon to be real for a deeper reason: the unity of Nature. He was fairly young when he made headlines around the world with E=mc2, and for the remaining decades of his career he strived to come up with a method, mathematically speaking, that would unify quantum mechanics and relativity.

In that project he failed, and no one has succeeded to this day. Why should this matter to the average person? Because right now quantum reality behaves in its strange way and the everyday world behaves in a mostly common-sense way. The two are in flat contradiction, as evidenced very close to home in the human brain.

The brain, like all physical objects, can be broken down, layer by layer, until you reach the level of the quantum. At that point, it basically vanishes. Seemingly solid matter diffuses into clouds of energy, these clouds spread out as ripples in the quantum field, and the ripples cannot be conceived except as mathematical configurations in hyperspace. It doesnt matter whether you start at the top or the bottom of the heap. You cant make mathematical configurations learn to think, and you cant keep the brain intact as a solid physical object.

To bring the issue even closer to home, your brain is like the red light bulb in the room. You cant prove that it exists without you to observe it. If Heisenberg was right and electrons are merely ideas that Nature turns into particles when human being dream up questions about electrons, then the brain is also an idea. It happens to be a huge, complex idea. The brain is Natures answer when someone asks, what does the mind look like?

Once you ask this question, the whole field of neuroscience pops into existence. Nature has tons of tiny answers about neurons, synapses, serotonin, and so on to fill out the one big answer. But the brain doesnt become real just because it provides lots of facts. These facts are linked to the basic rule that nothing can be real without an observer. To put it simply, every experience needs three things: an observer, the thing observed, and the process of observation. Einstein wanted to reduce the three parts to one: the thing observed (in this case, the moon).

His contention doesnt hold up, however, because as with the red light bulb, the whole universe cant be separated from an observer and the act of observation. You have to back up quite a few steps to reach this conclusion, too many steps for the average person, including the vast majority of scientists. But physics is still haunted by Einsteins question: Is anything out there real by itself?

Physics is in a funk today because it cant make this question go away. Two or three decades ago, physical stuff was real, and this whole business about the observer could be ignored, at least for workaday purposes like building high-speed particle accelerators. But the ground has shifted. Stuff has become our current model of matter and energy, and no one can agree on what this model should be.

A sizable quotient of very smart physicists believes that consciousness is an innate part of creation. This idea comes from thinkers who were backed into a corner. They couldnt, no matter how hard they tried, show how mind came aboutall physical explanations failed and continue to fail. Secondly, they couldnt take out the pesky need to include the observer and process of observationthe universe has to be participatory.

Revolutions often occur when old thought and received opinions are backed into a corner. That is happening right now, and in the next post well discuss why Einstein being wrong about the moon actually changes everything.

(to be cont.)

DEEPAK CHOPRA MD, FACP, founder of The Chopra Foundation, a non-profit entity for research on well-being and humanitarianism, and Chopra Global, a modern-day health company at the intersection of science and spirituality, is a world-renowned pioneer in integrative medicine and personal transformation. He is a Clinical Professor of Family Medicine and Public Health at the University of California, San Diego. Chopra is the author of over 89 books translated into over forty-three languages, including numerous New York Times bestsellers. His 90th book and national bestseller, Metahuman: Unleashing Your Infinite Potential (Harmony Books), unlocks the secrets to moving beyond our present limitations to access a field of infinite possibilities. TIME magazine has described Dr. Chopra as one of the top 100 heroes and icons of the century.

Excerpt from:
Why Einstein Was Wrong About the Moon - SFGate

Cough and cold remedies: If you have spent this winter sneezing and coughing, then including this immunity boosting turmeric latte in your diet can help you! Know the health benefits right here.

Cough and cold: Turmeric latte with nutmeg and black pepper can boost immunity in winter

Cough and cold: Winter is the time when you need a strong immunity to prevent catching cough, cold and infections every now and then. Your diet and lifestyle play an important role when it comes to strengthening your immunity and protecting your body from viruses, bacteria and other pathogens try to enter your body on a daily basis. Lifestyle coach Luke Coutiho recently shared an immunity boosting drink in one of his recent posts on Instagram. It is none other than turmeric latte, or the traditional haldi doodh. However, apart from milk and turmeric, he adds a variety of other spices that not just impart a soothing flavour to the drink, but also makes it more powerful and effective in terms health benefits.

Luke prepares his turmeric latte in coconut milk. Other ingredients that he adds are black pepper and nut meg.

Coconut milk is a healthy alternative for cow milk. It can be great for people with lactose intolerance as well. Coconut milk contains beneficial medium chain triglycerides (MCTs), which can be beneficial for aiding weight loss, improving body composition and metabolism. Additionally, coconut milk contains many beneficial compounds like antimicrobial lipids, capric acid and lauric acid, all of which have antibacterial, antifungal and antiviral properties. These properties can be made to use during the cold winter months when the body is more prone to catching diseases and infections.

Turmeric latte can be prepared with coconut milk as wellPhoto Credit: iStock

Also read: Coconut Water Or Coconut Milk; Which One Is Healthier?

Health benefits of turmeric can be magnified when consumed in combination with black pepper. Curcumin in turmeric and piperine in black pepper are the two active ingredients that contribute to their antioxidant, anti-inflammatory and disease fighting qualities. Adding a pinch of black pepper to your turmeric latte can thus have amazing immunity-boosting benefits for your health.

Turmeric and black pepper can together help in boosting immunityPhoto Credit: iStock

Also read: 7 Ways To Use Turmeric For Reducing Pimples And Keep Them Away Forever

One of the many benefits of nutmeg is that it boosts immunity. It is rich in iron, calcium and manganese. The spice has a calming effect on your body and can help in treating insomnia when consumed regularly. Essential volatile oils like elemicin, eugenol, safrole and myristicin can help in dealing with joint pain-which tends to worsen in cold winter months.

Take a cup of coconut milk and add to a pan. Add a pinch of nutmeg, black pepper and 1 tsp honey to sweeten the taste. Bring to the boil or heat it till it is suitable and comfortable for consumption. Have it before bed time every day.

Also read: Five Health Benefits of Nutmeg

If you have spent this winter sneezing and coughing, then including this immunity boosting turmeric latte in your diet can help you! Try it and let us know how it works for you.

(Luke Coutinho, Holistic Lifestyle Coach - Integrative Medicine)

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.

DoctorNDTV is the one stop site for all your health needs providing the most credible health information, health news and tips with expert advice on healthy living, diet plans, informative videos etc. You can get the most relevant and accurate info you need about health problems like diabetes, cancer, pregnancy, HIV and AIDS, weight loss and many other lifestyle diseases. We have a panel of over 350 experts who help us develop content by giving their valuable inputs and bringing to us the latest in the world of healthcare.

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Constant Cough And Cold Giving You A Hard Time? Try This Immunity Boosting Turmeric Latte For Some Relief - Doctor NDTV

A Migliore,1 G Gigliucci,1 RJ Petrella,2 RR Bannuru,3 X Chevalier,4 E Maheu,5 R Raman,6 G Herrero-Beaumont,7 N Isailovic,8 M Matucci Cerinc9

1Rheumatology Unit, San Pietro Fatebenefratelli Hospital, Rome, Italy; 2Department of Family Medicine, School of Kinesiology Western University, Western Centre for Public Health & Family, London, Ontario, Canada; 3Center for Treatment Comparison and Integrative Analysis Division of Rheumatology, Tufts Medical Center, Boston, MA, USA; 4Department of Rheumatology, Hpital Henri Mondor, Creteil, France; 5Rheumatology Department, AP-HP, Saint-Antoine Hospital, Paris, France; 6Academic Department of Orthopaedics, Hull and East Yorkshire NHS Trust, Castle Hill Hospital, Cottingham, UK; 7Joint and Bone Research Unit, IIS-Fundacion Jimenez Diaz UAM, Madrid, Spain; 8Division of Rheumatology and Clinical Immunology, Humanitas Research Hospital, Rozzano, Milan, Italy; 9Division of Rheumatology AOUC, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

Correspondence: N IsailovicDivision of Rheumatology and Clinical Immunology, Humanitas Research Hospital, Via A. Manzoni 56, Rozzano 20089, Milan, ItalyTel +39-02-8224-5118Email natasa.isailovic@humanitasresearch.it

Abstract: Osteoarthritis (OA) is a rheumatic disease that affects the well-being of the patient, compromises physical and mental function, and affects other quality of life aspects. In the literature, several evidence-based guidelines and recommendations for the management of knee osteoarthritis (KOA) are available. These recommendations list the different therapeutic options rather than addressing a hierarchy between the treatments and defining the real target. Therefore, a question arises: are patients and physicians satisfied with the current management of KOA? Actually, the answer may be negative, thus suggesting a change in our therapeutic strategies. In this article, we address this challenge by suggesting that it is time to develop a treat to target strategy for KOA.

Keywords: osteoarthritis, knee osteoarthritis, treat to target

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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It Is the Time to Think About a Treat-to-Target Strategy for Knee Oste | TCRM - Dove Medical Press

Please note: The information in this document is provided as a guide only. You should always check the latest information with a Thai Immigration official or professional visa agent.

Thailand remains a popular world location for retirees the beaches, climate, access to good medical care and great food.

There may be a few more potholes in the roads and some cultural aspects will remain perpetually confusing. But there is always adventure in Thailand and the infrastructure continues to improve every year as the Kingdom takes its place as south east Asias second largest economy, after Indonesia.

The cost of living is still relatively low, first-rate healthcare is available in the main population centres and the weather is conducive to a healthy lifestyle.

According to International Living, Thailand ranks ninth in the world as a place to retire with relative ease.

Nestled between Myanmar, Laos, and Cambodia, Thailand enjoys the warm-water coastlines of both the Andaman Sea and the Gulf of Thailand. This is a country that has never been colonized by any Western or European countries, so Thai culture is untouched, rich, and ancient. Whats more, its ideal for expat living International Living

Within a few hours you can visit a myriad of exotic countries, cultures and sites. Getting around is increasingly easy with a growing number of airlines flying in and out of the Kingdom. Many western passports will give you access to most of the countries nearby with either visa-on-arrival or minimal visa requirements.

Theres already an international expatriate community in Thailand, moreso than in the past when a handful of Europeans, British, Americans and Australians were the most populous expat populations. Now many Japanese, Chinese, Koreans and eastern Europeans also call Thailand home making expat life richer and more exotic. Many retirees were here for work and decided to stay. Others moved here for retirement.

You can get just about any food you like in Thailand now, but international foods are not cheap, whilst the local Thai fare is ubiquitous and available on every street in the country, fresh and aromatic. Yes, you can still get a Thai meal for less than 50 baht!

On the downsides, you need to be careful when driving but, statistically, if youre over 30, dont drink and drive, wear a hemet (if riding a motorbike) or drive a car youre, statistically, in no greater danger than 70% of the worlds roads. Thailand is currently ranked in sixth position as the most dangerous place to drive (WHO).

Theres also a long list of cultural faux pas and misunderstandings awaiting you in the Land of Smiles. The smiles can be very real, but theres also hidden dangers and scams awaiting the newbies. A few hours on the internet will save you a lot of pain. Really, its no different than most other places in the world in that regard.

Top 10 scams in Thailand. Read HERE.

Top 10 things NOT to do in Thailand. Read HERE.

Top 10 hard truths of living as an expat in Thailand. Read HERE.

On the plus side, there is an established expat community, outdoor activities are almost endless and youre living in one of the most dynamic and stable economic regions of the world.

Politics

Mmmm, this is a difficult one to explain to foreigners. From the outside it looks like Thailand is run by a quasi-military government with a veneer of democracy and elections. From the inside Thai life stumbles along with a growing economy and, compared to many other countries, a stable economy.

Thailand has a long history of military coups since it became a constitutional monarchy in 1932. The Thai Royal Family still enjoys strong respect amongst Thais. The new King, HM Maha Vachiralongkorn, has certainly become more hands on than his father (King Bhumibol Adulyadej who was on the throne from 1946 2016). But The King, with the support of the Royal Family, remains as the Head of State in all Thai constitutions since 1932.

All governments, even Army coups, need the support of the Thai monarch to be enacted.

Bottomline, the daily political life of Thailand provides, despite plenty of criticism, a stable country for its citizens.

There is a focus, certainly by Thai media, on the machinations and drama of Thai politics, but, in truth, Thailand has proven a stable and safe place for expats and retirees over the past five decades.

Visas

The first obstacle to entering any country is getting a visa. Retiring to Thailand is so popular that there is a specific visa classification for that the Non-Immigrant O visa covers a number of reasons for entering Thailand, as the name suggests, and one of them is retirement.

To qualify for a retirement visa, you need to meet two basic requirements:

You must be at least 50 years old You must have proof that you can financially support yourself You can either have a monthly income of 65,000 baht Or you must have 800,000 baht in a Thai bank account

For the 800,000 option, you need to be able to prove that the money has been in your account for at least two months before applying for the visa. You must also still have at least 400,000 baht in your account for at least three months after you get the visa.

In other words, you need to actually have the money you cant just borrow it for a few days to meet the visa requirements. The visa will need to be renewed annually and youll still need to meet these requirements each time.

You need to report to an Immigration Office every 90 days, any immigration office around the country is OK. These days the 90 day reporting can be completed online, once registered.

If you decide to do a 90 day report in person, it doesnt take long, once you get to the front of the queue. Arrive early if you want to keep your visit short. Dressing with a neat collared shirt will always go down well at the Immigration offices (actually that goes for just about anywhere in Thailand).

Youll also need

Visa application form, completely filled out Passport or travel document with at least 18 months of validity remaining Recent passport-sized photograph (3.5 x 4.5 centimetre), taken within the past 6 months Evidence of adequate finances (as above) Proof that you have retired

Applying for the Non-Immigrant O visa isnt too difficult but requires the paperwork to be properly prepared. There are also many agents in Thailand who will do the legwork for you and advise you as you go, for a fee. Getting a recommendation for a reliable visa agent is always better than trawling through the internet and hoping for the best.

There WILL be a few bumps along the way all the paperwork and forms are in Thai language to start with and an agent on your team will make things a lot smoother. Of course you can do all this by yourself but prepared for a few speed bumps. All immigration offices in the main population centres, have volunteer international staff who are an excellent first stop when you visit Immigration. They will check your documentation and advise before you end up sitting in front of a Thai immigration official.

While the requirement of an income when youre supposed to be retired is counter-intuitive, this can take the form of a pension or passive income. So youll therefore need to set up a means of regularly transferring money into the country.

There are various options available for transferring your pension, or other passive income into the country. Thai banking is very modern and all banks have safe phone apps to do international transfers.

The quickest and simplest approach to transferring money from an international port is to use a remittance service as the fees are lower, the transfer is instant and the exchange rate is better. Using a bank transfer is also possible, but is slower and generally less cost-effective.

If youre looking at how to retire in Thailand from the UK, its worth looking into QROPS (Qualifying Recognised Overseas Pension Scheme), which may enable you to relocate your pension to Thailand so that it pays out directly into your Thai bank account, according to blog.deemoney.com.

However, retirees from other countries may have to look into private pension schemes and particularly into the regulations regarding how they pay out.

Cost of living in Thailand

The good news is that 65,000 baht per month (or an 800,000 baht lump sum) can go a long way in Thailand, particularly if you pick where to retire with a degree of care. Bangkok, Phuket, Koh Samui, Pattaya, Chiang Mai and Hua Hin are the most popular. Theres also a growing expat community in the north-east of the country, aka. Isaan. Each region has its own benefits and attractions. Cities and tourist areas are going to be more expensive than up-country in central Thailand.

Bangkok is a large Asian city with a cosmopolitan culture and everything youd expect, and more, than any other major city in the world. Getting around is increasingly easy if youre willing to go public and take short hops on motorbike taxis. Driving yourself around Bangkok will drive you insane.

Phuket is the largest island in Thailand, on the Andaman Sea. It was once a tropical paradise. Now its a growing urban island but still has all the same amazing beaches, just a lot more tourists. Approximately, the west side of the island is expensive and where a lot of the tourists hangout. The east side is a lot cheaper and residential.

Koh Samui is the second largest island in Thailand, but in the Gulf of Thailand. Its a smaller version of Phuket with more of an island feel than its larger cousin. It suffers from an airline monopoly that makes it expensive to get there by air. Theres also ferry services connecting you to the mainland.

Pattaya is, well, Pattaya. It became famous as an R&R location for American soldiers during the Korean War, then the Vietnam War. Then it built on its R&R reputation by becoming a popular destination for western tourists, mostly male, in the 70s and 80s. Since then its thrived as a sex-tourism destination but, over the past decade, has become much more cosmopolitan and cleaned up its act with classy tourism attractions, food scene and hi-rise condos.

Chiang Mai is the northern Thai capital. Very laid back and steeped in the Lanna culture. Its a flat, easy-to-get-around city, surrounded by beautiful hills and a growing eco-tourism scene.

Hua Hin is a quieter seaside destination. A favourite for Bangkok weekenders, it now attracts a growing expat scene. Its a coastal strip, facing the Gulf of Thailand, about 3-4 hour easy drive to the capital.

Cost of living

When it comes to figuring out some basic costs of retiring in Thailand, your personal cost of living will vary a LOT depending how and where you choose to live. You can, probably, live as cheaply as 30,000 40,000 baht per month if youre prepared to live as a local and rough it a bit, and not in a touristy area.

For Bangkok

A comfortable one-bedroom apartment about 10-15,000 baht per month

Utilities (including internet, phone, water and electricity) about 2,500 -4,000 baht per month

Food (eating local food) 100 300 baht per day

Food (eating mostly foreign food) about 300 1000 baht per day

1 beer 100 150 baht, depending on the brand and where you buy it

Comprehensive medical insurance 4,000 10,000 baht per month (you would be MAD not to have full medical insurance)

Some other notes on cost of living

Foreign goods can be heavily taxed and may cost more in Thailand than where you came from

Anything involving local labour will likely cost a lot less massages, maintenance, car services, etc

If you choose to live in a beach resort, near the beach, eating international food and drinking imported beer all day, it will cost you more than you think

Health insurance

Health insurance is a big consideration for older expats and will eventually become a critical issue. Whilst Thailand has an excellent, and mostly free, public health system for Thais, and employees (including foreigners) of Thai companies, that doesnt extend to Retirees.

As an expat you can use the Thailands public health system, for a cost. The public system gets mixed reviews by foreigners but, generally, the medical care is good, if not as glamorous as the private hospitals.

But public will cost you a LOT less than the countrys private hospitals. These are very good indeed but come with a high price tag. But note that most of the Thai doctors working in the Private system in Thailand usually work in the Public sector as well.

Once youre over a certain age (70 maybe 75) many international private health schemes will drop you off their list. You need to check these details, the age limits, and your options once you are left to fend for yourself.

Your best health asset as a Retiree is to avoid ending up in a hospital in the first place. Preventative health is your best option and opportunities for a fun and healthy lifestyle abound in the Land of Smiles. Sadly, there are many stories of expat Retirees that get into bad habits, end up with health problems (and no insurance) who then fall between the cracks of Thai life and wither away. Dont let this be you.

Property

You can rent or buy property depending on what your goals are. The Thaiger would always recommend renting, at least for a while, to see how you settle in perhaps even renting for a month in a number of locales to give yourself a chance to try before you buy and commit to a long-term stay.

Buying property in Thailand is an entire post of its own. Heres a detailed website for just about everything you need to know about purchasing property in Thailand. Dont even THINK of buying property in Thailand until you have done your homework on the matter.

To look for Thailands largest range property, and rental properties available, go too FazWaz.com

Information originally published on blog.deemoney.com

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Retiring in Thailand, most of the things you need to know - The Thaiger

Motivation is a fickle beast: Some days, youre smashing your PB like nobodys business. Others involve the overwhelming need to stay under the covers and watch back-to-back eps of The Handmaids Tale.

Take it from Laura Henshaw. The Keep It Cleaner co-founder has been through enough workout lulls to know that the key to firing yourself up again is to stick with it no matter how badly youd rather be in bed.

Determination is checking in with yourself and knowing you can do it even if you cant find motivation and getting it done anyway, she captioned her latest Insta post a video of herself running like a MACHINE on the treadmill. It is proving to yourself on the days you dont want to get out of bed and dont think you can do it that you can.

RELATED:24 Hours With Keep It Cleaner Co-Founder Laura Henshaw

Its about digging deep and finding the confidence to know you can get through it.

Motivation doesnt show up straight away every day, but it will come, she added. I promise. It is so extremely powerful to prove it to yourself every now and then. You can do it.

She continued: Today I got to a speed and sustained it for the longest I ever have (I got to speed 22.9 and did 1 minute) I find pushing myself out of my comfort zone the most rewarding feeling. I never compare myself to anyone - just to my last personal best

So many fans thanked her for inspiring them to get their daily workout done. This made me get up and do a run this morning that I couldn't motivate myself to do. Thankyou! one read.

[This] was me today! Didnt want to get out of bed, went for awful jog/walk but went anyway! added another.

RELATED:Laura Henshaws Post About Chocolate Is Exactly What We Needed To Hear

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Laura Henshaw's Words Are Guaranteed To Get You Through A Workout When Motivation Wanes - Women's Health

Croatian scientists from the St. Catherine Specialty Hospital published an extremely important scientific paper in the Genes scientific journal, showing that the injection of the stromal and the mesenchymal stem cells into the knee joint shows long-term effects when measured 24 months after application.

The paper, which you can read here (full text of the paper is available if the reading of highly technical and scientific papers is your thing) is called "A 24-Month Follow-up Study of the Effect of Intra-Articular Injection of Autologous Microfragmented Tissue on Proteoglycan Synthesis in Patients with Knee Osteoarthritis. It's a multicentric project, with the goal to confirm the effect of micro-fragmented fat tissue (stromal vascular fraction from microfragmented lipoaspirate, so-called SVF) intra-articular injection 24 months after application, in the patients suffering from osteoarthritis (OA). The project head and the corresponding author of the paper was professor Dragan Primorac PhD, and the other authors are St. Catherine's Igor Bori, Damir Hudetz, Eduard Rod, eljko Jele, Andrea Skelin, Mihovil Pleko, and their partners from other Croatian scientific institutions Trpimir Vrdoljak, Ozren Polaek. Irena Trbojevi-Akmai and Gordan Lauc.

The results of this study suggest that the mesenchymal stromal and the mesenchymal stem cells separated from the microfragmented fat tissue lead to the increase of the key molecules of cartilage (the so-called glycosaminoglycans (GAGs)) two years after the application within the joint. Although the numbers for 24 months after the application were somewhat lower than when measured 12 months after the application, in over 50% of the subjects (52 per cent) they were higher than before the treatment. The glycosaminoglycans (GAG) content in cartilage by means of delayed gadolinium (Gd)-enhanced magnetic resonance imaging of cartilage (dGEMRIC), as well as the clinical outcome on observed level of GAG using standard orthopaedic physical examination

Lucija Zeni and Denis Polanec from the Srebrnjak Children's Hospital helped the team in using the methods of immunophenotyping and flow cytometry to determine the types and the content of the MSC, determining the dominant populations of cells. At the same time, while examining the clinical results of the treatment of the knee with the autologous micro-fragmented fat tissue it was determined that 85 per cent of the patients report the significant improvement, as confirmed by the standard orthopaedic tests, such as Knee Injury and Osteoarthritis Score (KOOS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), as well as pain intensity measurement - VAS scale.

At the same time, the team at St. Catherine's hospital wanted to report that the leading scientific magazine Nature published a chapter on "The Future of Cartilage Repair in the book they published called "Personalized medicine in Healthcare Systems", in which the doctors from their hospital participated as authors. They've argued that the production of the bioactive molecules increases the improvement of a number of measurable parameters in patients, and because of that specific effect they would like the "Mesenchymal Stem Cells" to be renamed the "Medicinal SIgnaling Cells". The new findings in the modern regenerative medicine and the available methods of therapy, performed at the St. Catherine's Specialty Hospital give new hope to the patient, provide the newest breakthroughs in the treatment of this disease, but also position the Croatian health system powerfully worldwide.

Osteoarthritis is one of the most common health problems in the world with the increasingly ageing population, and some estimated say that currently, over 600 million people suffer from it. The treatment has been based on relieving the symptoms and implanting the endoprosthesis when it was determined that the cartilage can not be salvaged.

Prof. Dragan Primorac, PhD said that the results published in the Gened magazine and the findings that were published changed some existing paradigms, and show the way towards a better understanding of the biology and the therapeutic effect of the treatment of the osteoarthritis with autologous stromal and stem cells present within the microfragmented fat tissue. In osteoarthritis and in numerous other diseases, the future of medicine will be based on the integration of the principles of personalized and regenerative medicine into the clinical practice. I am happy that the Croatian experts are allowed once more to prove their global excellence, and I'm especially happy that the results of our research have a great impact on the treatment of the patients suffering from osteoarthritis. It is clear that our results have an extraordinary significance in the development of the new diagnostic, therapeutic and prognostic algorithms related to osteoarthritis.

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St. Catherine Hospital Scientists Confirm Long-Term Benefits of Stem Cells Therapy - Total Croatia News

Dublin, Dec. 23, 2019 (GLOBE NEWSWIRE) -- The "Asia-Pacific 3D Cell Culture Market 2019-2027" report has been added to ResearchAndMarkets.com's offering.

Research conducted shows the 3D cell culture market in the Asia-Pacific would be fast progressing in terms of revenue, with a CAGR of 13.11% over the forecasting years 2019-2027.

India, Japan, China, South Korea, Australia & New Zealand, ASEAN countries and Rest of APAC countries together constitute the Asia-Pacific 3D cell culture market.

Several R&D projects are being initiated in South Korea to cater to the rising demand for stem cell therapies and regenerative medicine. In September 2017, the Cell Therapy World Asia 2017 was held in the country. Several cell therapy companies in Asia gathered for the conference to discuss the best practices & innovations in this field. Such factors are promoting the growth of the South Korean 3D cell culture market.

It has been anticipated that the 3D cell culture market in Japan would witness growth, owing to the country releasing new products in the market. Pluristem Therapeutics received a patent for their technology of using 3D cell culturing methods, that allow the creation of cell therapies from fat cells.

The Government of Japan has been focusing increasingly on Cell-based regenerative medicine, which indicates further advances in 3D cell culture technology over the projected period. In 2014, Japan-based Reprocell acquired Reinnervate Ltd., a spin-off of Durham University, agreeing to invest in the researches conducted in the university laboratories for scaffolding structures that support the growth of 3D cells.

COMPETITIVE OUTLOOK

The biggest brands in the 3D cell culture market are Merck KGaA, 3D Biotek, LLC, Thermo Fisher Scientific, Inc., Corning Inc., InSphero, Lonza Group AG, and Synthecon, Incorporated.

Key Topics Covered

1. Asia-Pacific 3D Cell Culture Market - Summary

2. Industry Outlook

2.1. Market Definition2.2. Porter'S Five Forces Model2.2.1. Threat Of New Entrants2.2.2. Threat Of Substitute2.2.3. Bargaining Power Of Buyers2.2.4. Bargaining Power Of Suppliers2.2.5. Threat Of Competitive Rivalry2.3. Economic Technological, And Political & Legal Outlook2.4. Regulatory Outlook2.5. Key Insight2.6. Market Attractiveness Index2.7. Market Drivers2.7.1. Growing Cancer Prevalence2.7.2. High Demand For Organ Transplantation2.7.3. Promising Developments Using Regenerative Medicine2.8. Market Restraints2.8.1. Lack Of Skilled Professionals2.8.2. Incompatibilities Of The Preferred Analytical Technologies With 3D Cell Culture2.9. Market Opportunities2.9.1. Increasing Usage Of 3D Cell Culture In Organ Transplantation And Drug Screening2.9.2. Technological Advancement2.10. Market Challenges2.10.1. Lack Of Availability Of Data For Research On 3D Cell Culture2.10.2. Challenges Associated With 3D Cell Culture In Performing Experiments

3. 3D Cell Culture Market Outlook - By Technology

3.1. Scaffold-Based3.1.1. Hydrogels3.1.2. Polymeric Scaffolds3.1.3. Micropatterned Surface Microplates3.2. Scaffold-Free3.2.1. Hanging Drop Microplates3.2.2. Spheroid Microplates Containing Ultra-Low Attachment (Ula) Coating3.2.3. Microfluidic 3D Cell Culture3.2.4. Magnetic Levitations & 3D Bioprinting3.3. 3D Bioreactors

4. 3D Cell Culture Market Outlook - By Application

4.1. Cancer4.2. Tissue Engineering & Immunohistochemistry4.3. Drug Development4.4. Stem Cell Research4.5. Other Applications

5. 3D Cell Culture Market Outlook - By Component

5.1. Media5.2. Reagents And Consumables

6. 3D Cell Culture Market Outlook - By End-User

6.1. Biotechnology And Pharmaceutical Organizations6.2. Research Laboratories And Institutes6.3. Hospitals And Diagnostic Centers6.4. Other End-Users

7. 3D Cell Culture Market - Regional Outlook

7.1. Asia-Pacific7.1.1. Country Analysis7.1.1.1. Japan7.1.1.2. China7.1.1.3. India7.1.1.4. Australia & New Zealand7.1.1.5. South Korea7.1.1.6. Asean Countries7.1.1.7. Rest Of Asia-Pacific

8. Company Profiles

8.1. Becton Dickinson And Company8.2. Tecan Group Ltd.8.3. Promocell Gmbh8.4. Corning Inc.8.5. Nano3D Biosciences, Inc.8.6. 3D Biotek, Llc8.7. Merck Kgaa8.8. Emulate8.9. Thermo Fisher Scientific, Inc.8.10. Ge Healthcare8.11. Insphero8.12. Lonza Group Ag8.13. Vwr Corporation8.14. Synthecon, Incorporated

Story continues

For more information about this report visit https://www.researchandmarkets.com/r/reo3ym

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

CONTACT: ResearchAndMarkets.comLaura Wood, Senior Press Managerpress@researchandmarkets.comFor E.S.T Office Hours Call 1-917-300-0470For U.S./CAN Toll Free Call 1-800-526-8630For GMT Office Hours Call +353-1-416-8900

Excerpt from:
Study of the 3D Cell Culture Market in Asia-Pacific, 2019-2027: Projecting a 13.11% CAGR, Driven by Promising Developments Using Regenerative Medicine...