Archive for February, 2021

India Stem Cell Market to surpass huge revenue of USD 1.27 Billion at CAGR +13% by 2028.

Stem cell therapy in India helps in treating several diseases, including leukaemia, lymphoma, thalassemia, Parkinsons, Alzheimers, stroke, cerebral palsy, spinal cord injury, muscular dystrophy, etc. Stem cell therapy in India has shown promising results in India and as well as all over the world.

In comparison, in India it costs INR 10-20 lakh in private hospitals, while in government hospitals it is much cheaper INR 3-6 lakh depending on the type of procedure, he said

On average, private banking of stem cells derived from cord blood costs INR 50,000-70,000. Banks claim to freeze the cells in liquid nitrogen so that it can be used up to 20 years from the date of preservation.

Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases. But unproven stem cell treatments can be unsafe so get all of the facts if youre considering any treatment. Stem cells have been called everything from cure-alls to miracle treatments.

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Key players profiled in the report includes:

Thermofisher Scientific India Pvt. Ltd., Pluristem Technologies Ltd., Becton Dickinson Private Limited, Stem Cell Technologies India Pvt. Ltd., Merck Lifescience Pvt. Ltd., Cordlife India Pvt. Ltd., LifeCell International Pvt. Ltd., StemCyte India Therapeutics Private Limited, Stempeutics Research Private Limited, ReeLabs Private Limited, CryoSave, Indu Stem Cell Bank, Path Care Labs Pvt

The aim of the report is to equip relevant players in deciphering essential cues about the various real-time market based developments, also drawing significant references from historical data, to eventually present a highly effective market forecast and prediction, favoring sustainable stance and impeccable revenue flow despite challenges such as sudden pandemic, interrupted production and disrupted sales channel in the India Stem Cell market.

Market segments on the basis of:

This research report is an amalgamation of all relevant data pertaining to historic and current market specific information that systematically decide the future growth prospects of the India Stem Cell market. This section of the report further aims to enlighten report readers about the decisive developments and catastrophic implications caused by an unprecedented incident such as the pandemic that has visibly rendered unparalleled implications across the market.

This report is well documented to present crucial analytical review affecting the India Stem Cell market amidst COVID-19 outrage. The report is so designed to lend versatile understanding about various market influencers encompassing a thorough barrier analysis as well as an opportunity mapping that together decide the upcoming growth trajectory of the market. In the light of the lingering COVID-19 pandemic, this mindfully drafted research offering is in complete sync with the current ongoing market developments as well as challenges that together render tangible influence upon the holistic growth trajectory of the India Stem Cell market.

Besides presenting a discerning overview of the historical and current market specific developments, inclined to aid a future-ready business decision, this well-compiled research report on the India Stem Cell market also presents vital details on various industry best practices comprising SWOT and PESTEL analysis to adequately locate and maneuver profit scope. Therefore, to enable and influence a flawless market-specific business decision, aligning with the best industry practices, this specific research report on the market also lends a systematic rundown on vital growth triggering elements comprising market opportunities, persistent market obstacles and challenges, also featuring a comprehensive outlook of various drivers and threats that eventually influence the growth trajectory in the India Stem Cell market.

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India Stem Cell Geographical Segmentation Includes:

North America (U.S., Canada, Mexico)

Europe (U.K., France, Germany, Spain, Italy, Central & Eastern Europe, CIS)

Asia Pacific (China, Japan, South Korea, ASEAN, India, Rest of Asia Pacific)

Latin America (Brazil, Rest of L.A.)

Middle East and Africa (Turkey, GCC, Rest of Middle East)

Some Major TOC Points:

Chapter 1. Report Overview

Chapter 2. Growth Trends

Chapter 3. Market Share by Key Players

Chapter 4. Breakdown Data by Type and Application

Chapter 5. Market by End Users/Application

Chapter 6. COVID-19 Outbreak: India Stem Cell Industry Impact

Chapter 7. Opportunity Analysis in Covid-19 Crisis

Chapter 9. Market Driving Force

And More

In this latest research publication a thorough overview of the current market scenario has been portrayed, in a bid to aid market participants, stakeholders, research analysts, industry veterans and the like to borrow insightful cues from this ready-to-use market research report, thus influencing a definitive business discretion. The report in its subsequent sections also portrays a detailed overview of competition spectrum, profiling leading players and their mindful business decisions, influencing growth in the India Stem Cell market.

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India Stem Cell Market speedy growth at US$ 1.27 Bn by 2028 with Thermofisher Scientific India, Pluristem Technologies, Becton Dickinson Private...

Introduction

Osteonecrosis of the femoral head is a progressive disorder that causes pain and often progresses to hip joint collapse, finally resulting in disabling arthritis.1,2 It occurs between 30 to 50 years of age, and prevails at a relatively younger age in Asians compared to their western counterparts.3 It is estimated that approximately 20,00030,000 new cases of osteonecrosis are diagnosed in the United States each year, accounting for 10% of total hip arthroplasties performed.4 The Indian Society of Hip and Knee Surgeons has reported that more than 50% of all hip replacements in India are performed for osteonecrosis.5 Many studies have reported osteonecrosis to be more prevalent in men compared to women (3 or 5:1).3 The underlying pathophysiology of osteonecrosis remains unclear; however, it is multifactorial and several traumatic and nontraumatic etiological factors may contribute to its development. Traumatic events that may cause osteonecrosis include femoral neck/head fracture, hip dislocation, or slipped capital femoral epiphysis. Nontraumatic factors include use of steroids, alcoholism, metabolic disorders such as Cushings syndrome, and inherited disorders such as sickle cell disease.6,7 Besides the known traumatic and nontraumatic causes, some cases of osteonecrosis are idiopathic.1,8

Osteonecrosis of the femoral head may progress to secondary arthritis, and degeneration of articulating surface from advanced osteonecrosis necessitates total hip arthroplasty (THA). A primary treatment target of osteonecrosis of femoral head is to delay/prevent progression to osteoarthritis. Core decompression (CD) is the most widely used procedure in clinical practice; however, it has shown poor clinical outcomes, with up to 40% of patients having to undergo THA despite undergoing core decompression procedure.8 Therefore, a more pathophysiological approach may be required to treat osteonecrosis of femoral head. Osteonecrosis is characterized by a reduction in the osteogenic progenitor cells, an increase in osteoblast death, and altered intramedullary vascular supply due to trauma.1 It was observed that the number and function of mesenchymal cells in hematopoietic tissue and stroma of the bone marrow decreased in osteonecrosis patients.2 This observation indicated potential for using bone marrow stromal cells for the treatment of osteonecrosis, and consequently, several clinical studies have demonstrated encouraging results.2 A meta-analysis also showed that treatment with cell therapy compared to core decompression alone increased Harris hip score, decreased necrotic area of femoral head and collapse of femoral head, and reduced THA conversion rate.9 However, a recent randomized study has shown that bone marrow cell implantation in addition to core decompression did not improve THA conversion rate in patients with grade 3 osteonecrosis.10 The ideal treatment goal for osteonecrosis is to facilitate new bone formation in the place of dead bone that can provide pain relief, cease disease progression, prevent joint collapse, and preserve the joint. The fact thatbone marrow aspirate consists of mesenchymal stem cells raised a possibility if bone marrow cells could be differentiated into bone forming cells or osteoblasts and characterized by bone alkaline phosphatase. In a randomized trial, autologous osteoblast implantation was shown to significantly delay the evolution to subchondral fracture and reduce pain compared to bone marrow aspirate.11

OSSGROW (Regrow Biosciences Pvt Ltd., Mumbai, India) is a commercially available technology that involves implantation of autologous adult live-cultured osteoblasts (AALCO) derived from mesenchymal stem cells sourced from the bone marrow aspirate for osteonecrosis of the hip that received conditional marketing approval in India in March 2017.12 Here, we evaluated the efficacy of OSSGROW implantation technique by assessing retrospective data from patients with osteonecrosis who underwent the procedure. We also evaluated the correlation between Ficat-Arlet stages of osteonecrosis and clinical outcomes of the AALCO implantation procedure.

This retrospective, observational, non-comparative study was conducted at 37 centers in India. We retrospectively reviewed the data of patients with osteonecrosis of the femoral head who had undergone OSSGROW (AALCO) from 2010 to 2015. Key inclusion criteria were patients aged 12 years with a confirmed diagnosis of osteonecrosis in one or both hip joints who had undergone AALCO implantation. Diagnosis, analysis, and classification of osteonecrosis were done according to Ficat-Arlet based on radiography, computed tomography (CT) scans, and magnetic resonance imaging (MRI) findings. Patients whose medical records were not complete or were lost to follow-up were excluded from the study.

The protocol was approved by the Institutional Ethics Committee - Regrow Biosciences Pvt Ltd. and as this study was a retrospective study, informed consent was not required to review medical records. We also sought permission from the head of the institutes/departments before data collection. Patient data confidentiality was maintained in this study.

All the patients had undergone AALCO implantation on the recommendation of their consulting orthopedic surgeon after having received an explanation of the complications of osteonecrosis, the therapeutic options available, and the risks involved with the implantation procedure. Osteoblasts from patients were obtained from bone marrow aspiration from the posterior/superior iliac crest. Mesenchymal stem cells from the bone marrow were isolated and differentiated ex vivo into osteoblasts. Osteoblasts were then cultured for approximately 4 weeks under stringent laboratory conditions and multiplied up to 48 million osteoblasts (Figure 1). The cultured cells were implanted using a gel (Tisseel kit from Baxter) at the site of osteonecrosis through a minimally invasive surgery in a 3-step procedure: core decompression, curettage, and injection of osteoblasts (Figure 2).

Figure 1 Microscopic image of osteoblast in culture used for the final cell product before cell implantation.

Figure 2 Steps of osteoblasts implantation. (A) Step 1 Insertion of guide wire in center of lesion as identified on the MRI. (B) Step 2 Guide wire and 8mm cannulated drill for core decompression. The entry point of the guide wire is near the vastus ridge, to prevent a fracture due to stress-riser, greater width of femur and faster healing due to cancellous bone. (C) Step 3 Curettage: a variety of angulated curettes is used to do forage (curettage to remove necrotic bone). This bone is sent for biopsy.

Patients were operated on under spinal anesthesia. Core decompression tunnels were created into the subchondral necrotic lesion of the femoral head, approximately 23 mm away from the joint cartilage, by using 2.0-mm K-wires under fluoroscopic guidance through the greater trochanter and the femoral neck, and over drilled using trephine was performed by the centrally positioned K-wire. Cultured osteoblasts were injected following the curettage, and necrotic tissues were removed.

The patients had to undergo appropriate rehabilitation therapy after the implantation, which included complete bed-rest for 4 weeks post-implantation. After 4 weeks, passive lower limb exercises were performed for 2 weeks following post-implantation. Accordingly, non-weight bearing, partial weight bearing, and full weight bearing exercises were suggested as per the study protocol. Descriptive demographic and clinical data recorded before and after the procedure were collected from patient records. Past medical history, concomitant medications, and surgical treatments undertaken before and after the AALCO were recorded. Pre-existing risk factors for osteonecrosis such as steroid intake, alcohol consumption, comorbid conditions, or trauma were also noted.

Improvement in functional capacity and pain reduction were evaluated using Harris Hip Score (HHS) and visual analog scale (VAS) respectively at the time of pre- and post-operative consultations. Continued use of steroids or alcohol consumption after undergoing the AALCO implantation was recorded. The main outcome of the study was the need for THA (THA conversion rate). Based on these parameters, the treatment outcome was determined to be either improved (better score after AALCO implantation), stable (same condition as before AALCO implantation), or progressive (worse scores following AALCO implantation).

Continuous and quantitative variables were summarized using descriptive statistics and compared using Students t-test or nonparametric test, as applicable. Categorical data were presented as frequency count (n) and percentages (%) and were compared using the 2 test or Fishers exact test. P-values <0.05 were considered significant. All analyses were performed using the SPSS version 10.0.

Data from 64 patients were collected and analyzed as per the study protocol, and 101 hip joints were assessed. The age of patients ranged from 1270 years and BMI ranged from 20.632 kg/m2. The majority of the patients were men (79.7%). The mean duration since diagnosis of osteonecrosis was 7.4 1.6 years and the mean duration of AALCO treatment was 6.3 1.4 years (Table 1). Unilateral involvement of the hip joint was seen in 42.2% of cases. Bilateral involvement of hip joints was seen in 57.8% of patients. The majority of hips diagnosed were grade III (42.1%) and grade IV osteonecrosis (10.5%). While the exact cause for osteonecrosis was not known (idiopathic) in 25% of patients, 35.9% of cases were linked to steroid use and 26.6% to alcohol abuse. Records of concomitant medications revealed that 91.9% of patients were on analgesics, 8.1% were on ayurvedic treatment, and 1 patient took bisphosphonate.

Table 1 Demographic Characteristics

A total of 98 hip joints were assessed as data of 3 patients were not available for changes in mean VAS scores (improvement in pain), before and after the AALCO implantation. As shown in Figure 3A, the mean VAS score reduced significantly after a mean 6.3 years of AALCO treatment compared to the baseline (32.2 32.1 vs 58.8 13.8; mean difference: 26.5 35.2, p = 0.001) indicating significant improvement in pain. Similarly, HHS also improved post-operatively (47.1 12.3 vs 63.7 27.7; mean difference: 16.7 28.7, p = 0.001) showing functional improvement of patients. We categorized patients based on their HSS score (<70: poor, 7080: fair, 8090: good, 90100: excellent). At baseline, 96 hips (98%) had HSS score of <70, each of the two remaining hips had scores of <80 and <90, respectively. Improvement in HSS scores was seen at follow-up with 42 hips (43.3%) with HSS <70, 11 (11.3%) with 7080, 26 (26.8%) with 8090, and 18 (18.6%) with HSS scores of 90100.

Figure 3 (A) Changes in visual analog scale (VAS) and Harris hip scores. (B) Need for hip replacement surgery in different grades of osteonecrosis. (Osteonecrosis graded according to Association Research Circulation Osseous criteria).

The mean follow-up period since diagnosis of osteonecrosis was 6.3 years (range 49 years). Following AALCO treatment, 29 (28.7%) hips underwent THA, indicating that AALCO treatment could prevent and delay THA for 71.3% of hips. The mean time to THA was 3.2 2.0 years (range: 19 years). A total of 9 (39.1%) grade II, 11 (47.8%) grade III, and 3 (13%) grade IV hip joints required THA surgery (Figure 3B). In other words, AALCO treatment could delay THA for up to 3 years in 80% of hips in early stage osteonecrosis (Grades I and II) and 72% of hips in late stage osteonecrosis (Grades III and IV). Univariate analysis showed that the age of the patient, BMI, gender of patients, the side of osteonecrosis, and duration of disease had no effect on the clinical success of the procedure. Following AALCO treatment, 35.9% of patients continued using steroids and 29.7% continued with alcohol consumption. Of the total 29 hip joints that required surgery at follow-up, 20.7% and 41.4% had an associated etiology of alcohol consumption and steroid intake, respectively (Figure 4A). Overall, a significantly greater number of patients with underlying etiologies of alcohol consumption, smoking, or taking steroids required THA compared to those without these etiologies (14 [37.8%] vs 3 [11.1%], p = 0.017).

Figure 4 (A) Need for hip replacement stratified as per etiology of osteonecrosis. (B) Overall outcome stratified as per the grades of osteonecrosis.

Abbreviations: RA, rheumatoid arthritis; SLE, systemic lupus erythematous.

Based on the pre- and post-operative data, the condition of 65.6% of patients improved and 1.6% remained stable following AALCO treatment. Overall, the condition of 65.9% of hips (56/85) in grade I to grade III improved (Figure 4B). For quick reference, the pre- and post-operative radiograph images for a given patient are presented in Figure 5.

Figure 5 Pre- and posttransplantation MRI and X-ray images (A): pre-operative MRI (male patient [35 years]): Ficat and Arlet Stage II B with a subchondral fracture of right hip with a large anterolateral lesion(arrow) involving more than 40% of femoral head and less than 2mm depression at high risk of collapse. Etiology is post steroid AVN. (B) Post-operative MRI at 5 months post-surgery. (C) Post-operative X-ray at 4 years after surgery; anteroposterior (AP) view and lateral view.

We retrospectively studied the clinical outcomes of AALCO treatment. Our results showed that there was a reduction in pain and improvement in joint function following AALCO implantation, as was evident from a statistically significant reduction in the mean VAS score and increase in the HHS score. Of all the hips that underwent the AALCO implantation, 60% improved and 38% worsened with a THA conversion rate of 28%.

AALCO is a minimally invasive, surgical 3-step procedure with each step contributing significantly to the overall effectiveness of the treatment. The first step is core decompression that reduces pressure allowing increased blood flow. In the second step, the necrotic bone is debrided by a curette that promotes new bone formation. The third and most important step is implantation of osteoblasts that form new bone. The THA conversion rate is reported lower with core decompression compared to natural progression of disease, but approximately 40% of patients still required THA.8 Bone marrow cell therapy was shown to improve the THA conversion rate further.9 In a recent randomized trial, implantation of autologous bone marrow aspirate concentrate did not show any improvement in patients with grade 3 osteonecrosis.10 In our study, AALCO implantation avoided THA in 72% of hips in late grade osteonecrosis, suggesting that the technique may even benefit patients in advanced stages of disease; however, our results are limited by the relatively small numbers of patients belonging to each stage.

The differences in the THA conversion may not be directly comparable to those with others may be due to the diversity in the presentation of patients, differences in the follow-up period, or the AALCO technique.13,14 The THA conversion rate certainly remains low with AALCO treatment compared to 75% THA conversion rate reported in patients with natural progression to osteoarthritis resulting from osteonecrosis of the femoral head.15,16 A randomized study found autologous osteoblastic cells implantation to be more efficacious than bone marrow implantation as an adjunct to core decompression. The disease progression rate was found to be 20% in patients who had undergone autologous osteoblasts implantation vs 47% in patients in the bone marrow implantation group.11 Bone alkaline phosphatase-characterized osteoblasts have better regenerative potential compared to heterogeneous bone marrow cells.17,18 Use of these characterized cells could explain the favorable outcomes of AALCO implantation in our study.

Intake of alcohol and/or steroids is known to adversely affect bone renewal by causing an imbalance between the normal progenitor cells and the fat-storing bone marrow progenitor cells.1,19,20 The latter phenotype also leads to fat embolism and arteriosclerosis reducing the blood supply to necrotic tissues.1,19,20 In our study, alcohol and steroid intake were associated with occurrence of osteonecrosis of the femoral head in more than a quarter of patients. These results highlight the adverse impact of alcohol and steroid intake on the progression of osteonecrosis that is already evident in the literature in the pathogenesis of osteonecrosis.2125 As expected, THA conversion rate was also higher among patients who consumed alcohol and/or used steroids compared to those who did not in our study, signifying the adverse impact of alcohol and steroids on the AALCO treatment outcomes. However, a consensus on the specific mechanisms leading to these observations is yet to be reached.

A major limitation of our study was the retrospective data collection, and the lack of assessments of radiographic progression of the affected hips.

The results of this study substantiate the therapeutic potential for AALCO in improving clinical outcomes in terms of pain and functional activity, and reducing the risk of disease progression and the need for THA in patients with osteonecrosis. However, this study was limited by the small sample size and the retrospective data collection limiting the power of study for some subgroup comparisons. Further, clinical studies and long-term trials are warranted to confirm the findings of this study.

Authors acknowledge CBCC Global Research for providing medical writing and submission support funded by Regrow Biosciences Pvt. Ltd.

The authors report no conflicts of interest in this work.

1. Hernigou P, Poignard A, Zilber S, Rouard H. Cell therapy of hip osteonecrosis with autologous bone marrow grafting. Indian J Orthop. 2009;43(1):4045. doi:10.4103/0019-5413.45322

2. Gangji V, Hauzeur J-P, Matos C, De Maertelaer V, Toungouz M, Lambermont M. Treatment of osteonecrosis of the femoral head with implantation of autologous bone-marrow cells: a pilot study. J Bone Joint Surg Am. 2004;86(6):11531160. doi:10.2106/00004623-200406000-00006

3. Vardhan H, Tripathy SK, Sen RK, Aggarwal S, Goyal T. Epidemiological profile of femoral head osteonecrosis in the North Indian population. Indian J Orthop. 2018;52(2):140146. doi:10.4103/ortho.IJOrtho_292_16

4. Moya-Angeler J, Gianakos AL, Villa JC, Ni A, Lane JM. Current concepts on osteonecrosis of the femoral head. World J Orthop. 2015;6(8):590601. doi:10.5312/wjo.v6.i8.590

5. ISHKS registry. Available from: http://www.ishks.com/pdf/ISHKS-registry-2019.pdf. Accessed December 17, 2020. 2019.

6. Xie XH, Wang XL, Yang HL, Zhao DW, Qin L. Steroid-associated osteonecrosis: epidemiology, pathophysiology, animal model, prevention, and potential treatments (an overview). J Orthop Translat. 2015;3(2):5870. doi:10.1016/j.jot.2014.12.002

7. Jaffr C, Rochefort GY. Alcohol-induced Osteonecrosisdose and duration effects. Int J Exp Pathol. 2012;93(1):7879. doi:10.1111/j.1365-2613.2011.00798_1.x

8. Houdek MT, Wyles CC, Martin JR, Sierra RJ. Stem cell treatment for avascular necrosis of the femoral head: current perspectives. Stem Cells Cloning. 2014;7:6570. doi:10.2147/SCCAA.S36584

9. Xu S, Zhang L, Jin H, et al. Autologous stem cells combined core decompression for treatment of avascular necrosis of the femoral head: a systematic meta-analysis. Biomed Res Int. 2017;2017:6136205. doi:10.1155/2017/6136205

10. Hauzeur JP, De Maertelaer V, Baudoux E, Malaise M, Beguin Y, Gangji V. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. Int Orthop. 2018;42(7):14291435. doi:10.1007/s00264-017-3650-8

11. Hauzeur JP, Toungouz M, Lechanteur C, et al. Autologous osteoblastic cells (PREOBy) versus concentrated bone marrow implantation in osteonecrosis of the femoral head: a randomized study. Revue de Chirurgie Orthopdique et Traumatologique. 2016;102(7):S73. doi:10.1016/j.rcot.2016.08.002

12. Cuende N, Rasko JEJ, Koh MB, Dominici M, Ikonomou L. Cell, tissue and gene products with marketing authorization in 2018 worldwide. Cytotherapy. 2018;20(11):14011413. doi:10.1016/j.jcyt.2018.09.010

13. Pepke W, Kasten P, Beckmann NA, Janicki P, Egermann M. Core decompression and autologous bone marrow concentrate for treatment of femoral head osteonecrosis: a randomized prospective study. Orthop Rev (Pavia). 2016;8(1):6162. doi:10.4081/or.2016.6162

14. Zhao D, Cui D, Wang B, et al. Treatment of early stage osteonecrosis of the femoral head with autologous implantation of bone marrow-derived and cultured mesenchymal stem cells. Bone. 2012;50(1):325330. doi:10.1016/j.bone.2011.11.002

15. Hernigou P, Habibi A, Bachir D, Galacteros F. The natural history of asymptomatic osteonecrosis of the femoral head in adults with sickle cell disease. J Bone Joint Surg Am. 2006;88(12):25652572. doi:10.2106/00004623-200612000-00002

16. Tomaru Y, Yoshioka T, Sugaya H, et al. Ten-year results of concentrated autologous bone marrow aspirate transplantation for osteonecrosis of the femoral head: a retrospective study. BMC Musculoskelet Disord. 2019;20(1):410. doi:10.1186/s12891-019-2797-4

17. Birmingham E, Niebur G, McHugh PE. Osteogenic differentiation of mesenchymal stem cells is regulated by osteocyte and osteoblast cells in a simplified bone niche. Eur Cell Mater. 2012;23:1327. doi:10.22203/eCM.v023a02

18. Prins H-J, Braat AK, Gawlitta D, et al. In vitro induction of alkaline phosphatase levels predicts in vivo bone forming capacity of human bone marrow stromal cells. Stem Cell Res. 2014;12(2):428440. doi:10.1016/j.scr.2013.12.001

19. Cui Q, Wang GJ, Balian G. Steroid-induced adipogenesis in a pluripotential cell line from bone marrow. J Bone Joint Surg Am. 1997;79(7):10541063. doi:10.2106/00004623-199707000-00012

20. Hernigou P, Beaujean F, Lambotte J. Decrease in the mesenchymal stem-cell pool in the proximal femur in corticosteroid-induced osteonecrosis. J Bone Joint Surg Br. 1999;81(2):349355. doi:10.1302/0301-620X.81B2.0810349

21. Sakaguchi M, Tanaka T, Fukushima W, Kubo T, Hirota Y. Impact of oral corticosteroid use for idiopathic osteonecrosis of the femoral head: a nationwide multicenter case-control study in Japan. J Orthop Sci. 2010;15(2):185191. doi:10.1007/s00776-009-1439-3

22. Kubo T, Ueshima K, Saito M, Ishida M, Arai Y, Fujiwara H. Clinical and basic research on steroid-induced osteonecrosis of the femoral head in Japan. J Orthop Sci. 2016;21(4):407413. doi:10.1016/j.jos.2016.03.008

23. Cooper C, Steinbuch M, Stevenson R, Miday R, Watts N. The epidemiology of osteonecrosis: findings from the GPRD and THIN databases in the UK. Osteoporos Int. 2010;21(4):569577. doi:10.1007/s00198-009-1003-1

24. Fukushima W, Fujioka M, Kubo T, Tamakoshi A, Nagai M, Hirota Y. Nationwide epidemiologic survey of idiopathic osteonecrosis of the femoral head. Clin Orthop Relat Res. 2010;468(10):27152724. doi:10.1007/s11999-010-1292-x

25. Kang JS, Park S, Song JH, Jung YY, Cho MR, Rhyu KH. Prevalence of osteonecrosis of the femoral head: a nationwide epidemiologic analysis in Korea. J Arthroplasty. 2009;24(8):11781183. doi:10.1016/j.arth.2009.05.022

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[Full text] Retrospective Study on Implantation of Autologous-Cultured Osteoblasts | ORR - Dove Medical Press

The Report Titled on Orthopedic Regenerative Medicine Market which provides COVID19 Impact analysis on Market Size (Production, Capacity, Value, Values & Consumption), Regional and Country-Level Market Size, Segmentation Market Growth, Market Share, Competitive Landscape, Sales Analysis, Impact of Domestic and Market Players. Orthopedic Regenerative Medicine Market detailed study of historical and present/future market data. Economic growth, GDP (Gross Domestic Product), and inflation are some of the elements included in this report to offer crystal clear picture of the Orthopedic Regenerative Medicine industry at global level.

Orthopedic Regenerative Medicine Market competitive landscapes provides details by topmost manufactures like (Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.), including Capacity, Production, Price, Revenue, Cost, Gross, Gross Margin, Growth Rate, Import, Export, Market Share and Technological Developments.

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Market Segmentation & Coverage:

This research report categorizes the Orthopedic Regenerative Medicine to forecast the revenues and analyze the trends in each of the following sub-markets:

By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

Based on Geography, the Orthopedic Regenerative Medicine Market studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas region surveyed across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific region surveyed across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa region surveyed across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus. As authorities encourage social distancing and consumers stay indoors, several businesses are hit. However, coherent, coordinated, and credible policy responses are expected to offer the best chance at limiting the economic fallout.

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The Orthopedic Regenerative Medicine Market on the basis of Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Competitive Strategic Window:

Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth.

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Orthopedic Regenerative Medicine Market Size to Witness A Lucrative Growth Over 2020-2027 | Curasan, Inc., Carmell Therapeutics Corporation, Anika...

World Cancer Day: Blood cancer can be managed with treatments such as chemotherapy, radiation therapy

World Cancer Day 2021: This day is observed on February 4. Blood cancer originates in the blood forming tissues when abnormal blood cells start growing out of control, thereby interrupting the functioning of the normal blood cells. The normal blood cells help strengthen the immune system by fighting infection and producing new blood cells. Most blood cancers begin in the bone marrow where blood is produced. The three most common blood cancers are lymphoma, leukaemia and multiple myeloma. The common symptoms include weakness, shortness of breath, minimal injury resulting in fractures, excessive or easy bruising, bleeding gums, recurrent infections and frequent vomiting sensations. Blood cancer can be managed with treatments such as chemotherapy, radiation therapy and stem cell transplant.

Multiple myeloma

Multiple Myeloma develops in the bone marrow and affects plasma cells of the body. Plasma cells are responsible for producing antibodies that attack infections and diseases. When these cells become cancerous, they collect in the bone marrow and weaken the bones, causing pain on movement. They also produce antibodies that are useless and make the body weaker. Some common symptoms for multiple myeloma include low blood count, high calcium levels, kidney problems and spinal cord compression due to weakened bones.

Also read:Cervical Cancer During Pregnancy: Here's All You Need To Know

Lymphoma

Lymphoma affects the lymphatic system, which is responsible for getting rid of toxins in the body. When the immune cells, or lymphocytes, grow out of control, they collect in the lymph nodes, spleen and in other tissues, and organs. The main types are Hodgkins and non-Hodgkin lymphoma. Some common symptoms for lymphomas include painful swelling in the neck, groin, and armpits, fever and drenching sweats, fatigue, unexplained weight loss and shortness of breath.

Leukaemia

Leukaemia is cancer in the bone marrow that gradually spreads to the bloodstream. It is the most common cause of death due to cancer in India. In Leukaemia, the bone marrow produces metamorphosed cells, that outgrow the healthy blood cells gradually. There are multiple forms of leukaemia, but the diagnosis is determined based on speed of symptom development and the type of blood cells that accumulate. Some common symptoms for leukaemia include severe and frequent infections, recurrent nosebleeds, tiny red spots on the skin and excessive sweating and pain in the bones and joints.

While lymphomas and leukaemia affect both children and adults, Myeloma is more prevalent among adults.

Also read:What To Do When A Cancer Patient Tests Positive For COVID-19?

There are several therapies that can be used for treating the different kinds of blood cancer such as:

While there have been developments and advancement in therapies and treatments available for cancer, a significant portion of the future cancer burden can be prevented if we take necessary precautionary measures in the early stages. Better control on tobacco sale and consumption, dietary changes, expansion and equitable distribution of medical facilities, awareness about education programs and risks, prevention, and knowing the benefits of bone marrow donation can go a long way in reducing the burden of blood cancer.

Also read:Alarming Cancer Symptoms Men Should Not Ignore

(Dr Nitin Sood, Director, Hemato Oncology and Stem Cell Transplant Medical and Haemato Oncology, Cancer Institute, Medanta)

Disclaimer: The opinions expressed within this article are the personal opinions of the author. NDTV is not responsible for the accuracy, completeness, suitability, or validity of any information on this article. All information is provided on an as-is basis. The information, facts or opinions appearing in the article do not reflect the views of NDTV and NDTV does not assume any responsibility or liability for the same.

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World Cancer Day 2021: Know All About The Different Types Of Blood Cancer From Expert - NDTV Doctor

The Daily Beast

Andrew Harnik/APSenate Majority Leader Chuck Schumer (D-NY) stood alongside high-profile progressives in Congress in front of a podium that said #CANCEL STUDENT DEBT, a favorite slogan of the activist class, to push the Biden administration on a key economic issue.The resolution, which Schumer first introduced last fall with Sen. Elizabeth Warren (D-MA), would cancel $50,000 in student loan debt for each borrower through executive action, a sum that goes far beyond what Biden has already pledged to nix while in office.In an outdoor briefing on Thursday, the Democratic leader said he has already had a receptive response from the White House.We have met with the president, we are pushing the president and his people, and we are very hopeful, Schumer said, sharing that he and Warren met with Biden and administration officials privately for 45 minutes to lay out a proposed executive action.Biden has promised to eliminate $10,000 in federal student loan debt for each student.Asked about the renewed push later in the afternoon, White House press secretary Jen Psaki reiterated Bidens support for his original proposal, suggesting that it was unlikely that anything more would be done through executive orders.On day one, the first day of his administration, he directed the Department of Education to extend the existing pause on student loan payments and interest for millions of Americans with federal student loans, Psaki said. That was a step he took through executive action, but he certainly supports efforts by members in Congress to take additional steps, and he would look forward to signing it.Schumer was joined by Warren and Squad Reps. Ayanna Pressley (D-MA) and Ilhan Omar (D-MN)the original co-sponsors of the companion House resolution from last Decemberas well as other House members pressing the issue.America does not suffer from scarcity, we suffer from greed, Omar said, linking burdensome debt to the differing chances of students who come from wealthy families versus those in middle and working class households.Progressives Cant Find Anyone in Biden's Cabinet to Be Mad AboutYetSchumers desire to publicly present a loan forgiveness alternative to what Biden has offered has been perceived by some on the left as a way to help stave off a possible primary challenge in his native New York. The senior Democrat is up for re-election in 2022 and Rep. Alexandria Ocasio-Cortez (D-NY) is thought to be contemplating a primary challenge for this Senate seat.Read more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

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Evotec and Medical Center Hamburg-Eppendorf Enter Partnership to Develop iPSC-Based Tissue Therapy for Heart Failure - Yahoo Finance UK

Excitement took wing in the scientific community in the early 1990s, when the first gene therapy trial showed significant success, only to crash at the end of the decade with a patients tragic death.

Twenty years later, the excitement is back and greater than before. Although safety remains a concern, investigators are breaking ground in cell and gene therapy, and many believe that ultimately, a string of cured cancers will follow.

In 2017, the excitement over these therapies returned in spades when the FDA signed off on a cell-therapy drug for the first time, approving the chimeric antigen receptor (CAR) T-cell treatment tisagenlecleucel (Kymriah; Novartis) for patients with B-cell precursor acute lymphoblastic leukemia. At last, scientists had devised a way to reprogram a persons own T cells to attack tumor cells.

Were entering a new frontier, said Scott Gottlieb, MD, then-FDA commissioner, in announcing the groundbreaking approval.

Gottlieb was not exaggerating. The growth in CAR T-cell research is exploding. Although only a handful of cell and gene therapies are on the market, the FDA predicted in 2019 that it will receive more than 200 investigational new drug applications per year for cell and gene therapies, and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year.

We can absolutely cut the number of cancer deaths down so that one day in our lifetimes it can be a rare thing for people to die of cancer, said Patrick Hwu, MD, president and CEO of Moffitt Cancer Center in Florida and among gene therapys pioneers. It still may happen here and there, but itll be kind of like people dying of pneumonia. Its like, He died of pneumonia? Thats kind of weird. I think cancer can be the same way.

Essentially, you can kill any cancer cell that has an antigen that is recognized by the immune cell, Hwu said. The key to curing every single cancer, which is our goal, is to have receptors that can recognize the tumor but dont recognize the normal cells.

Community oncologists will need to be increasingly familiar about the various products, including their immediate and longer-term risks, Bo Wang, MD, and Deepu Madduri, MD, recently wrote in OncologyLive.1 It is key to understand the optimal time for referring these patients to an academic institution, as well as how to manage the requisite post CAR T-cell therapy in the community setting. Madduri is an assistant professor of medicine, hematology and medical oncology, as well as associate director of cellular therapy service, and director of clinical operations with the Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai in New York, New York. Wang is a third-year clinical fellow in hematology/oncology at Mount Sinai.

Early referral to academic centers and hospitals equipped to deliver therapies is crucial for patients eligible for therapy. However, as advances continue in the field, community practices may be called upon to administer therapies in their clinic.

The Community Oncology Alliance (COA) envisions a broader role for the settings in which CAR T-cell therapies can be administered. When the Centers for Medicare & Medicaid Services (CMS) was considering coverage for CAR T-cell therapies in 2019, COA officials argued against limiting approvals to hospitals.

It is important to understand that there are state-of-the-art community oncology practices that have significant experience and capabilities in administering highly complex treatments, COA officials wrote in a letter to CMS. For example, stem cell transplants, which are similar in complexity to CAR T therapy, are performed successfully in the community oncology practice setting.2

Broader use of gene therapies depends on several factors, including navigating the logistics of gene therapies, addressing the high costs, and managing toxicities.3

Autologous CAR T-cell therapies involve a manufacturing process that requires coordination between the treating facility and the processing facility. Following leukapheresis, patients may require maintenance therapy to control disease progression during the manufacturing time, which can take 3 to 5 weeks.

In terms of cost, gene and cell therapies can cost from $375,000 to $475,000 per dose and they may face coverage restrictions from payers. Approvals could take weeks to obtain.3,4

Because of cytokine release syndrome and neurotoxicities associated with CAR T-cell therapy, the FDA mandates risk evaluation and mitigation strategy training for centers.

Further, providers may find that real-world experiences with gene therapies are different from those seen in the clinical trial setting, according to Ankit J. Kansagra, MD.

In a presentation at the 2020 American Society of Clinical Oncology Virtual Education Program, Kansagra, an assistant professor of medicine and Eugene P. Frenkel, MD, Scholar in Clinical Medicine at Harold C. Simmons Comprehensive Cancer Center in Dallas, Texas, said that in practice patients may be older and have more aggressive disease, with double- and triple-hit lymphomas.4

Specifically, Kansagra noted that medications such as steroids and/or tocilizumab (Actemra) to prevent or treat cytokine release syndrome or other toxicities were more frequently used in the real-world setting than what had been seen in clinical trials.

As it stands now, only a fraction of eligible patients are receiving CAR T-cell therapies, Kansagra said. Potentially, 9750 patients a year may be eligible for CAR T-cell therapies in approved and upcoming hematologic indications. From 2016 to 2019, a total of 2058 patients received CAR T-cell infusion.4

Next steps for transplanting these novel therapies to clinical practice will require changes in key areas, Kansagra said, such as supply chain management, patient support, and financial systems (Figure).4

Figure. Next Steps for Effective Delivery of Gene and Cell Therapies4

Meanwhile, multiple myeloma experts advise providers to be ready for change. As commercially available myeloma CAR T-cell therapies are approved, it will be even more important for community oncologists to better understand these therapies so they can offer them to their patients, Wang and Madduri wrote.1

Cell therapy involves cultivating or modifying immune cells outside the body before injecting them into the patient. Cells may be autologous (self-provided) or allogeneic (donor-provided); they include hematopoietic stem cells and adult and embryonic stem cells. Gene therapy modifies or manipulates cell expression. There is considerable overlap between the 2 disciplines.

Juliette Hordeaux, PhD, senior director of translational research for the University of Pennsylvanias gene therapy program, is cautious about the FDAs predictions, saying shed be thrilled with 5 cell and/or gene therapy approvals annually.

For monogenic diseases, there are only a certain number of mutations, and then well plateau until we reach a stage where we can go after more common diseases, Hordeaux said.

Safety has been the main brake around adeno-associated virus vector [AAV] gene therapy, added Hordeaux, whose hospitals program has the institutional memory of both Jesse Gelsingers tragic death during a 1999 gene therapy trial as well as breakthroughs by 2015 Giants of Cancer Care winner in immuno-oncology Carl H. June, MD, and others in CAR T-cell therapy. Sometimes there are unexpected toxicity [events] in trials.I think figuring out ways to make gene therapy safer is going to be the next goal for the field before we can even envision many more drugs approved.

In total, 3 CAR T-cell therapies are now on the market, all targeting the CD19 antigen. Tisagenlecleucel was the first. Gilead Sciences received approval in October 2017 for axicabtagene ciloleucel (axi-cel; Yescarta), a CAR T-cell therapy for adults with large B-cell non-Hodgkin lymphoma. Kite Pharma, a subsidiary of Gilead, received an accelerated approval in July 2020 for brexucabtagene autoleucel (Tecartus) for adults with relapsed/ refractory mantle cell lymphoma.

Another CD19-directed therapy under FDA review for relapsed/refractory large B-cell lymphoma, is lisocabtagene maraleucel (liso-cel; JCAR017; Bristol Myers Squibb). Idecabtagene vicleucel (ide-cel; bb2121; Bristol Myers Squibb) is under priority FDA review, with a decision expected by March 31, 2021. The biologics license application for ide-cel seeks approval for the B-cell maturation antigendirected CAR therapy to treat adult patients with multiple myeloma who have received at least 3 prior therapies.5

The number of clinical trials evaluating CAR T-cell therapies has risen sharply since 2015, when investigators counted a total of 78 studies registered on the ClinicalTrials. gov website. In June 2020, the site listed 671 trials, including 357 registered in China, 256 in the United States, and 58 in other countries.6 Natural killer (NK) cells are the research focus of Dean A. Lee, MD, PhD, a physician in the Division of Hematology and Oncology at Nationwide Childrens Hospital in Columbus, Ohio. He developed a method for consistent, robust expansion of highly active clinical-grade NK cells that enables repeated delivery of large cell doses for improved efficacy. This finding led to several first-in-human clinical trials evaluating adoptive immunotherapy with expanded NK cells under an FDA investigational new drug application. Lee is developing both genetic and nongenetic methods to improve tumor targeting and tissue homing of NK cells. His efforts are geared toward pediatric sarcomas.

The biggest emphasis over the past 20 to 25 years has been cell therapy for cancer, talking about trying to transfer a specific part of the immune system for cells, said Lee, who is also director of the Cellular Therapy and Cancer Immunology Program at Nationwide Childrens Hospital, at The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital, and at the Richard J. Solove Research Institute.

However, Lee said, NKs have wider potential. This is kind of a natural swing back. Now that we know we can grow them, we can reengineer them against infectious disease targets and use them in that [space], he said.

Lee is part of a coronavirus disease 2019 (COVID-19) clinical trial, partnering with Kiadis, for off-the-shelf K-NK cells using Kiadis proprietary platforms. Such treatment would be a postexposure preemptive therapy for treating COVID-19. Lee said the pivot toward treating COVID19 with cell therapy was because some of the very early reports on immune responses to coronavirus, both original [SARS-CoV-2] and the new [mutation], seem to implicate that those who did poorly [overall] had poorly functioning NK cells.

The revolutionary gene editing tool CRISPR is making its initial impact in clinical trials outside the cancer area. Its developers, Jennifer Doudna, PhD, and Emmanuelle Charpentier, PhD, won the Nobel Prize in Chemistry 2020.

For patients with sickle cell disease (SCD), CRISPR was used to reengineer bone marrow cells to produce fetal hemoglobin, with the hope that the protein would turn deformed red blood cells into healthy ones. National Public Radio (NPR) did a story on one patient who, so far, thanks to CRISPR, has been liberated from the attacks of SCD that typically have sent her to the hospital, as well from the need for blood transfusions.7

Its a miracle, you know? the patient, Victoria Gray of Forest, Mississippi, told NPR.

She was among 10 patients with SCD or transfusion-dependent beta-thalassemia treated with promising results, as reported by the New England Journal of Medicine.8

Stephen Gottschalk, MD, chair of the department of bone marrow transplantation and cellular therapy at St Jude Childrens Research Hospital, said, Theres a lot of activity to really explore these therapies with diseases that are much more common than cancer.

Animal models use T cells to reverse cardiac fibrosis, for instance, Gottschalk said. Using T cells to reverse pathologies associated with senescence, such as conditions associated with inflammatory clots, are also being studied.

CAR T, I think, will become part of the standard of care, Gottschalk said. The question is how to best get that accomplished. To address the tribulations of some autologous products, a lot of groups are working with off-the-shelf products to get around some of the manufacturing bottlenecks. I believe those issues will be solved in the long run.

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Harnessing the Potential of Cell and Gene Therapy - OncLive

In pursuit of life everlasting, some turn to God. Others turn to science. Or rather, something science-ish.

If you've ever hoped to be cryogenically frozen, you might come across a legal hurdle: while human cryonics is legal in several countries, you have to be dead before going into the cryonics tank. Otherwise, freezing someone alive is tantamount to killing. So, as it is, you can only get your dead body or head frozenand when thawed, you'd still be dead.

This doesn't deter some people, who simply hope to be cryopreserved until the day comes that humanity masters the art of resurrection, so scientists can re-animate them and cure their ailments. Or upload their consciousness into the cloud. Whichever comes first.

But for those of you who would prefer to go on ice before the immutability of brain death takes hold, there may be a legal loophole to help. According to The Telegraph, one company hopes to avoid that legal issue entirely by building a cryonics lab in a country where human euthanasia is legal.

If Russian cryonics company KrioRus manages to fund it, they plan to buy a bunker in Switzerland and convert it to a cryopreservation lab. People with one foot in the grave could fly in from around the world and be placed in a cryopreservation tank, awaiting the day when their otherwise-fatal disease is cured, and their body is revived to go on living. (Alternatively, they can consider being awoken when we can upload our consciousness to computers, and we won't need our flesh-prisons. I hear that day is near.)

Cryonics is the idea that you can use extremely low temperatures to preserve humans and animals through cryogenic freezing. It's basically like the premise of Futurama, but without the egg timer. However, the procedure is controversial, and the only humans that have been revived after cryogenic freezing are living embryos. The process would probably kill an adult. In Switzerland, though, that could potentially be passed off as "euthanasia."

However, cryonics is unregulated, controversial and unproven to work. Technically, though, cryogenic freezing of non-humans can be used for less science-fictiony endeavors and is not synonymous with cryonics.

According to its website, KrioRus is the first Eurasian company to preserve people and pets, hosting 50 human bodies or heads and 20 animals in tanks in Moscow and St. Petersburg. They have so far only worked with people who have been declared legally dead (and not Walt Disney ). Freezing your body is $36,000, and a head will set you back $12,000.

There's no guarantee that the Swiss pursuit of pre-mortem freezing will go anywhere, let alone conquer mortality. Perhaps the field of cryonics is just trading one eternal, icy embrace for another.

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Cryonics company hopes to use legal loophole to freeze ...

At the age of 18, Emil Kendziorra had a life plan.

First, he was going to become a doctor. Then he was going to make heaps of money. Then he was going to use that money to start a longevity business helping people (and himself) live a much longer life.

One of the things that motivates me is the fear of death, Kendziorra tells Sifted. I dont want to die.

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The first bit of the plan went exactly as imagined.

He became a doctor. Then he made a lot of money in tech founding companies, including software business Solid Media, a restaurant review site Onfeedback and then doctor-on-demand-network Medlanes (which was acquired last month).

But there was a snag. When researching what was happening in the longevity sector to start his new business, he felt pessimistic that the science would go far enough in his lifetime so he and others really could live forever.

One of the things that motivates me is fear of death

This was a tough moment for the 35-year-old, who had to rethink the next stage of his life plans. If you look at how far science has gotten, it is unlikely that a solution will be found within my lifetime, he says.

This prompted him to take a new path, getting into an even more esoteric field: the cryogenic freezing of people on their deathbed.

He now has a business called Tomorrow Biostasis that in exchange for an insurance payment of 30100 per month will cryopreserve users bodies from -130 to -196 degrees celsius with the idea that they will one day be resurrected.

Its part of a growing trend of companies getting into this field. But why is he freezing people? How does it work? And does it even work?

If there is a fair bit of scepticism out there about the whole science of longevity, or living forever, there is even more so about cryonics.

Cryonics is probably best known for showing up in films like 2001: A Space Odyssey, Vanilla Sky or the television series Futurama.

The technology was also recently featured in a documentary on Netflix in which the parents of a terminally ill two-year-old decided to cryogenically preserve her brain.

The idea of inducing metabolic stasis in humans using cryogenic temperatures was proposed in the 1960s as a way of preventing structural decay of the brain, following the terminal failure of the body.

Indefinitely preserving the brains physical state was though to leave open the possibility of resuscitating consciousness: in other words, by restoring function to the brain using one of several theorised but as of yet undeveloped techniques such as digital reconstruction or nanobot cellular repair.

The idea of the technology has long been to freeze the human body shortly after pronounced legally dead, replace the blood with a solution designed to preserve the organs and then adding a so-called cryoprotectant solution that freezes cells without causing crystal formation. Then the body is kept in cold storage until the technology has developed enough to successfully revive the body.

The trouble is that this might, of course, never actually work something Kendziorra readily admits. But he says that there are few scientists who say that this will definitely never be possible just different ideas about how likely it is to ever work.

From scientists in the community, that I would all say are good scientists, the range is from, 2%, to 90% [likelihood that it will work], he says.

But just because it is described as science fiction doesnt mean that one should give up, according to Kendziorra.

The first heart transplant was done in 1967 and if you had asked doctors before that, if it was possible, their answer would probably have been no, you are insane.But that is not reason enough not to try making it happen.

In late 2018, Kendziorra set up a company called Tomorrow Biostasis where people all over Europe are able to sign up for cryogenically freezing and storing when they die.

Working with big insurance companies, users pay a monthly fee for the right to be frozen. Similar to life insurance, it only is a guarantee as long as you are under the age of 60 or 70 depending on the plan.

So far the startup says it is on the trajectory of having 500 customers signed up in the next few months.

But even the freezing is hard.

One thing that is very important, logistically speaking, is if someone dies, you need to be there quickly to start the cooldown process, otherwise the cell damage starts to happen, Kendziorra says.

Alcor, one of the leading US companies when it comes to cryopreservation, believes that the process needs to start within minutes of death, however, this rarely happens due to delays at the hospital where the patient died.

Others would argue that severe cell damage caused by a body left dead for several hours, cannot be reversed, not even with the best medical nanorobots of the future.

Kendziorra is a bit more optimistic and Tomorrow Biostasis picks up people across Europe.

We have a medical response team that has a specialised ambulance vehicle, which is basically a mobile operating room, that is dispatched to pick up the patient, he says.

When the patient is ready for long-term storing, Tomorrow Biostasis uses non-profit organisations set up for this work.

According to Kendziorra, 100k is set aside for each patient. That money is then invested with the idea of 23% return of investment per year 2% for inflation and 1% to pay for the storage of the body.

The idea is that over time, even if it takes 50 or 100 years, you only use the interest and always keep the principle that you had in the beginning. Then you have this money available to pay for revival, Kendziorra says.

And some of that money would also be put aside as pocket money after one is revived. Whether money even exists and how one would fit into society a century from now are two different questions.

Apart from Tomorrow Biostasis, there arent a lot of cryonic startups in Europe. According to Kendziorra, the Swiss-Russian company Kriorus had some internal problems that had a negative effect on the reputation of the company.

One thing that is very important, logistically speaking, is if someone dies, you need to be there quick to start the cooldown process, otherwise the cell damage starts to happen

Kendziorra believes that trust and stability are key for a cryonics company. So far Tomorrow Biostasis has only raised an undisclosed amount from angel investors in Berlin and Silicon Valley but is planning for a larger funding round for 2021.

If you want more companies to choose from, youd better turn to the US.

Based in Arizona and by being around for 40 years, Alcor has perhaps helped the reputation of the technology, particularly in Silicon Valley.

To put yourself on ice is something that both PayPal founder Peter Thiel and computer scientist Ray Kurzweil have signed up to. In 2017, the AI-run hedge fund Numerai allowed employees cryonic body preservation as a benefit.

To be afraid of dying is not the only motivator for people that sign up for cryopreservation, according to Kendziorra.

Apart from not liking the idea of non-existence, I believe that people, who want this, think positively about life and therefore want it for longer. Another common motivation is also a curiosity about how life will look in the future. I think its always a combination of these three motivations. And I would say I subscribe to all of them, he says.

Mimi Billing is Sifteds Nordic correspondent. She also covers healthtech, and tweets from @MimiBilling

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Putting dead heads on ice until the technology catches up - Sifted

With her sun-kissed hair and flawless golden skin, it's easy to forget that Heidi Klum is in her mid 40s. Genetics certainly help. But so do Heidi Klum's favourite skincare products by Glossier and Drunk Elephant, plus a reminder of home courtesy of German beauty brand The Cream by Augustinus Bader.

In a rare selfie, Klum showed off the Perfectil Hair Skin And Nails Vitamins she takes daily, alongside this smorgasbord of beauty products, which proves the supermodel takes her skincare seriously.

Here are some of her favourite products:

More from womanandhome:

Drunk Elephant T.L.C. Framboos Glycolic Resurfacing Night Serum

This night serum contains a hefty dose of glycol acid to exfoliate built-up dead skin cells and resurface dull, uneven skin. Expect brighter, smoother skin when you wake.

Drunk Elephant T.L.C. Sukari Babyfacial 25% AHA + 2% BHA Mask

If you like to feel a product working, you'll positive love this mask. Like an AHA/BHA facial in a bottle, it resurfaces skin to reveal greater clarity and improved skin tone.

Drunk Elephant C-Firma Day Serum

This vitamin C day serum is packed with antioxidants to protect skin from urban aggressors.

Glossier Solution

A liquid exfoliator that you apply a bit like toner, it buffs away dead dulling skin with a single swipe.

Mario Badescu Drying Lotion

We know, we know, even supermodels get spots. This cult zit lotion contains salicylic acid, sulfur, and zinc oxide to dry up blemishes - fast.

Augustinus Bader The Rich Cream

The brainchild of a stem cell scientist no less, this overnight treatment uses amino acids and vitamins to re-energise cells to repair damage more effectively.

Original post:
Heidi Klum loves to pamper her skin with goodies from Drunk Elephant and Glossier - Woman & Home

CHICAGO, Feb. 2, 2021 /PRNewswire/ -- Paragon Biosciences, a life science innovator that creates, invests in and builds life science companies in biopharmaceuticals, cell and gene therapy and synthetic biology utilizing artificial intelligence, today announced the launch of CiRC Biosciences, a cell therapy company developing treatments for serious diseases with high, unmet needs with an initial focus on the eye.

"The addition of CiRC Biosciences to our portfolio builds upon our cell and gene therapy platform, an area that has tremendous potential to address serious genetic diseases," said Jeff Aronin, founder, chairman and chief executive officer of Paragon Biosciences. "CiRC Biosciences gives us the science to target retinal diseases that could lead to vision restoration with numerous other applications in the years ahead."

CiRC Biosciences is currently advancing pre-clinical development of chemically induced retinal cells for vision restoration in Geographic Atrophy Age-Related Macular Degeneration (Dry AMD), which is the most common cause of irreversible vision loss over the age of 65, and advanced Retinitis Pigmentosa (RP), a genetic disorder that causes tunnel vision and eventual blindness. There are no U.S. Food & Drug Administration (FDA) approved treatments to restore vision loss in Dry AMD or RP.

The company's novel mechanism of action is designed for direct chemical conversion of fibroblasts into other cell types using a cocktail of small molecules in an 11-day chemical conversion process. Pre-clinical studies have shown efficacy in blind mice that demonstrated vision restoration. CiRC Biosciences has provisional patent applications to protect its platform.

"Our technology transforms ordinary skin cells into specialized retinal cells using a cocktail of small molecules," said Sai Chavala, M.D., co-founder and chief scientific officer of CiRC Biosciences. "This process is potentially safer, quicker, more cost effective and easier to manufacturer than using traditional stem cells. Working with Paragon Biosciences to build and advance CiRC Biosciences provides us the opportunity to efficiently progress this technology through research and development stages.

CiRC Biosciences first reported its discovery in the highly respected scientific journal Nature (April 15, 2020). A recently published New England Journal of Medicine article (Nov. 5, 2020)discussed CiRC's technology of using chemically induced cells to restore retinal function. The article concluded, "The new and emerging strategies for the rescue, regeneration, and replacement of photoreceptors suggest a bright future in the fight to preserve and restore vision in blinding eye diseases."

The abstract in Nature is available here: https://www.nature.com/articles/s41586-020-2201-4

Access to the NEJM article is available here: https://www.nejm.org/doi/full/10.1056/NEJMcibr2027602

About CiRC Biosciences CiRC Biosciences is a privately held cell therapy company dedicated to developing treatments for serious diseases with high, unmet needs with an initial focus on the eye. Currently it is pre-clinical phase for Geographic Atrophy Age-Related Macular Degeneration (Dry AMD) and advanced Retinitis Pigmentosa (RP). CiRC Biosciences is a portfolio company of Paragon Biosciences. Visit our website: https://circbiosciences.com/.

About Paragon Biosciences Paragon is a life science innovator that creates, invests in and builds life science companies in biopharmaceuticals, cell and gene therapy and synthetic biology utilizing artificial intelligence. The company's current portfolio includes Castle Creek Biosciences, CiRC Biosciences, Emalex Biosciences, Evozyne, Harmony Biosciences, Qlarity Imaging, Skyline Biosciences, and a consistent flow of incubating companies created and supported by the replicable Paragon Innovation Capital model. Paragon stands at the intersection of human need, life science, and company creation. For more information, please visit https://paragonbiosci.com/.

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Evelyn M. O'Connor Paragon Biosciences 312-847-1335 [emailprotected]

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As we continue to stare down several more weeks of winter (or more, pending what Punxsutawney Phil determines in a few days), its more important now than ever to take care of our winter-worn skin and hair. And under quarantine where, lets face it, a lot of us have been skipping certain steps in our self-care routines, having the kind of products that can not only protect but help restore some neglected areas is all the more important.

You (and your skin) are in luck: M3 Naturals has a wide range of personal care products perfect to help you feel and look better with every scrub, lather and shampoo. And today only, you can get up to 60 percent off these Amazon best-sellers.

Whether youre looking to battle wrinkles, clear up your skin, or just treat yourself in the shower, make sure to grab these before the deal ends its only for today.

With over 13,000 five-star reviews, this salt scrub boasts a plethora of good-for-your-skin benefits, from detoxifying and clearing to anti-aging, thanks to the potent blend of collagen and stem cells in the formula. Plus, natural ingredients like lychee fruit and sweet almond oil make it great for cleansing. Even better? Its made in the USA.

Shoppers cant get enough of the scrub, with one reviewer raving: Worth every penny! SO HAPPY I BOUGHT! adding, I love the relaxing feeling I get Scrubbing in the shower I instantly feel better.. all dead skin gone and left with super soft amazing looking skin!

Shop it: M3 Himalayan Salt Scrub, $14 (was $33), amazon.com

Battling crows feet and fine lines around your eyes? Just a few dabs once or twice a day can help reduce wrinkles, puffiness, or dark circles. With a combination of hyaluronic acid, stem calls and collagen, the M3 Naturals Eye Cream is designed to deliver results. Plus, it has nearly 2,400 five-star reviews!

Story continues

I have had bags and wrinkles under my eyes my entire life, one reviewer noted, I figured I would give this a try because of the reviews and such a difference! It was hard to capture the dark circles but those have lightened soooo much too. I am so excited and plan to buy another when I run out!

Shop it: M3 Eye Cream, $23 (was $29), amazon.com

Hair loss can affect both men and women, and while its certainly less stigmatized (thanks to Charlize Theron in Max Max for showing us that a cropped look can be mega stylish), we still want to be in control over our hairstyle, instead of letting our follicles decide for us. For those of us who want to give our scalp a push in the right direction, look no further than the M3 Hair Growth Shampoo. Its combination of collagen, biotin and argan oil help encourage thicker, healthier hair with a DHT blocker formula.

Hundreds of shoppers swear by this shampoo, with one sharing: My hair is very thin and I am only 39 years old...I have been using this only for a week and can already see a difference in the growth of my hair and also the thickness. It leaves your hair feeling so clean literally all day not like when I use other shampoo products. It smells pretty good actually and it has not left my hair greasy or anything. I also noticed I no longer have dandruff. I love this stuff.

Shop it: M3 Hair Growth Shampoo, $14 (was $18), amazon.com

This made-in-the-USA retinol is designed to be used on both your face and neck, and thanks to a potent infusion of collagen and stem cells, can tackle both fine lines and deep wrinkles. Its not just a wrinkle buster, either: The formula hydrates, brightens, and firms.

Shoppers agree, with one five-star reviewer happily reporting: This moisturizer is REALLY good! First, I love that it comes in a jar where you simply push down on the top and the lotion comes out. You get to control how much of the product actually comes out. (No more putting your fingers into a jar of lotion over and over.) Second, the lotion is thick, but not too thick. It is just the right consistency for a good facial moisturizer. It doesn't have a smell, and it doesn't take much product to cover your entire face and neck. I have only been using it for about a week, but I already completely love it!

Shop it: Retinol Moisturizer, $14 (was $18), amazon.com

For those of us who live and die by the drip of our Nespresso, were prone to believe coffee is nothing short of a miracle bean. But even the most devoted drinker will be blown away by how effective this Arabica Coffee Scrub is at cleansing and revitalizing skin. Not only does this scrub help promote smoother, healthier skin, but the subtle scent will help give you an extra bit of pep in your step. Looks like your favorite bean is just as good on your skin as it is in your cup.

Over 1,600 five-star shoppers found this scrub irresistible, with one reviewer who bought it as a gift admitting: This coffee scrub is fantastic! I bought it for my husband but I ended up using it, too! It really removes dead skin and doesn't leave your skin dry like other scrubs do. It is gentle enough for sensitive skin but works really well on rough patches of skin, too. It rinses clean and smells AMAZING.

Shop it: Arabica Coffee Scrub, $23 (was $29), amazon.com

The reviews quoted above reflect the most recent versions at the time of publication.

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According to Persistence Market Researchs new report,globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceedUS$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

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Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

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North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

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Fatigue is one of the most common adverse events of systemic therapy in patients with metastatic renal cell carcinoma (RCC). The aim of multicenter randomized phase 2 study was to determine the efficacy and safety of testosterone in patients with fatigue developed during targeted therapy.

Male patients with metastatic clear-cell RCC, normal prostate-specific antigen level, low testosterone level, and no evidence of hypothyroidism receiving first-line sunitinib or pazopanib with fatigue were randomly assigned (1:1) to either testosterone undecanoate (1000mg) and targeted therapy or targeted therapy alone. The primary endpoint was the mean change of fatigue from baseline to 28 days according to the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary endpoints were safety, Functional Assessment of Cancer Therapy-Kidney Symptom Index 19, testosterone serum concentrations, red blood cell count, and hemoglobin level.

Sixty patients were assigned to receive testosterone and targeted therapy (N=30) or targeted therapy alone (N=30). As of the data cutoff on December 30, 2019, median follow-up was 18.2 months. The study achieved its primary endpoint based on the significant differences at day 28 favoring testosterone over targeted therapy alone regarding the decreased level of fatigue (difference between groups, 22.5 points; 95% confidence interval, 18.4-26.6; P=0.012). Significant changes in scores demonstrating the enhanced quality of life with testosterone compared with targeted therapy were also observed for Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 disease-related symptoms (P=0.01). There were nonsignificant differences in red blood cell count and hemoglobin level between the 2 groups (all P>0.05).

Male patients with metastatic RCC and hypogonadism receiving testosterone had less fatigue and better symptom control during targeted therapy.

American journal of clinical oncology. 2021 Jan 27 [Epub ahead of print]

Ilya Tsimafeyeu, Yulia Tishova, Ruslan Zukov, Pavel Borisov, Anastasia Bondarenko, Kristina Zakurdaeva

Kidney Cancer Research Bureau Institute of Oncology, Hadassah Medical Moscow RUDN University I.M. Sechenov First Moscow State Medical University RakFond, Moscow V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk City Clinical Oncology Center, St. Petersburg, Russia.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/33512910

Originally posted here:
Testosterone for Managing Treatment-related Fatigue in Patients With Metastatic Renal Cell Carcinoma: A Pha... - UroToday

If you find yourself managing busy family life, social life, and career, its common to feel tired and achy sometimes. But do ever wonder if youre achiness and fatigue maybe something more? Are they symptoms of a stressful life, or could they be tied to an underlying condition like an autoimmune disease?

Dr.Redd, a Chiropractic Physician with a Masters in Human Nutrition from RedRiver Health and Wellness is addressing why many people with low thyroid and auto-immunityissues still have their symptoms after being on medication and seeing many specialists. Symptoms of autoimmune disease may be severe in some people and mild in others, but there is a way to get help as one lifelong athlete found.

Nicole, an avid fitness fan and now a recovered patient of RedRiver Health, explained how she feels after seeing Dr.Redd. RedRiver works to make patient satisfaction a top priority and every chiropractic physician and administrative team member works hard to ensure that each patient receives attention and individualized care.

Suffering from chronic symptoms that affect your ability to live your life can be frustrating. Many people visit multiple doctors and specialists and still cant find good answers about what is causing symptoms. People often brush symptoms off as just being the result of a busy and active lifestyle, or the result of stress from kids, work, and life in general. But when they start to get in the way of your ability to live your life its time to figure out exactly whats causing these symptomsa proper diagnosis is critical to find the right treatment.

RedRiver start with extensive testing that delves deeper than most lab panels, then add testing for everything from food sensitivity or intolerance to parasites, hormone imbalances, and adrenal function. They work to understand exactly what is happening inside your body so we can effectively eliminate the issues you are experiencing today while avoiding future flare-ups or a return of symptoms.

RedRiver Health and Wellness has offices in Springville, St. George, Logan, and South Jordan.

For more information, visitRedRiver Health or call (866) 36-RIVER for a free consultation or download a free guide on their website.

This story contains sponsored content.

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Lifelong athlete recovers from a hidden health condition that plagued her for years - ABC 4

USADA announced today that Abu Azaitar, of Rabat, Morocco, has accepted a seven-month sanction for a violation of the UFCAnti-Doping Policy.

Azaitar, 34, tested positive for tamoxifen and/or tamoxifen metabolite 3-hydroxy-4-methoxy-tamoxifen as the result of urine samples collected on August 25, 2020, September 4, 2020, September 9, 2020 and September 17, 2020. Tamoxifen is a Specified Substance in the class of Hormone and Metabolic Modulators and is prohibited at all times under the UFC Anti-Doping Policy and UFC Prohibited List.

After being notified of his positive test, Azaitar provided evidence (including medical records), that he was prescribed tamoxifen by a physician to treat symptoms. Tamoxifen is a selective estrogen receptor modulator used therapeutically to treat certain types of cancer in females and also prescribed off-label for males with various other conditions. Although the substance was taken at the direction of a physician, Azaitar lacked a valid Therapeutic Use Exemption (TUE) and his subsequent application for a retroactive TUE was denied due to lack of sufficient medical justification. Under the applicable rules, Azaitar was eligible for a reduction to the period of ineligibility based on the specific circumstances of his case and for his Full and Complete Cooperation.

Azaitars seven-month period of ineligibility began on August 25, 2020, the date his first positive sample was collected.

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Hi, everyone. I'm Dr Kenny Lin. I am a family physician at Georgetown University Medical Center, and I blog at Common Sense Family Doctor.

Kenneth W. Lin, MD, MPH

2020 was a very tough year for primary care clinicians, even when we weren't regularly treating patients with COVID-19. Last spring, the number of preventive services provided at community health centers well-child visits, Pap smears, A1c tests for patients with diabetes, and screening mammograms fell by one half to two thirds compared with the previous year and had not returned to their usual levels by the end of the summer. Although in some cases telehealth can replace in-person visits, a retrospective analysis posted online ahead of print by the American Academy of Family Physicians' Robert Graham Center suggested that two thirds of typical primary care visits require at least one in-person service, such as an immunization or blood draw.

Pandemic-related declines in well-child visits and adult physical examinations not only had negative financial effects on primary care practices, but also raised fears that delayed cancer diagnoses would lead to thousands of preventable deaths in children (O'Neill A and colleagues; Ding Y and colleagues) and in adults (Sharpless NE; Maringe C and colleagues). As a result, even though daily death and hospitalization rates from COVID-19 are exceeding the peaks from last spring and summer, hospitals and medical practices have been strongly encouraging patients not to defer routine care.

Medical offices are generally safer for patients now than they were during the first few months of the pandemic, when infectious disease protocols were not well established, and in many places surgical masks and other PPE were in short supply. But we do patients a disservice by pretending that primary care can or should return to "business as usual." Preventive services, by definition, are offered to persons without symptoms of the diseases we are trying to prevent, and false-positive test results can lead to harmful diagnostic cascades. For example, one study found that nearly 1 in 5 seniors who underwent a Medicare annual wellness visit in 2014 received at least one nonrecommended test (eg, electrocardiography, urinalysis, thyroid-stimulating hormone), and many of these "low value" tests led to further tests that required additional in-person encounters.

Even for recommended screenings, overall benefits may only exceed harms by a small margin (Ropeik D; Carr T). Compared with management of acute symptoms or chronic conditions, cancer screening does not help most patients; the best evidence indicates that one needs to screen approximately 1000 patients to avoid one death from breast, colorectal, or prostate cancer.

Last summer, current and former members of the Canadian Task Force on Preventive Health Care argued that the increased infection risk associated with an in-person healthcare visit during the pandemic should cause us to consider extending recommended screening intervals and permanently abandon the evidence-free tradition of performing annual or periodic physical examinations on adults without a specific indication. I wholeheartedly agree!

The development of effective coronavirus vaccines has raised hopes that disruptions to primary care will only persist until enough people have been immunized to make it safe to fill up our waiting rooms again. That prediction may turn out to be true, but it would be a shame to miss this once-in-a-lifetime opportunity to reassess the value of routine medical services.

Sorenson and colleagues have suggested that health professional organizations develop "do not restart" lists for their members on pandemic-deferred services that are wasteful or likely to do more harm than good; the American Board of Internal Medicine's Choosing Wisely campaign is a good place to begin. I propose that family medicine's "do not restart" list include not only outdated tests but office processes, too, including the aforementioned waiting room. As is routine in many restaurants and hair salons, patients could wait outside or in their vehicles and receive a text message when it's time for them to be seen, limiting exposure to other potentially ill persons and allowing the practice to use the no-longer-needed waiting space for another purpose.

Kenny Lin, MD, MPH, teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journalAmerican Family Physician.

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Ditch the Waiting Room (and Other Post-COVID Ideas) - Medscape

Every year, the month of January is celebrated as Thyroid Awareness Month to raise awareness regarding the various health problems related to the thyroid gland. The thyroid is a small, butterfly-shaped gland located at the base of the neck and plays a major role in the metabolism, growth, and development of the human body. It also helps in regulating several body functions by releasing hormones into the bloodstream.

If the thyroid gland doesnt function properly, you may develop several diseases, including hyperthyroidism, hypothyroidism, Hashimotos disease, Graves disease, goiter, and thyroid cancer.

Thyroid awareness month seeks to raise awareness regarding these diseases, their causes, symptoms, treatment, and prevention.

Symptoms of Hypothyroidism

Symptoms of Hyperthyroidism

Stand in front of a mirror, tilt back your head, and take a sip of water

Observe the area below Adams apple for signs of bulging

Repeat the process a few times and note down the observations

If you see excessive bulging, nodules, or enlarged glands, contact your physician immediately

The only way to be sure, however, is to perform a blood test that measures your thyroid hormone levels. Usually, a physician would recommend a TSH (Thyroid Stimulating Hormone) test. Depending on the amount of hormone present in your system, the physician can then zero in on the type of thyroid disorder that you may be suffering from and prescribe appropriate treatment accordingly.

It is much more difficult to diagnose thyroid-related disorders in senior citizens because many of the symptoms associated with a malfunctioning thyroid gland overlap with the symptoms of aging. Symptoms like loss of memory, weight gain, and constipation are a few examples.

January is thyroid awareness month: All you need to know about thyroid disorders

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January is thyroid awareness month: All you need to know about thyroid disorders - India Today

Since February is American Heart Health month, what better time to raise awareness of heart disease and stroke, especially among women. Did you know that heart disease is the No. 1 cause of death for women in the United States? More women than men die of heart disease, but many women are unaware of the danger theyre in.

Heart disease is a term that covers several types of diseases of the heart, blood, arteries, and veins. Having heart disease can often result in heart failure, heart attack, stroke, or peripheral artery disease. The risks for developing heart disease range from age, gender, family history, diet, blood pressure, level of cholesterol, diabetes, obesity, and stress.

It doesnt take much to improve your heart health for both men and women. In fact, heart disease is about 80 percent preventable when you make the right choices. Ready to make over your heart? Lets get started.

There are a couple of things that always need to be stressed. First, avoid cigarette smoking and secondhand smoke. The reasons are clear: Smoking contributes to the buildup of fatty substances in the arteries, increases blood pressure, and lowers good (HDL) cholesterol. Plus, a double whammy for the heart, smokers also tend to have more difficulty exercising.

You dont have to quit alone. Smoking cessation classes are offered at Bingham Memorial Hospital. For more information, please call (208) 785-3820.

Physical activity is so powerful. If you can do nothing else, move every day. People who are active are better at controlling their weight, keeping blood pressure low, and managing cholesterol levels.

You dont need to huff and puff to reap the benefits a daily 30-minute brisk walk (or three 10-minute walks) is a good start.

A healthy diet is essential to a healthy heart. Start by avoiding processed foods and loading up on fruits and vegetables. Having a colorful plate leads to heart-healthy choices. Favor vegetables over fruit preferably.

One of the keys to a healthier ticker is managing stress.

Stressful situations can start a number of chain reactions. Your body releases adrenaline, a hormone that temporarily causes your breathing and heart rate to speed up, and if youre under constant stress, this can keep happening on and off.

While researchers are still trying to understand the exact link, they do know that stress raises blood pressure levels. And for some people, it might invite unhealthy coping mechanisms, like smoking or alcohol.

So what can you do to chill out? Its easy. Youll feel better with just 20 minutes of daily laughter, meditation, yoga, or even just deep breathing.

When we dont get enough sleep, we see increases in the stress hormone cortisol and blood pressure levels. Constantly elevated cortisol and blood pressure damages the lining of the blood vessels of the heart. Try to aim for seven to eight hours of shuteye each night.

6. See Your Doctor Once a Year

High blood pressure and elevated blood sugar and cholesterol levels raise your risk of heart disease. But you wont know whether your numbers are high without seeing your family medicine provider or a cardiologist.

To promote good heart health, be sure to take care of yourself and visit your primary care physician at least once a year. Have a discussion with your primary care doctor to see where you are. If your levels are out of range, your doctor may prescribe medications that can help control these risk factors.

About Bingham Healthcare Cardiology

Bingham Healthcares cardiologists are certified to diagnose and treat disorders of the circulatory system and the cardiovascular system the heart, arteries and veins. Using the latest and state-of-the art technology, they provide initial diagnostic services, including basic cardiology evaluations, consultations, stress tests, heart pathology, and arrhythmia detection.

With complete cardiology coverage throughout Eastern Idaho, the following cardiologists are always welcoming new patients.

Call to schedule a consultation in Blackfoot: (208) 785-3897.

Call to schedule a consultation in Idaho Falls: (208) 524-9404.

Call to schedule a consultation in Pocatello: (208) 239-8027.

Dont wait until its too late to treat cardiovascular disease. Youll be glad you did.

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Give your heart a makeover - Post Register

From getting first-hand information at our fingertips to interacting with the world around us, it is beyond question how technology affects every area of our lives. Although it offers humanity the platform to access information that is beyond reach, its increased usage can greatly affect our mental health. The associated risks to technology happen when its use is not controlled. Every day, technological advancements keep increasing at the speed of light as breakthroughs in almost every field are a result of it. But, understanding its double-edged impact can greatly influence how we use it. Starting with its negative effects, lets take a look at the various impacts of tech on our mental health.

Adverse Effects of Technology

Sleep Problems

According to Dr. Saju Matthew a board-certified family medicine physician, excessive exposure to bright lights from your smartphone, computer, and tablet can block the secretion of the hormone that helps you sleep. So it is advisable that you set a bedtime and you put away your phone and other smart devices that can interfere with your sleep as this time approaches. Sleep is very important to our health because it removes toxins that build up while you are awake from your brain, it also allows your body to repair itself. Poor sleep can affect your mood by causing anxiety disorders which weakens your bodys ability to fight diseases.

Are you always eager to know whats up online past your bedtime? You may be suffering from problematic internet use. If you find it difficult to keep up with work demands or your relationships due to your mobile device. This may be a sign that it has taken over your life, and you should see a mental health physician.

Emotional Problems

Although social media connects you to the world. Its prolonged use can disconnect you from family and friends in real life. It can make you feel inadequate and dissatisfied with your life when you compare your achievements to others. These negative emotions can affect your mood in a bad way by making you feel stressed and anxious. These symptoms will further increase your addiction to social media and the cycle continues if you dont seek medical help on time. If you discover that your use of social media is making you angry, aggressive, or distracted, you need to control your use of it by reducing time spent online. Also, in a situation where you suffer from cyberbullying or you find yourself doing crazy things to get likes and shares, you need to re-access your use of social media.

Digital Eye Strain

Do you experience eye discomfort when viewing digital screens for extended periods? You may be having digital eye strain. Digital eye strain goes along with symptoms such as dry eyes, itchy eyes, blurry vision, headache, difficulty in concentrating when reading, and increased sensitivity to light. Other factors are bad lighting, screen glare, and bad viewing distance. A poor vision can affect your daily tasks and even your social life which in turn will affect your mental health. To relieve your eyes from strain, reduce your screen time, and adjust the lighting around you.

Musculoskeletal Problems

According to a study, using smartphones for extended hours can cause problems in the nerves, joints, tendons around the shoulders and arm resulting in musculoskeletal disorders. Leaning forward when using a smartphone can stress your neck, spine, and shoulders. You can also experience repetitive stress injuries around the wrist and arms. Repetitive stress injury occurs when you stress the same muscles over time through bad posture. Symptoms include swelling, stiffness, weakness, numbness, and pain ranging from mild to severe. With this disorder, carrying out your daily activities can become a problem. It can lead to depression if you dont get social support on time.

If you are feeling pain from the use of technology, maintaining a proper posture while working and taking frequent breaks to stretch will reduce these issues but if symptoms persist, see a physician.

Children and Technology

Adults are not the only ones that suffer from the negative use of technology, technology affects the mental health of children and teenagers too because they spend a lot of time watching television, playing video games, and using tech toys. Too much screen time can cause sleep problems and behavioral problems in children. Low academic performance and creativity have been associated with children who overuse technology. To control the negative effect of technology on children and teens, use the American Academy of Pediatrics screen time recommendation as a guide:

-Reduce the amount of time spent watching educational programs for children between 18 24 months.

-For children between ages 2-5 years, reduce non-educational programs to 1 hour per weekday and 3 hours during weekends.

-Incorporate healthy screen habits for children between ages 6 and older.

-Use the screen to build creativity and togetherness with family and friends.

-Help your child learn other activities like music, arts, and sports that do not involve a screen.

Positive Effects of Technology

With over 800 apps dedicated to mental health alone, technology has made mental therapy accessible via some mental health apps. Some of these applications provide valuable insights into how you can feel much better whenever you are feeling depressed. They come either free or affordable, making it easier for many people to get.

Many people living in areas far away from their primary care providers can access online treatment in a timely fashion. While using smartphone apps cannot be compared to doctor-to-patient physical consultation, they provide vital information to mental health professionals.

Imagine a world without technology. Navigating physical interactions and mental wellbeing will have been impossible especially in a time like this when various lock-down restrictions are put in place to reduce the spread of the coronavirus. The pandemic increased online engagements across various social media platforms. And most importantly, it has offered avenues for many websites to provide social support.

Optimizing the Use of Technology to Boost Mental Health?

You need no soothsayer to predict that technology will continue to change the world. Rather than exploit it to the point where it becomes harmful to your health, you can explore new ways to maximize its power to improve your health. This can be achieved by using wearable devices, telehealth, and health apps while you enjoy the bond that comes with spending time with real-life friends.

Read the original:
The Effects of Technology on Mental Health - Thrive Global

Suzy Cohen, Columnist Published 5:02 a.m. ET Feb. 1, 2021

Having an autoimmune condition, or a thyroid condition can make you more susceptible to COVID-19 complications.(Photo: Eraxion / Getty Images)

Having an autoimmune condition, or a thyroid condition can make you more susceptible to COVID-19 complications. Think of autoimmune conditions in the same manner you would other immunosuppressive disorders (i.e. cancer, organ transplantation, history of radiation treatment or chemotherapy).

As it pertains to Hashimotos thyroiditis, Graves disease or hypothyroidism you need to be extra vigilant while youre out in public because your immunity is compromised.

The right dose of thyroid medication, and the right kind are critical because you may not be getting enough active thyroid hormone (T3) to your immune system which resides primarily in the intestines. While your body struggles to make do with whatever hormone is available in your body, you may experience symptoms such as poor concentration, chronic fatigue, hair loss, apathy, sensations of being cold, depression and/or anxiety.

If you have autoimmune thyroid disease, or hypothyroidism, your immune system may not be able to protect you from foreign antigens or invaders. These include new cancer cells, microorganisms, toxins, and even simplistic signals that your body should see and dont due to low thyroid. If youre low in thyroid, your protection against invaders is hindered.

When you have poor T4 to T3 conversion, I call it being thyroid sick and the solution is thoroughly discussed in my best-selling book called, Thyroid Healthy, available on Amazon. The situation makes you hypothyroid and you could have many, if not all, the symptoms that go with it, especially suppressed immune function, and more frequent colds, fever blisters, rashes and UTIs.

Some doctors prescribe both medications to a patient, meaning both T4 drugs and T3, but getting the right dose is tough on doctors (and patients) because its like trying to hit a moving target.

Generally speaking, because the cytokines will be imbalanced in a person with autoimmunity, the recovery time from an infection could be lengthened. There are vitamins that can keep your immune system in tip-top shape during the season. And, Im passionate about herbal medicine. One reason that herbs work well and have strong anti-viral, anti-bacterial and anti-parasitic effect is because they have a wide spectrum of medicinally active constituents.

This means they have a wide range of beneficial impacts in the body aside from their kill action.

I want each of you to be very thoughtful while reading this and remember to never suddenly go off your medication because of something you read. Going off a medication can be problematic for two main reasons:

If youd like to receive my newest ebook on immunity, download it now at https://www.store.suzycohen.com/strengthen-immune.

More: Ask the Pharmacist: How hawthorn lowers blood pressure

And: Ask the Pharmacist: Solutions for gastrointestinal upset

Also: Ask the Pharmacist: Five effective tips to lose weight

Suzy Cohen is a registered pharmacist. The information presented here is not intended to treat, cure or diagnose any condition. Visit SuzyCohen.com.

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Ask the Pharmacist: Autoimmune disorders and infection risk - Marco News

During a Targeted Oncology Case-Based Peer Perspective Roundtable, Sara M. Tolaney, MD, MPH, associate director, Susan F. Smith Center for Womens Cancers, director, Clinical Trials, Breast Oncology, director, Breast Immunotherapy Clinical Research, senior physician, Dana-Farber Cancer Institute, and associate professor of Medicine, Harvard Medical School, discussed therapies available for the treatment of a 42-year0old women with HER2-positive breast cancer.

Targeted OncologyTM: What are your thoughts on the results of the poll?

TOLANEY: It looks like most people voted for TCHP [docetaxel, carboplatin, trastuzumab (Herceptin), pertuzumab (Perjeta)] and then 1 voted for AC [doxorubicin, cyclophosphamide] + THP [paclitaxel, trastuzumab, pertuzumab]. I think these are both reasonable choices. I think knowing that there is lymph node involvement is prompting people to use pertuzumab-based therapy. So, the question [is:] do you want to give anthracycline-based therapy versus nonanthracycline-based treatment? Given some newer data, I [tend] to now use nonanthracycline- based therapy for the vast majority of my patients since I have been using TCHP.

How would you assess this patients risk, and what factors should you keep in mind when assessing risk?

This was a fairly sizable tumor with nodal involvement [that was] high grade, HER2 positive, ER negative...These are all high-risk features. And so, certainly prior to the advent of trastuzumab [Herceptin], this patient would have a high risk of recurrence. The issue about ER will often come up as to whether or not it is truly a prognostic indicator in HER2-positive disease, where so much of the benefit from therapy is really driven by HER2.

If you look at long-term outcomes from HER2-positive patients in the adjuvant setting, and you were to compare the ER-positive versus ER-negative patients, you can see that their long-term outcomes are not that dissimilar. ER-positive, HER2-positive patients tend to do slightly better. They have a different time frame to recurrence, though. Youll see that ER-positive, HER2- positive cancers tend to have recurrences a bit later than the ER-negative, HER2-positive cancers. But in the long run, when you follow them out 8 to 10 years, the difference is quite small between their long-term outcomes. But we do know that in a preoperative setting that the ER-positive, HER2-positive patients do have a lower likelihood of achieving pCR [pathologic complete response] to preoperative therapy, even though...their long-term outcomes are not that dissimilar.

Would you recommend neoadjuvant systemic therapy for such patients?

I find it hard to know what to do for that patient because if they ended up having, [for example], 1.2-cm HER2-positive cancer that was node negative, you take them straight to surgery and they could get away with just TH [paclitaxel, trastuzumab]. We know that their long-term outcomes will be good with TH [in the] stage I setting, with 98% recurrence-free interval out to now almost 7 years.1

But the problem that I have is I dont know their nodal status, and I dont really know how much cancer they have. So, Im always a little worried that Im either under- or over- treating them, depending on what you end up finding out later. Because of that fear, I have tended to take most of my patients [with masses] under 2 cm to surgery first, so that I know what [they are dealing with, in order to make] that final treatment decision.

It does put you at risk potentially for finding [a patient with] stage II disease, which is problematic, because I would have wanted to give them preoperative therapy. Then I could potentially give them postoperative T-DM1 [ado-trastuzumab emtansine; Kadcyla] if they had residual disease. But on the flip side, I worry that if the patient who I think has stage I disease ends up having stage II disease and has nodal involvement, then Ive undertreated them. And so, I find it a little tricky to know how much to give them if [their tumor is] small. I think its a balance, because you dont want to overtreat, you dont want to undertreat, particularly when you are at this high 1s1.8, 1.9 cm; that is where I struggle a bit.

There are a lot of studies ongoing that I think could...make this a little more comfortable. There is a preoperative trial through the [National Cancer Institute], the CompassHER2- pCR study [NCT04266249], which is looking at preoperative THP. And if someone achieves pCR, they go on to [receive] HP [trastuzumab, pertuzumab]. In my mind, if that study pans out and shows that we could potentially get away with THP in stage 2 patients, for example, then I would not feel so bad about giving my [patient with a] 1.8-cm mass THP up front because it was probably an effective amount of therapy; maybe they didnt need the pertuzumab. We know from the APHINITY study [NCT01358877], for example, [that] there is no benefit from pertuzumab in our node- negative patients.

But at least I didnt give them a ton of chemotherapy that they didnt need; TCHP, in my mind, is difficult; with carboplatin, pertuzumab, they have a chance of diarrhea, so thats not easy. Whereas weekly THP is easy for most patients; its not so bad. And so, we need to find a middle ground and were just not quite there yet. It sort of seems [as though] were picking between extremes of TH and then TCHP. And I think thats part of whats driving some of this problem.

For [a patient such as] this, it would be clear to do preoperative treatment.

Would you consider using anthracyclines in a patient such as this in the preoperative setting?

[You may] remember BCIRG 006 [NCT00021255], which compared TCH [docetaxel, carboplatin, trastuzumab] with ACT [AC followed by docetaxel] or AC-TH, showed that the anthracycline and nonanthracycline arms had fairly similar disease-free survival [DFS]. This was prior to pertuzumab becoming a standard, and it was also at a time when the study wasnt powered to technically compare AC-TH to TCH, but we knew the DFS looked similar regardless of nodal status.2

But a more modern era trial is the TRAIN-2 trial [NCT01996267]. In this case, it was a different because they used paclitaxel with carboplatin and HP, not the traditional docetaxel and carboplatin. The comparator arm is also a little different than I typically would use because its FEC [5-fluorouracil, epirubicin, and cyclo- phosphamide] with HP followed by the taxane with HP.

What we showed was that the pCR was the same with either armanthracycline versus nonanthracycline. Now we have follow-up to almost 50 months,3 and the event-free survival is also the same. So, [there was] no statistically significant difference in event-free or overall survival.

There is also a subgroup analysis that showed that even if you looked at the high-risk, node-positive patients in this study, there was still no difference in event-free survival between the 2 arms. And [analysis showed] less cardiac toxicity, numerically less leukemia, and less febrile neutropenia with a nonanthracycline-based therapy.

Since these data have emerged, it has made me feel much more comfortable using nonanthracycline therapy because were seeing that, even with long-term follow-up in a modern era of pertuzumab-based therapy, there is no difference in long-term outcomes between anthracycline and nonanthracycline therapy. In my mind, there isnt much rationale to consider anthracycline- based treatment for HER2-positive patients.

Do you agree with this approach?

If you look at the preoperative trials, generally pCR rates are in the 60% range from TCHP. So, it is a highly effective preoperative therapy. We do know that those patients who achieve pCR have better long-term outcomes than those who have residual disease. And so, trying to maximize chances to get pCR makes sense for patients, and generally that is my approach, as well.

Obviously, there is interest in trying to develop less-toxic approaches. I fully admit that were seeing more toxicity with anthracycline-based therapy. I think we all are seeing that HER2- directed therapies are improving. With time were seeing better biologic treatments. There is a potential that we could get rid of some of the chemotherapy. Do we need to give everyone TCHP, I think, is the question. I think there are some patients who probably dont need all this chemotherapy and probably would be fine with single-agent taxane and dual HER2-directed therapy. The problem is, how do we identify who those patients are? And who really needs the full TCHP?

I think [its being thought of now as], Well, maybe we can use the achievement of pCR to help us figure that out. Could we, for example, as COMPASS is doing, take THP and give it a test run and see if it works? Does it give a pCR? If it does well, we did good. If it doesnt, then we need to escalate therapy, then we can give those patients who didnt get the pCR more treatment. Could they get AC, followed by T-DM1, for example? They would have completed AC-THP and T-DM1 as if they had received AC-THP preoperatively and then T-DM1 out back.

I think this is what were trying to learn, how can we tailor therapy. Were not quite there yet. Outside of clinical trials, I try to follow more textbook-like approaches, rather than these deescalation approaches, which I think should be reserved for trials at this point in time. I generally recommend TCHP.

What are some of these escalation/ deescalation strategies?

There are other trials that are ongoing in this space, and there are lots of deescalation approaches, [which try] to give less therapy. One deescalation approach could be to use T-DM1.

The KRISTINE trial [NCT02131064] had taken patients and randomized them to get TCHP or to get T-DM1 and pertuzumab. Technically the T-DM1 [arm], from a preoperative standpoint, had a higher pCR rate.4 But what was interesting to me is if you followed all the patients out for invasive disease-free survival [iDFS] after surgery, it was the same in both arms. So iDFS, if you follow people postop was exactly the same with T-DM1 + pertuzumab and TCHP.

The problem was in the preoperative setting. Some of the T-DM1 + pertuzumab patients had local regional progression, and those tended to be patients who had heterogeneous HER2 expression. If you think about it, these are patients who youre trying to get to pCR by just HER2-directed therapy. So, if they have any HER2 heterogeneity, its not going to work perfectly right. If you have a HER2-positive 2+ patient who is borderline FISH-amplified, T-DM1 probably isnt going to be a home run for this patient.

I think thats another issue thats going to come up as we try these deescalation approaches. Maybe it does need to be [an individual] who is strongly HER2-positive, 3+, to get away with an ADC [antibody-drug conjugate] such as T-DM1, which in my opinion, is much better tolerated than something [such as] TCHP and could be a wave of the future to try to deescalate therapy.

But on the flip side, I think were also trying to escalate treatment for the individuals who need it. There are trials ongoing trying to do more. One study, for example, in the high-risk population would be to potentially add immunotherapy to chemotherapy and HER2-directed therapy. There is a Roche study [NCT03135171] thats adding a tocilizumab [Actemra] to AC-THP in the preoperative setting. And there are some investigator-initiated trials also adding pembrolizumab to THP preoperatively.

There are some studies that are trying to replace trastuzumab with margetuximab [Margenza] in the preoperative setting, trying to escalate therapy. There is work on both sides of the spectrum, trying to get the right amount of treatment to the right patient. I think as we learn more, hopefully, well be able to do that. Its going to be interesting to see if well ever have biomarkers that will help us or if it will need to be something else.

There are some data that suggest early [PET scan] response could be a way to judge if youre giving an appropriately deescalated therapy. That could be a way to have early markers of response to know if we can get away with a little bit less.

Whats your approach to a suboptimal response pathologically after neoadjuvant chemotherapy?

This patient received TCHP and had residual disease. Generally speaking, I tend to give 14 cycles of T-DM1, as per the KATHERINE trial [NCT01772472], because we know that that will reduce chances of recurrence by about half.5 But if they achieve pCR, then I tend to complete HP-based therapy outback. I think the question that will arise is, do you give [a patient] neratinib [Nerlynx] after completion of adjuvant HER2- directed therapy?

We have data from the ExteNET trial [NCT00878709], for example, that showed that giving a year of neratinib after completion of trastuzumab did have a significant improvement in iDFS.6 I think my challenge is that that study was done at a time when we were not giving pertuzumab. We were not giving postrehab T-DM1. And so, we dont know what the benefit of neratinib would be in a modern-era patient.

That being said, the big benefit in ExteNET was in the hormone receptorpositive, HER2-positive patients, where, if you looked at the subgroup in that trial that had residual disease that was ER-positive and HER2-positive, there was a 7% absolute difference in iDFS and a trend toward survival benefit. And so, I have taken the stance, even though its completely not data driven, if [a patient] has ER-positive, HER2-positive disease and has residual disease after preoperative therapy, then goes on to complete their T-DM1 afterward, I offer neratinib.

What about the risk of diarrhea associated with neratinib?

[There are] some newer antidiarrheal approaches. The one that I tend to like best is the dose-escalation strategy, where you can start at just 2 pills a day and then escalate up a pill a week. [In my opinion,] just purine loperamide works well because patients tachyphylaxed to the diarrhea. If you start low and go up to full dose, Ive noticed that they tolerate that well.

In fact, in the CONTROL trial [NCT02400476], which looked at various antidiarrheal regimens with neratinib, that was the best- tolerated approach with the lowest rate of discontinuation.7 The other approaches include budesonide with loperamideso thats the oral steroid thats not absorbable or using colestipol, which is a bile acid sequestering [agent], and that works well with purine loperamide I find.

Any of those strategiescolestipol/loperamide, budesonide/ loperamide, or dose-escalation neratinibhave been much better than the days of using a purine loperamide, which doesnt work as [we have seen] with the 40% rate of grade 3/4 diarrheas reported in ExteNET.6

If this patient has pCR, would you still do trastuzumab and pertuzumab because of the nodal status?

We have no answer because no one has done that study to see if you could deescalate the pertuzumab in a pCR patient. But there was a large meta-analysis, where they looked at patients who had a pCR and they looked at their risk of recurrence, and they found that baseline nodal status and tumor size were still prognostic. They were still independent prognostic indicators, even in a pCR patient. Those patients with upfront nodal involvement still have a higher rate of recurrence than the upfront node-negative patient with pCR; their baseline risk is still prognostic.

In this patient who does have high-risk [disease], we know that pertuzumab-based therapy for a year, based on APHINITY, did [lead to] risk reduction.

What is next in terms of adjuvant therapies?

There are studies that are ongoing trying to see if we can do even better than KATHERINE. Certainly, KATHERINE was very impressive with a 3-year iDFS of 88% with a 50% risk reduction.5 But there still was no reduction in CNS [central nervous system] recurrences in KATHERINE. And if you look at the node-positive subgroup of KATHERINE, their iDFS was about 83% at 3 years. So, in my mind, theres still room for improvement in the high- risk, node-positive patients.

There are studies ongoing. One is called the CompassHER2-RD study [NCT04457596], which is looking at taking patients with residual disease and randomizing them to get T-DM1 or T-DM1 plus tucatinib [Tukysa] with the idea that there are some data to suggest tucatinib, the oral TKI [tyrosine kinase inhibitor] [works] synergistically with T-DM1. Could it enhance activity and potentially even prevent CNS recurrences, knowing that tucatinib penetrates CNS?

That study will take patients with residual disease, and, just [as in] KATHERINE, randomize them to T-DM1 with or without tucatinib. And then theres a study opening through NRG [Oncology], looking at trastuzumab deruxtecan [Enhertu] in patients with residual disease [DESTINY-Breast05; NCT04622319]. Its randomizing the residual disease patient to trastuzumab deruxtecan or T-DM1, again trying to escalate therapy for that high-risk patient.

I think well see more with time about whether we can do even better for the high-risk patients, but for now, outside of a trial, T-DM1 would be the standard.

What adjustments have you made in treatment as a result of the coronavirus disease 2019 (COVID-19) pandemic?

One thing our group has started thinking about is using subcutaneous HP [Phesgo]. There are now data that compared the IV [intravenous] and subcutaneous formulations in the preoperative setting [from] the FeDeriCa study [NCT03493854].

The pCR rates were the same [59.5% vs 59.7%].8 They looked at pharmacokinetics between the 2, and they were also the same. [In terms of] adverse events, there werent any significant differences. There was a little more skin reaction at the site of the injection with the subcutaneous [formulation], but outside of that no real differences in toxicity profiles.

The other thing that I think is interesting, and I think this is a pretty cool study, is a preference study called PHranceSCa [NCT03674112], where they took people who received IV HP and then switched them to subcutaneous or did the reverse. They asked [the patients what they preferred], because every patient had been exposed to either formulation, and [more than] 80% of people preferred subcutaneous when they had received both.9

Obviously, the chair time and infusion are a lot less if you just give a 10-minute push of both drugs, rather than having to give 2 IV drugs 30 minutes each. Our group has started switching people over. It turns out when we compared the cost of subcutaneous with IV, subcutaneous was [less expensive]. I think Roche was clever in the way they priced it to try to encourage utilization. I think there are even some more advantages to chair time in the infusion center by using subcutaneous.

Our new practice has been that when we start, for example, TCHP, we just give everyone the subcutaneous formulation instead of IV. And then Ive started offering my other patients who are in maintenance HP in the adjuvant setting after their pCR, for example, the subcutaneous version because they can be in and out of infusion much [more quickly].

We usually use the thigh [for the subcutaneous infusion], and youre supposed to rotate location. Its 1 shot, theyre both drugs are mixed into 1. Thats why its nice. The problem is, it is quite a bit of volume. And so, its, [for instance], 10 cc of fluid getting pushed subcutaneously and it has to be a very slow push for 10 to 12 minutes. So, its not like a quick subcutaneous push. But patients have really liked it.

There is a study ongoing where theyre sending nurses to [patients homes] and administering the HP there. I think particularly during COVID-19 theres a big push to figure out how to do home administration of drugs. And since so many patients are on maintenance afterward, its nice for them not to have to come into clinic so much. I think well see more about the feasibility of home administration, but for now, this has to be done by a nurse in our infusion center; its not something that can be done by patients at this time.

I also use the subcutaneous trastuzumab, as well. For example, when I give TH, Ive switched over to using just subcutaneous trastuzumab, because thats also quicker, particularly when youre on just the trastuzumab maintenance. After the first 12 weeks, thats in and out of infusion very fast. I havent had any insurance pushback, which is quite interesting, when using the subcutaneous trastuzumab formulation. Its gone through just fine.

The rest is here:
Use of Anthracycline or Nonanthracycline Therapy Is Considered in HER2+ Breast Cancer - Targeted Oncology

Diabetes is a group of diseases that negatively affect how your body uses glucose or blood sugar. This is an issue because glucose is important to our health, it is an important source of energy for our body. It is also a main fuel source for our brain. Individuals affected by diabetes can either have Type 1 diabetes or Type 2 diabetes or pre-diabetes.

In Type 1 diabetes, the body just doesnt make insulin. Typically, the body is supposed to break down carbs that are eaten into glucose that it then uses for energy, and insulin is the hormone that is necessary to get blood sugar from the bloodstream into the cells. The Centers for Disease Control and Prevention (CDC), estimates that around 1.6 million Americans have Type 1 diabetes, with about 187,000 of that number being children and adolescents. Type 1 diabetes can occur in anyone at any age and it affects every race, and people of every size. The exact cause of type 1 diabetes is unknown. What is known is that your immune system which normally fights harmful bacteria or viruses attacks and destroys your insulin-producing cells in the pancreas. This leaves you with little or no insulin. Instead of being transported into your cells, sugar builds up in your bloodstream. Type 1 is thought to be caused by a combination of genetic susceptibility and environmental factors, though exactly what those factors are is still unclear. Weight is not believed to be a factor in type 1 diabetes. There are resources available to anyone affected by it. This is a condition that can be managed, by practicing healthy lifestyle habits (exercise and proper diets). Individuals with this condition can live a full and normal life.

Type 2 diabetes is when the body doesnt use insulin properly, and this is the most common type of diabetes. Different people require different treatment plans, some people can control their glucose levels by eating healthy and exercising but some may need to use medication or insulin to help them. Either way, there are resources and support available to help everyone affected.

A large and important part of managing type 2 diabetes is maintaining a healthy diet and exercising. It is essential to find a diet that can be maintained, by finding a healthy diet that you actually enjoy. Fitness is also important, and thankfully there are many options available to those who want to get moving. Find activities that you enjoy doing and do them in your free time. Working with your physician to determine what physical activity level you can actually handle and that you should engage in, is a good first step to take to get active.

Another health condition related to diabetes is prediabetes. This is where your glucose levels are higher than normal but not quite high enough to be diagnosed as type 2 diabetes. According to the CDC, 88 million American adults have prediabetes, with more than 80% of them knowing that they have it. Prediabetes puts you at risk of developing type 2 diabetes, stroke, and heart disease. However, if you have prediabetes lifestyle changes can be made to delay or even prevent the onset of type 2 diabetes and the other serious health problems that prediabetes puts you at risk for.

Regardless of the type of diabetes certain signs and symptoms occur. They include increased thirst, frequent urination, extreme hunger, unexplained weight loss, presence of ketones in the urine (ketones are a byproduct of the breakdown of muscle and fat that happens when theres not enough available insulin), fatigue, irritability, blurred vision, slow-healing sores, frequent infections, such as gums or skin infections and vaginal infections. Ask your healthcare provider for help and testing if you notice any of these symptoms.

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Originally posted here:
LIVE WELL: The importance of knowing the aspects of diabetes - Stillwater News Press

Choosing to avoid meat and eat a plant-based diet has never seemed so virtuous and necessary. Between the intrinsic cruelty of industrial livestock production and livestocks climate footprintestimated by the U.N.s Food and Agriculture Organization to be 14.5% of all greenhouse gases world-wide, significantly greater than that of plant agricultureit has become increasingly difficult to defend the place of meat and animal-sourced foods in our diets. Jonathan Safran Foer, the novelist turned animal-rights activist, may have best captured this thinking in his 2019 nonfiction book, We Are the Weather: Saving the Planet Begins at Breakfast. As he writes, We cannot keep the kind of meals we have known and also keep the planet we have known. We must either let some eating habits go or let the planet go. It is that straightforward, that fraught.

An essential part of this argument is the proposition that animal-sourced foods, and particularly red and processed meats, arent just bad for the planet but harmful for the people who eat them. As the journalist Michael Pollan famously urged in his 2008 bestseller In Defense of Food, that is why we should eat mostly plants. This has become the lone piece of dietary counseling on which most nutritional authorities seemingly agree. It creates a win-win proposition: By eating mostly (or even exclusively) fruits, vegetables, whole grains and legumes, while getting our proteins and fats from plant-based sources, we maximize our likelihood of living a long and healthy life while also doing whats right for the planet.

But is it that simple? A growing body of evidence suggests it isnt, at least not for many of us.

The other food movement that has won increased acceptance over the past decade is the low-carbohydrate, high-fat ketogenic dietketo, for shortwhich has emerged as a direct response to the explosive rise in the incidence of obesity and diabetes. More than 70% of American adults are now obese or overweight, according to the Centers for Disease Control and Prevention; nearly one in 10 is severely obese, and more than one in 10 is diabetic. An unavoidable implication of these numbers is that the conventional wisdom on weight losseat less, move your body morehas failed tens of millions of Americans.

These are the people who, sooner or later, may well experiment with alternative approaches, venturing into the realm of fad diets. They may try plant-based eatingvegetarian or even veganand if those dont return them to health, try keto or one of the many variations on low-carbohydrate, high-fat diets, from the original Atkins diet to the South Beach diet to paleo to the latest trend, carnivore. If they find that an unconventional approach works for them, allowing them to achieve and maintain a relatively healthy weight without enduring hunger, that will be their motivation to sustain it. But because this way of eating is most easily accomplished with animal-sourced foods, they may come to believe that whats good for them (and even their children) isnt good for the planet.

See more here:
The Keto Way: What If Meat Is Our Healthiest Diet? - The Wall Street Journal

While regular use of contraceptives is the best choice to prevent pregnancy, emergency contraception is a safe way to prevent an unwanted pregnancy after having unprotected sex.

If you've recently had unprotected sex and are looking for emergency contraception your main options are:

Here's a breakdown of the pros and cons of each type and how to choose the best emergency contraception for you.

Levonorgestrel is a synthetic hormone that stops the release of the egg from the ovaries to prevent fertilization, says Julie Levitt, MD, a gynecologist at The Women's Group of Northwestern.While there are several popular brands, including Plan B One-Step, My Way, and After, the effectiveness is the same no matter which pill you take.

When can I use it? You can use levonorgestrel for up to 72 hours (3 days) after unprotected sex, but it is best to take the pill as soon as possible for better efficacy.

How effective is it? Numerous studies have found levonorgestrel to be 60% to 94% effective in preventing pregnancy depending on how soon you take the pill.

Do I need a prescription? No, you can buy the pill over the counter and most pharmacies or drug stores carry it.

Ella is an emergency oral contraceptive that contains a drug called ulipristal acetate. While it does not contain estrogen or progesterone, it is a single-dose steroid medication. Taking a single tablet prevents ovulation, delaying a woman from releasing the egg from her ovary.

When can I use it? Ella is effective up to five days (120 hours) after unprotected sex. Like the copper IUD, this method does not diminish over time, but it is best to take it as soon as possible to avoid ovulation. If you vomit within three hours after taking the pill, ask your medical provider whether you should take another one.

How effective is it? It's around 65% to 85% effective at preventing pregnancy depending on how soon you take the pill, says Bartz.

Do I need a prescription? Yes, you need a prescription for Ella. There are some certified online prescription services or contact your doctor as soon as you can after unprotected sex.

A copper intrauterine device, or IUD, is a small T-shaped frame that is inserted into the uterus. The device contains no hormones and instead copper keeps sperm from the egg, preventing pregnancy from occurring. This makes it a good option for those who are sensitive to hormonal side effects or can't use hormones due to medical conditions. The copper IUD can provide up t

When can I use it? You can use a copper IUD as emergency contraception up to five days (120 hours) after unprotected sex, but some studies have found it can be effective up to 10 days after.

How effective is it? The copper IUD is the most effective emergency contraception, says Deborah Bartz, MD, MPH, a gynecologist at Brigham and Women's Hospital in Boston, MA. It is over 99% effective in preventing pregnancy and works just as effectively on day one as day five.

Do I need a prescription? No, you do not need a prescription, but a copper IUD must be inserted by a medical professional, such as a women's doctor or nurse. It may be challenging to rely on this method because it requires a prompt appointment.

Birth control pills are an oral contraceptive that contains the hormones estrogen and progestin, which prevents pregnancy by blocking the release of the egg from the ovaries. While these pills are normally taken as a form of daily birth control, they may be also used as emergency contraception after unprotected sex. This is known as the Yuzpe regimen.

There are many different types of birth control pills some with hormone levels that change each week, others with a steady dose daily. For this reason, the exact number of tablets to take for the first dose may vary, and a second dose is generally taken 12 hours later.

The exact dosage needed in total is 200 mcg Ethinyl estradiol the estrogen component and 1 mg progesterone. However, it is not recommended that you do this independently due to the irregularity of the dosing and the high possibility for side effects. Speak with your OBGYN to determine if this is the right method for you to pursue.

When can I use it? The Yuzpe regimen is effective up to 72 hours (3 days) after unprotected sex, but it is recommended to use only if the other contraceptive methods are not readily available. You should also only use it under the direction of a healthcare provider.

How effective is it? Much like the other oral contraceptives, the longer you wait to take the birth control dose, the less effective the method will be. The American College of Obstetricians and Gynecologists no longer recommend this method because it is the least effective (with an average of 74% effectiveness) and has high side effect risks, such as nausea and vomiting.

Do I need a prescription? Yes. You can get a prescription from a healthcare professional, such as an OBGYN, a physician at a Planned Parenthood, or a licensed pharmacist.

When considering which emergency contraception to use, there are some factors to keep in mind.

When you last had sex: Non-hormonal contraceptives, i.e. Ella and the copper IUD, can work up to five days after, or possibly longer, while most hormonal options plan B and the pill are limited to 72 hours.

Weight: If you weigh more than 155lb, pills containing levonorgestrel, like plan B, may be less effective, and you should ask your doctor for an Ella prescription. However, if you weigh over 195 lbs, Ella may not be as effective.Weight has no effect on the copper IUD.

What research says: A 2015 study found that the rate of pregnancy in women over 165 lbs increased significantly (5% to 6%) when taking levonorgestrel. Another large 2012 study found the rate of pregnancy in obese women increased by 7% when taking ulipristal acetate.

Affordability and accessibility: Generally, contraceptives with levonorgestrel are the easiest to find. Meanwhile, Ella is less common in pharmacies and requires a prescription.

Planned Parenthood can be an affordable option for emergency contraception, says Levitt, since they are able to provide care at a lower cost. The organization also has a nifty quiz you can take to determine which emergency contraception is right for you.

Emergency contraception after unprotected sex can come in non-hormonal and hormonal options that vary in effectiveness and method. Choosing which is best for you can depend on various factors, such as weight, when you last had sex, and accessibility, and should be discussed further with your healthcare provider.

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Emergency contraception: Which type is best for you? - Insider - INSIDER

Investigators are seeking to determine whether amcenestrant (SAR439859), an investigational oral endocrine therapy, can generate meaningful antitumor activity when administered as short-term preoperative therapy to postmenopausal patients with newly diagnosed early breast cancer.

The phase 2 AMEERA-4 trial (NCT04191382) is testing 2 dose levels of amcenestrant versus letrozole given for 14 days to patients with estrogen receptor (ER)-positive, HER2-negative localized breast cancer who are candidates for breast conserving therapy or upfront mastectomy.1

The study will measure the impact of the short course of endocrine therapy on Ki-67, a protein biomarker of cellular proliferation that has been shown to be a prognostic indicator of survival and recurrence in patients with early breast cancer, with higher levels associated with worse outcomes.2

Ki-67 expression has been correlated with poor cancer-specific survival at a cutoff point greater than 14% of tumor nuceli.3 AMEERA-4 is a window of opportunity study, a validated strategy for rapid exploration of proof-of concept treatment approaches, investigators said in a poster presentation at the 2020 American Society of Clinical Oncology Virtual Scientific Program.4

The trials goals include determining the best dosage for further study of amcenestrant in this clinical setting, said principal investigator Mario Campone, MD, a medical oncologist at the Institut de Cancrologie de lOuest, Ren Gauducheau, in St Herblain, France.

Some clinical trials have demonstrated that when you have a decrease in Ki-67 after 2 weeks you have a better outcome compared with the patients who do not have a decrease in this surrogate marker, he said in an interview with OncologyLive.

Amcenestrant is a selective ER degrader (SERD), a class of drugs that works by serving as a competitive antagonist to the ER, inducing conformational changes that lead to degradation of the receptors. In preclinical studies, the agent has demonstrated antitumor efficacy and regression in ER-positive breast cancer models.5 Further, amcenestrant can be administered as an oral therapy because of its favorable pharmacokinetic profile, as opposed to fulvestrant (Faslodex), a SERD that must be given via intramuscular injection because of pharmacokinetic limitations.5,6

AMEERA-4, an international, open-label study, was initiated in December 2019 and is being conducted at 16 active sites with 34 planned sites, Campone said.

Participants are being randomized 1:1:1 to receive daily amcenestrant at 400 mg, daily amcenestrant at 200 mg, or daily letrozole at 2.5 mg for 14 days, with the last dose administered on the day before surgery. Biopsies are performed at baseline and during surgery (FIGURE).1,4

The primary end point is a change in Ki-67 expression measured by immunohistochemistry after a 14-day treatment period compared with baseline levels. Secondary end points include the proportion of patients with relative decrease from baseline in Ki-67 expression of 50% or more, change in ER expression compared with baseline, and safety and tolerability.

Efficacy will be assessed via pathological complete response (pCR), which is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary nodes after treatment. ECOG performance status response will be measured after the 14-day treatment based on breast tumor shrinkage and pCR. Additionally, a preoperative endocrine prognostic index derived from pathologic tumor and node stages, Ki-67 levels, and ER status of the surgical specimen will be assessed after the 14-day treatment period.

Investigators are seeking to recruit 126 patients for the study. So far, 14 patients have been enrolled, and the study could be completed sometime this year, with data analysis projected for 2022, Campone said.

After completion of the AMEERA-4 study, Sanofi, the agents developer, plans to initiate a pivotal clinical trial to study amcenestrant in early breast cancer.7 AMEERA-6 will be a registrational study with invasive disease-free survival as the primary end point. This study will be supported in part by data generated from AMEERA-4, which is expected in to be available in 2021, according to a Sanofi spokesperson. AMEERA-6 is expected to begin recruiting patients by the end of 2021.

The use of amcenestrant as monotherapy has shown encouraging signals in the ongoing phase 1/2 AMEERA-1 trial (NCT03284957). In interim results reported at the 2020 San Antonio Breast Cancer Symposium, amcenestrant monotherapy elicited antitumor activity in heavily pretreated, postmenopausal women with advanced or metastatic ER-positive breast cancer.8

Results showed that the objective response rate (ORR) was 8.5% with amcenestrant with a clinical benefit rate (CBR) of 33.9% among pooled results from 59 patients who received amcenestrant at 150 mg or more daily. In a cohort of 33 patients who had received 3 or fewer prior lines of therapy in the metastatic setting, the ORR was 15.2% and the CBR was 42.4%. Moreover, in a subgroup of 14 patients who did not receive prior CDK4/6 inhibitors, mTOR inhibitors, or fulvestrant, the ORR was 21.4% and the CBR was 64.3%.8

In AMEERA-1, which is a first-in-human study, investigators are evaluating the safety and efficacy of amcenestrant as a single agent and in combination with targeted therapies in patients with ER-positive, HER2-negative metastatic breast cancer. In part A of the trial, which was the dose-escalation phase, investigators evaluated amcenestrant at oncedaily doses ranging from 20 mg to 600 mg. In part B, which was the dose-expansion phase, the recommended dose for amcenestrant as monotherapy was determined to be 400 mg once daily.

Amcenestrant was found to have a favorable safety profile with 62.9% of patients experiencing treatment-related adverse events (TRAEs), none of which were grade 3 or higher. The most common (5%) TRAEs in the pooled population of patients who were treated with amcenestrant at the 150-mg or higher daily dose included hot f lush (16.1%), constipation (9.7%), arthralgia (9.7%), decreased appetite (8.1%), vomiting (8.1%), diarrhea (8.1%), nausea (8.1%), and fatigue (6.5%).8

Pivotal results are expected in the f irst half of 2021, according to Sanofi. Amcenestrant as a monotherapy may be available as a second- and third-line treatment for patients with metastatic breast cancer in 2022, the company said.7

Amcenestrant monotherapy is also being evaluated versus physicians choice of therapy in the open label, phase 2 trial AMEERA-3 trial (NCT04059484), which will enroll 372 patients. The control treatment involves choosing monotherapy from a list of agents with different mechanisms of action: anastrozole, letrozole, or exemestane, which are aromatase inhibitors; tamoxifen, a selective estrogen receptor modulator; or fulvestrant. The primary end point is progression-free survival (PFS). Secondary end points include OS, ORR, disease control rate, CBR, and duration of response (DOR).9

Another study, AMEERA-5 (NCT04478266), is testing amcenestrant in combination with palbociclib (Ibrance), a CDK4/6 inhibitor, versus letrozole plus palbociclib as a first-line therapy for patients with ER-positive, HER2negative locoregional or metastatic breast cancer. The study, which aims to recruit 810 patients, has a primary end point of PFS and secondary end points of OS, ORR, DOR, and CBR.10

Additionally, the Quantum Leap Healthcare Collaborative announced in June 2020 that amcenestrant was selected to be part of a new I-SPY 2 study arm.

The study, known as the I-SPY 2 Endocrine Optimization Protocol (EOP), is focused on patients with molecularly low-risk, clinically high-risk, hormone receptorpositive, HER2negative clinical stage II or III invasive breast cancer. Amcenestrant will be tested as a monotherapy and in combination with up to 3 other agents.11

The I-SPY program was designed to identify therapies that are most effective in specific patient subgroups based on biomarker signatures. Sanofi is supplying the drug and providing financial support.

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Trial Explores Preoperative Window for Amcenestrant Therapy in Early Breast Cancer - OncLive