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Monthly Archives: August 2021
Preimplantation Genetic Testing Demand to Grow by 9% CAGR Annually, through 2031 – BioSpace
Posted: August 5, 2021 at 2:00 am
Preimplantation Genetic Testing Application in Embryo HLA Typing for Stem Cell Therapy will Increase, Surpassing US$ 70 Mn by 2031
The study of the preimplantation genetic testing market offers compelling insights into key factors affecting market growth trajectory. The survey report discloses insights into preimplantation genetic testing demand outlook in terms of test type, end user, application, and technology. The report also highlights the scope of preimplantation genetic testing over the forecast period
Fact.MR A Market Research and Competitive Intelligence Provider: As per a survey conducted by Fact.MR, the global preimplantation genetic testing market reached a valuation of US$ 550 million in 2020, expanding at a CAGR of 8% between 2016 and 2020.
Owing to the increase in incidence of chronic diseases and disabilities across the globe, the market for preimplantation genetic testing is estimated to surge at a robust CAGR of 9% over the forecast period 2021 to 2031.
Preimplantation genetic testing is gaining traction on the back of rising prevalence of genetic disorders among children and disabilities among the aged population. According to a study by Genetic Alliance, in the U.K., out of every 25 children, 1 child is affected by a genetic disorder and nearly 30,000 babies are diagnosed with the disease every year. Besides this, over 500 million adults and children are living with a genetic disorder in the country.
As preimplantation genetic testing is proven as an effective solution for diagnostics of genetic disorders, it is increasingly being used by healthcare providers and institutions for identifying defects present in embryos before implantation.
Thus, the need for effective diagnostic solutions to curb the rising prevalence of genetic disorders in newborns will spur the demand for preimplantation genetic testing over the coming years.
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Embryo Human leukocyte antigen (HLA) typing for stem cell therapy is anticipated to dominate the market, accounting for over 40% of the revenue share. In response to the increasing application of preimplantation genetic testing in the procedure, the segment is projected to surpass a valuation of US$ 70 million by the end of 2031.
Several healthcare institutes and research centers are increasingly investing in research & development (R&D) to find novel techniques to minimize the risks associated with the preimplantation genetic testing. Their efforts are expected to bode well for the market, creating opportunities for growth, says the Fact.MR analyst.
Key Takeaways from Preimplantation Genetic Testing Market Survey
Key Drivers
Key Restraints
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Competitive Landscape
The global market for preimplantation genetic testing is highly consolidated, where a small group of leading players are accounting for nearly half of the global sales. Key player in the landscape are focusing on engaging into strategic collaboration with other players to strengthen their market footprint. For instance,
Some of the prominent preimplantation genetic testing providers profiled by Fact.MR are:
More Valuable Insights on Preimplantation Genetic Testing Market
Fact.MR, in its new report, offers an unbiased analysis of the global preimplantation genetic testing market, analyzing forecast statistics through 2021 and beyond. The survey reveals growth projections on in the preimplantation genetic testing market with detailed segmentation:
Key Questions Covered in the Preimplantation Genetic Testing Market Report
Explore Fact.MRs Coverage on the Healthcare Domain
Genetic Testing Services Market - The future expansion of genetic testing services is heavily reliant on the advancement of information technology. Throughout the projected period, North America is expected to dominate the worldwide genetic testing services market. Increased demand for genetic testing to determine ancestry, as well as an increase in demand for in-vitro fertilization (IVF) and pre-implantation testing, are some of the primary reasons boosting market share. According to projections, the North American genetic testing market will account for over two-fifths of the total.
Rheumatoid Arthritis Stem Cell Therapy Market - Over the forecast period, the global market for rheumatoid arthritis treatments is expected to rise moderately. Over the projected period, the allogeneic mesenchymal stem cell segment is expected to lead the global rheumatoid arthritis stem cell therapy market. As the most accessible channel, hospitals are likely to account for a sizable portion of the global rheumatoid arthritis stem cell therapy market.
Serological Transplant Diagnostics Market - Serological transplant diagnosis, which is a critical component of successful and efficient organ transplantation, has grown rapidly in recent years. Growth in important distribution channels, such as hospitals and organ transplantation centres, to name a few, has boosted demand during the last five years, from 2016 to 2020, attracting more stakeholders to the business. Serological transplant diagnostic equipment sales are being fueled by an increase in incidence of serious lung, liver, and kidney disorders, as well as medical and diagnostic developments.
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Market research and consulting agency with a difference! Thats why 80% of Fortune 1,000 companies trust us for making their most critical decisions. We have offices in US and Dublin, whereas our global headquarter is in Dubai. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analyzed. Reach out to us with your goals, and well be an able research partner.
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Preimplantation Genetic Testing Demand to Grow by 9% CAGR Annually, through 2031 - BioSpace
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Astellas and Minovia Therapeutics Announce Strategic Collaboration for Novel Mitochondrial Cell Therapy Programs – Business Wire
Posted: August 5, 2021 at 2:00 am
TOKYO & HAIFA, Israel--(BUSINESS WIRE)--Minovia Therapeutics, Ltd. (CEO; Natalie Yivgi-Ohana, Ph.D., Minovia) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas) today announced a worldwide strategic collaboration and license agreement for the research, development, and commercialization of novel cell therapy programs for diseases caused by mitochondrial dysfunction.
Through this strategic collaboration, Astellas and Minovia aim to accelerate the creation of allogeneic mitochondrial cell therapy programs. The two companies will jointly research cell therapy program candidates comprised of cells derived from Astellas proprietary genetically-engineered, induced pluripotent stem cells and augmented with Minovias proprietary MAT platform technology. The goal of these programs will be to treat diseases caused by mitochondrial dysfunction, through the transfer of healthy mitochondria to restore the patients tissues.
Minovia is a leading company in the field of mitochondrial cell therapy that utilizes mitochondrial transfer to deliver healthy mitochondria to a patients diseased cells. Minovia has a unique technology platform called Mitochondrial Augmentation Therapy (MAT), where the patients own cells are isolated, loaded with healthy mitochondria obtained from a healthy donor, and then re-infused back into the patient. Minovia is currently conducting research, development and clinical studies with MAT in mitochondrial diseases.
Astellas is engaged through its US subsidiary companies, Astellas Institute for Regenerative Medicine (AIRM) and Universal Cells Inc., to advance allogeneic, off-the-shelf, differentiated cell therapy programs derived from pluripotent stem cells1. The new collaboration with Minovia extends Astellas capabilities in mitochondrial biology, and follow its recent acquisition of Mitobridge, Inc. and Nanna Therapeutics Limited2,3.
We are excited and honored to collaborate with Astellas, stated Minovias Co-founder and Chief Executive Officer, Natalie Yivgi-Ohana, Ph.D. We share with Astellas both their passion for mitochondrial science and their commitment to patients in need of new therapies. As Minovia continues the development of Mitochondrial Augmentation Therapy, we believe this partnership is critical to accelerate the development of off-the-shelf, allogeneic cell therapy programs for the many patients living with mitochondrial diseases caused by mitochondrial dysfunction.
Naoki Okamura, Representative Director, Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, at Astellas said, "We, at Astellas, have positioned mitochondrial biology as one of the Primary Focuses of our research and development strategy to develop therapies for patients with unmet medical needs. One of the aspirations of this Primary Focus is to establish a mitochondrial cell therapy platform. Minovia is pioneering mitochondrial cell therapy and has unique technologies for enhancing delivery of healthy mitochondria to the patients cells. This strategic collaboration with Minovia will accelerate and expand our pipeline of treatment options for patients with diseases with underlying mitochodrial dysfunction.
Under the terms of the agreement, Minovia receives an upfront cash payment of $20M USD. Through the joint research program with Minovia, if Astellas develops and commercializes product candidates for diseases caused by mitochondrial dysfunction, Minovia is eligible to receive up to $420M USD per product in future development, regulatory and commercial milestone payments from Astellas.
*1: R&D Meeting (December 10, 2020). Available at: https://sw4503.swcms.net/ja/ir-library/ir-meetings/inframe/main/014/teaserItems1/07/linkList/0/link/RDmeeting2020_pre_jp.pdf *2: Astellas Corporate website Accelerating the discovery and development of novel drugs that target mitochondrial functions.. Available at: https://www.astellas.com/jp/en/stories/science/mitobridge *3: Astellas Corporate website Primary Focus - Mitochondria Biology. Available at: https://www.astellas.com/jp/en/partnering/primary-focus#Mitochondria-Biology
About MinoviaMinovia Therapeutics, Ltd. is a clinical stage company and the first to use a mitochondrial cell therapy approach with the hope of bringing life-changing therapies to patients living with mitochondrial diseases, through their proprietary Mitochondrial Augmentation Therapy (MAT) platform. Minovia has an on-going autologous cell therapy program in clinical development, utilizing MAT for the future potential treatment of primary and secondary mitochondrial diseases. For more information, please visit our website at https://www.minoviatx.com.
About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.
Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on managements current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
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Is This Small-Cap Biotech a Buy After Its Second Approved Gene Therapy? – Motley Fool
Posted: August 5, 2021 at 2:00 am
Despite recently getting its third drug approved, Bluebird Bio (NASDAQ:BLUE) only has a $1.7 billion market cap. Will the company overcome its past pricing issues and fly to new highs? And could its lead in sickle cell disease clinical trials translate into massive gains for investors?
Bluebird Bio already had a multiple myeloma CAR T-cell therapy, Abecma, approved earlier this year, and now it has not one, but two gene therapy approvals for rare genetic diseases in the EU. On July 21, the rapidly maturing biotech received EU approval for its latest gene therapy, Skysona, for cerebral adrenoleukodystrophy (CALD). This rare pediatric neurodegenerative disease affects boys, with just over 1,000 patients having been diagnosed in the U.S., and just over 6,000 in Europe. Devastating and irreversible, it worsens over time, causing deterioration of nerve cells in the brain. Most patients die within two years of diagnosis.
Before Skysona was approved, the only option available to CALD patients was a stem cell transplant -- a treatment that is less likely to cause complications if the donor is a sibling. However, it is estimated that fewer than 20% of CALD patients have a matched sibling donor.
Image source: Getty Images.
Skysona, a one-time gene therapy, has proven very effective against CALD -- 90% of patients who underwent the treatment were free from major functional disabilities at least 24 months afterward. But cost is liable to be an issue. Bluebird Bio priced its first gene therapy, Zynteglo (marketed for a different rare genetic disease, transfusion-dependent beta-thalassemia), at $1.8 million, so I expect it to price Skysona similarly. With approximately 6,000 CALD patients in Europe, that's an addressable market worth just over $10 billion.
Despite Zynteglo's great benefits for patients, Bluebird has had trouble reaching reimbursement agreements with payers for the treatment. The biotech even withdrew Zynteglo from the German market in April after it could not agree on a price with that nation's public health insurance system. There is also the question of who is diagnosing such a rare disease. In most EU countries, newborns are not screened for CALD, and in the U.S., only 20 states and the District of Columbia screen for it. Unfortunately, the lack of testing may be leaving a significant percentage of CALD patients undiagnosed.
All of this may at least be partially factoring into Wall Street's weak revenue forecasts for Skysona. One analyst at Jefferies projects peak annual sales of only $74 million for the CALD gene therapy.
While Skysona can be a life-extending therapy for CALD patients, as Zynteglo is for transfusion-dependent beta-thalassemia patients, these are incredibly rare diseases. Bluebird Bio's next target, sickle cell disease, is more common, affecting approximately 100,000 Americans and 1 out of every 365 African-American births, according to the Centers for Disease Control and Prevention. Given that its sickle cell disease treatment utilizes a lentivirus-based delivery system similar to the ones used by Zynteglo and Skysona, the company will have quite a bit of safety data to lean on when it goes to the FDA for approval of its sickle cell treatment. That's tentatively scheduled to happen in 2023.
While CRISPR-based treatments have generated a lot of hype,the sickle cell treatment utilizing CRISPR that is the most advanced in clinical trials is CTX001, which is being developed jointly by CRISPR Therapeutics (NASDAQ:CRSP) and Vertex (NASDAQ:VRTX). Thus far, they have only delivered data on seven CTX001 recipients in a phase 1/2 trial. By contrast, Bluebird Bio's sickle cell therapy has already moved into phase 3 trials after showing significant promise in its earlier-stage studies. So Bluebird Bio seems to have at least a two- to three-year lead on its CRISPR-based rivals in its efforts to get a therapy approved for this large potential market.
In a sense, Zynteglo and Skysona are warmups for Bluebird Bio as it prepares for all of the pricing issues and negotiations that will come with the massive addressable market that is sickle cell disease gene therapy. With approximately 100,000 people suffering from the disease in the U.S. alone, even at just 5% penetration, this could be a $10 billion a year opportunity. If it can approach that level of market penetration, Bluebird Bio could surge past its current market-cap peak to reach over $15 billion -- which would make it just under a 10-bagger from here. And that does not factor in the estimates for more than $1 billion in annual sales for Abecma by 2026.
Considering that Bluebird Bio currently has a market cap of $1.7 billion with just over $1 billion in cash on the books, there is a lot of potential upside here. Given its significant head start in the race to FDA approval for a sickle cell gene therapy, plus significant experience in the gene therapy field from its other endeavors, I'm rooting for this cutting-edge biotech to overcome its prior missteps and reward both patients and investors.
This article represents the opinion of the writer, who may disagree with the official recommendation position of a Motley Fool premium advisory service. Were motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.
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Improving the Treatment Gap in Diffuse Large B-Cell Lymphoma – Targeted Oncology
Posted: August 5, 2021 at 2:00 am
Gilles Salles, MD, discusses the need for new therapies to treat diffuse large B-cell lymphoma.
Gilles Salles, MD, the lymphoma service chief at Memorial Sloan Kettering Cancer Center, discusses the need for new therapies to treat diffuse large B-cell lymphoma (DLBCL).
According to Salles, once patients fail primary therapy, limited options remain. For approximately 50% of the patient population, those with limited comorbidities or those under a certain age, the standard of care is salvage chemotherapy followed by stem cell transplant.
However, for the approximately half of patients who are not eligible for this route, the treatment is usually immuno-chemotherapy, according to Salles. For most regimens, the response rate is limited. For patients who do respond, the duration of response (DOR) is typically only between 4 to 6 months. The median survival after the second-line therapy is about a year.
News agents have made progress in this space. For example, chimeric antigen receptor T cells show promise, but eligibility and access remain a major hurdle for many patients. New agents are also in the pipeline, though according to Salles, many have a short DOR.
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The Basics of MDS: Diagnosis and Staging – Curetoday.com
Posted: August 5, 2021 at 2:00 am
Myelodysplastic syndromes, known commonly as MDS, are a group of bone marrow diseases characterized by bone marrow failure, or an inadequate production of blood counts called cytopenia.
In a presentation at the CURE Educated Patient Leukemia Summit, Dr. Rami Komrokji, section head for Leukemia and MDS and Vice Chair of the Department of Malignant Hematology at Moffit Cancer Center, gave a run down on the diagnosis and staging process for MDS.
Diagnosing MDS
Komrokji explained that the myelo- prefix means bone marrow, and -dysplasia means abnormal-looking cells. When a patient has cytopenia, they may experience certain symptoms.
If patient is anemic, they will have shortness of breath, fatigue, palpitations, said Komrokji in an interview with CURE. If they have low platelets, they will have bleeding tendency, bruising. If they have low white blood cell counts, they will have maybe infections. So usually, either some of those symptoms will prompt blood testing, or on routine physical exam, the patients are found to have low blood counts. So that's usually the initial step.
Doctors will usually look into nutritional deficiencies such as B12, folate and ferritin, said Komrokji. Eventually, the patients will get a bone marrow aspirate and biopsy to diagnose their disease, which includes several parts.
There is the morphologic part, which means the pathologists are looking at the cells under a microscope, explained Komrokji. And then there is also some genetic testing. We look at cytogenetics nowadays, we look at gene mutations. So we put all of this information together to make the diagnosis.
The hematopathologist must see dysplasia, increased myeloblasts (immature cells known as blasts within the bone marrow) or certain cytogenetic abnormalities to make their diagnosis, Komrokji said.
Sometimes the diagnosis is straightforward, but sometimes it could be challenging, he added. It truly depends on an experienced hematopathologist to make the diagnosis.
Staging and Risk Stratification
Once a patient receives an MDS diagnosis, their doctor will go over risk stratification, or understanding what the risk of their disease is, which is what they consider staging, Komrokji said.
Now in MDS, its not like a lung cancer or colon cancer, he said. The disease does not spread around. The staging is based on the blood counts, on the percentage of those myeloblasts or immature cells (and) the chromosomal makeup of the cells. And nowadays, we sometimes also incorporate the presence of gene mis-happenings as well. So we get a lump score to estimate the risk.
Doctors typically use the International Prognostic Scoring System (IPSS) to categorize patients into one of five categories very low, low, intermediate, high and very high. The risk is the impact on survival and whether the disease will transform to leukemia, Komrokji explained. The disease risk must be known in order to tailor the patients treatment to them.
I always advise patients to see a specialized center in MDS, because obviously, those are not that common diseases, he said. A community oncologist could see a few (cases) per year, while an experienced center like in our place, we see like 15 to 20 per week.
Gene Mutations
Komrokji said that understanding gene mutations is an evolving field that is slowly becoming routine.
I advise all patients to inquire if theyve gotten genetic testing or not, he said. This sort of testing will help them understand any abnormalities. Doctors can look at a patients individual gene levels and detect for mutations, of which at least one was identified in 90% of patients with MDS.
Understanding the patients mutation(s) helps them tell whether there is a clonal hematopoiesis or mis-happening that occurred. It can also impact prognosis and allow them to further understand the disease risk.
And finally, some of them are targetable or important to follow through the treatment, said Komrokji. So patients should probably definitely have a genetic testing done. And sometimes after a treatment failure, we repeat it because we see other mutations that we could target with new drugs.
What Causes MDS?
In most cases, the cause of a patients MDS diagnosis is unknown.
We think it's phenomena of senescence or aging of those stem cells in the bone marrow that produces the blood, said Komrokji. Obviously, the process is very complicated. We have billions and billions of cells divide billions of times a day. So you know, as those cells age, mistakes can happen in them.
In most cases, he said, the mis-happenings which lead to the disease are random and at no fault of the patient. It is extremely rare for MDS to be inherited through familial genes.
There are, however, several known risk factors of MDS. If someone has history of another form of cancer and has received chemotherapy or radiation therapy, they may have possible stem cell damage and can develop MDS this is called therapy-related MDS. There has also been association of the disease with benzene exposure, chemical exposure and radiation exposure. Patients who have connective tissue diseases such as rheumatoid arthritis and lupus are at a slightly higher risk of getting MDS due to inflammation in the body and certain medications used to treat those diseases.
I would say there's a lot of better understanding of the disease in the past several years, of genetic mutation testing and incorporating them in practice, Komrokji said. And I think, you know, there are a lot of new treatments on the horizon for patients; there are several clinical trials in advanced phase.
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Clinical Protocols based on Molecular Cancer genetics and DNA OncoPharmaceutics to detect aberrant cellular malformations induced by DNA methylation…
Posted: August 5, 2021 at 1:59 am
Molecular Targets and OncoDNA Therapeutics Drive Precision Medicine Across Multiple Solid Tumor Types and 4 Hematologic Malignancies in Decoding and Disabling Treatment Resistant Cancers
SAN FRANCISCO, Aug. 4, 2021 /PRNewswire/ -- Nathan Sassover, CEO of World Cancer Institute Inc. today stated: We are presenting further clinical guidance on the progression of the multivalent CancerVX / OncoVacx combinatorial therapeutic platform:
"Our first 2017 reported favorable Breast Cancer patient outcome in a Stage 3b ductal infiltrating carcinoma was followed by several years of additional refinement in creating an enlarged optimal platform of compound protocols which conjoin molecular cancer genetics with epigenetic DNA reversible pharmaceutics and epigenomic targeting of a spectrum of solid tumor and hematologic cancers often resistant to chemotherapy and radiation.
"It is our continued belief that this primary focus on the causal point of aberrant cell formation / replication at the nexus of the mitotic spindle and microtubule chromosomal interface is the dynamic and formative inflection point and catalyst within the tumor microenvironment." The integration of DNA demethylation and HDAC -Histone Regulation via Histone Deacetylase Methyltransferase Inhibitors remains the clinical focal point of our therapeutic framework."
World Cancer Institute Protocols conjoining CancerVX / OncoVacx have been designed as a monotherapy or combination therapy comprising multivalent compound conjugates within a clinical framework addressing the majority of prevalent cancers.
Sassover added:
"The spectrum of our most recent 2018 / 2019 reported Case Studies and additional planned Case Studies are intended to add more clinical credence to the targeted safety / efficacy outcomes and targeted patient treatment endpoints. We feel it further affirms World Cancer Institute's view that OncoEpigenomics defines the future of cancer immunotherapies as more likely to be systemically safe in contrast to CRISPR and other gene editing protocols requiring extraction and re-infusion of modified DNA to initialize any interventional treatment.
Story continues
To date the benefits derived from these gene modification/editing procedures have been limited to small subsets of patients, while notable immediate and delayed side effects, coupled with other adverse events have been reported by medical institutions and medical journal published outcomes have revealed patient responses with notable increase in levels of post-treatment complications. There have been continuing clinical reports of diminished efficacy of various 'in laboratory' gene editing therapies over time,
Sassover further commented: "Oncologists and scientists would concur that the endpoints of cancer treatment should be defined by rapid onset effective treatment as well as more probable bioactive prevention of adverse events, relapse and disease recurrence."
CASE STUDY OVERVIEW: PATIENT PROFILE
A relatively rare and aggressive cancer type -Metastatic Testicular Carcinoma is currently in review by World Cancer Institute for administration of the OncoEpigenomic IECT [ IntraTherapies Epigenetic Cancer Therapies] CancerVX / OncoVacx compound as a next phase adjuvant protocol as described in this article and more definitively in the attached Medical Guide in reference to the specific 43 year old male Testicular Carcinoma-Metastatic case.
Proposed Treatment Protocol
The proliferating and rapidly replicating characteristics of this initial testicular Carcinoma was diagnosed followed by immediate surgical procedure at Eisenhower Medical Center Rancho Mirage CA. The patient initiated contact with World Cancer Institute in March 2018 and after describing the condition was immediately directed to proceed to Eisenhower for emergency evaluation.
Following surgery and extended chemotherapy the case continues to be evaluated as a clinical setting for initiating a multivalent treatment protocol comprising CancerVX / OncoVacx 4Q Quadravalant Protocol to mediate the manifold issues which are shown to be a challenge to all noted chemotherapy combinations utilized to date in this patient following original surgery and subsequent discovery of an abdominal mass altering the sequence and modality of treatment preceding Onco DNA ImmunoTherapeutics based on original diagnosis of testicular cancer originating in March 2018.
Additionally, following left orchiectomy further diagnostics revealed a hyper metabolic malignant abdominal mass requiring surgery and continued extended chemotherapy treatment.
OncoEpigenomic Drug Combinatorial Treatment Protocol may create multipoint MOA-Mechanisms of Action and extended efficacy in treatment resistant cancer types when conjoined with a PARP Inhibitor Treatment for certain advanced Breast Cancers [Stage 3 /3b/Stage 4] and further extending to hematologic malignancies including CML- advanced Leukemia, and MDS-Myelodysplastic Syndrome now under clinical consideration in other treatment resistant cancers.
HYBRID EPIGENOMIC GENE EXPRESSION / SUPPRESSION DYNAMICS FURTHER AUGMENT AND EXTEND ENHANCED ALTERABLE DNA ATTRIBUTES OF CANCERVX / ONCOVACX IN AGGRESSIVELY INDUCING RAPID CELL DEATH IN ABERRANT CELL STRUCTURES IMPLICATED IN INCIPIENT STAGES OF CANCER DEVELOPMENT.
Microscopic images of a breast cancer cell with DNA damage. Left, six hours after treatment with either the epigenetic agent alone or the PARP inhibitor alone. Right, six hours after treatment with both a CancerVX/OncoVacx type DNA Demethylation/Histone Regulation conjoined Epigenetic drug and in parallel with a specific PARP inhibitor. [Yellow staining indicates trapping of the PARP enzyme at site of the DNA damage.]
Drugs defined as PARP inhibitors, which functionally sabotage cancer cells' ability to repair damage to their DNA have shown some instances of clinical promise in treating human breast cancers that contain BRCA1 and BRCA2 gene mutations. A referenced new study suggests that significantly enhanced efficacy with extended effect over time is achievable in other forms of breast cancer and not linked to BRCA mutations. Research further reveals benefits extending to advanced Leukemia by adding DNA Demethylation / Histone Regulation via Histone Deacetylase Methyltransferase Inhibitors as the specific epigenetic drug intervention conjoined with a PARP Inhibitor resulted in a strong antitumor response against breast cancer cells without BRCA mutations as well as clinically demonstrated efficacy in achieving a halt to the growth of acute myeloid leukemia cells 8 days after the start of the combination therapy.
The surprise that leukemia cells were this sensitive to the combination treatment and further research confirms initial findings with some probable benefit for breast cancer and ovarian cancers for which PARP inhibitors work by blocking the poly (ADP-ribose) polymerase enzyme or PARP, which helps repair naturally occurring breaks in strands of DNA. Notably, some cancers exhibit more frequent reliance on PARP than others.
For tumors sensitive in that way, the inhibitors are one clinical weapon in sabotaging the cancer cells' ability to repair their own DNA. Continuing PARP research further demonstrates that PARP inhibitors also vary in functional value according to how intensely and durably the PARP enzyme is trapped at certain DNA damage sites. This suggests a possible ramp up in the duration and intensity of this trapping, could potentially increase the efficacy of the drug.
The research team found that the combination PARP / Epigenetic treatment increased the time that PARP was trapped at sites of DNA damage in cancer cells, extending the time from 30 minutes to three to six hours following treatment. Epigenetic drugs specifically of the CancerVX / OncoVacx type demonstrate a MOA-Mechanism of Action which initializes molecular alteration of the specific property of DNA and the process by which it is coiled and processed. Specifically, epigenetic PK- pharmacokinetics- block proteins that attach gene-regulating methyl groups to DNA and traps those proteins on DNA.
The proteins blocked by the CancerVX / OncoVacx type construct also exhibit dynamically interact with PARP enzymes at DNA damage sites,
World Cancer Institute debuted its first targeted epigenetic DNA ImmunoTherapeutics in 2008-2010 and further enlarged its spectrum of protocols as more specifically targeted OncoEpigenomic platforms which emerged as the result of clinical guidance provided by Dr. Brent Treiger during 2008-2010. Dr Treiger, a Northern California based Oncologist who died in 2011 was highly regarded worldwide as the scientist of Doxil, the preeminent therapeutic drug for ovarian cancer and also prescribed for breast cancer.
Dr. Treiger worked closely with World Cancer Institute and Nathan Sassover, Founder/CEO of World Cancer Institute commencing in 2008 in guiding criteria for both monotherapy based treatment as well as combination protocols, optimal drug delivery for CancerVX as well as guidelines for dosage range of the monotherapy and combination protocols and compound conjugates comprising the epigenomic Cancer DNA therapeutics developed by World Cancer Institute.
Contacts: Karen Howard : News@WorldCancerInstitute.com Source: World Cancer Institute
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Major Effects Drinking Wine Has on Your Health, Says Science | Eat This Not That – Eat This, Not That
Posted: August 5, 2021 at 1:59 am
Whether you love drinking a glass of chardonnay with your midday meal or can't make your famous pasta sauce without adding a pour of pinot, countless people consider wine an essential component of many a meal. However, while you may imagine you're sipping your way to better health with every glass, the benefits you reap from your wine intake have a lot to do with how much you consume, your biology, and other possible risk factors you may not even realize.
Before you pour another glass, read on to discover the major effects drinking wine has on your health, according to science. And for some dietary additions virtually everyone could benefit from, check out The 7 Healthiest Foods to Eat Right Now.
While many people know that alcoholic beverages like wine can have an effect on their liver health, it's not as commonly known that those drinks can have a profound effect on a person's risk of cancer north of the neck, too.
In fact, a 2004 study published in Oral Oncology found that, similar to other alcoholic beverages, wine was associated with an increased risk of both oral cancer and cancer of the pharynx, with risk increasing along with total alcohol consumption.
Want to better protect your health? Start by ditching the 50 Worst Foods to Never Eat if Cancer Runs in Your Family.
If you want to reduce your lifetime cancer risk, you may want to scale back your wine consumption starting now.
According to a 2019 research article published in BMC Public Health, drinking a bottle of wine a week increases a person's lifetime cancer risk as much as smoking five cigarettes for men and 10 cigarettes for women.
RELATED: For the latest healthy eating news delivered to your inbox, sign up for our newsletter!
While alcohol has a reputation for being harmful to your liver, wine may have less of a detrimental effect on this vital organ than other types of boozein fact, it may actually have a protective effect.
According to a 2018 study published in The American Journal of Gastroenterology, among patients with non-alcoholic fatty liver disease, those who drank wine in a non-binge-type fashion were less likely to have liver scarring than those who drank other types of alcohol or no alcohol.
READ MORE: Drinking Habits That May Cause Liver Damage, According to Science
You've likely heard that wine is good for your heart, and research suggests that's truewhen consumed in moderation, at least.
A 2001 study published in the International Journal of Molecular Medicine found that the polyphenol resveratrol in red wine may help protect against heart disease. However, other studies have found that high rates of alcohol consumptionbut not specifically wine consumptioncan increase a person's risk of various types of cardiovascular disease, so it's important to keep those drinks to a minimum.
For more ways to protect your cardiovascular health, start by cutting The 50 Foods That Have Been Linked to Heart Disease.
If you want to keep those pearly whites healthy, making wine part of your regular routine is a good place to start. A 2018 study published in the Journal of Agricultural Food Chemistry found that the caffeic and p-coumaric acids found in red wine made it more difficult for the bacteria that form dental plaque and cavities to adhere to teeth and gums, lessening the likelihood that they will cause decay and disease over time.
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Mel-Mont Medical announces the validation of its patented self-sampling technology, Ma by XytoTest, for molecular screening using HPV-DNA and 7-Type…
Posted: August 5, 2021 at 1:59 am
KLOKKARSTUA, Norway, Aug. 4, 2021 /PRNewswire/ -- Mel-Mont Medical, a boutique medical device and technology company dedicated to improving women's health through the use of its DNA and mRNA patented self-sampling screening kit, Mia by XytoTest, receives clinical validation as being equally effective to clinician-collected sampling.
"Current estimates indicate that every year 569,847 women are diagnosed with cervical cancer, and 311,365 die from the disease. Cervical cancer ranks as the third most frequent cancer among women in the world," according to Globocan information center on HPV and cancer.
The Mia by XytoTest device can be safely used by women at home, or in-office by a clinician, without the need for a vaginal speculum. The uniqueness of Ma by XytoTest empowers sexually active women to further their self-care opportunities and pre-screen for HPV-caused cancers. The patented technology that is Mia by XytoTest enables laboratories to detect Hr-HPV DNA and allows for risk stratification by detecting biomarkers mRNA E6/E7 from the seven HPV-types proven to be the most crucial for progression to cervical cancer.
"The idea of self-collection using Ma by XytoTest arose from the need to raise awareness of self-care and the need for accessible, routine preventative testing among the sexually active female population. Molecular screening increases sensitivity and specificity, adding clinical value to fight diseases with high morbidity and mortality rates that are ironically preventable, such as cervical cancer," said Mel-Mont Medical's CEO, Frank Melndez.
A recent publication1comparing self-collected to clinician-collected cervical samples to detect HPV infections by a 14-type HPV DNA test and a 7-type HPV mRNA E6/E7 test concludes that Mia by XytoTest equals clinician-collected samples in quality.
"Claiming self-collected specimens accessible for HPV mRNA testing was CE marked to the IVD directive 98/97/EC cleared, making PreTect and its E6/E7 mRNA technology a pioneer for this promising strategy," said Bente Marie Falang, Global Director of In-vitro Division at PreTect, AS.
In addition to providing effective self-sampling options, women who test positive for HPV are, along with their physicians, then prescribed appropriate treatment recommendations specific to each woman's mRNA biomarkers.
Mia by XytoTest and 7-type mRNA E6/E7 afford women new and innovative alternatives in cervical cancer prevention and are now being used across Europe and Mexico. Further, the device permits women in healthcare-deprived countries or with economically-distressed circumstances to access affordable, live-changing technology.
"Integrative multi-disciplinary molecular testsaccurately triaging exfoliated cervical specimens will improve cervical cancer prevention programs while simplifying healthcare procedures in HPV-infected women. Hence, the concept of a "liquid biopsy" (i.e., "molecular" Pap test) highly specific for early identification of cervical precancerous lesions is of critical importance in the years to come,"2 indicated Ana Gradssimo, Ph.D. from Albert Einstein College of Medicine, Bronx, NY a recent publication (2).
About Mel-Mont Medical, Inc.:Mel-Mont Medical, having offices in the United States and Europe, is a boutique medical device and technology company initially focused on products that use mRNA to screen and diagnose, through minimally-invasive means, HPV-caused cancers.
About PreTect, AS:PreTect AS, a fully ISO 13485:2016, CE/IVD certified, and FDA registered mRNA manufacturing facility based in Klokkarstua, Norway, is a wholly-owned subsidiary of Mel-Mont Medical, Inc.
1https://rdcu.be/clGVo 2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5904788/
For more information: Bente Marie FalangUstadhagan 8 /N-3490Klokkarstua, NorwayPhone: +47.32.79.88.00Email: [emailprotected]Web: http://www.mel-montmedical.com
SOURCE Mel-Mont Medical, Inc.
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Kennesaw State graduate blends arts and science, evolves as researcher – News
Posted: August 5, 2021 at 1:59 am
Hope Didier
KENNESAW, Ga. (Jul 30, 2021) Hope Didier forged her own path at Kennesaw State an academic journey that blended divergent passions in dance and the sciences.
The July graduate will earn two bachelors degrees this week in fields not typically paired: dance and molecular and cellular biology. Didier intertwined the two degrees seamlessly, serving as stage manager in multiple dance productions and spearheading cancer cell research that led to scholarly recognition at state and national levels. This fall, she will continue her education at Wake Forest University in a molecular medicine doctoral program.
I would take certain biological principles or ideas and use them as a foundation for a piece I was choreographing or to better educate my peers on what our bodies are actually doing as we move and dance in space, said Didier, who has been dancing since age 3.
As a scientist and dancer, I can appreciate the movement of the often unseen aspects of life under a microscope, in a way that Im not sure many would, and then translate that work in a manner that could be understood by more individuals, no matter their background or expertise.
Didier credits her parents, who teach middle school math and science, for her biology enthusiasm. She added that her parents encouraged creativity and curiosity, and also have a strong interest in music, which likely led to her dance involvement at an early age. Like many of her friends, Didier contemplated a ballet career, having danced with the Atlanta Ballet throughout high school and performed at the Fox Theatre and the Cobb Energy Centre.
Didiers interest in KSU Journey Honors College led her to apply to its Presidents Emerging Global Scholars (PEGS) program, an initiative that challenges Honors students to grow as scholars, leaders and innovators. She was impressed by the faculty who interviewed her for the program and the opportunity to study abroad in both Costa Rica and Italy during her first year.
A friend from the PEGS program introduced her to Jonathan McMurry, a biochemistry professor in the College of Science and Mathematics, since Didier was eager to explore scientific research as an undergraduate.
Hope was so obviously driven, intelligent, and genuinely interested in research, McMurry said. I saw untapped potential in her as a freshman, and thats the type of student researcher every professor wants to encounter.
Didier evolved into an accomplished and disciplined researcher, focusing on using cell-penetrating peptides, or short chains of amino acids, to deliver biomolecular cargo into cervical cancer cells to stop cell growth and catalyze cell death.
She presented aspects of her work at the National Conference on Undergraduate Research twice, and Posters at the Georgia State Capitol in 2020. She won the Top Poster Award at the Birla Carbon Symposium, in which she spent the entire summer conducting research, and received the Anthony Shuker Scientific Award at the Georgia BioInnovation Summit, both in 2018.
Didiers research interests in the healthcare field carried over into volunteering and conducting research at the Emory Winship Cancer Institute and working in the trauma/surgery ICU at Wellstar Health Systems Kennestone Hospital as an operating room surgical technician.
I witnessed firsthand the frontlines of the global pandemic and had the terrifying privilege of holding the hands of critically ill and dying patients, Didier said. It was physically and emotionally challenging, but also made it increasingly clearer to me that I am meant to serve patients and advocate for the very best healthcare practices.
Ultimately, the Peachtree City, Ga. native knew that her trajectory would lean more toward a career in medicine.
Classes like kinesiology and nutrition and learning the way the body moves and works has opened my eyes to how I could meld my two passions, she explained. Im going to keep dancing as part of my life, whether Im teaching on the side or doing small work for studios or companies.
As part of KSU Journey Honors College, Didier completed two Honors theses one in biology on the deterioration and death of cervical cancer cells and the other in dance, focused on a kinesiological approach for understanding the biological phenomenon of programmed cell death.
Didier credits the dance program for expanding her knowledge and techniques, preparing her for any aspect of dance. She learned about the production side of dance from part-time instructor David Tatu, and worked alongside him last spring on a unique production, Moon Dust, a collaboration between the College of the Arts and the College of Computing and Software Engineering.
As an artist and a scientist, I have found that there is this shared zeal for inquiry and constant curiosity, which makes solving problems and creating art so exciting, she said. My two worlds have a lot to learn from one another, and I look forward to future opportunities in which my passions can come together to create something beautiful and share knowledge in an innovative way.
Now Didier is ready to take on the next challenge, pursuing a doctorate in molecular medicine and translational science at Wake Forest University. She will then transition into the physician assistant program in the Wake Forest School of Medicine.
My entire time at KSU has been a massive highlight of my life and always will be, Didier said. The people are what make KSU amazing, and for that I am eternally grateful.
Jolle Walls
Photos by David Caselli
A leader in innovative teaching and learning, Kennesaw State University offers undergraduate, graduate and doctoral degrees to its more than 41,000 students. With 11 colleges on two metro Atlanta campuses, Kennesaw State is a member of the University System of Georgia and the second-largest university in the state. The universitys vibrant campus culture, diverse population, strong global ties and entrepreneurial spirit draw students from throughout the region and from 126 countries across the globe. Kennesaw State is a Carnegie-designated doctoral research institution (R2), placing it among an elite group of only 6 percent of U.S. colleges and universities with an R1 or R2 status. For more information, visit kennesaw.edu.
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Journal Board Members Resign After Controversial Papers – The Intercept – First Look Media
Posted: August 5, 2021 at 1:59 am
Eight members of the editorial board of a scientific journal have resigned after it published a slew of controversial papers that critics fear could be used for DNA profiling and persecution of ethnic minorities in China.
The journal, Molecular Genetics & Genomic Medicine, is the latest to be caught up in controversy involving ethically fraught research. Emails obtained by The Intercept show that the journals editor-in-chief has been slow to respond to queries about the papers, which involve research on Tibetans and Uyghurs, among other ethnic groups, and were first brought to her attention in March. The journal is published by Wiley, a multinational company based in New Jersey that is one of the worlds premier scientific publishers.
Studies involving DNA profiling, facial recognition, and organ transplantation have sparked controversy at other journals, but this is the first time that so many members of a journals editorial board eight of 25 have resigned in response to such issues.
Yves Moreau is seen at the Thermodynamics Instituteat the University of Leuven in Leuven, Belgium, on Feb. 4, 2020.
Photo: Lies Willaert
The papers were flagged by Yves Moreau, a bioinformatician at the University of Leuven in Belgium who over the past few years has waged a tireless campaign to get journals to retract troubling or unethical papers.
Moreaus quest began in 2015, when Kuwait announced plans for compulsory collection of DNA from all citizens, residents, and visitors. He helped spearhead an international campaign against the law and won an early victory when it was overturned the following year. He became convinced that if left unchecked, science and artificial intelligence would be used to further authoritarianism. In technology, we have this nice comfortable geek image, he said. But when you really look at the history of technology, you see that it has been a nexus of power forever for at least 2,000 years. While many geneticists have worked for decades to overturn the idea that race is a scientific concept, Moreausaw that authorities around the worldcould exploit new technologies like readily available DNA testing for political gain.
Moreau later turned his attention to DNA profiling in China, particularly in Xinjiang, where an estimated1 million Uyghurs and other ethnic minorities have been interned in camps or forced into labor. Authorities there have alsocollected DNA samples from residents. Moreau periodically runs an automated search for papers on ethically charged topics. Earlier this year, that search turned up 18 papers at Molecular Genetics & Genomic Medicine.
Some of the papers describe genetic differences between ethnic groups. Police can use such research for DNA profiling, to better match crime suspects with DNA samples from the broader population. Other papers relied on samples that Moreau suspected were taken without proper consent. The Chinese government has been collecting DNA from men of all ethnicities, with the aim of building out genetic information for all 700 million males in China. Chinese police also forcibly collect DNA from certain groups, including migrant workers and political dissidents.
While Molecular Genetics & Genomic Medicine isnt a leading outlet for genetic research, it has an impact factor of 2.183, meaning that its papers are cited and read by other scientists. The Wiley name lends it an imprimatur of respectability.
As its title suggests, the journal was founded to focus on genetics research with medical applications. Many of the editorial board members study how genetics can help doctors treat patients or help scientists cure disease. But in 2019, the journal started publishing papers by authors in China on forensic genetics, a field that involves close collaboration with police. Forensic genetics has long been controversial in the United States. It is even more problematic in China, where DNA collection is part of a sustained effort to persecute ethnic minorities and other groups.
The title of one paper published by the journal is Forensic characteristics and genetic affinity analyses of Xinjiang Mongolian group using a novel six fluorescent dye-labeled typing system including 41-Y-STRs and 3 Y-InDels. Another maps genetic differences between branches of Chinas majority ethnic group, Han Chinese, and other groups, including Tibetans and Hui Muslims. Several of the papers list co-authors or funding from institutions affiliated with Chinese police. One lists a co-author from the Public Security Bureau in Tibet, the police agency in the region.
A graphic published in the journalMolecular Genetics & Genomic Medicinepurports to represent the genetic distance between various ethnic groups, including Uyghur groups.
Credit: onlinelibrary.wiley.com
Hart replied the next day. I am looking into this matter and will respond shortly, she wrote. Moreau sent several follow-up emails. But months passed without an update, he told The Intercept.
On Tuesday, in response to questions from The Intercept, the Wiley public affairs office emailed a statement from Hart. We are actively investigating and driving toward a timely, transparent resolution, Hart said. We take the concerns expressed extremely seriously and regret that delayed communications may have indicated otherwise.
In June, Moreau took the issue to the entire editorial board. In a lengthy email, he listed the suspect papers and explained how police in China use forensic genetics.
Other board members echoed his calls for an investigation. Several said they were not actively involved in the journals work and had no idea that the papers had even been published. The journals editorial board positions are honorary; scientists often sit on multiple boards at once.
In emails obtained by The Intercept, Hart wrote to the board that same day, explaining that she had experienced adeath in her familyand had drafted a message to Moreau that ended up trapped in her outbox. I will send a message soon outlining our decision on how to address this issue, she wrote.
A few weeks later, when she had not provided any further explanation to the board or to Moreau, board members started resigning.
I would have wanted to hear much more quickly from the editorial staff, said Ophir Klein, a pediatric medical geneticist at the University of California San Francisco and one of the board members who quit. The lack of communication made me really concerned, he added.
The lack of communication made me really concerned.
Another board member, Joris Veltman, told The Intercept that he has remained on the board so that he can push for scrutiny of the papers. On July 7, Veltman, who is the dean of the Biosciences Institute at Newcastle University Medical School in the United Kingdom, escalated the issue by emailing Wileys management. The publishers director of research integrity, Chris Graf, responded that Wiley would begin an investigation immediately. Veltman asked why Wiley hadwaited so long.
In a statement, a Wiley spokesperson wrote that the companys Integrity in Publishing Group was overseeing the matter. We have completed the first step of the investigation, which is to assess concerns vis--vis our publishing standards, the statement read. We are now proceeding to connect with the authors and the institutional review boards associated with the papers to clarify the consent procedures for the research undertaken. The spokesperson said that the company could not provide a timeline for the investigation, beyond to say that it would likely continue into September.
Moreau said the focus on consent is too narrow. The larger question, he said, is whether the journal should be publishing research on vulnerable minorities, some of which directly involves the authorities persecuting them. Klein, the board member, said that if the research is determined to be unethical, at a minimum it should be retracted.
Moreau is not holding his breath. He has previously secured retractions from IEEE and Springer Nature, two other major scientific publishers, but Wiley has declined to retract a paper on ethnicity and facial recognition that he and others flagged in 2019. In September 2020, the journal, WIREs Data Mining and Knowledge Discovery, issued an expression of concern. The note focuses only on possible misrepresentation of a data set and figure in the article, not broader ethical issues.
Last month, The Guardian reported that the editor of another Wiley journal, Annals of Human Genetics, resigned in September 2020 after Wileydeclined to publish a letter he co-authored with Moreau and others proposing that his and other journals boycott papers from China. In turning down the letter, Wiley senior managers said that publishing it could cause problems for its China office, he told the paper.
Moreau said he will persist. At this point, you cannot stay silent, he told the Molecular Genetics & Genomic Medicine editorial board in one email. This situation is creating a shameful embarrassment that reflects poorly on all medical genetics journals and on the entire medical genetics community. Public trust in human genetics depends on our communitys ability to transparently abide by its moral duty.
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