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Archive for the ‘Diagnostics and Lab Tests’ Category


Detecting SARS-COV-2 antibodies in serum and plasma samples

Reporter: Irina Robu, PhD

Convalescent plasma therapy is a possible treatment under investigation where antibodies from recovered patients are transfused to current COVID-19 patients with the intent to help them fight the infection and buy time until their immune system can produce antibodies. Yet, not all recovered patients have the same quantity of antibody titers suitable for such transfusions. In some patients it will minimize the severity of the disease length.

The U.S. Food and Drug Administration authorized convalescent plasma therapy for patients with coronavirus disease 2019 and it permitted to be used during the pandemic because there is no approved treatment for COVID-19. The donated blood is processed to remove cells, leaving behind liquid and antibody.   

Companies like Forte Bío are developing instruments such as Octet HTX Instrument, Octet RED384 Octet RED96e Instrument and Octet K2 Instrument to detect SARS-COV-2 antibodies in serum and plasma samples. The Octet technology allows quantification with high resolution comparable to an HPLC . The instrument utilizes BLI enabling label-free detection for protein quantitation and kinetic characterization at unmatched speed and throughput. The instrument can  measure up to 96 samples simultaneously allowing both unlimited characterization capacity for various applications and custom assay tailoring to maximize analytical throughput or sensitivity and preventing bottlenecks. 

 How are antibodies tested ?

  1. Immobilize a virus protein such as the receptor binding domain (RBD) of the SARS CoV-2 spike protein.
  2. Dip the coronavirus biosensor into diluted patient plasma or serum samples.
  3. Block the biosensor with non-relevant serum or blocking buffer if needed to prevent non-specific binding.

Even the researchers believe that the risk to donors is low, there are additional risks such as allergic reactions, lung damage, difficulty breathing or infections such as HIV, hepatitis B and Donated blood must be tested for safety prior to administering to patients.

What to expect ? It is up to the doctor treating the patient, if convalescent plasma therapy is an option.  Even though data from clinical trials suggest that convalescent plasma may diminish the severity or duration of the COVID19, more research is needed to determine if convalescent plasma therapy is an effective treatment.

SOURCE

https://www.fortebio.com/covid19research19research

https://www.medrxiv.org/content/10.1101/2020.07.17.20156281v1

 

Other related articles were published in this Open Access Online Scientific Journal including the following:

https://pharmaceuticalintelligence.com/2020/05/18/race-to-develop-antibody-drugs-for-covid-19

https://pharmaceuticalintelligence.com/2020/05/18/race-to-develop-antibody-drugs-for-covid-19

 

 

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Tiny biologic drug to fight COVID-19 show promise in animal models

Reporter : Irina Robu, PhD

A research team at University of Pittsburg School of Medicine identified an antibody component that is 10 times smaller than a full-sized antibody. Their research published in Cell, indicates that the drug, Ab8 based on it is effective in mice and hamsters. The research was started by screening a library of about 100 billion antibody fragments to identify candidates that bound tightly to the spike protein on SARS-CoV-2’s surface, which the virus uses to enter and infect human cells.

A typical antibody consists of two heavy chains and two light chains. The chosen molecule is the variable domain of the heavy chain of an immunoglobulin, which is a type of antibody. The heavy chain variable domain is essential for binding with an antigen. Ab8 was created by fusing the variable, heavy chain domain with part of the immunoglobulin tail region, giving it immune functions but doing so with a molecule that’s about half the size of a full immunoglobulin.

The smaller size of the antibody can improve the therapeutic efficacy for infectious diseases and can be delivered through inhalation. Their research showed that Ab8 completely neutralized SARS-CoV-2 in lab dishes. The drug developed showed that inhibited the virus in lung tissue in animal body even at the lowest dose 2 mg/kg as compared to untreated controls.

The research team is looking to determine the drug effect in hamsters, which were reported to have better clinical signatures of COVID-19. And the hamsters that got the drug display less severe pneumonia that did the control animals. Drugs with alternative administration routers could provide additions to the first wave of COVID-19 therapies and vaccines.

What is more important, Ab8 does not appear to bind to human cells which is a good sign that it won’t have negative side effects.

SOURCE

https://www.fiercebiotech.com/research/small-sized-biologic-against-covid-19-shows-promise-animal-models

 

 

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FDA Authorizes Convalescent Plasma for COVID-19 Patients

Reporter: Irina Robu, PhD

The U.S. Food and Drug Administration authorized convalescent plasma therapy in August 2020 for people with coronavirus disease 2019. The convalescent plasma shows promising efficacy in hospitalized patients with COVID-19 and the benefits outweighs the risk  and FDA gave emergency use authorization. The approval is not  for any particular convalescent plasma product, but for preparation collected by FDA registered blood establishments from individuals whose plasma contains anti-SARS-CoV-2 antibodies, and who meet all donor eligibility requirements.

What exactly is convalescent plasma ? It is blood donated from patients who have recovered from COVID-19 has antibodies to the virus that causes it. The donated blood is processed by removing blood cells, leaving behind plasma and antibodies, which can be given to people with COVID-19 to boost their ability to fight the virus. According to FDA, COVID-19 covalescent plasma with high antibody titer can be effective in reducing mortality in hospitalized patients, but low antibody titer can be used based on health care provider discretion.  FDA also indicated that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients.

To confirm the results, the FDA recommended randomized trialsas COVID-19 convalescent plasma does not yet describe a new standard of care based on the current available evidence.

SOURCE

https://www.medpagetoday.com/infectiousdisease/covid19/88225?xid=NL_breakingnewsalert_2020-08-23

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Toaster Sized Machine Detects COVID-19

Reporter: Irina Robu, PhD

DnaNudge, a small UK-based DNA testing company designed a toaster sized machine that can detect COVID-19 in 90 min without lab analysis. The machine invented by Christofer Toumazou, professor at Imperial College was designed to aid people tailor their diet based on heredity, but changed the design due to the pandemic. The machine needs a nose swab or some saliva to detect traces of coronavirus. It can even spot other diseases such as the flu and a common virus infection called Respiratory Syncytial Virus (RSV). It will also notify the operator if a proper sample has been taken or if a test needs to be retaken.

Currently, the UK National Health Service ordered 5,000 of the machines, as well as cartridges to start testing coronavirus patients, as part of a $211 million contract. They are hoping that the machine designed by DNANudge states that can prove helpful in triaging potential COVID patients.

SOURCE

 https://futurism.com/neoscope/machine-covid-90-minutes?mc_eid=8eae667eea

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An expert opinion by Dr. Ofer Markman

A sweet perspective on the COVID-19 pandemic – glycobiologist view on the effort to curb the pandemic.

The sugars involved in a viral disease are unique in many ways when compared with the DNA/RNA or the proteins involved: they are almost totally dependent on the infected cells and tus are not affected by the viral mutation rate or by the virus at all. Nevertheless they are affected by the cells, their type and their sugar production mechanisms and in some respect to the production rate by which the virus in manufactured by the infected cells. Mutations may have neverthless major effect not on the structures of the glycans but rather on the axsistance of the glycosylation site, and thus the glycan at all, but not on its structures.

This may make the gycomolecule a good target for diagnostics as stability in the molecule may mean longer life time of the diagnostic kits.

Unique sugars are already predicted/found in the virus from certain chinese origin, in this case an o-linked glycan/s not previously detected.

https://www.tandfonline.com/doi/full/10.1080/22221751.2020.1739565

Nevertheless, if the virus can infect multiple cells once current cells are not going to be available for any reason those viruses may present other glycans.

Once one starts to treat the infected person via modulation of protein production or by other means the change in the dynamic of protein production vs. protein glycosylation may cause changes in protein glycosyation, including their structures, this is well known to biotechnologists producing glycoproteins in labs and production.

This may either be a problem in understanding the state of disease or an advantage as it may help following response to the treatment and help as a co-treament diagnostics.

For that purpose we are starting to see pioneering players in that regard:

https://www.technologynetworks.com/diagnostics/news/carbohydrate-based-diagnostics-a-new-approach-to-covid-19-testing-332313

Glycans may play a role in treatment as well, TAMIFLU is uch an example. Tamiflu is directed to the flu enzyme Neuraminidaze that is part of the viral structures. This approch was also explored to develop treatments.

https://www.pharmasalmanac.com/articles/pneumagen-ltd-leverages-its-novel-glycan-approach-to-target-coronavirus-covid-19-infections

but glycans do not only effect their own involvement in treatment/diagnostics they also are effecting protein based diagnostics for this see statement by Dr. Michael Mercier of UAH

https://www.newswise.com/articles/we-re-dealing-with-covid-19-but-what-s-a-virus-in-the-first-place

also related and already published and commented

https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v1

Jiao Zhao, Yan Yang, Han-Ping Huang, Dong Li, Dong-Feng Gu, Xiang-Feng Lu, Zheng Zhang, Lei Liu, Ting Liu, Yu-Kun Liu, Yun-Jiao He, Bin Sun, Mei-Lan Wei, Guang-Yu Yang,  View ORCID ProfileXinghuan Wang, Li Zhang, Xiao-Yang Zhou, Ming-Zhao Xing,  View ORCID ProfilePeng George Wang

doi: https://doi.org/10.1101/2020.03.11.20031096

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2020 World Medical Innovation Forum – COVID-19, AI and the Future of Medicine, Featuring Harvard and Industry Leader Insights – MGH & BWH, Virtual Event: Monday, May 11, 8:15 a.m. – 5:15 p.m. ET

 

Thermo Fisher provides the technologies required to return to work as well as to combat a COVID-19 resurgence. CEO Marc Casper shares perspectives with MGB EVP Peter Markell.

Marc Casper

CEO, Thermo Fisher

Moderator

Peter Markell

EVP and CFO,

Mass General Brigham

 

VIEW VIDEOS from the event

https://www.youtube.com/channel/UCauKpbsS_hUqQaPp8EVGYOg

 

From: “Coburn, Christopher Mark” <CMCOBURN@PARTNERS.ORG>

Date: Tuesday, May 12, 2020 at 6:48 AM

To: “Coburn, Christopher Mark” <CMCOBURN@PARTNERS.ORG>

Subject: REGISTRANT RECAP | World Medical Innovation Forum  

 

Dear World Forum Attendee, 

On behalf of Mass General Brigham CEO Anne Klibanski MD and Forum co-Chairs Gregg Meyer MD and Ravi Thadhani MD, many thanks for being among the nearly 11,000 registrants representing 93 countries, 46 states and 3200 organizations yesterday. A community was established around many pressing topics that  will continue long into the future. We hope you have a chance to examine the attached survey results. There are several revealing items that should be the basis for ongoing discussion. We expect to be in touch regularly during the year. Among the plans is a “First Look” video series highlighting top Mass General Brigham Harvard faculty as well as emerging Harvard investigators.  As promised, we  wanted to also share visual Forum session summaries.  You will be able to access the recordings on the Forum’s YouTube page . The first set will go up this morning

We hope you will join us for the 2021 Forum!  

Thanks again, Chris

e-Proceedings 2020 World Medical Innovation Forum – COVID-19, AI and the Future of Medicine, Featuring Harvard and Industry Leader Insights – MGH & BWH, Virtual Event: Monday, May 11, 8:15 a.m. – 5:15 p.m. ET

https://pharmaceuticalintelligence.com/2020/04/22/world-medical-innovation-forum-covid-19-ai-and-the-future-of-medicine-featuring-harvard-and-industry-leader-insights-mgh-bwh-virtual-event-monday-may-11-815-a-m-515-p-m-et/

Tweets & Retweets 2020 World Medical Innovation Forum – COVID-19, AI and the Future of Medicine, Featuring Harvard and Industry Leader Insights – MGH & BWH, Virtual Event: Monday, May 11, 8:15 a.m. – 5:15 p.m. ET

https://pharmaceuticalintelligence.com/2020/05/11/tweets-retweets-2020-world-medical-innovation-forum-covid-19-ai-and-the-future-of-medicine-featuring-harvard-and-industry-leader-insights-mgh-bwh-virtual-event-mond/

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via Dr. Giordano Featured in Forbes Article on COVID-19 Antibody Tests in Italy and USA

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Pharmaceutical Companies Racing Together to Find a Cure for COVID-19

Reporter: Irina Robu, PhD

The global outbreak has put pressure on companies and the Food and Drug Administration (FDA) to act quickly to make medications available to patients. Several companies are working together to find solutions to treat those infected by the virus and prevent it from spreading.

AstraZeneca is responding to the COVID-19 (novel coronavirus) outbreak to accelerate the development of its di diagnostic testing capabilities to scale-up screening and is also working in partnership with governments on existing screening programs to supplement testing. In addition, AstraZeneca is working to identify monoclonal antibodies to progress towards clinical trial evaluation as a treatment to prevent COVID-19.

Bayer, German multinational pharmaceutical and life sciences company is donating malaria drug, Resochin to the US government for possible use to treat COVID-19. Resochin, made of chloroquine phosphate is a current approve treatment for malaria. China is evaluating it for potential use of COVID-19 and presented decent effects against the first SARS virus in 2003. Doctors consider it a promising treatment for seriously ill coronavirus patients.

AbbVie is research-driven biopharmaceutical company dedicated to developing innovative advanced therapies for four primary therapeutic areas: immunology, oncology, virology and neuroscience. The company declared plans to evaluate HIV medicine as COVID-19 treatment and go into partnerships with health authorities in various countries to explore the efficacy and antiviral activity of the medication.

Boehringer Ingelheim, research driven company  is collaborating with the German Center for Infectious Research to develop therapies and diagnostic tools for COVID-19. Their research teams are screening their entire molecule library with more than one million compounds to identify novel small molecules with activity against the virus.

EMD Serono is the biopharmaceutical business of Merck KGaA, Germany donated interferon beta-1a to French Institute of National Health and Medical Research to use for a clinical trial. Interferon beta-1a is presently in use to treat multiple sclerosis and is under investigation as potential treatment for people with COVID-19 coronavirus disease caused by the SARS-nCoV-2 virus. When confronted with the virus, each cell shoots an emergency flare of interferon to tell the immune system to strengthen its defenses. The interferon beta1a cytokine activates macrophages that engulf antigens and natural killer cells, which are integral to innate immune system. The trial is subsidized by INSERM and its start has been announced by the French Health authorities on March 11. To date, Merck interferon beta-1a is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.

GLAXOSMITHKLINE (GSK) has been working to make vaccine using its established pandemic vaccine adjuvant platform technology available. Sanofi and GSK announced on April 14, 2020 they will collaborate to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies. Sanofi will donate its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology gives an exact genetic match to proteins found on the surface of the virus and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.GSK will contribute its proven pandemic adjuvant technology to the collaboration, since it may reduce the amount of vaccine protein required per dose, letting more vaccine doses to be produced and consequently contributing to protect more people.

JOHNSON & JOHNSON has started research into a vaccine, leveraging the same innovative technology used for  Ebola vaccine. Janssen, the pharmaceutical arm of J&J has donated medicines for use in laboratory-based investigations to support efforts in finding a resolution against COVID-19.

Eli Lilly entered into an agreement with AbCellera to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform, established under the DARPA Pandemic Prevention Platform Program, along with Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies. Eli Lilly has also entered an agreement with NIH, NIAID to study baricitinib as an arm in NIAID’s Adaptive COVID-19 treatment trial. Baricitinib, an oral JAK1/JAK2 inhibitor is accepted in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Because of the inflammatory cascade in COVID-19, baricitinib’s anti-inflammatory activity has been hypothesized to have a potential beneficial effect in COVID-19 and needs further study in patients with this infection. Eli Lilly is also using an investigational selective monoclonal antibody against Angiopoientin-2 to Phase 2 testing in pneumonia patients hospitalized with COVID-19 who are at higher risk of delveoping acute respiratory distress syndrome. The company will look whether inhibiting the effects of Angiopoientin-2 with monoclonal antibody which can reduce the progression of acute respiratory distress syndrome. The trial will start in April 2020.

Pfizer and BioNTech work together to develop a potential COVID-19 vaccine which aims to accelerate development of BioNTech’s potential first-in-class COVID-19 mRNA vaccine program, BNT162 . A clinical study is expected to start by the end of April 2020. The collaboration is a continuation of the original agreement in 2019 between the two companies to develop mRNA-based vaccines for prevention of influenza.

Roche, Canada has been designated as a participant in a Phase III clinical trial evaluating the safety and efficacy of one of Roche’s portfolio medicines in hospitalized adult patients with severe COVID-19 pneumonia. The company announced the future launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to SARS-CoV-2 that causes the COVID-19 disease. Antibody testing is vital to help detect people who have been infected by the virus, particularly those who may have been infected but did not display symptoms. Furthermore, the test can support priority screening of high-risk groups who might by now have advanced a certain level of immunity and can continue serving and/or return to work.

Takeda Pharmaceutical Company is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19, although also investigating whether Takeda’s currently marketed products may be effective treatments for infected patients. Hyperimmune globulins are plasma derived-therapies that have been effective in the treatment of severe acute viral respiratory infections and could be a treatment option for COVID-19. Takeda has the research expertise to develop and manufacture a potential anti-SARS-CoV-2 polyclonal H-IG.

Takeda is presently in discussions  with multiple national health and regulatory agencies and health care partners in the US, Asia, and Europe to expeditiously move the research into anti-SARS-CoV-2 polyclonal H-IG forward. The research requires access to source plasma from people who have efficaciously recovered from COVID-19. The donors have developed antibodies to the virus that could possibly alleviate severity of illness in COVID-19 patients and perhaps prevent it. By transferring the antibodies to a new patient, it may help that person’s immune system respond to the infection and increase their chance of recovery. These efforts to find a vaccine are at an early stage nevertheless being given a high priority within the company.

SOURCE

https://www.marketwatch.com/story/these-nine-companies-are-working-on-coronavirus-treatments-or-vaccines-heres-where-things-stand-2020-03-06

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Medicine in 2045 – Perspectives by World Thought Leaders in the Life Sciences & Medicine

Reporter: Aviva Lev-Ari, PhD, RN

 

This report is based on an article in Nature Medicine | VOL 25 | December 2019 | 1800–1809 | http://www.nature.com/naturemedicine

Looking forward 25 years: the future of medicine.

Nat Med 25, 1804–1807 (2019) doi:10.1038/s41591-019-0693-y

 

Aviv Regev, PhD

Core member and chair of the faculty, Broad Institute of MIT and Harvard; director, Klarman Cell Observatory, Broad Institute of MIT and Harvard; professor of biology, MIT; investigator, Howard Hughes Medical Institute; founding co-chair, Human Cell Atlas.

  • millions of genome variants, tens of thousands of disease-associated genes, thousands of cell types and an almost unimaginable number of ways they can combine, we had to approximate a best starting point—choose one target, guess the cell, simplify the experiment.
  • In 2020, advances in polygenic risk scores, in understanding the cell and modules of action of genes through genome-wide association studies (GWAS), and in predicting the impact of combinations of interventions.
  • we need algorithms to make better computational predictions of experiments we have never performed in the lab or in clinical trials.
  • Human Cell Atlas and the International Common Disease Alliance—and in new experimental platforms: data platforms and algorithms. But we also need a broader ecosystem of partnerships in medicine that engages interaction between clinical experts and mathematicians, computer scientists and engineers

Feng Zhang, PhD

investigator, Howard Hughes Medical Institute; core member, Broad Institute of MIT and Harvard; James and Patricia Poitras Professor of Neuroscience, McGovern Institute for Brain Research, MIT.

  • fundamental shift in medicine away from treating symptoms of disease and toward treating disease at its genetic roots.
  • Gene therapy with clinical feasibility, improved delivery methods and the development of robust molecular technologies for gene editing in human cells, affordable genome sequencing has accelerated our ability to identify the genetic causes of disease.
  • 1,000 clinical trials testing gene therapies are ongoing, and the pace of clinical development is likely to accelerate.
  • refine molecular technologies for gene editing, to push our understanding of gene function in health and disease forward, and to engage with all members of society

Elizabeth Jaffee, PhD

Dana and Albert “Cubby” Broccoli Professor of Oncology, Johns Hopkins School of Medicine; deputy director, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

  • a single blood test could inform individuals of the diseases they are at risk of (diabetes, cancer, heart disease, etc.) and that safe interventions will be available.
  • developing cancer vaccines. Vaccines targeting the causative agents of cervical and hepatocellular cancers have already proven to be effective. With these technologies and the wealth of data that will become available as precision medicine becomes more routine, new discoveries identifying the earliest genetic and inflammatory changes occurring within a cell as it transitions into a pre-cancer can be expected. With these discoveries, the opportunities to develop vaccine approaches preventing cancers development will grow.

Jeremy Farrar, OBE FRCP FRS FMedSci

Director, Wellcome Trust.

  • shape how the culture of research will develop over the next 25 years, a culture that cares more about what is achieved than how it is achieved.
  • building a creative, inclusive and open research culture will unleash greater discoveries with greater impact.

John Nkengasong, PhD

Director, Africa Centres for Disease Control and Prevention.

  • To meet its health challenges by 2050, the continent will have to be innovative in order to leapfrog toward solutions in public health.
  • Precision medicine will need to take center stage in a new public health order— whereby a more precise and targeted approach to screening, diagnosis, treatment and, potentially, cure is based on each patient’s unique genetic and biologic make-up.

Eric Topol, MD

Executive vice-president, Scripps Research Institute; founder and director, Scripps Research Translational Institute.

  • In 2045, a planetary health infrastructure based on deep, longitudinal, multimodal human data, ideally collected from and accessible to as many as possible of the 9+ billion people projected to then inhabit the Earth.
  • enhanced capabilities to perform functions that are not feasible now.
  • AI machines’ ability to ingest and process biomedical text at scale—such as the corpus of the up-to-date medical literature—will be used routinely by physicians and patients.
  • the concept of a learning health system will be redefined by AI.

Linda Partridge, PhD

Professor, Max Planck Institute for Biology of Ageing.

  • Geroprotective drugs, which target the underlying molecular mechanisms of ageing, are coming over the scientific and clinical horizons, and may help to prevent the most intractable age-related disease, dementia.

Trevor Mundel, MD

President of Global Health, Bill & Melinda Gates Foundation.

  • finding new ways to share clinical data that are as open as possible and as closed as necessary.
  • moving beyond drug donations toward a new era of corporate social responsibility that encourages biotechnology and pharmaceutical companies to offer their best minds and their most promising platforms.
  • working with governments and multilateral organizations much earlier in the product life cycle to finance the introduction of new interventions and to ensure the sustainable development of the health systems that will deliver them.
  • deliver on the promise of global health equity.

Josep Tabernero, MD, PhD

Vall d’Hebron Institute of Oncology (VHIO); president, European Society for Medical Oncology (2018–2019).

  • genomic-driven analysis will continue to broaden the impact of personalized medicine in healthcare globally.
  • Precision medicine will continue to deliver its new paradigm in cancer care and reach more patients.
  • Immunotherapy will deliver on its promise to dismantle cancer’s armory across tumor types.
  • AI will help guide the development of individually matched
  • genetic patient screenings
  • the promise of liquid biopsy policing of disease?

Pardis Sabeti, PhD

Professor, Harvard University & Harvard T.H. Chan School of Public Health and Broad Institute of MIT and Harvard; investigator, Howard Hughes Medical Institute.

  • the development and integration of tools into an early-warning system embedded into healthcare systems around the world could revolutionize infectious disease detection and response.
  • But this will only happen with a commitment from the global community.

Els Toreele, PhD

Executive director, Médecins Sans Frontières Access Campaign

  • we need a paradigm shift such that medicines are no longer lucrative market commodities but are global public health goods—available to all those who need them.
  • This will require members of the scientific community to go beyond their role as researchers and actively engage in R&D policy reform mandating health research in the public interest and ensuring that the results of their work benefit many more people.
  • The global research community can lead the way toward public-interest driven health innovation, by undertaking collaborative open science and piloting not-for-profit R&D strategies that positively impact people’s lives globally.

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New Targeted Cancer Therapy may be ‘Possible Hope’ for Some Pancreatic Cancer Patients

Reporter: Irina Robu, PhD

 

UPDATED on 7/18/2019

BREAKTHROUGH PANCREATIC CANCER TREATMENT PHASE III TRIAL OPENS IN ISRAEL

Hope is that successful trials will allow Rafael Pharmaceuticals will receive expedited FDA approval by late 2020.

BY MAAYAN JAFFE-HOFFMAN  JULY 18, 2019 18:30

“What it does is feeds misinformation to these regulatory elements, making them feel that there is too much carbon flow through both of these complexes, causing them to be inhibited,” Pardee said. “It simultaneously inhibits both complexes so tumor cells that are primarily driven by glucose cannot utilize glucose in the TCA cycle. Tumor cells that are primarily driven by glutamine usage cannot use glutamine-derived carbons in the TCA cycle. And, importantly, tumors cannot switch from one source to the other in the presence of CPI-613,” he explained.

He said that hitting two complexes simultaneously has many advantages. One is that the carbon source the tumor is primarily dependent on does not matter; another is that evolved resistance for both complexes simultaneously is very unlikely to happen.

Pardee said CPI-613’s key differentiators are that it is highly selective on the uptake and target level in cancer cells, which leads to less toxicity to healthy cells. This allows for patients to receive extended treatment courses and for the drug to be used in combination with other drugs.

CPI-613 is being administered in this clinical trial with a chemotherapy combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin, called FOLFIRINOX.

SOURCE

https://www.jpost.com/HEALTH-SCIENCE/Breakthrough-pancreatic-cancer-treatment-phase-III-trial-opens-in-Israel-596059

 

New Targeted Cancer Therapy may be ‘Possible Hope’ for Some Pancreatic Cancer Patients

Pancreatic cancer is the 12th maximum common cancer and the fourth leading cause of cancer death. The cancer is often difficult to diagnose as there is no cost-effective ways to screen for the illness. For over 52% of people who are diagnosed after the cancer has spread and with a 5-year survival rate.

Scientists at Sheba Medical Center in Israel developed a targeted cancer therapy drug together with AstraZeneca and Merck which can offer a possible new solution for patients with a specific kind of pancreatic cancer by delaying the progression of the disease. To evaluate the safety and test the efficacy of a new drug treatment regimen based on Lynparza tablets. The tablets are a pharmacological inhibitor of the enzyme poly (ADP-ribose) polymerase which inhibit the enzyme. They were developed for a number of indications, but most prominently for the treatment of cancer, as numerous forms of cancer are more dependent for their development on the enzyme than regular cells are. This makes poly (ADP-ribose) polymerase an attractive target for cancer therapy.

Their study included 154 patients who were randomly assigned to get the tablets at a dose of 300 mg twice a day with metastatic pancreatic cancer who carried the genetic mutation called BRCA 1 and BRCA 2. BRCA1 and BRCA2 are human genes that produce proteins accountable for repairing damaged DNA and play a substantial role in preserving the genetic stability of cells. Once either of these genes is mutated, DNA damage can’t be repaired properly and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

Patients with these mutations make up six to seven percent of the metastatic pancreatic cancer patients. The trial using the using the medicine Lynparza offers possible hope for those who suffer from metastatic pancreatic cancer and have a BRCA mutation and slows down the disease progression. According to the researchers this is the first Phase 3 biomarker that is positive in pancreatic cancer and the drug gives incredible hope for patients with the advanced stage of the cancer.

SOURCE
https://www.timesofisrael.com/israeli-researchers-find-potential-hope-for-some-pancreatic-cancer-patients/

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