Between Wet Discovery Natural Mark Disease

<h1>Between Wet Discovery Natural Mark Disease</h1>

Between Wet Discovery Natural Mark Disease

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Prednisone For Dogs: Dosages, Unintended effects, And The whole lot You need to Know

<h1>Prednisone For Dogs: Dosages, Unintended effects, And The whole lot You need to Know</h1>

Prednisone For Dogs: Dosages, Unintended effects, And The whole lot You need to Know

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Contraindications Of Vitamins & Prednisone

Contraindications Of Vitamins & Prednisone

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Sangamo: A Competitive Intelligence Report On Empowers And Champions – Sangamo Therapeutics, (NASDAQ:SGMO)

<h1>Sangamo: A Competitive Intelligence Report On Empowers And Champions – Sangamo Therapeutics, (NASDAQ:SGMO)</h1>

Sangamo: A Competitive Intelligence Report On Empowers And Champions – Sangamo Therapeutics, (NASDAQ:SGMO)

Investing in stocks is an art, not a science, and people who’ve been trained to rigidly quantify everything have a big disadvantage. – Peter Lynch
On Feb. 07, 2019, Sangamo ( SGMO ) published the results of the Phase 1/2 ( Empowers and Champions) studies for its orphan disease franchise. As follow, Empowers and Champions are investigating the efficacy and safety of the lead gene-editing molecule (SB-318 and SB-913) in patients afflicted by the lysosomal diseases coined Mucopolysaccharidosis (“MPS”) Type I and II, respectively. Interestingly, the market was unimpressed with the clinical outcomes because there was a 30% sell-off in one trading session. In this Competitive Intelligence Report (“CIR”), we’ll provide readers with an in-depth analysis of the latest data release.
Figure 1: Sangamo chart (Source: StockCharts)
Disease Background As lysosomal storage disorders , MPS Type I and II are caused by a deficiency in the lysosomal enzymes required for the breakdown of a mucopolysaccharide known as glycosaminoglycan (“GAG”) and heparan as well as dermatan sulfate. As these sugars build up, they compromise the function of lysosome (i.e. the storage organ of the cell) and thereby leads to a plethora of symptoms that include the following: abnormal facial appearance, enlarged liver and spleen (hepatosplenomegaly), heart disorders, dwarfism, neurocognitive decline, and deafness. While both types exhibit similar symptoms, MPS II (Hunter syndrome) tend to manifest later in the disease course. Additionally, patients with Hunter have distinctive papular skin lesion.
Disease Enzyme deficiency Drug Product buildup Clinical trial MPS I (Hurler, Scheie) alpha-L-iduronidase (“IDUA”) SB-318 glycosaminoglycans (“GAGs”), heparan sulfate, and dermatan sulfate Empowers (Phase 1/2) MPS II (Hunter) iduronate 2-sulfatase (“IDS”) SB-913 glycosaminoglycans (“GAGs”), heparan sulfate, and dermatan sulfate Champions (Phase 1/2) Table 1: Lysosomal storage disease (Source: Integrated BioSci Investing)
Gene-Editing Therapy Accordingly, the gene-editing therapies (SB-318 and SB-913) are packaged inside the adeno-associated virus (“AAV”) 2 and 6. Inside the viral vector are the correct genes encoding the enzymes (IDUA and IDS) plus a zinc finger nuclease (“ZFN”). As a molecular scissor, ZFN cuts the genetic blueprint (“DNA”) for the correct genes to be inserted.
We believe it is quite strategic that SB-318 and SB-913 transferred the correct genes next to a ” promoter ” of the albumin protein: this enables the ramping of gene expression inside the liver. In our view, this approach is more competitive than conventional enzyme replacement therapy (“ERT”) due to the less frequent need for treatment that, in and of itself, leads to better compliance and improve disease outcome. Furthermore, it replaces the need for a bone marrow transplant which has a long waiting time and other associated complications .
Champions’ Interim Results For Empowers and Champions, the investigators initially measured the patients’ baseline level of urinary GAG and IDUA or IDS enzymatic activity. These patients were then given an injection of either SB-318 or SB-913 in different dosages, ranging from low, mid to high. Their enzyme activity and urinary GAG were subsequently assessed every two to four weeks. Back in Sep. 05, 2018, Sangamo reported what seemed to be excellent week-16 data for Champions. We noted in our prior research:
The corresponding mean reduction of GAG, dermatan sulfate, and heparan sulfate of Group (Cohort) 2 at week-16 were 51%, 32%, and 61%. The low-dose group (Cohort 1) showed mixed results for all three metrics. The fact that the medium dose Cohort 2 exhibited the positive outcomes (for GAG, dermatan sulfate, and heparan sulfate) proves that the SB-913 works by a dose-response relationship. In other words, the higher dose works better than the low dose and thus indicates good therapeutic efficacy.
Table 2: Champions week-16 results (Source: Sangamo )
Latest Empowers And Champions Data Despite the highly favorable interim results at week-16, the latest outcomes at week-24 for Empowers and Champions were disappointing to investors. Be that as it may, there are more to this story than what is apparent in the press release .
In Champions, the primary objective was met because the drug was well-tolerated. For instance, most side effects were mild (i.e. Grade 1). Re the secondary outcome that is efficacy, there were small increases in IDS enzymatic activity from baseline for two patients (on the mid-dose) and one patient (on the high-dose). Unfortunately, the increased level still remained within the baseline range at week-24. Specifically, the activity level persisted at less than 10 nmol/hour/mL versus the normal range of 82 nmol/hour/mL. Additionally, the urinary GAG did not demonstrate a meaningful improvement from baseline.
Pertaining to Empowers, the safety profile was similar to Champions. In terms of efficacy, there was a “dose-dependent increase in leukocyte IDUA activity, with activity levels rising above baseline and in the normal range (normal range is 6.0-71.4 nmol/hr/mg).” Nevertheless, the plasma IDUA activity was similar to baseline for all three patients. Furthermore, the urinary GAG did not indicate a meaningful improvement from baseline.
CIR Take Home Viewing the totality of the results, we strongly believe that the efficacy was there: the reverse transcription polymerase chain reaction (RT-qPCR) confirmed the expression of the IDS mRNA transcript in two patients who got the mid-dose SB-913.
The fact that there was low enzyme activity indicates that an immune reaction most probably occurred against SB-318. After all, SB-913 demonstrated very high activity at week-16 in the prior interim results reported last year. Something must have developed in the intervening period to lower the enzymatic activity level at week-24. Our belief that an immune response is the culprit coincides with the statement made by Sangamo:
A more substantial increase in plasma IDS activity was measured in the second patient in the high dose cohort, with levels rising to approximately 50 nmol/hour/mL by week-6 following SB-913 administration. The plasma IDS activity levels subsequently decreased in the context of development of a mild transaminitis – a known risk of AAV-based therapies – due to a suspected immune response.
In our view, the human body has a way of defending against injected “foreign” materials. And, gene-editing therapy is considered foreign to the immune system. Hence, it’s quite likely that the trial investigators either did not pretreat patients with a steroid or the steroid was delivered at a sub-therapeutic dose. Notwithstanding, we believe that this can be easily ameliorated by pretreatment with the proper steroid dosage (i.e. prednisone).
Another plausible explanation is that these patients are concurrently being treated with an ERT. Despite some setbacks like antibody formation , ERT is an efficacious and safe management approach that has been utilized for decades. Consequently, we believe that the effects of ERT might have masked the therapeutic efficacy of SB-318 and SB-913. To tease out this potential confounder , Sangamo initiated the ERT-withdrawal protocol. Per the company :
One mid-dose patient was recommended to resume ERT approximately 3 months after initiation of ERT withdrawal due to fatigue and increasing GAGs. Analyses from these withdrawals will be available later in 2019.
That aside, it’s quite likely that the low efficacy was due to the use of AAV2 and AAV6. They are early-generation delivery vectors which can have significant issues, especially immunogenicity. Of note, companies like Regenxbio ( RGNX ) and Solid Biosciences ( SLDB ) are employing the next-generation AAVs (7-9) which have better delivery success. Fortunately, for shareholders, Sangamo is also tinkering with the second-generation ZFN. According to the press release:
Sangamo has developed second-generation, potentially more potent ZFN constructs designed to increase editing efficiency. Preclinical data of these second-generation ZFNs were reviewed by U.S. regulators. The preclinical data showed three potential advantages for use in the clinic: (1) a 5- to 30-fold improvement in efficiency and potency due to structural changes; (2) the ability to function equally well in the patients who have a single nucleotide polymorphism (“SNP”) in the target locus in the albumin gene (approximately 20% of the population); (3) improved specificity. The second-generation ZFNs are already being manufactured and are expected to be ready for evaluation in the clinic later this year. Additional data from Sangamo’s in vivo genome editing programs will be assessed before potential integration plans for the second-generation ZFNs are finalized.
Final Remarks In all, Sangamo is brewing a highly diverse therapeutic pipeline to have more “shots on goal” of finding a blockbuster. Despite what is seemingly subpar clinical outcomes for SB-319 and SB-913, the situation can be ameliorated with trial protocol adjustment. As the company is targeting the orphan disease market, if the investigational drugs pass their clinical studies and ultimately gain approval, they can procure substantial revenues. The average reimbursement for an orphan drug is $140K annually. Therefore, this can generate significant cash flow to fund more lifesaving innovation. While Sangamo is a highly promising company, we’ll wait for the firm to adjust the clinical protocol and provide more data prior to making our next long-term recommendation. Last but not least, you can learn more about specific investment strategy and recommendation on Sangamo by visiting our marketplace service.
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Additional disclosure: As a medical doctor/market expert, Dr. Tran is not a registered investment advisor. Despite that we strive to provide the most accurate information, we neither guarantee the accuracy nor timeliness. Past performance does NOT guarantee future results. We reserve the right to make any investment decision for ourselves and our affiliates pertaining to any security without notification except where it is required by law. We are also NOT responsible for the action of our affiliates. The thesis that we presented may change anytime due to the changing nature of information itself. Investing in stocks and options can result in a loss of capital. The information presented should NOT be construed as recommendations to buy or sell any form of security. Our articles are best utilized as educational and informational materials to assist investors in your own due diligence process. That said, you are expected to perform your own due diligence and take responsibility for your action. You should also consult with your own financial advisor for specific guidance, as financial circumstance are individualized.

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How To Develop Turmeric & 10 Amazing Ways To Work With It

<h1>How To Develop Turmeric & 10 Amazing Ways To Work With It</h1>

How To Develop Turmeric & 10 Amazing Ways To Work With It

by AgustinHooley52 on 8 seconds ago 3 views Currently pregnant women should really not take turmeric, because it may well stimulate uterine contractions, however, most other individuals should really be ready to safely consider suggested dosages. Diluted apple company cider white vinegar contains natural bleaching and zero-bacterial properties and is particularly yet another quite valuable and easy to implement herbal treatment for acne breakouts and acne breakouts. Turmeric has turn out to be popular through the Western side in modern times even though it became initially introduced to Countries in europe as long in the past for the reason that thirteenth century. Turmeric has powerful anti-inflammatory and anti-oxidant properties that have already been employed for centuries to fight common conditions these types of as common colds, influenza, sore throat and coughing. Chronic back pain, for case in point, which influences hundreds of thousands of Americans every day, is considered the number one particular cause older people search for help from the medical care professionals. Laboratory tests has determined that curcumin has chelating, antioxidant, zero-tumor, anti–arthritic, contra –amyloid, contra–ischemic, anti-coagulant, anti-inflammatory, zero-diabetic and anti-cancer activity. Research workers have identified that working with added, animal – based enzymes, the most effective becoming substantial – potency pancreatic enzyme intricate, can consequence in tremendously advanced health. Healthceuticals Turmeric Curcumin Complicated incorporates each purely natural phospholipids for considerably improved ingestion and organically produced black colored pepper extract standardized to piperine to greatly increase bioavailability. Citrus Many fruits, Peppers, Strawberries – accommodate ascorbic acid – Ascorbic acid abutment affiliation tissues in the health benefit of turmeric ( Recommended Resource site ) joint parts, provides respected antioxidant activity, and helps arrest inflammation. Chronic inflammation has been connected to allergic reactions, arthritis, bronchial asthma, atherosclerosis, coronary heart disease, diabetes, digestive diseases, bodily hormone instability, brittle bones, psoriasis, cerebrovascular accident or cva, and arthritis. During the long-term, nearly anything accompanied by a laxative effect disrupts the body’s natural reduction functions, will cause lack of fluids, electrolyte imbalances and mal-absorption of nutrients. General practitioners point out this condition should very clear in approximately months, however it can become chronic leaving suffers getting frequent flare-ups decades immediately after their very first diagnosis. In simple fact, turmeric incorporates a synergistic action with specific medications prescribed in arthritis like indomethacin, diclofenac sodium, phenylbutazone, ibuprofen, prednisone, methotrexate and many others. Super fast ahead to these days and also in our concludesubstantially less search for first time treatment methods just for this and the, modern day researchers are re-examining health claims from yesteryear. In american international locations, chronic inflammation is common and it has brought up a variety of diseases like cancer, metabolic disorder, Alzheimer’s, as well as other neurodegenerative diseases.

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Finasteride Oral : Uses, Unwanted side effects, Interactions, Photos, Warnings & Dosing

Finasteride Oral : Uses, Unwanted side effects, Interactions, Photos, Warnings & Dosing

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The failure to offer cytology check ends in a well timed and proper manner can create the same issues because the failure to provide the same data on surgical specimens. Finasteride, also known with the model identify of Proscar, is 5-alpha reductase inhibitor. I assume inflammation can mean a variety of things in a general sense, however I feel there is a enough evidence on the market to say that having a number of ‘inflammation’ is dangerous for you. Advil warns in its packaging insert that patients with a historical past of stomach ulcers should consult their docs before taking the drug. All it’s important to do is to purchase your Ink Cartridges from an esteemed Online Supplier and in this respect the title that you could imagine is Madwall Inks. 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Quick Action Eases Sting of Poison Ivy

Quick Action Eases Sting of Poison Ivy

You can get it mowing the lawn, whacking weeds, petting the dog, hiking through the woods, burning logs in a fireplace, gardening, retrieving a lost ball, using the great outdoors for a toilet, putting clothes in the washing machine or removing yo…

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Genetically Engineered Drug Approved for Kidney Transplants

Genetically Engineered Drug Approved for Kidney Transplants

The Food and Drug Administration yesterday approved a new type of genetically engineered drug for kidney transplant patients. The drug, Zenapax, appears to help prevent the rejection of the transplanted organ without the side effects of the common…

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