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Acer Therapeutics’ Edsivo (celiprolol) is not expected to win approval from the US Food and Drug Administration (FDA) for vascular Ehlers-Danlos syndrome (vEDS), as the registrational trial was too small and not well-controlled, according to experts.Celiprolol

Ehlers-Danlos syndrome treatment

EDS is a group of rare inherited conditions that affect connective tissue, of which vEDS is a rare type that is often considered to be the most serious. It affects the blood vessels and internal organs, which can cause them to split open and lead to life-threatening bleeding, according to the National Health Service.

An analyst report was optimistic about Edsivo’s FDA approval. It noted the previous data, as well as the fact that the drug is used as an off-label treatment in Europe and there is an unmet need in the US.Celiprolol is approved as a beta-blocker for hypertension. However, while one expert interviewed expressed hope for approval based on off-label use and unmet need, she declined to comment on the data’s validity.

Trial size too small

Other experts interviewed said that given the trial comprised of 53 patients, the Phase IV trial (NCT00190411) was too small even for a rare disease like vEDS.Furthermore, far fewer patients were recruited than the initial number needed to power the trial appropriately, said one of the experts.

Additionally, many more patients with the collagen 3A1 (COL3A1) gene mutation was in the control group with no beta blockers rather than the Edsivo group, said the experts.The COL3A1 mutation defines patients with vEDS, and thus non-vEDS patients may also have been included in the trial, one of the experts noted.

In terms of safety, while all the experts agreed that the trial results showed no red flags, two pointed to recently presented mouse data showing that Edsivo may increase death. While the data gave one of them pause, another expert cautioned on translating those results to humans.

Acer submitted a New Drug Application (NDA) to the FDA in October 2018 and has requested priority review for Edsivo, which could result in a late second quarter 2019 FDA review date, according to a company press release.Sales are predicted to reach $400 million, according to the analyst report. Acer’s market capitalisation is $239 million. Acer declined an invitation to comment for this article.

Efficacy data not robust enough

The study that the approval of Edsivo would be based on was not well-designed, with an overall small trial size, said vEDS expert Dr Harry Dietz, Co-director of the Medical Genetics Fellowship Training Programme and Professor of Paediatrics at The Johns Hopkins Hospital, Baltimore, Maryland, US.Only 53 patients were enrolled in the trial, indicating recruitment was likely to have been challenging, said Dietz, pointing out the trial was almost half the size that was initially targeted.

Lancet paper findings

The trial powering was based on enrolling at least 50 vEDS patients in each group, as 40 primary events were needed to achieve a power of 80% as cited in the Lancet paper where the study is published (Ong, K. et al. 2010 Oct 30; 376 (9751): 1476-84).

Additionally, the number of patients with vEDS is very low, which may have been the reason why so few patients were enrolled in the study, said Dr Paul Grossfeld, Pediatric Cardiologist with the Rady Children’s Hospital, San Diego, California and Francesca Cortini, PhD, Research Fellow at the University of Milan, Italy.The Lancet paper stated that there were 87 individuals eligible for the study but 12 refused to participate and four were unable to move.

Eighteen subjects who were previously treated with beta blockers were included in the follow-up cohort. The frequency of vEDS is estimated to be 1 in 50,000 to 1 in 200,000 (Am J Med Genet C Semin Med Genet. 2017 Mar; 175 (1): 40-47).While the major adverse cardiovascular events (MACE) primary measure is clinically significant, it can pose difficulties in recruiting patients, as an aortic dissection over five years is difficult to find, said Dr Grossfeld.

The MACE outcome measure in the clinical trials is a composite of clinical events that occur in patients. The Lancet paper stated that the reduction in the MACE primary outcome measure at a five-year follow-up was reached by five (20%) in the Edsivo group and by 14 (50%) controls (hazard ratio 0.36; 95% confidence interval [CI]; p=0.04), which is not a sufficient set of data to gain FDA approval, according to Dr Dietz and Dr Grossfeld.The results indicate there were more patients on the placebo arm who had aortic rupture than the Edsivo arm, the expert added.

Besides the low patient figures, the imbalance between the experimental and control arms in terms of patients with the COL3A1 mutation means the results are also insufficient for FDA approval, said Dr Dietz and Dr Grossfeld.Another study with the same number of patients with the mutation in each group or higher for both groups would be needed to identify the true Edsivo effects.

In the treatment group, 53% of the 25 patients in the Edsivo group had the mutation, while in the placebo group, 71% out of 28 patients had the mutation, the Lancet paper reported.A trial that compares only patients with the COL3A1 mutation to placebo patients can best identify any clinically significant benefit with Edsivo, said Dr Grossfeld.

Furthermore, when patients do not have the COL3A1 mutation but exhibit similar symptoms, then they may have another disorder such as Loeys-Dietz syndrome. Therefore, some of the trial’s patients may have not even had vEDS.

In its press releases, Acer has not indicated another trial would be run; rather it says the data in the Lancet paper, with an Acer-sponsored retrospective source verified analysis of the trial data and manufacturing, non-clinical and other components of the regulatory package, will go into the NDA.

While Ms Cortini did not comment on the results’ potential to trigger FDA approval, she said she hoped Edsivo would be approved, as it has been used in Europe as an off-label treatment. In fact, she noted, it is the standard of care for vEDS in France.
Used to strengthen the immune system, antibacterial role.
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Packing: Packaged in the net vacuum aluminum foil bag then packed in carton.
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Nootropic Powder J147 CAS 1146963-51-0 with Top Quality

J 147 is a novel neurotrophic drug for cognitive enhancement and Alzheimer's disease. J147 is an exceptionally potent, orally active and broadly neuroprotective compound has the ability to enhance memory in normal animals as well as to prevent memory deficits in Alzheimer's disease (AD) transgenic mice. The neurotrophic and memory-enhancing activities of J147 are associated with an increase in brain derived neurotrophic factor (BDNF) levels and the expression of BDNF responsive proteins, the enhancement of LTP, the preservation of synaptic protein, the reduction of amyloid plaques.
147 (CAD-031) is a Curcumin and Cyclohexyl-Bisphenol A (CBA) derivative that is a potent neurogenic and neuroprotective drug. It was developed for the use of treating neurodegenerative conditions associated with aging.

Unlike the current drugs approved for Alzheimer's Disease, J147 is neither an acetylcholinesterase inhibitor nor a phosphodiesterase inhibitor, yet it enhances cognition with a short-term treatment. J147 can cross the BBB into the brain (strong) and induce neuronal stem cell production.

Enhance mental intelligence; Boost memory and leaning capabilities;Improve brain power to solve problems and protect it from any chemical or physical injury;Enhance motivation level;Enhance the control of cortical/subcortical brain mechanism;Improve sensory perception.
Glutathione Skin Whitening is a tripeptide that contains an unusual peptide linkage between the amine group of cysteine and the carboxyl group of the glutamate side-chain. Glutathione Skin Whitening is an antioxidant, preventing damage to important cellular components caused by reactive oxygen species such as free radicals and peroxides.Alpha-lipoic Acid

Freeze-dried powder:
A sterile injection made by freezing liquid into solid state under aseptic environment and sublimating water to dry under vacuum is a physical state of a component rather than a component.

Vitamin c:
Natural antioxidant, used to prevent and treat skin sunburn, prevent melanin precipitation, whitening, freckle removal, anti-inflammatory effect.
1. Fast decomposition of melanin in human skin, whitening skin
2. Improve that facial spot and prevent melanin formation
3. Repair damaged cells and delicate skin
4. Inhibiting cell oxidation
5. Promoting Metabolism
The wealth of products available these days to target visible signs of aging such as fine lines, crow’s feet, dark under-eye circles and dull skin are a gift and a curse. The options are so extensive that it can actually feel quite overwhelming figuring out a skin care regimen that works best. So when and where does one begin?
Experts agree that skin starts to age around 20 years old, and recommend that you start the road to prevention early. “I recommend my patients to start incorporating anti-aging skin care products in their 20s and 30s, when our skin slowly starts to lose collagen,” says Y. Claire Chang, a board-certified cosmetic dermatologist at Union Square Laser Dermatology in New York City.L(+)-Arginine powder
The first step to reduce signs of premature aging is daily sunscreen use. Sun exposure contributes greatly to the skin’s aging process. “The best thing to follow a good skin regimen requires one to wear sunscreen — SPF 50 or higher — and to moisturize daily,” according to board-certified dermatologist Naana Boakye of New Jersey’s Bergen Dermatology.
The next step in the anti-aging skin care fight is to identify the best key ingredients in the wide breadth of products available. Boayke, and most skin experts, recommend those with vitamin A derivatives like retinol, retinyl esters or retinaldehyde to improve fine lines and skin laxity. She explains: “Oxidative stress/UV radiation plays an important role in the skin aging process by creating enzymes that degrade collagen and elastin which ultimately lead to pigmentation and wrinkles. Wrinkle-fighting creams that contain vitamin A derivatives can promote new deposition of collagen and prevent its degradation by increasing Type I procollagen.” Collagen is a protein that gives skin its elasticity and firmness, which makes the skin appear more youthful. In a nutshell: start with retinol.
How you layer products is also key to getting the highest return on your skin care investment. “After cleansing, the layering should go as follows: In the morning — exfoliator, toner, serum or gel, cream, any treatment product and then sunscreen. In the evening — exfoliator, toner, serum or gel, cream, retinoid,” says Natasha Sandy of PolisheD Dermatology. Keep in mind that some concentrations of key ingredients can be irritating to certain skin types, so a pea-sized amount can go a long way.
Key ingredients to keep an eye out for when scanning the label of anti-aging products, include hyaluronic acid, antioxidants like ascorbic acid (vitamin C) and vitamin E, glycolic acid, peptides and ceramides. We’ve rounded up a list of some of the best anti-aging products on the market, along with the benefits of each of these key ingredients — shop them below!
Yahoo Lifestyle’s shopping team is committed to finding you the best products at the best prices. We may receive a share from purchases made via links on this page.
Antioxidants like vitamins E and C protect the skin from free radicals that damage cells, and vitamin A increases cell turnover (how we produce new skin cells). With a potent concentration of both, plus a safflower oil base, this vegan treatment oil comes highly recommended for individuals with sensitive skin. Use of this product can improve overall skin texture, minimize fine lines, brown spots and large pores, and stimulate collagen production.
“Sun protection is the easiest way to protect the skin from aging, and should be started as early as possible,” says Chang. You can’t go wrong with anti-aging skincare that combines moisture and sun protection, and Neutrogena Hydro Boost Water Gel Lotion SPF 50 offers both, with the added bonus of being water light and virtually invisible under makeup. That means none of those white streaks or greasy residue that we normally see after applying sunscreen.
Hyaluronic acid sounds scary, but it’s actually a powerful moisturizer and assists with intense hydration of the skin. “As we age, our skin loses hydrating elements, including ceramides and hyaluronic acid,” says Chang. So, it’s important to use products that replace those “elements.” CeraVe also contains ceramides, which seal in moisture, so this is a great product for those with extremely dry skin. And with a high concentration of hyaluronic acid, this serum hydrates and protects the skin, improving the appearance of dry lines.
Glycolic acid is an effective chemical exfoliant that gets rid of dead skin, boosts collagen and elastin production and evens the skin’s texture and tone, which is huge when addressing hyperpigmentation. The Ordinary is a brand known for its no-frills product range, and this toning solution acts as a mild chemical exfoliant.
People with deeper, darker complexions tend to show signs of aging like hyperpigmentation more so than those with lighter complexions, and green tea helps to calm that inflammation and even the skin tone. Mario Badescu’s cult facial spray contains aloe, green tea and cucumber to calm, protect and hydrate the skin. Sandy also highly recommends adding products with green tea and caffeine for those in their 40s because they aid in cell regeneration.
Product Description of FASORACETAM
Synonyms: FASORACETAM;(5R)-5-(piperidine-1-carbonyl)-2-pyrrolidone;(5R)-5-(piperidine -1-carbonyl)pyrrolidin-2-one;(5R)-5-piperidin-1-ylcarbonylpyrrolidin-2-one; 2-Pyrrolidinone, 5-(1-piperidinylcarbonyl)-, (5R)-;(5R)-5-(Piperidine-1-Carbonyl)Pyrrolidin-2-One (5R)-5-[Oxo-(1-Piperidyl)Methyl]-2-Pyrrolidinone;aka NS-105;LAM-105)
CAS: 110958-19-5
MF: C10H16N2O2
MW: 196.248

FASORACETAM Descriptions:
Fasoracetam is a research compound and member of the racetam family of nootropics,primarily known for their cognitive enhancing abilities.Fasoracetam is also an axiolytic and may be able to improve mood as well. This racetam works by affecting three receptors within the brain: acetylcholine,GABA and glutamate, all of three of which are involved in the creation and retention of memories.Best Nootropics Fasoracetam Powder
Fasoracetam Usage :
Through the stimulation of metabotropic glutamate receptors play a role in enhancing memory

Fasoracetam How Does Fasoracetam Work?
There is no conclusive evidence as to how fasoracetam works to improve cognition, but theories suggest it interacts with the cholinergic system and receptors of GABA and glutamate.

Fasoracetam Dosage
There is no standardized dose of fasoracetam for humans yet. The anecdotal evidence suggests smaller doses range around 10 - 15 mg with larger doses in the 30 - 50 mg per serving three times per day.The latter heavy dose was used by someone who tried using GABA up-regulation to resolve phenibut withdrawal symptoms, however.
What's Pramiracetam?

Ever since the discovery of the racetams in the 1970's, the racetam family of compounds has been a compelling route for people trying to improve general cognition, memory, and learning capabilities.pramiracetam dosage

In the world of nootropics, the racetams are the go-to nootropics for boosting brain power. While there is some variety of racetam forms, and not all racetams are as well understood as the parent compound, one of the more widely known and studied is Pramiracetam.

Pramiracetam (N-[2-(dipropan-2-ylamino)ethyl]-2- (2-oxopyrrolidin-1-yl)acetamide) is a GABA-like compound derived from the original racetam. The chemical difference between the two is that Pramiracetam has a dipropan-2-ylaminoethyl group rather than an amide.

Pramiracetam is remarkable for high oral-bioavailability and high potency. For this reason, users take Pramiracetam in smaller doses than it's prototype.

This more potent racetam is sometimes taken as an alternative to weaker racetams for people who don't feel they give them the sense of well-being that they are after or people who don't want to take as much powder as less potent racetams can require.

Pramiracetam Side Effects and Benefits

As with other racetams, the direct mechanism of Pramiracetam is not fully known. It has been conjectured that racetams increase acetylcholine receptors, or are antioxidants, but more study is required. There is also speculation that racetams interact heavily with glutamate receptors, but, again, the action is unclear.
Pramiracetam most likely works by increasing cholinergic neuronal impulse flow in specific regions of the brain based on certain in vitro observations.

While the mechanisms are not clearly understood, the outcomes of the racetams have been looked into extensively. Since their first debut in the early 1970's, a lot of interest has been put into the many racetams.

Advantageous Pramiracetam side effects include improved memory and reduced delayed verbal recall. There is also some evidence to suggest that Pramiracetam is superior to the original racetam in helping with memory retrieval and orientation.

Pramiracetam has also shown to improve some test scores on cognitive ability up to three hours after being taken. It remains a highly popular nootropic and an inexpensive way to optimize mental performance.

Pramiracetam Dosage

Users typically take Pramiracetam powder in doses around 250 mg a few times a day with meals. As with most racetams, many people take a choline source along with it. Some say taking choline along with the proper Pramiracetam dosage can improve the overall experience.
Galanthamine is a kind of anticholinesterase drug, which can better improve the conduction between nerve and muscle. it could be used myasthenia gravis, progressive myodystrophy, post polio syndrome, child brain paralysis, sense obstruction, cinesipathy and polyneuritis induced by nervous system diseases.galantamine powder

Galantamine Hydrobromide Function:

1) anti-oxidation series:
bilberry extract, cranberry extract, grape seed extract, elderberry extract, lutein, zeaxanthin, pine bark extract, rosemary extract, pine bark extract. lemon balm extract.

2) liver protecting:
silybum marianum extract, artichoke extract, antrodia camphorate extract, schisandea extract.

3) immune system enhancer series:
wolfberry extract, echinacea extract, tribulus terrestris extract, resveratrol, 5htp, citrus aurantium extract, nettle extract, red cover extract, reishi extract, rhodiola rosea extract, black cohosh extract, astragalus extract, ginseng extract, cinnamomum cassia extract, schisandra chinensis extract.

4) heat-clearing and detoxifying series:
lemon balm extract, dandelion extract.

5)weight loss series:
white kidney bean extract, garcinia cambogia extract, cassia nomame extract, 5htp.

6)man and woman healthy:
yohimbe bark extract, common cnidium extract, epimedium extract, pygeum africanum extract, saw palmetto extract, soybean extract, pueraria lobata extract, wild yam extract.

7) mushroom extract:
reishi extract, maitake extract, shitake extract, cordceps extract.

8) anti-cancer:
resveratrol, wolfberry extract, flaxseed extract, pomegranate extract, bilberry extract.

9) anti-depressant:
passiflora incarnate extract, st john's wort extract.

10) antibacterial:
white willow bark extract, citrus aurantium extract, pomegranate extract, senna extract, magnolia extract, ginger extract, scutellaria baicalensis extract, shikimic acid,echinacea purpurea extract, chlorogenic acid.

Galantamine Hydrobromide Dosage
Oral, one time 5mg, 4 times a day; three days later changed to a 10mg, 4 times a day or as directed. Epilepsy, hyperactivity, mechanical intestinal obstruction, bronchial asthma, angina and bradycardia are hanged.Glaucoma patients should not be used.
Product name: Galantamine Hydrobromide
Assay: 99%
CAS NO.: 1953-04-4
Use: Treatment of Polio sequelae
molecular formula C17H21NO3.HBr
molecular weight 368.27
Specification: Tablets, capsules, powder
Appearance: white powder
Clinical mainly for the treatment of poliomyelitis (poliomyelitis) sequelae, muscle atrophy and myasthenia gravis. Can also be used for children with cerebral palsy, traumatic sensory dyskinesia, polyneuritis and spinal nerve root inflammation.galantamine nootropic

This product is anticholinesterase drugs, a weaker anticholinesterase role, through the blood-brain barrier, so the role of the central nervous system is relatively strong. The obstruction of nerve and muscle conduction recovery, improve the various peripheral neuromuscular disorders paralysis.

The treatment of a wide range of less toxic, more tolerable patients. Clinical mainly for the treatment of poliomyelitis (poliomyelitis) sequelae, muscle atrophy and myasthenia gravis. Can also be used for children with cerebral palsy, traumatic sensory dyskinesia, polyneuritis and spinal nerve root inflammation.

This product is anticholinesterase drugs, a weaker anticholinesterase role, through the blood-brain barrier, so the role of the central nervous system is relatively strong. The obstruction of nerve and muscle conduction recovery, improve the various peripheral neuromuscular disorders paralysis.

The treatment of a wide range of less toxic, more tolerable patients. Clinical mainly for the treatment of poliomyelitis (poliomyelitis) sequelae, muscle atrophy and myasthenia gravis. Can also be used for children with cerebral palsy, traumatic sensory dyskinesia, polyneuritis and spinal nerve root inflammation.
Corcarbata (MKC-231) is a lasatin drug that is said to be a cognitive enhancement drug. When they are damaged, it is able to keep choline uptake in neurons, but there is no evidence to show the inherent anisotropic effect.Coluracetam Review

Coralcitabine is a relatively new swimming-driving drug. The idea behind this powerful compound is that it acts as a choline uptake enhancer. In other words, the purpose of this heterosexuality is to increase the effect of choline on the brain and the body.

This includes increasing the yield of acetylcholine, which may not be able to move our muscles, even remember the simple facts. Acetylcholine not only increased the production of acetylcholine, but also accelerated the flow of brain synapses. The product was first registered in 2005, completed in 2010 2A test.


After acquiring the trademark from Mitsubishi Tanabe, BrainCells Inc. immediately began testing the effects of Coluracetam. As there weren't enough participants to take part in clinical trials for Coluracetam, most of these tests were conducted on rats instead. From these tests, Coluracetam was shown to markedly improve memory, learning and anxiety.

1. Memory and Learning

Coluracetam is shown to improve cognitive function and memory in rats, and theoretically, humans expect the same results. A study conducted by BrainCells Inc showed that the rats were challenged with a substance of AF64A (neuron-specific neurotoxin) at a dose of 3 mg for 8 days. These rats were able to mark their ability through standardized Morris water maze through them, even after the last 8 mg dose 72 hours. Another important finding of this study was that the results were still evident after 3 days of the last dose, even if the serum albumin concentration was negligible.

2. Depression and Anxiety

BrainCells Inc found that a dose of 240 mg (divided into three doses of 80 mg) was useful for the treatment of severe depression complications with GAD (generalized anxiety disorder). However, among patients who did not find remission in standard antidepressants, the difference was most pronounced. There was no significant difference after one dose, but 36% of the two doses at 80 mg improved in the depression assessment test.

3. Eyesight

Coluracetam has been associated with optic benefits such as enhanced color vision, recognition and vividness. Although there isn't any conclusive evidence to support the mechanisms behind this benefit, experts believe that Coluracetam works in the part of the brain that runs visual processes.
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