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Step in direction of an HIV/AIDS vaccine

 

There has been a four decades long challenge to develop a vaccine against the deadly HIV virus that causes AIDS. Last Saturday the research bore fruit when a team of scientists announced that a trial drug has shown immune response in humans and also protected laboratory monkeys from HIV infection.

3d rendered HIV Virus in Blood Stream in color background. Image Credit: RAJ CREATIONZS

3d rendered HIV Virus in Blood Stream in color background. Image Credit: RAJ CREATIONZS

During the initial stages of the drug testing, the researchers have found that the drug can trigger an immune response when administered to humans. This immune response could protect the humans from the infection. They also tried the drug on 72 laboratory monkeys and proceeded to infect them with six injections of HIV like viruses. Two thirds of the tested monkeys’ immune systems resisted the incoming infection proving the vaccine successful in them. In early human trials the vaccine has been found to be safe in humans.

The study results from these early trials have been published in the latest issue of the Lancet. The team tested this new agent on 393 healthy, HIV-free adults from East Africa, South Africa, Rwanda, Uganda, United States and Thailand between ages of 18 and 50 years. All of the participants were randomly divided into seven groups and administered severe different vaccine combinations or a placebo. This is called a “mosaic” of vaccines. They were administered 4 injections over a period of 48 weeks and their immune system response was noted. According to the study authors, the vaccine produced “robust (high levels of) immune responses” in the participants. Only five of the recipients of the vaccine reported side effects such as dizziness, diarrhoea, stomach pain, low back pain etc.

Now it is to move on to the next stage of human clinical trials wherein it would be tested on 2,600 women in southern Africa to check if it prevents HIV infection in them. The drug is named HVTN705 is called “Imbokodo” (meaning the ‘rock’ in Zulu). It is still too early to speculate that it would work with 100 percent success say the researchers but they are hopeful. Study leader Dan Barouch, a Harvard Medical School professor said that the results till now are “promising” but it is best to be “cautious”. He explained that more data needs to come in from human trials to deem this as safe and protective against HIV infection. The results from the upcoming trials on humans are expected to arrive by around 2021 or 2022.

Barouch reminded that this is the “fifth HIV vaccine concept” that has been tested in the four decades of the advent of HIV. The last promising molecule was RV144 in 2009 that reduced the risk of HIV infection in over 16000 Thai individuals by 31.2 per cent. The achievement was considered to be too small for the drug to go ahead and come into the market as a HIV vaccine.

HIV has infected around 80 million people worldwide since it was first detected in the 1980’s. At present around 37 million individuals are living with HIV/AIDS with 1.8 million new infections and 1 million deaths annually says the World Health Organization.

This study was funded by Janssen Vaccines & Prevention BV along with International AIDS Vaccine Initiative among others.

Source:

https://doi.org/10.1016/S0140-6736(18)31364-3

Posted in: Drug Trial News | Medical Research News | Disease/Infection News

Tags: AIDS, Back Pain, Blood, Diarrhoea, Fruit, HIV, HIV/AIDS, Immune System, Laboratory, Medical School, Molecule, Pain, Placebo, Research, Stomach, Stomach Pain, Vaccine, Virus, Viruses

Seven Years After “Charlotte’s Net,” A CBD Therapy for Epilepsy Strikes One Step Nearer to FDA Approval

 

A number of years in the past, individuals who used the cannabis-derived substance cannabidiol (CBD) risked arrest – or had been compelled to maneuver to states similar to Colorado, the place marijuana merchandise are authorized. That has modified as extra states have legalized hashish and marijuana legal guidelines have been relaxed. This month, the FDA took a big step ahead on this difficulty by recommending approval for the primary CBD medicine from a significant pharmaceutical agency, which is meant to deal with signs of a particular type of epilepsy referred to as Dravet Syndrome.

In 2011, the Stanleys, seven brothers residing in Colorado, developed a hybrid pressure by crossing hashish with industrial hemp, leading to a product that was wealthy in CBD, however low in tetrahydrocannabinol (THC). The latter, after all, is the biochemical that creates the “excessive” for leisure customers, whereas the previous doesn’t. ‘’

CBD does, nonetheless, present quite a few medical advantages. This was actually the case for younger Charlotte Figi, who had suffered extreme epileptic seizures since she was an toddler. It was the Stanley pressure, finally dubbed “Charlotte’s Net,” that just about stopped her seizures altogether.

Now, a significant UK-based drug producer, GW Prescribed drugs, is making an attempt to enter the prescription drug market with its personal model of “Charlotte’s Net.” The corporate submitted a New Drug Software (NDA) final fall. Final week, 13 members of the FDA advisory committee unanimously voted to suggest full approval for the product referred to as Epidiolex, after medical research confirmed a constructive benefit-risk profile.

Over a 14-week medical trial, Epidiolex was proven to be twice as efficient in controlling epileptic seizures in kids who got the drug in comparison with these within the management group. The brand new medicine could be the primary cannabis-based prescription medicine to get FDA approval if the company follows the committee’s suggestion.

GW Prescribed drugs manufactures the same drug, referred to as Sativex, which is accredited in a number of European international locations for the therapy of involuntary muscular contractions symptomatic of a number of sclerosis. That medicine is a hashish extract containing equal components THC and CBD, and isn’t obtainable within the US. Different drug corporations have provide you with medicines primarily based on artificial compounds much like CBD. Epidiolex is basically a pure CBD extract.

Right here is the rub: if accredited and delivered to the market, the worth tag for Epidiolex might be as a lot as $ 60,000 a 12 months, in keeping with monetary analysts (GW Prescribed drugs has declined to remark). Then again, CBD merchandise at present obtainable at marijuana retailers will be bought for as little as $ 100 per 30 days. After all, FDA approval might imply that the price of Epidiolex could be lined by medical insurance coverage.

GW Pharmaceutical CEO Justin Grover factors out that their product “is the topic of rigorous and intense manufacturing controls. Sufferers have the reassurance that the product is what we are saying it’s and what they assume it’s.” Many people who find themselves already treating their epileptic kids efficiently with CBD merchandise are understandably skeptical, given Large Pharma’s observe report of promoting dangerous merchandise and a historical past of value gouging. One mother or father interviewed within the New York Instances stated, “My child’s steady. I’m not touching it. I don’t want a double-blind placebo-controlled research to know one thing [works].”

Most cancers Immunotherapy Takes a Step Ahead

 

Utilizing the physique’s personal defenses in opposition to cancerous tumors has been the digital “Holy Grail” for oncology researchers. One of many major challenges on this discipline of research lies in the truth that most cancers cells aren’t international pathogens. Fairly, they’re native cells which have mutated in such a means that they now not undergo apoptosis or pure “cell dying.” Due to this fact, antibodies don’t usually acknowledge them as invaders. Lately, nevertheless, researchers have been discovering varied methods to make use of the physique’s personal immune defenses in opposition to most cancers. The newest breakthrough on this space includes a category of medicine often known as checkpoint inhibitors.

These “checkpoints” are proteins that establish a cell and whether or not its a standard a part of the physique’s system or a pathogen invading from exterior. Killer T-cells – the entrance line of the immune system – actually “verify” these identifiers as a way to decide whether or not or not the cells in query characterize a menace, similar to an an infection. Nonetheless, most cancers cells, behaving like digital “id thieves,” are in a position to applicable these immune checkpoints and use them to cover from T-cells. Checkpoint inhibitors are in a position to rip away this protein “masks” and reveal a most cancers cell’s true id – clearing the best way for an assault by the immune system.

There are a selection of checkpoint inhibitors available on the market at present, a few of which goal the mechanism that T-cells (PD-1) use to find out whether or not a cell is benign or malignant. These embody pembrolizumab (Keytruda) and nivolumab (Opdivo). Different medicine on this class embody atezolizumab (Tecentriq), avelumab (Bavencio) and durvalumab (Imfinzi). These medicine act to inhibit the checkpoint proteins current on course cells (PD-L1).

Keytruda, a product of Merck Oncology, was accredited by the FDA final yr as a first-line therapy for adenocarcinoma, or non-small cell lung most cancers – the most typical type of the illness, accounting for about 75 % of all circumstances. Till now, nevertheless, oncologists have been hesitant to make use of it as a result of a restricted research failed to indicate any advantages in extending survival charges. Nonetheless, a latest research from the Perlmutter Most cancers Heart at New York College has demonstrated that Keytruda, administered together with normal chemotherapy therapies, can enhance affected person survival by as a lot as 100 %.

The research concerned 616 chemotherapy sufferers. Half of the group got Keytruda. These within the management group had been allowed to take the drug if their most cancers acquired worse. After twelve months, 69 % of the Keytruda group had been nonetheless alive versus 49 % of those that acquired chemotherapy alone. The research additionally discovered that including Keytruda to the chemotherapy routine delayed metastasis by a median of 9 months.

There was a draw back: four % of the Keytruda group wound up creating lung irritation, with three contributors dying because of this. Nonetheless, the outcomes are promising sufficient that many physicians consider the usage of immunotherapy medicine will ultimately turn out to be the brand new normal of therapy.

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