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
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.
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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
Not all valsartan-containing drugs are a part of this recall
A number of drugs containing the energetic ingredient valsartan are being recalled after the Meals and Drug Administration (FDA) introduced that these medicine comprise N-nitrosodimethylamine (NDMA), an impurity categorised as a possible human carcinogen.
The recalled drugs embrace Valsartan Tablets manufactured by Main Prescription drugs, Solco Healthcare, and Teva Prescription drugs, in addition to Valsartan/Hydrochlorothiazide Tablets from Solco Healthcare and Teva Prescription drugs. “We have now fastidiously assessed the valsartan-containing drugs offered in the US, and we have discovered that the valsartan offered by these particular firms doesn’t meet our security requirements,” mentioned Janet Woodcock, MD, director of the FDA’s Heart for Drug Analysis and Analysis. “For this reason we have requested these firms to take instant motion to guard sufferers.”
As valsartan is used to deal with numerous cardiovascular situations together with coronary heart failure and hypertension, sufferers ought to proceed to take their drugs till they’ve a substitute product. Not all valsartan-containing drugs are a part of this recall; sufferers ought to contact the pharmacy that distributed the remedy to see if the drug got here from lots particularly manufactured by an organization talked about above.
Healthcare professionals are urged to report any potential unwanted effects associated to this recall to the FDA’s MedWatch Program. Within the meantime, the Company plans to proceed its investigation into the potential results NDMA might need on sufferers who’ve been taking these merchandise. Addressing a potential scarcity due the recall, FDA Commissioner Scott Gottlieb, MD, mentioned “As we search the removing of sure drug merchandise at this time, our drug shortages crew can also be working onerous to make sure sufferers’ therapeutic wants are met in the US with an ample provide of unaffected drugs.”
Ludwig Most cancers Analysis and the Most cancers Analysis Institute (CRI) announce the initiation of a medical trial to judge the mixture of ONCOS-102, an experimental anti-tumor virotherapy, with the checkpoint blockade antibody IMFINZI® (durvalumab) for superior ovarian and colorectal cancers.
The Section I/II trial, which has accomplished enrollment and the security analysis for the primary affected person cohort, might finally enroll as many as 78 grownup sufferers in a multi-center program at main tutorial facilities together with Memorial Sloan Kettering Most cancers Middle (MSK), the Roswell Park Most cancers Institute, Sylvester Complete Most cancers Middle on the College of Miami (UM/Sylvester) and the College of Virginia Well being System (UVA). It’s chaired by Ludwig and CRI investigator Dmitriy Zamarin of MSK. Kunle Odunsi of the Roswell Park Most cancers Institute and Brian Slomovitz of UM/Sylvester are overseeing the trial at their respective establishments with places to be added for the brand new cohorts. MedImmune, the worldwide biologics analysis and improvement arm of AstraZeneca that developed durvalumab, and Targovax, the biopharmaceutical firm that developed ONCOS-102, are additionally collaborators within the medical trial.
“Sufferers identified with superior ovarian and colorectal cancers which have progressed on commonplace therapies have only a few therapy choices obtainable to them,” stated Vanessa Lucey, director of the CRI Enterprise Fund and Scientific Accelerator. “Below a singular partnership mannequin, this examine leverages the capabilities of two outstanding nonprofit teams, accelerates innovation with high tutorial facilities, and consists of two totally different bio-pharmaceutical firms. That is the kind of coordination and collaboration we have to speed up progress for sufferers.”
“Though checkpoint blockade antibodies have been remarkably efficient in treating a wide range of cancers, many sufferers fail to reply to these immunotherapies,” stated Jonathan Skipper, Ludwig’s govt vp for know-how improvement. “Eliciting therapeutic responses in such sufferers by way of mixture therapies is a high precedence of Ludwig’s medical analysis program, and a significant goal of CRI’s as nicely. We have now good motive to imagine that combining checkpoint blockade with oncolytic virotherapy is a extremely promising technique to that finish. We very a lot stay up for seeing the outcomes of this trial.”
ONCOS-102 is a serotype 5 adenovirus–a relative of the chilly virus–that has been engineered to selectively infect and kill most cancers cells. The virus has additionally been modified to precise a gene for an immune issue referred to as granulocyte-macrophage colony stimulating issue (GM-CSF), which boosts important components of the immune response. ONCOS-102 has been proven in a earlier trial to be protected and to induce anti-cancer immune responses.
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Durvalumab, which is already accredited for medical use in different cancers, is a human monoclonal antibody directed towards PD-L1. PD-L1 ordinarily protects wholesome cells from destruction by a runaway immune response. Tumor cells, nonetheless, can co-opt PD-L1 to evade assault by the immune system’s killer T cells. Durvalumab blocks PD-L1 interplay with PD-1 and CD80, countering the tumor’s immune-evading ways and inducing an immune response.
There’s rising proof that combining checkpoint blockade with virotherapy might have a therapeutic impact towards cancers. Viral an infection of most cancers cells is hypothesized to attract activated killer T cells into tumors. As soon as within the tumor, the T cells are uncovered to telltale antigens launched by dying most cancers cells, probably awakening an immune response towards the malignancy as nicely.
Preclinical analysis performed on mice by Zamarin and others has proven that infecting a tumor with an oncolytic virus and following up with a checkpoint blockade remedy elicits a systemic immune response that targets not solely the contaminated tumor but in addition different tumors within the physique. It’s hoped that the GM-CSF expressed by the virus because it multiplies in most cancers cells will additional increase this type of anti-tumor response.
The present trial is enrolling sufferers whose colorectal or ovarian cancers have change into proof against all standard therapy and whose tumors have unfold into the peritoneum–the membrane across the stomach cavity. ONCOS-102 is being delivered immediately into the peritoneal membrane, whereas durvalumab will likely be given systemically.
The targets of this open label trial are to check the security and preliminary efficacy of the mixture, optimize dosing, consider the feasibility of peritoneal supply of ONCOS-102 and inform present and future translational analysis.
This text initially appeared on Renal and Urology Information.
Researchers discovered “no clinically significant variations” between the biosimilar epoetin alfa-epbx and epoetin alfa.
For hemodialysis (HD) sufferers with anemia, the biosimilar erythropoiesis-stimulating agent (ESA) epoetin alfa-epbx seems to be as secure and efficient as epoetin alfa over the quick time period, based on new examine findings.
In a multicenter, double-blind examine, Steven Fishbane, MD, of Hofstra Northwell College of Medication in Hempstead, New York, and colleagues randomly assigned 612 HD sufferers with secure hemoglobin ranges, sufficient dialysis, and adequate iron shops who have been receiving intravenous epoetin alfa to proceed on epoetin alfa or change to epoetin alfa-epbx for 24 weeks. Drug dosing was adjusted through the remedy interval.
In response to an internet report within the Medical Journal of the American Society of Nephrology, the least squares imply distinction between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin over the trial interval was -Zero.12 g/dL – throughout the prespecified equivalence margin of -Zero.5 to Zero.5 g/dL. The least squares imply distinction between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of physique weight was Zero.37 U/kg per week – throughout the prespecified equivalence margin of -45 to 45 U/kg per week. These margins have been established based mostly on earlier research.
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Opposed occasions occurred in 77.1% vs 75.three% of epoetin alfa-epbx and epoetin alfa recipients, respectively. Critical hostile occasions occurred in 24.9% vs 27.Zero% and deaths in 5 vs 6, respectively. These variations have been thought-about minor. Through the trial 5 sufferers at baseline and 1 affected person per group examined constructive for anti-recombinant human erythropoietin antibodies. Nevertheless, not one of the sufferers had neutralizing antibodies or pure pink cell aplasia.
“The outcomes of this examine demonstrating no clinically significant variations in efficacy and security between epoetin alfa-epbx and epoetin alfa assist the chance to broaden the advantages of erythropoietin remedy to extra sufferers at a decrease total value,” concluded the authors.
This examine was funded by Hospira Inc., a subsidiary of Pfizer Inc., which markets epoetin alfa-epbx (Retacrit).
Reference
Fishbane S, Singh B, Kumbhat S, et al. Intravenous epoetin alfa-epbx versus epoetin alfa for remedy of anemia in end-stage kidney illness. Clin J Am Soc Nephrol. doi: 10.2215/CJN.11631017
Scientists from the Diabetes Analysis Institute (DRI) on the College of Miami Miller Faculty of Drugs right now introduced the launch of a brand new scientific trial that may assess the affect of high-dose omega-Three fatty acids and vitamin D supplementation on halting the development of kind 1 diabetes (T1D). The DRI has obtained FDA IND clearance to proceed with the Part I/IIa trial, named the POSEIDON Research (Pilot examine of Omega-Three and Vitamin D Excessive Doses in T1D), to check the consequences of the proposed intervention in youngsters and adults newly recognized and in these with longer-standing T1D to judge any advantage of early and late interventions.
A number of scientific studies have recommended that using high-dose omega-Three and vitamin D, each of which have recognized anti-inflammatory and immunomodulatory properties, could provide a possible useful impact on autoimmune situations, like kind 1 diabetes. DRI researchers hypothesize that the therapy could delay or forestall the illness.
“My impetus for beginning this examine is to find out if modulating irritation and immunity may halt, or at the least delay, the development of kind 1 diabetes. Irritation could also be one of many triggers for autoimmunity that results in the onset of the illness, but in addition has an impact on insulin resistance and, subsequently, islet dysfunction,” mentioned Camillo Ricordi, M.D., examine sponsor and Director of the Diabetes Analysis Institute on the Miller Faculty of Drugs. “Outcomes from our latest case research analyzing the function of omega-Three/vitamin D in preserving beta cell operate in three pediatric topics with kind 1 diabetes warrant additional investigation of this potential therapeutic technique,” continued Dr. Ricordi, referring to his latest findings in collaboration with Italian facilities in Rome and Novara, together with these printed in European Assessment for Medical and Pharmacological Sciences.
The DRI plans to enroll 56 adults and youngsters within the two-arm, open-label examine. The investigators will evaluate youngsters and adults with kind 1 diabetes, each newly recognized and people greater than six months post-diagnosis, who take both vitamin D alone or together with omega-Three fatty acids. The contributors shall be handled for one yr, adopted by a one-year remark interval to measure any long-term impact on blood sugar management, improve in endogenous insulin manufacturing, and different outcomes.
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Members shall be randomized to both 25-hydroxyvitamin D (cholecalciferol) alone, or together with ultra-refined omega-Three EPA/DHA derived from fish oil. Though preliminary dosing shall be primarily based on components like age and physique weight, investigators will monitor and modify vitamin D dosing each 4 months. They may even modify the omega-Three fatty acids dosage primarily based on month-to-month monitoring of the ratio of arachidonic acid to eicosapentaenoic acid (AA/EPA).
The next AA/EPA ratio is taken into account detrimental as a result of AA is believed to advertise irritation and reduce the regulatory cells that would defend towards autoimmunity, whereas EPA could be protecting. Extra EPA may enhance different situations the place irritation performs a key function.
“Reversing autoimmunity could possibly be useful effectively past topics with kind 1 diabetes. In actual fact, related methods needs to be examined in different autoimmune illnesses like Crohn’s, rheumatoid arthritis and lupus erythematous,” Dr. Ricordi mentioned.
All contributors will obtain normal diabetes therapy with insulin and dietary management.
“If mixture omega-Three and vitamin D remedy is ready to delay development or halt autoimmunity in kind 1 diabetes, that is anticipated to end in retention of insulin secretion, minimal use of exogenous insulin, and improved metabolic management thus minimizing the dangers related to unstable blood glucose ranges,” Dr. Ricordi mentioned.
