ACE-031
ACE-031 is a promising peptide drug that belongs to the class of myostatin inhibitors. It is based on a solution of extracellular elements of ActRIIB receptors, which are connected to the Fc fragment of immunoglobulin G. The action of the drug is based on blocking myostatin (there is a complete blocking of the signal through the ActRIIB receptor [1] ), as a result of which accelerated muscle growth and strength, indicators are observed.
This peptide has a high potential for use in bodybuilding in order to provide better muscle growth and fat burning.
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ACE-031
Not so often, it is possible to get the results of research on peptides. The very ones that are now being sold with might and main both in Ukraine and in Russia. We are talking about one peptide, more precisely, a propeptide - ACE-031, which is an inhibitor of myostatin.
I must say that the company that synthesized ACE-031 for Sale - Acceleron Pharma - stopped research on it. But the propeptide is still being synthesized by third-party laboratories and is entering the online market. It is worth talking about it, especially since myostatin inhibitors are a rather extensive and interesting topic. He is talking about a completely official study, the results of which were published in the March issue of the scientific journal Muscle & Nerve.
The study involved 48 people. All of them were women aged 45-75 years (women for such experiments are chosen, as a rule, in order to minimize the influence of external factors, in particular, testosterone ). He was given only one injection of ACE-031, but of different volumes: 0.02, 0.05, 0.1, 0.3, 1 & 3 mg per kilogram of body weight. One injection, in this case, was quite enough, since the half-life of the drug is about 20 days. The concentration in the blood plasma increases quite quickly, reaching a maximum in about 3-4 days. After 8-10 days, the concentration begins to gradually decline.
I must say that satisfactory results were obtained only with a very significant volume of injections - 1 and 3 mg per kilogram of own weight. The remaining dosages did not give a particular advantage over placebo injections. However, the "three-milligram" group received a significant increase in muscle volume - 5 per cent. Dry muscle mass increased by 3%, while some fat was consumed. I emphasize: three per cent for a hundred-kilogram athlete is 3 kg of precisely the muscles that "grow" in just two to three weeks.
But we are talking specifically about MILLIONS per kilogram of weight. And usually, purchase ACE-031 is sold in bottles containing only 1 mg (1000 mcg). You can imagine how many such bottles are needed for just one injection. Finally, it is worth mentioning why Acceleron Pharma has so far discontinued research into its myostatin inhibitor.
In the experiment described above on women, almost all subjects experienced a sharp decrease in the level of FSH. Perhaps there is nothing dangerous in these "side effects", but experts from Acceleron Pharma decided to thoroughly understand everything - away from sin. Those who continue to buy ACE-031 do it at their own risk.
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Clinical Trials ACE-031
On May 2, 2013, a press release, Acceleron Pharma and Shire PLC announced that they had concluded their joint work on ACE-031 and related molecules and that they would not start re-launching this program. John Knopf, CEO of Acceleron said: "Despite the fact that we express our dissatisfaction with the results of the ACE-031 program, at the same time, thanks to the study, we received valuable information that can be used in the process of Acceleron developing new compounds, they will also benefit our patients in the future."
Another event, dated May 2, 2013: while communicating with Jane Larkindale, AMD Vice President of Research, Kenneth Attie representing Acceleron and Lawrence Charles of Shire reported that clinical trials of ACE-031 had been suspended since February 2011. "From that moment," they continued, "we have presented a number of additional preclinical and toxicological studies, but, unfortunately, the results of these studies do not ensure their further development." They expressed gratitude to AMD for her participation in the ACE-031 program and noted that: "Each company remains committed to developing new therapeutic methods for treating AMD and other rare diseases."
The following is the original search story - "ACE-031 clinical studies of Duchenne muscular dystrophy are currently being stopped," published May 3, 2011.
On April 21, 2011, biopharmaceutical companies Acceleron Pharma and Shire announced that the AMD-supported clinical studies of ACE-031 on Duchenne muscular dystrophy (DMD) were suspended.
Phase 2 work on the dose-escalation study of buy ACE 031 in boys with MDM was discontinued, and the extension of the clinical study for boys, which was completed as part of the initial study, was suspended based on preliminary safety data.
Both studies were conducted in Canada, and the plan was to open research centres in the USA sometime in the future.
The negative effects experienced by the test participants - minor bleeding from the nose and gums, as well as the expansion of the blood vessels of the skin - both in general and by themselves, were not recognized as dangerous. However, the companies involved and regulators say they need a full understanding of these events before the clinical trials of ACE-031 are continued.
The development of ACE-031 was fully discussed in the April 2011 issue of AMD's Quest magazine, which focuses on health and quarterly research. The discussion was published under the heading "Distracting and unwanted protein." Companies are looking forward to resuming testing of the ACE 031 buy after security issues have been fully explored.
Acceleron and Shire are complete ACE-031 studies in rats and monkeys. Researchers will analyze data from people and animals in order to get an idea of ​​the resulting adverse events. Companies say they hope to resume human trials of ACE-031 after the results of these tests are received and reviewed by the US Food and Drug Administration (FDA) and the Canadian Department of Health.
Acceleron and Shire made the following statement on April 21:
"In order to maintain a situation in which the Duchenne Muscular Dystrophy Association is constantly informed, Acceleron and Shire are going to provide updated clinical status data for ACE-031."
"In clinical trials in healthy adults and boys with DMD, some participants showed minor nosebleeds, bleeding gums and/or slight dilation of blood vessels in the skin. These phenomena were completely eliminated after the cessation of treatment. "
"Minor bleeding and vasodilation alone were not considered a serious safety issue in the context of this study."
"However, based on an analysis of this safety data conducted jointly with the FDA and the Department of Health Canada, Acceleron discontinued the A031-03 DMD study and suspended the collection and dosing of the subsequent extended study A031-06 ."
"Acceleron and Shire continue to be associated with the international clinical DMD program, as well as with the ACE-031 development project. In pursuit of these goals, we express our intention to start conducting new ACE-031 studies in the framework of work with the DMD, and relevant monitoring will be carried out on issues, as well as subsequent discussions with regulatory authorities."
"In the coming months, we will provide new information for the DMD Association, as it should be."
Importance for Duchenne Muscular Dystrophy Families
The emergence of safety concerns associated with an experimental drug is never good news for families expressing hope for new methods of therapeutic treatment. However, clinical trials of an experimental drug are inherently risky. And its benefits to patients who could potentially have serious side effects should be considered in terms of side effects that need to be clarified before they pose a threat to health or life.
"Although we are disappointed with this turn of events in the development of ACE-031, this underscores the importance of conducting properly designed and controlled research," said Sanjay Bidichandani, MDA Research Vice President.
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