After being fired, I became the light of medicine

Chapter 108: Clinical trials of hepatocytes have begun in the United States (a big bonus for Feng Qi Que De Fu Chen!)

The process of FAD clinical certification in the United States is basically the same as the clinical trial process in China.

To be precise, since the US pharmaceutical industry has a history of clinical trials for nearly a hundred years, China's clinical trial processes and models are basically based on the FDA.

and,

Due to the high degree of commercialization of the US FDA, the speed of clinical trial approval is faster than that in China.

of course,

Also because the FDA is the world's most authoritative, professional, and commercialized drug clinical trial certification agency, almost all pharmaceutical companies in the world conduct clinical trials of their own drugs at the FDA.

As a result, a black market group that specializes in participating in clinical trials has formed in the United States.

Novartis quickly contacted a group of eligible subjects to participate in the Phase I clinical trial of the "hepatocyte regeneration activator".

Jamin Anderson was one of the subjects.

He is a traditional American white man. Because he loves hamburgers, hot dogs and cola, his weight has reached 130 kilograms at the age of . He currently suffers from severe fatty liver, hypertension, diabetes and other diseases.

Such weight made him lose interest in work, and by chance he joined the "drug testing organization".

This time, when he learned that Novartis was recruiting patients with severe fatty liver disease and that the reward for drug testing was as high as US$8000 for two months, he felt obliged to join the Phase I clinical trial of the "liver activator".

Soon, the first week passed and he didn't feel any changes at all.

Of course, as a 260-pound fat man and a person who makes a living from this, he doesn't care whether there are any changes.

As long as the time is right and you can get the money, that's enough.

The second week passed quickly and he received his first payment of US$2000.

At this time he still didn't feel any changes.

but.

When the third week ended, through the feedback from the clinical trial center, he suddenly found that his transaminase level had dropped by 20 units compared with the previous week.

"Oh, shit! The transaminase level actually dropped by 20 units. Is this an instrument error?"

Surprised, Anderson took a photo of his latest blood results and posted it in the "work group".

"Damn it, look at what's happening to my body, my transaminase has dropped by 20 units, oh, my liver, is my fatty liver going to disappear?"

"Oh, let me see... Anderson, stop teasing me. The normal value is 80. Your value has only dropped from 200 to 180. You said your fatty liver is going to disappear?"

"Haha, dear James, since I weighed over 250 kilograms, my transaminase has not dropped below 200. I even suspect it's an error in the instrument...

Oh, no! I remember that the drug I am currently taking part in the trial seems to have an effect of alleviating fatty liver disease? Could this really be the cause of this new drug?"

As soon as this last message was sent, it immediately attracted more replies in the group.

"Anderson, are you crazy? Do you really think that a drug in the first phase of clinical trials is really effective?"

"Mygod, Fatty, it's lucky these medicines didn't burst your kidneys. Do you still hope they can save your liver?"

"Haha, David, don't scare Anderson."

"Fuck, forget it if you don't believe me. I'll check next week to see if my transaminase has gone down!"

Just as Anderson sent his inspection report to the group, on the other side, in the senior conference room of Novartis headquarters, four senior executives were having a heated discussion.

"I won't waste any more time. This time, we have recruited 30 subjects for the first phase of clinical trials, including 10 normal volunteers, 10 patients with fatty liver disease, and 10 patients with cirrhosis."

"We have been tracking clinical data since the first week, and we did not find any significant changes in the data in the first and second weeks. However, yesterday, in the third week,
Ten patients with fatty liver disease showed varying degrees of decrease in transaminase levels. Although the decrease was not large, it is definitely not due to instrument error. "

"For the ten patients with cirrhosis we followed, not only did their transaminases decrease slightly, but through liver ultrasound examination, ten liver elasticity indicators of cirrhosis did not deteriorate." "So, I am almost certain now that if the current treatment effect can be maintained, there is a high probability that it will pass the Phase III clinical trial."

The speaker is David Friedman.

Perhaps it was because he was the one who fully promoted this drug from Qingshan Pharmaceutical, so he was very confident and left almost no room for maneuver when he spoke.

President Green and another vice president Klein naturally would not agree with his statement so easily.

Although they are also optimistic about this drug, it is only in Phase I clinical trials and it is still very early.

Thinking of this, President Green looked at Coles, the head of the drug research and development center.

In fact, since signing the agency contract with Tsingshan Pharmaceutical and obtaining the drug for clinical trials, Green immediately arranged for Coles to conduct a component analysis of the "liver activator" in the laboratory.

The purpose, of course, is to determine through experimental analysis how effective this drug is on liver regeneration and activation, and whether it can achieve the effect of liver protection and reversal.

His eyes fell on Coles' face, and Coles couldn't help but reveal an awkward smile.

After a moment, he shrugged and suddenly said:

“Mr. President, I might agree with Friedman.”

"This 'liver activator' will most likely pass the Phase III clinical trial even if its current ingredients are not modified."

When these words came out, Green, Klein, and even Friedman were stunned.

Coles stood up, walked to the conference table, connected his iPhone, and said slowly:

"This is the result we got from the lab this morning. I wanted to confirm it again before telling you, but since we've come to this point, I'll just tell you all at once."

As he spoke, he turned on the conference room screen and a picture of the drug appeared on the screen.

"We discovered a new inducing factor in the drug ingredients. This inducing factor can actually bind to receptors on the surface of liver cells, triggering a series of intracellular signal transduction, thereby successfully interfering with the connection between liver cells and the immune system."

"It is well known that one of the main causes of liver cirrhosis is that liver cells are affected by inflammation, which causes them to regenerate and die continuously, eventually triggering the immune system to control liver cells to stop regenerating and form sclerotic nodules."

"You see, this is the Wnt/β-catenin signaling pathway. Now this inducing factor blocks the connection between liver cells and the immune system, which means that even if inflammation continues, liver cells will not stop regenerating and sclerotic nodules will no longer form."

Everyone was stunned.

Cirrhosis of the liver is caused by the formation of hardened nodules. If drugs are used to prevent liver cells from turning into hardened nodules, the development of cirrhosis can undoubtedly be controlled.

"It's more than that."

"This drug ingredient not only blocks liver cells from turning into hard nodules,
Through a large number of experiments, we found that its ingredients include necrosis factor-α (TNF-α), interleukin-1 (IL-1) and interleukin-6 (IL-6), which can regulate the activity of immune cells and reduce inflammatory responses. These ingredients can greatly reduce the infiltration of inflammatory cells in the liver and effectively promote liver regeneration..."

"So, I think their clinical results match our laboratory results, and this 'hepatocyte activator' does have a certain effect on liver regeneration.
Just like Friedman said, if we can maintain the current effect in Phase II and Phase III clinical trials, we will most likely pass the clinical trials.”

However, Coles didn't seem to have finished speaking yet.

"What surprised me the most was that, through communication with Qingshan Pharmaceutical, they told me that they had found a better drug ingredient, and there was a high probability that the therapeutic effect would be further improved..."

Found a better drug ingredient?

When these words fell, Green and Klein were completely shocked.

However, Friedman, who was standing by, was startled when he heard this. He said anxiously:

"Coles, can you tell them that the current treatment effect is good enough?!"

"We will complete the clinical trial based on the current samples?"

(End of this chapter)