Chapter 108: Promoting liver cells starts clinical trials in the United States (big update for the dust blown away by the wind!)
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 U.S. pharmaceutical industry has a history of clinical trials for nearly a century, China’s clinical trial processes and models are basically borrowed from the FDA.
Furthermore,
Due to the higher degree of commercialization of the US FDA, the approval speed of clinical trials is faster than that in China.
Of course,
Also because the FDA is the most authoritative, professional and commercial drug clinical trial certification agency in the world, almost all pharmaceutical companies in the world will conduct clinical trials of their own drugs at the FDA.
As a result, a group of black producers have formed in the United States who specialize in participating in clinical trials.
Novartis quickly contacted a group of eligible subjects to participate in the Phase I clinical trial of "activating agents that promote liver cell regeneration".
Jamie Anderson is one of the subjects.
He is a traditional American white man. Because he loves hamburgers, hot dogs, and Coke, his weight reached 130 kilograms at the age of only 28. He currently suffers from severe fatty liver, high blood pressure, diabetes and other diseases.
This weight made him unintentional to work, so he joined the "drug trial organization" by chance.
This time when he learned that Novartis was recruiting patients with severe fatty liver disease, and that the trial drug remuneration was as high as 8,000 US dollars for two months, he was obliged to join the first clinical phase 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 specializes in eating this bowl of rice, he doesn't care if there are any changes.
As long as the time is up and you can get the money, that's all.
The second week passed quickly, and he received his first payment, US$2,000.
He still didn't feel any changes at this time.
However.
At the end of the third week, through the feedback results from the clinical trial center, he suddenly found that his transaminases had dropped by 20 units compared to the previous week.
"Oh, shit! The transaminase dropped by 20 units. Is this an instrument error?"
Surprised, Anderson immediately took a photo of his latest blood results and posted it in the "work group" .
“Hell, look at what’s going on with my body. My transaminase dropped by 20 units. Oh, my liver, is my fatty liver going away?”
"Oh, let's see... Anderson, stop teasing me, the normal value is 80, you Now it has only dropped from 200 to 180. You said your fatty liver is going away?"
"Haha, dear James, my transaminase has not dropped below 200 since I gained 250 pounds. I even doubt whether it is an error in the instrument...
Oh, no! I remembered that the drug I am currently participating in the trial seems to have an effect of relieving fatty liver? Could it really be the reason for this new drug? "
As soon as the last message was sent, it immediately attracted more replies in the group.
"Anderson, are you not crazy? Do you really think that the drugs in the first clinical phase are really effective? "
"Mygod, little fat boy, it's good that these medicines didn't burst your kidneys. Do you still hope that it can save your liver? "
"Haha, David, don't scare Anderson. ”
"Fuck, forget it if you don't believe me. I'll see if my transaminases have dropped next week!"
Just as Anderson posted his test report in the group, on the other side, in the senior conference room of Novartis headquarters, The four senior executives were having a heated discussion.
“I won’t go into too much nonsense. This time we recruited 30 subjects in the first clinical phase, including 10 normal volunteers, 10 patients with fatty liver, and 10 patients with cirrhosis. ”
“We have been tracking clinical data from the first week, first No obvious data changes were found in the first and second weeks. However, just yesterday, in the third week,
Ten patients with fatty liver disease experienced a decrease in transaminases to varying degrees, although the decrease was not large. , but it is definitely not an instrument error value.”
"And among the ten patients with cirrhosis we are following, not only did their transaminases decrease slightly, but through liver ultrasound examination, none of the ten cirrhosis liver elasticity (liver elasticity) indicators worsened." "So, I am almost certain now that if we can If the current treatment effect is maintained, there is a high probability that it will pass clinical phase III trials.”
The speaker was David Friedman.
Perhaps it is because he is fully promoting the drug of Qingshan Pharmaceutical this time, so he is very confident and leaves little room for error when he speaks.
President Green and the other vice president Klein naturally would not agree with his statement so easily.
Although they are also optimistic about this drug, it is only in the first phase of clinical trials and 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 an agency contract with Qingshan Pharmaceutical and receiving the drugs for clinical trials, Green immediately arranged for Coles to conduct component analysis of the "liver-stimulating activator" in the laboratory.
The purpose is naturally to determine through experimental analysis how much effect this drug has on liver regeneration and whether it can achieve hepatoprotective and reversal effects.
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 may agree with Friedman."
"This 'liver activator' even now If the ingredients are not modified, there is a high probability that it will successfully pass the Phase III clinical trial.”
When these words came out, Green, Klein, and even Friedman were stunned.
Coles stood up, walked to the conference table, connected to his iPhone, and said slowly:
"This is the result that the laboratory just got this morning. I originally wanted to confirm it again before telling you, but now that it's all said and done, I'll tell you all together."
As he said that, he opened the A picture of a drug appears on the conference room screen.
“We discovered a brand-new induction factor in the drug ingredient. This induction factor can actually bind to receptors on the surface of liver cells, triggering a series of intracellular signaling, thereby successfully interfering with liver cells. Connection with the immune system ”
“It is well known that one of the main causes of liver cirrhosis is that liver cells are affected by inflammation and continue to regenerate and die. death, and finally triggers the immune system to control liver cells to stop regeneration and form sclerotic nodules.”
“You see, this is the Wnt/β-catenin signaling pathway. Now this inducer blocks liver cells and the immune system. This connection means that even if the liver cells are continuously exposed to inflammation, they will not stop regenerating and will no longer form sclerotic nodules.”
Everyone was stunned.
Liver cirrhosis is caused by the formation of sclerotic nodules. If drugs are used to prevent liver cells from turning into sclerotic nodules, the development of cirrhosis can undoubtedly be controlled.
“It’s not just that.”
“This drug ingredient can not only prevent liver cells from turning into hard nodules,
We found through a large number of experiments that the ingredients in it It can regulate the activity of immune cells and reduce inflammatory reactions. Corresponding necrosis factor-α (TNF-α), interleukin-1 (IL-1) and interleukin-6 (IL-6). These components can greatly reduce the infiltration of inflammatory cells in the liver, while also Can effectively promote liver regeneration..."
"So, I think their clinical results match our laboratory results. This 'hepatocyte activator' does have a certain effect on liver regeneration,
As Friedman said just now Similarly, if the current results can be maintained in the second and third clinical phases, there is a high probability that it will pass clinical trials.”
However, Coles’ words do not seem to be over yet.
“What surprised me the most was that through communication with Qingshan Pharmaceutical, they told me that they had found better drug ingredients, and there is a high probability that they can further improve the therapeutic effect. …”
Find a better pharmaceutical ingredient?
When the words fell, Green and Klein were completely shocked.
However, Friedman on the side was startled when he heard this. He said anxiously:
"Coles, can you tell them that the current treatment effect is enough? Okay?”
“Let’s complete the clinical trial with the current sample?”
(End of this chapter)