After being fired, I became the light of medicine

Chapter 72 Phase II clinical trial with cytotoxicity!

Zhang Yang's original design idea was very simple.

By changing the covalent bonds of the toxic compound "phenylpropion" in the finished product "Acofenprofovir", the toxicity can be reduced to a minimum during the first phase of clinical trials.

When it comes to the second phase of clinical trials, he will slowly adjust the effective toxic components to the most reasonable range, and finally make it a complete product.

In this way, not only can the toxicity test of Phase I clinical trials be easily avoided, but Phase II clinical trials can also be passed more easily.

But he didn't expect that Wei Tian would find out, and the hidden benzoyl toxicity would be revealed.

Wei Tian did not notice Zhang Yang's surprise and said slowly:
"I have been studying the drug you provided for the past few months."

"After multiple trials, I adjusted some of the drug ingredients and dosages, and eventually used them in the last batch of Phase I clinical trials with patients."

"But we didn't expect that normal subjects did not experience any side effects, and all indicators were normal. Only the hepatitis B subjects experienced strong side effects after taking the medicine, including nausea and vomiting, rapid increases in transaminase and bilirubin, and obvious acute liver damage."

"Fortunately, the side effects of the drug disappeared immediately after I stopped taking it."

After hearing this, Zhang Yang was certain that this was how the cytotoxicity of "Abrocitinib" manifested itself!

and.

Wei Tian did modify the drug ingredients.

At this moment, Wei Tian showed a trace of guilt on his face, and then said:

"However... because of the serious side effects, it attracted the attention of the Ethics Review Committee."

"They are now asking us to test it at the lowest dose and to repeat the animal experiments immediately..."

"So, Mr. Zhang, I'm sorry, the progress of our Phase I clinical trial may be delayed."

Instead of being angry, Zhang Yang showed a smile on his face.

It is not a big deal to attract ethical attention, and redoing the animal experiment will only take a little time and cost money.

Compared to this, Wei Tian was a little surprised that he could find the poison he had hidden, even...

Surprise!

He knew very well that he understood the cytotoxicity of "Acofenafovir" because he had read the complete answer, while Wei Tian discovered the hidden toxicity through his own efforts in a pile of fog.

Although he made the process sound easy, to discover the secret in just three months would require not only a lot of experiments, but also...

A strong and keen talent for medicine!

He looked at Wei Tian again.

Wei Tian is very young, only twenty-six years old, and his work experience is also very ordinary.

Before coming to Qingshan Pharmaceutical, he had only worked as an assistant drug researcher in a pharmaceutical company. This time, he was asked to be in charge of the clinical trials of "Icofenafovir" because of his previous seriousness and responsibility in working on "ITG human ovarian hormone".

Unexpectedly, after being able to take charge of a situation on his own, Wei Tian actually showed his talent.

He stood up and patted Wei Tian on the shoulder:

"It's okay. Isn't it just redoing the animal experiment? Isn't it just a toxicity issue?"

"In the next period of time, I will work with you to research and develop, and try to solve the toxicity problem as soon as possible!"...

Wei Tian's modification of the drug ingredients disrupted Zhang Yang's plan. In the following period, Zhang Yang fully joined the R&D team and began to participate in the improvement and development of "Acofenprovir".

At this time, he also thought clearly that since Wei Tiandu had already discovered the toxicity of "Acofenprofovir", there was no need to hide it anymore and he could just adjust the dosage of the poison to the standard dosage.

In this way, not only will the subsequent clinical trials be safer, but the safety of the subjects will also be better protected!

Soon, under the leadership of Zhang Yang, the dosage of the toxicant "Acofenprofovir" was adjusted to the standard dosage and determined.

At the same time, while it is less toxic to the liver, the inactivation rate of hepatitis B virus is further improved.

The improved "Avofovir" began to be tested on animals again.

In laboratories, mice are generally used for animal experiments. For example, to test the toxicity of "Avofovir" to hepatitis B patients, a group of mice infected with the hepatitis B virus must be bred first.

However, the hepatitis B virus cannot parasitize in mice, so the experimental subjects became experimental monkeys.

There are specialized companies that breed experimental mice and monkeys. After receiving orders from Tsingshan Pharmaceutical, they will infect the experimental monkeys with hepatitis B virus, and then sell the experimental monkeys with the virus bred to Tsingshan Pharmaceutical, thus completing the animal experiments.

Compared to the cheap price of mice, the price of a monkey for hepatitis B virus experiment is about 25 yuan, which is expensive.

Although money was spent like water, fortunately, half a month later, Tsingshan Pharmaceutical and GlaxoSmithKline successfully signed the UK agency agreement for "ITG Human Myeloid Positin". The next step is to complete the Phase III clinical trial and "ITG" can be successfully launched in the UK.

Simultaneously,

With the launch of "ITG Human Growth Factor" in Southeast Asia, the Southeast Asian market has taken the lead in setting off a sales wave.

Gao Qiang from Fuxing Pharmaceutical has been smiling all the time recently.

Compared to the poor people in the UK who are still waiting for "ITG" to go public, many middle-class people in Europe and the United States can't wait to go to the Philippines, Thailand, Vietnam and other places for treatment.

no way,
It is very difficult to get a three-month visa in China, but Southeast Asia is visa-free. For this reason, many travel groups in Thailand and the Philippines have even launched "medical tourism" specifically for European and American patients.

The three-month tour group not only allows you to cure your illness, but also allows you to travel at the same time.

This made Gao Qiang itchy, and he was eager to raise the price to US$5000 per piece.

However, because of the "price control clause" with Qingshan Pharmaceutical, he could only think about it. If he wanted to raise the price significantly, he had to get the permission of Qingshan Pharmaceutical...

Thinking of Qingshan Pharmaceutical and Zhang Yang, he suddenly shuddered.

The Southeast Asian market is booming right now. If they form an industrial chain one day, I wonder if Zhang Yang will suddenly rip them off!

hiss!
possible!
Just when Gao Qiang was daydreaming, with the assistance of Zhang Yang, "Acofenprofovir" successfully completed the animal experiment again.
And in the subsequent Phase I clinical trial, it also passed the toxicity test with difficulty.

but,

When the approval notice for the Phase II clinical trial of "Acofenprofovir" came down, Wei Tian not only couldn't laugh, he even felt a little uncomfortable.

Due to the intervention of the Ethics Review Committee, the exposure of cytotoxicity of "Alefovir" in Phase I clinical trials, and the fact that "Alefovir" is indeed cytotoxic,
In the Phase II clinical trial announcement, the Ethics Committee explicitly required that "cytotoxicity" must be specifically marked in any recruitment and promotional materials about "Abrocitinib".

Moreover, when all subjects sign the informed consent form for the clinical trial, they must be clearly informed again that there is “unknown” cytotoxicity!
"Cytotoxicity, this makes it difficult to recruit for Phase II clinical trials..."

Wei Tian sighed heavily.

(End of this chapter)