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CLINICAL INFO

Clinical Information.

Treatment of pancreatic cancer
Limitations of treatment
Treatment strategy (BEY1107P)

Treatment of pancreatic cancer

Surgery

The only treatment that can be expected to cure pancreatic cancer is surgery. However, only about 20% of patients are eligible for curative surgery, and surgical resection is only applicable if the cancer is confined to the pancreas. Surgery is determined by the location of the lesion. Surgery is used to remove some or all of the pancreas, or to remove the surrounding tissues, depending on the situation. Whipple operation or whipple procedure, pylorus preserving pancreaticoduodenectomy, pancreatectomy and distal pancreatectomy are well known.

출처 아이콘 Source - National Cancer Information Center

Chemotherapy

Cancer chemotherapy is a method of removing cancer cells that spread throughout the body by using chemical substances such as anti-cancer drugs. Anti-cancer drug is a generic term for chemical agents that inhibit the growth and proliferation of cancer cells. Depending on the administration method, there is the no-pain easy method of oral administration and direct injection method. Cancer chemotherapy is used for the purpose of prolonging life and alleviating symptoms when the cancer is metastatic and difficult to operate, or to suppress the growth of cancer cells that may remain after surgery. Unlike gastric, colon, lung and breast cancer, which can utilize various kinds of anti-cancer drugs, there is a lack of effective anti-cancer drugs for pancreatic cancer, and only limited anti-cancer drugs are still used today. Until about 10 years ago, the only anti-cancer drug used in pancreatic cancer was the 5-FU that was developed 30 years old. After the effects of gemcitabine against pancreatic cancer were proven, it has now been used as a standard therapy for pancreatic cancer.

5-FU
5-FU (5-fluorouracil, 5-fluorouracil) is an anti-cancer drug developed 30 years ago that inhibits DNA synthesis and inhibits growth of cancer cells. It can be injected in a short period of time, or it can be administered slowly in combination with fluid, which is known to be more effective.

Gemcitabine
It is widely used as a standard therapy for metastatic pancreatic cancer and is also used for non-small cell lung cancer, cervical cancer, ovarian cancer and breast cancer. Like the 5-FU, the action mechanism interferes with the DNA synthesis of cancer cells. Usually, it is mixed with liquid and injected into blood vessels. After three injections once a week, resting on the fourth week is the most commonly used method. Gemcitabine monotherapy is superior to 5-FU monotherapy. It is currently used in combination with radiation therapy, and various combinations of anti-cancer drugs are used based on gemcitabine.

Tarceva
Tarceva is used in combination with gemcitabine to treat patients with advanced pancreatic cancer who have not previously received chemotherapy. It is widely consumed once a day on an empty stomach or 1~2 hours after a meal.

출처 아이콘 Source - tarceva homepage

Abraxane
Abraxan is used in combination with gemcitabine for advanced pancreatic cancer patients. Usually, it is mixed with liquid and injected into blood vessels. After three injections once a week, resting on the fourth week is the most common method.

출처 아이콘 Source - abraxane homepage

FOLFIRINOX
FOLFIRINOX is a combination of 4 drugs, 5-FU, oxaliplatin, irinotecan and leucovorin. Studies have shown that it is more effective than when gemcitabine was administered alone.

출처 아이콘 Source - FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

Radiation therapy

Among pancreatic cancer patients, 40% of those who can not undergo surgical resection but have no metastasis are treated with radiation therapy. Combined with radiotherapy and chemotherapy, the survival period is prolonged. Also during surgery, radiation is irradiated which can shoot large amounts of radiation to only the cancer tissues while minimizing the damage to surrounding tissues. On the other hand, patients with cancer that have metastasized to the bones have expressed severe pain and in some cases experienced bone fractures. Especially, when the metastasis causes vertebral fractures, the spinal cord may be damaged. Therefore, radiotherapy is performed as soon as a bone metastasis is found for pain relief and fracture prevention.

Side effects

When treating cancer, it is virtually impossible to remove or destroy only whole cancer cells without damaging normal cells and tissues, so a number of side effects may occur during the treatment process. The types and severity of side effects vary from person to person, even with the first and following treatment.

Surgery

Early postoperative complications include leakage of anastomotic sites of the pancreas and section after duodenal area of small intestine, abscesses, local peritonitis, pancreatitis and hemorrhage. Postoperative complications include delayed gastric emptying time, and others. Leakage of the anastomosis can sometimes cause serious problems and cause death after surgery. In addition to this, there are other complications related to old age or previous surgery, cardiovascular problems such as myocardial infarction, cerebrovascular problems such as stroke, pneumonia, pulmonary embolism (embolism, lodging of an embolus, blocking inside a blood vessel), renal insufficiency, Problems, liver function abnormalities, thrombosis may also occur. If the pancreas is partially or totally resected from surgery, the digestive juices and insulin may not be secreted sufficiently, resulting in various problems. In addition, although it is not a complication, patients may complain of pain at the surgical site or their back immediately after the operation.

Chemotherapy

Cancer chemotherapy affects whole body cells and causes various side effects. Common side effects include infection, bleeding, nausea, vomiting, diarrhea, oral wounds, diarrhea, and anorexia. Anti-cancer drugs destroy bone marrow cells, causing the side effects of reducing the amount of red blood cells, white blood cells, and platelets. Therefore, it may cause mild bleeding or easily bruising symptoms, and symptoms of bacterial infection may occur as immunity drops.

Radiation therapy

When radiation therapy is given, the skin changes color, such as reddening of the area where the radiation is irradiated, and it may become dry and itchy. Like cancer chemotherapy, it also affects other cells in the body, leading to hair loss, nausea, vomiting, diarrhea, and digestive problems. Side effects due to radiation therapy are mostly gone when the treatment is over and you may consider taking medication during treatment to reduce your discomfort by consulting your doctor.

RESISTANCE

Cancer resistance in pancreatic cancer is a major obstacle to the treatment of pancreatic cancer. Due to this resistance, it has been known to disable the delivery of anti-cancer drugs and a wide variety of mechanism is known. However, the recent presence of cancer stem cells has received attention as an important cause of cancer metastasis, resistance and recurrence. Cancer stem cells are known to self-replicate and have the ability to differentiate into various types of cancer cells to form, grow and induce metastasis. At the same time, cancer stem cells are also activated by a variety of mechanisms to transmit and neutralize traditional anti-cancer drugs. Cancer stem cell resistance in pancreatic cancer has been reported to have poor prognosis even after chemotherapy. Recent studies have shown that the treatment of gemcitabine, which is often used as a first line therapy for pancreatic cancer, increases the number of pancreatic cancer stem cells and aggravates pancreatic cancer.

출처 아이콘 Source - 1. Distinct Populations of Cancer Stem Cells Determine Tumor Growth and Metastatic Activity in Human Pancreatic Cancer
2. Combined Targeted Treatment to Eliminate Tumorigenic Cancer Stem Cells in Human Pancreatic Cancer.
3. Cancer drug resistance: an evolving paradigm

SHORT EXTENSION

The limitation of anti-cancer drugs is that the life expectancy of pancreatic cancer patients is not long. Abraxane, Tarceva, and FOLFIRINOX, which are pancreatic cancer treatments approved through clinical trials, did not significantly increase life expectancy. According to the results of clinical trials, the survival period was increased by an average of 2.1 months when Abraxane and Gemcitabine were used together compared to Gemcitabine used alone. Combined administration of Tarceva and Gemcitabine only increased the period by 0.3 months on average. Among the drugs, FOLFIRINOX (a complex of four anti-cancer drugs) showed enhanced efficacy compared to Gimcitabine, with a 4.3-month increase in average survival time, while it has severe adverse effects due to the complexation of the four anti-cancer drugs with high toxicity.

출처 아이콘 Source - FDA review, NIH national cancer institute

<Clinical trial results in pancreatic cancer using existing therapeutic agents>

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Experimental drug Chemical substance category Indications / PHASE Main test group Control group Difference between main test group and
control group
(Month)
Administered drug Average survival period
(Month)
(*OS or **PFS)
Administered drug Average survival period
(Month)
(*OS or **PFS)
Abraxane Treatment drug for pancreatic cancer
(Combination therapy)
Metastatic pancreatic cancer
/ Phase III
Abraxane+
Gemcitabine
8.7 Gemcitabine 6.6 2.1
5.5 3.7 1.8
Tarceva Pancreatic cancer / Phase III Tarceva+
Gemcitabine
6.24 Gemcitabine 5.91 0.33
3.75 3.55 0.2
FOLFIRINOX Metastatic pancreatic cancer
/ Phase III
FOLFIRINOX 11.1 Gemcitabine 6.8 4.3
6.4 3.3 3.1
Average survival period (Month) 6.95 4.98 1.97

*OS : Overall Survival (Total survival period) **PFS : Progression Free Survival (Non-administered survival period)

Treatment drug for pancreatic cancer

BEY1107P

What is BEY1107P?

BEY1107P is a new anti-cancer substance that acts on CDK1 and inhibits cell cycle control. As a result of our research, BEY1107P has been shown to stop the G2 / M cell cycle phases of the cancer cells and exhibit excellent anti-cancer activity by inhibiting the survival and proliferation of cancer cells. In addition, it was found to remove or weaken cancer stem cells that have recently received attention as the cause of building resistance against anti-cancer drugs. Therefore the combination of BEY1107P and gemcitabine will solve the problem of substance resistance induced from gemcitabine, expecting to provide better therapeutic effects than the existing therapy.

Expectations of BEY1107P through the effects of existing CDK inhibitors

The results of the clinical trials of breast cancer showed that the median survival time was prolonged by about 3 months in the test group compared to the control group whereas chemotherapy with the CDK inhibitor had an increased median overall survival period of at least 7 months and up to 10 months in the test group compared to the control group. Because of these excellent clinical results, CDK inhibitors (CDK4 / 6 inhibitors) have received the final approval from the US FDA through rapid screening even to the 3rd CDK inhibitor, despite the fact that there are new similar drugs that use similar target. These studies also demonstrate that CDK inhibitors play a crucial role in anti-cancer activity.

출처 아이콘 Source - FDA review

Since BEY1107P is not a CDK4 / 6 inhibitor but a similarly functioning CDK1 inhibitor, BEY1107P is expected to be superior to other pancreatic cancer treatments in the treatment of pancreatic cancer. Furthermore, BEY1107P is able to regulate cancer stem cells, which can solve the problem of resistance to cytotoxic anti-cancer drugs, and thus has a big difference from CDK4 / 6 target anti-cancer drugs.

<Clinical trial results of breast cancer using CDK inhibitor and other anti-cancer drugs>

드래그 안내 아이콘 Drag left and right 드래그 안내 아이콘

Chemical substance category Indications Experimental drug Main test group Control group
Administered drug Average survival period(Month) Administered drug Average survival period(Month)
Estrogen receptor
antagonist
Breast cancer Faslodex Faslodex 16.6 Arimidex 13.8
Aromatase inhibitor Femara Femara 9.4 Tamoxifen 6
Nucleoside metabolic
inhibitor
Xeloda Xeloda +
Taxotere
6.2 Taxotere 4.27
Antibody Kadcyla Kadcyla 9.6 Tyverb +
Xeloda
6.4

<Clinical trial results of breast cancer using CDK inhibitors>

드래그 안내 아이콘 Drag left and right 드래그 안내 아이콘

Chemical substance category Indications Anticancer drug Main test group Control group
Administered drug Average survival period(Month) Administered drug Average survival period(Month)
CDK4/6
Inhibitor
Breast cancer Ibrance Ibrance +
Letrozole
24.8 Letrozole 14.5
Kisqali Kisqali +
Letrozole
25.3 Letrozole 16
Verzenio Verzenio +
Faslodex
16.3 Faslodex 9.3

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