Vietnam - US cooperate in research and testing of new cancer drugs

On December 12, in Hanoi , Tam Anh General Hospital and Tam Anh Research Institute (TAMRI) announced the implementation of a phase 2A clinical trial of the American oral immunotherapy drug RBS2418. The study is expected to be successful, bringing new life to patients with late-stage and resistant cancer.

The announcement was attended and witnessed by representatives of the Ministry of Health, the Ministry of Foreign Affairs, and the US Centers for Disease Control and Prevention (CDC).

Safe first step

RBS2418 is a potential oral immunotherapy cancer drug approved for clinical trials by the US Food and Drug Administration (FDA).

Dr. Nguyen Ngo Quang, Director of the Department of Science, Technology and Training (Ministry of Health), presented the decision to grant a license for phase 2A clinical research for the oral immunotherapy cancer drug RBS2418 in Vietnam on December 12, 2024. PHOTO: TAM ANH HOSPITAL

In phase 1, research at more than 10 prestigious hospitals and medical centers in the US, the results were safe. This potential drug RBS2418 continues to be approved for phase 2 research on response effectiveness in patients with late-stage colorectal cancer, no longer responding to existing treatments. The phase 2 clinical trial was approved by the FDA to be implemented in September 2024, and immediately after that, the Vietnamese Ministry of Health approved it in early December 2024. It is expected that in the current phase 2A, VISTA-1 will recruit 150 patients in the US and Vietnam. In Vietnam, the clinical trial will first be conducted at Tam Anh Hospital in Hanoi, Tam Anh Hospital in Ho Chi Minh City, and is expected to expand to 3 other major hospitals in the near future. The VISTA-1 study was developed by the American biotechnology company Riboscience, along with a group of prestigious experts from Riboscience, Stanford University School of Medicine. The study will initially focus on patients with advanced, metastatic colorectal cancer who have failed or are intolerant to existing therapies, opening up an opportunity for them to access a potentially innovative solution. The drug is in oral form, easy to use, reduces costs, and increases access for many patients, especially for cancers that are notoriously expensive to treat.

Tam Anh Hospital meets all the high requirements of clinical trials equivalent to the US.

In November 2023, in the US, Tam Anh General Hospital System, Tam Anh Research Institute and Stanford Institute for Microbiology and Epidemiology signed a cooperation agreement.

Professor Jeffrey S. Glenn, Director of the Stanford Institute for Microbiology and Infectious Diseases, spoke at the event. PHOTO: TAM ANH HOSPITAL

To become the official research site of VISTA-1, Tam Anh has made great preparations and investments in human resources, equipment, machinery, and working processes, especially proactively approaching and participating from the very early stage of the initial research in the US. Doctors from Tam Anh Hospital and Tam Anh Research Institute joined with experts in the US to develop a research outline for phase 2, receiving standard research procedures to develop a modern laboratory system that meets international standards. In particular, Tam Anh Hospital System has invested in a completely new testing center with the most modern equipment to become a central laboratory for performing biological markers in parallel with the research laboratory in the US. "We have worked with Tam Anh Hospital in another phase of cooperation with Stanford University. During that process, Tam Anh Hospital learned that Riboscience Company was conducting a clinical trial of this new experimental cancer drug. Tam Anh's leadership was very interested and enthusiastic about bringing this experimental cancer drug to Vietnam. After visiting Tam Anh Hospital, I was very impressed with the facilities and staff, the medical care was very advanced and on par with international standards. I believe that Tam Anh Hospital will conduct a successful clinical trial with us," affirmed Prof. Dr. Jeffrey S. Glenn, Director of the Stanford Institute for Microbiology and Epidemiology.

According to Professor Jeffrey S. Glenn, new drug research consists of 4 phases: 1, 2A, 2B, 3 and 4. Phase 4 is the phase of monitoring the effectiveness and long-term side effects of the drug after it is licensed for circulation and applied in practice. In the process of researching and developing a new drug, clinical trials play a key role in evaluating the safety and effectiveness of the drug in humans.

Great significance for cancer patients and Vietnamese healthcare

Sharing with us, Mr. Hoang Anh Tuan, representative of the Consulate General of Vietnam in San Francisco (USA), affirmed that choosing Tam Anh as Stanford's center outside the US for research and clinical trials on cancer treatment was not a random choice. Stanford chose Tam Anh because they found it a completely worthy choice. According to him, the factors that decided this include good facilities, a team of good experts, financial capacity and management leadership, determination... of the entire Tam Anh ecosystem. The important thing is to have the support of the Government, the Ministry of Health, and related ministries and branches. "This is a world-class research and our cooperation like this opens the first step for Vietnam to become a research center, a development center, a center for treating serious diseases in the world. I think at that time, international research organizations will have to line up and this will create the premise for us to become a scientific center not only in artificial intelligence, medicine but also in other fields," said Mr. Hoang Anh Tuan. Dr. Nguyen Ngo Quang, Director of the Department of Science, Technology and Training (Ministry of Health), added that this is the first and only project currently transferring technology and implementing experimental research. Therefore, if this project is successful, it will demonstrate the remarkable development of technology, including research technologies, participating in research to develop new drugs, as well as creating many products for patient care, especially cancer patients in Vietnam. "We also hope that through this project, Vietnam will have further opportunities to receive technology transfer on research and production of new drugs with other major partners in Europe and Japan, to serve patients in Vietnam," Mr. Ngo Quang believes. VISTA-1 is of great significance to cancer patients when they have access to research drugs right in Vietnam, equivalent to patients in the US. This is also an important step forward for the medical industry and innovative and breakthrough science in Vietnam when it is ready to meet the conditions to be able to receive and implement clinical research at a very early stage such as phase 2A, not just phase 3 research as before.

Dr. Vu Huu Khiem, Head of the Oncology Department, Tam Anh Hospital, Hanoi, said that according to statistics from the Global Cancer Registry (Globocan), colorectal cancer is the third most common cancer in the world, with more than 1.9 million new cases in 2022. According to estimates from Globocan, the International Agency for Research on Cancer (IARC), by 2045, the mortality rate from colorectal cancer in Asia alone could increase by nearly 80% compared to the present. In Vietnam, this is the fourth most common cancer, with a new incidence rate of 16,835 cases and a mortality rate from colorectal cancer of 8,454 cases. Statistics show that 15 - 30% of newly diagnosed patients are already in the metastatic stage; 50 - 60% of local cancer cases eventually progress to metastasis. Late detection, at an advanced stage of the disease, makes the treatment process very difficult; the 5-year survival rate of patients with metastatic cancer is only about 10 - 20%. Meanwhile, in Vietnam, many metastatic cancers, if using targeted drugs or immunotherapy, have a 5-year survival rate of up to 30 - 40%. On the other hand, immunotherapy, a significant advance in cancer treatment in the past 10 years globally, is currently only effective with about 5% of patients with metastatic colorectal cancer. Source: https://thanhnien.vn/viet-nam-my-hop-tac-nghien-cuu-thu-nghiem-thuoc-ung-thu-moi-185241213000403589.htm