(From left) CRM chief executive officer Dr Akhmal Yusof, Dr Dzulkefly, Health director-general Datuk Dr Muhammad Radzi Abu Hassan and Roche (M) Sdn Bhd country medical director Dr Wendy Tay at the announcement.
HOSPITAL Umum Sarawak (SGH) in Kuching has been selected by Roche Pharma-ceuticals as its site for a first-in-human (FIH) clinical trial.
Roche is the first top multinational company to bring its FIH trials under a rheumatology indication to Malaysia, a testament to the country’s growing clinical trial capabilities.
The announcement was made during a Clinical Research Malaysia (CRM) event launched by Health Minister Datuk Seri Dr Dzulkefly Ahmad.
This makes Malaysia the seventh country included for the study and the first in Asia-Pacific, joining other sites in Europe and South Africa.
In his speech, Dr Dzulkefly said Malaysia’s clinical trial ecosystem had developed rapidly with over 2,300 clinical research projects conducted since 2012.
The CRM, he said, through its Phase One Realisation Project (P1RP) had overseen the development of the country’s ecosystem to enable the safe and regulated conduct of early phase research, especially FIH trials.
“Following the completion of P1RP in 2021, Malaysia conducted one FIH and two first-in- patient studies, with Roche’s study being the first FIH in Malaysia under a rheumatology indication,” he said.
The FIH trial is on a new experimental drug to treat patients with systemic lupus erythematosus (SLE), an autoimmune condition affecting the joints, skin, brain, lungs, kidneys and blood vessels.
The study is led by consultant rheumatologist Dr Teh Cheng Lay and will be conducted in SGH’s Clinical Research Centre, an accredited FIH facility under the National Pharmaceutical Regulatory Agency.
She said SLE predominantly affected women between 15 and 50 years old, as this group made up 80% of over 10,000 people diagnosed with SLE in Malaysia.
Dr Teh said there was a need to explore new treatment options that provide minimal side effects, as many SLE patients develop other health complications.
“Hence, we are excited to have Sarawak General Hospital selected among the other competing global institutions.
“I believe that with our experience and resources, we will contribute to pertinent safety data of this experimental drug among the Asian population,” Dr Teh added.
Roche (Malaysia) Sdn Bhd general manager Deepti Saraf said one concern for women with SLE was its impact on fertility and pregnancy.
“At Roche, women’s health is a priority.
“We aim to empower women to take charge of their well- being through education, early detection and personalised care,” she said.
So far in Malaysia, Roche has launched 33 late phase clinical trials on various diseases includng breast cancer, gastrointestinal cancer, hematology, diabetes and cardiovascular disease.
Since 2012, the company has invested around RM190mil in clinical trials in Malaysia.
Deepti also said Roche, working together with CRM and SGH’s Clinical Research Centre, was committed to further strengthening clinical research and clinical trial capability in the country.
“With this milestone, we believe Malaysia with its diverse population and capable clinical trial workforce can contribute to global health outcomes,” said Deepti.
