| Health Science | october , 2020 | The Health
HWGB Biotech ’ s answer to the dire need of a vaccine
Ho Wah Genting ’ s subsidiary makes commitment to invest in vaccine for Covid-19
Figure : The 3D crystal structure of SARS 1 versus Polio . Both the poliovirus and coronavirus are positive-strand RNA viruses . Furthermore , crystal structure analysis has demonstrated structural similarities of RdRp between Poliovirus and SARS .
BY ASSOC PROF DR LONG CHIAU MING
Ho Wah Genting Berhad ( HWGB ),
through its wholly-owned subsidiary HWGB Biotech Sdn Bhd , has entered into a joint venture agreement with US-based E-Mo Biology Inc ( EBI ) for the research and development of vaccines , immunological treatment and diagnostic product development in relation to the Covid-19 virus .
With the success of the clinical trial , HWGB will launch its own vaccine and embark on the manufacturing and distribution of the vaccine .
The role of E-Mo Biology Inc
EBI , founded by Prof Xie QiYi , is responsible to undertake Phase IV clinical trials for new indication of using oral polio vaccine ( OPV ) for the prevention of Covid-19 , subject to the approval from the Food and Drug Administration ( FDA ) on the Investigational New Drug ( IND ) application .
HWGB Biotech ’ s commitment in financing Phase IV clinical trial post-FDA approval
HWGB Biotech will invest US $ 1 million as the sponsor of EBI upon the FDA ’ s approval to conduct the clinical trials . The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death caused by Covid-19 .
What is Phase IV clinical trials ?
A Phase IV trial is also known as a post-marketing surveillance trial . Phase IV trials involve the safety surveillance ( pharmacovigilance ) and ongoing technical support of a drug after it receives permission to be sold ( e . g . after approval under the FDA Accelerated Approval Program ). Phase IV studies is one of the criteria set by the FDA for drug repurposing .
Why repurpose polio vaccine ?
Both the poliovirus and coronavirus are positive-strand RNA viruses , which means it is likely that they will induce and be affected by common innate immunity mechanisms . Furthermore , crystal structure analysis has demonstrated structural similarities of RdRp between Poliovirus and SARS ( refer to figure ).
Over one billion doses of oral polio virus vaccine are produced and used annually in more than 140 countries . There are multiple advantages to using OPV : a strong safety record , the existence of more than one serotype that could be used sequentially to prolong protection , low cost , ease of administration and availability . — The Health
Dr Long is Associate Professor at PAPRSB Institute of Health Sciences , Universiti Brunei Darussalam . He has 13 years of academic , research and industrial experience and has published more than 160 SCOPUS / ISI indexed research papers in the field of antibiotics , translational research , product development and pharmaceutical sciences .
Higher cancer risk if tumour cell clusters discovered in normal individuals
A landmark study published in the American Association of Cancer Research ’ s ( AACR ) prestigious journal ‘ Cancer Prevention Research ’ has shown that it is possible to identify healthy individuals with higher risk of cancer based on a simple blood draw . The study reports that seemingly normal , asymptomatic middle-aged men and women with no history of cancer but having detectable clusters of Circulating Tumor Cells ( abbreviated as ‘ C-ETACs ’) in their blood have a 230 times higher one year risk of developing cancer as compared to individuals where such clusters were undetectable in blood samples .
In this multi-institutional international
collaborative study led by Datar Cancer Genetics , the investigators screened more than 10,000 asymptomatic individuals for detection of C-ETACs and subsequently followed up on these individuals over a period of one year .
Simultaneously , blood from more than 4,000 cancer patients with various malignancies (‘ solid organ cancers ’) was also studied . The study findings revealed that C-ETACs were almost invariably found in cancer patients (> 90 per cent ) but were extremely rare (< 5 per cent ) in normal individuals with no diagnosis or symptom of cancer .
Subsequently , over a one-year followup , 3.475 per cent of C-ETAC positive normal individuals were diagnosed with
various cancers as opposed to 0.015 per cent of C-ETAC negative individuals thus yielding a 230-fold increase in one year risk of cancer diagnosis .
The study is significant because early detection of cancer and risk stratification of seemingly normal individuals remains an ongoing public health challenge . Around 9.6 million individuals worldwide succumb to cancer each year mainly because of late detection and even the World Health Organization in its 2014 Report has identified early detection as its major objective .
The C-ETAC detection technology and the test are developed by Datar Cancer Genetics using an innovative approach for selective destruction
of non-cancer cells in the blood for harvesting C-ETACs . The accuracy of the test is 95.6 per cent and overs more than 20 cancers including breast , lung , ovarian , stomach , pancreatic , colon and prostate .
Commenting on the results , Dr Tim Crook , Medical Oncologist at Broomfield Hospital , UK and one of the authors of the paper said that ‘ C-ETACs are virtually a non-invasive micro-biopsy that will enable high confidence screening and risk stratification of seemingly normal individuals .
“ The technology represents a major advancement for early detection of cancer . The large size of the study is significant .” — The Health