Press Release

Date	Title and Summary	View
1 Feb, 2019	Latest Results of BCT-100 Preclinical Studies and Clinical Trials Are Announced in the “Second Symposium on Pegylated Recombinant Human Arginase in Human Cancers and Autoimmunity”
29 March, 2018	BCT Wins Prestigious Christian Doppler Lab Award
4 October, 2017	Phase I Clinical Trial of BCT-100 in the US Shows Promising Results
28 September, 2016	Phase II Study of BCT-100 in Patients of Relapsed and Refractory Acute Myeloid Leukemia in Hong Kong
28 December 2014	Dr Paul Cheng, CEO of BCT, will be Presenting at JP Morgan 33rd Annual Healthcare Conference
10 December 2014	Results of our Phase IIa Clinical Trial in Patients with HCC Accepted for Publication in Investigational New Drugs
15 September, 2014	Phase I Study on Patients with Advanced, Arginine Auxotrophic Solid Tumors to Commence in US
17 March, 2014	Phase II Study of BCT-100 as Second-line Treatment Following Sorafenib Failure to Commence in Hong Kong
23 February, 2014	Phase II Study of Oxaliplain in Combination with Capecitabine and BCT-100 (PACOX) on Hepatocarcinoma Cellular Patients to Commence in Hong Kong
23 December, 2013	Dr Paul Cheng, CEO of BCT, will be Presenting at JP Morgan 32nd Annual Healthcare Conference
26 June, 2012	BCT- 100. Hong Kong's First Novel Biologic Anti-Cancer Drug, Granted IND from US FDA
25 June, 2012	BCT at BIO 2012 International Convention, Boston

BCT-100 shows promising results in US and UK clinical trials

(February 1, 2019)

International scholars have announced the latest results of BCT-100’s preclinical studies and clinical trials at the “Second Symposium on Pegylated Recombinant Human Arginase in Human Cancers and Autoimmunity” in Hong Kong on January 31 – February 1, 2019.

A melanoma patient who took part in the US clinical study has achieved complete remission after receiving the BCT-100 treatment and still remains cancer-free as of today – almost three years after his first dose of BCT-100. The phase I study also saw a substantial number of stable diseases among prostate cancer patients. BCT is planning to launch a multi-centre phase IIb/III in the US once the phase I extension study is completed by Q4.

BCT also completed the phase I PARC study in paediatric cancers, sponsored by Cancer Research UK, confirming the PK/PD and safety of BCT-100 in paediatric patients. In parallel, sponsored by Bloodwise, BCT is now recruiting patients for the UK acute myeloid leukaemia (AML) trial LI-1, which is expected to be completed by Q4 in 2019.

Dr. Paul Cheng, MD and co-founder of BCT, said, “For BCT-100 to achieve full compliance with the EU GMP requirements and be approved by UK MHRA for clinical trial is a major milestone for Hong Kong’s biotechnology industry. We are extending the PARC study to Institut Gastave Roussy in Paris, and soon to the Netherlands and Australia.”

Beyond the positive results seen for cancer treatment, preclinical results also evidenced BCT-100 has immunomodulating properties that can be applied into treating autoimmune diseases, such as rheumatoid arthritis.

For more information about LI-1 and PARC, please visit isrctn.com

BCT-100, Hong Kong's First Novel Biologic Anti-cancer Drug, Granted IND from US FDA – International Recognition of Local R&D and Technologies Represents an Outstanding Achievement for Hong Kong

(June 26, 2012)

Bio-Cancer Treatment International Limited ("BCT" or the "Company"), a biotechnology company at the HK Science Park which focuses on the research and development of anti-cancer drugs, announces that its biologic drug for the treatment of liver cancer, BCT-100 has become the first novel drug developed in Hong Kong to obtain approval from the US Food and Drug Administration (FDA) to commence human clinical studies in the US by the issuance of Investigation New Drug (IND). This approval marks an important milestone in the development of the biotechnology and pharmaceutical industry in Hong Kong. The research and development of BCT-100 commenced in 2001 and the investment to date has exceeded HK$100 million.

Some malignant tumours, which include liver cancer, melanoma, prostate cancer, T cells and myelocytic leukaemia, will perish when the non-essential amino acid arginine is removed from circulation; normal cells, on the other hand, can utilize another intermediate called citrulline, which is found in abundance in circulation, as a surrogate and survive. With recombinant DNA and pegylation technologies, BCT has turned hepatic arginase, a natural enzyme in human liver, into a novel anti-cancer drug capable of removing arginine safely from circulation and consequently exerts its anti-cancer effect. Bio-Cancer's early research was performed at the Polytechnic University of Hong Kong in collaboration with professors Thomas Leung and Thomas Lo, who are experts in protein engineering and recombinant DNA technology.

In 2008, with the approval given by the Hong Kong Department of Health, BCT sponsored a phase Ia dose finding study and a phase Ib efficacy study in a group of patients with terminal liver cancer at Queen Mary Hospital. The principal investigator of the clinical study was Professor Ronnie Poon at the Department of Hepatobiliary and Pancreatic Surgery of The University of Hong Kong. The phase I clinical study, which is now published in the Journal of Investigation New Drugs, indicates that BCT-100 is well tolerated and safe. It also has good signals of anticancer activity in liver cancer. A separate clinical study combining traditional chemotherapy, which is proven to be active in liver cancer with BCT-100 is now in planning stages and BCT anticipates this important study to commence in last quarter of 2012.

With the issuance of the US FDA IND, BCT will initiate a new phase I clinical trial at the Loma Linda University, Los Angeles, in the last quarter of this year to further evaluate the clinical efficacy of BCT-100 in a variety of cancer types. BCT-100 will be the first anti-cancer biologic developed entirely in Hong Kong to be used in a clinical setting in the US.

BCT's preclinical data also indicates that BCT-100 has potential anti-cancer activities in certain refractory leukaemias and lymphomas. A phase I clinical study in refractory leukaemias and lymphomas has just commenced at the Department of Paediatrics at The University of Hong Kong. Further clinical trials are in the planning stage to define possible clinical efficacies of BCT-100 in other tumour types.

Dr Paul N M Cheng, CEO and co-founder of BCT, said, "It is challenging to conduct bio-technological research in Hong Kong. The issuance of US FDA IND to conduct clinical studies in the US is a stamp of approval that our technology is in par with the rest of the developed world. We owe our success to a number of HKSAR departments, VCs and local academic institutions, including private venture capitals in the early stage, Morningside Technologies, The University of Hong Kong, as well as the Hong Kong Polytechnic University. BCT was among the first batch of local companies to enter Hong Kong Science Park in Sha Tin in 2006. This enabled us access to the facilities and services provided by Hong Kong Science and Technology Parks Corporation (HKSTPC) so as to enable us to concentrate on our R&D and clinical trials."

Mr. Andrew Young, Vice President of Marketing and Sales, HKSTPC, is encouraged by the achievements of BCT. "I take this opportunity to congratulate BCT on this landmark achievement in the field of bio-pharmaceutical R&D, which I am happy to say is entirely Hong Kong-based. We are proud as this not only proves that Hong Kong's bio-pharmaceutical research has attained global standards, but it is also a testimony of the role of HKSTPC in assisting companies in the Park to advance their research and be successful in the industry."

The BCT-100 project has also gained recognition and supports both internationally and locally in HK and PRC. The project was showcased at the 33^rd International Exhibition of Inventions of Geneva co-organized by the Swiss Federal Government and the State of the City of Geneva in April 2005 and won two Gold Medals from both the Swiss Ministry of Education and Research and the Romanian Government for merit in potential commercialization. At the start of the project, while the drug development was incubated at the Hong Kong Polytechnic University, BCT was supported through the Innovation & Technology Fund and the Small and Medium Entrepreneur Research Assistance Programme under the Innovation and Technology Commission of the Hong Kong SAR government. In 2010, the BCT-100 project was included in the "Key New Drug Creation and Manufacturing Programme" by the Ministry of Science and Technology of China, ranking it among the key subsidized science and technology projects within the Eleventh Five-Year Plan. The Shanghai Government and the Zhangjiang High-Tech Industrial Development Zone have also given their support through granting of sizable funds to the project and expressed strong confidence in the prospect of the project.

Dr Paul N M Cheng said, "The development of BCT-100 has been relatively cost-effective when compared to developing a new drug in the West, which, on average, require at least US$500 million until commercialization. BCT will continue to advance our R&D and clinical trials in the hope of one day bringing the drug into the market and offer cancer patients a ray of hope of an eventual cure."