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Bio-Cancer Treatment International Limited (BCT) is
a Hong Kong-based biotech company founded by Dr. Paul N.M. Cheng,
a local medical oncologist cum hematologist, and his partner, Dr. Jun Sing Lee in 2001.
A local team of young scientists headed by Dr. Cheng and two outstanding bio-tech experts from the Hong Kong Polytechnic University,
Dr. Thomas Lo, a MIT-trained fermentation expert and Dr. Thomas
Leung, an Oxford University graduate specializing in protein engineering,
have undertaken the project since its inception in early 2001 to its present state of development.
The company has developed its first anti-cancer drug candidate,
BCT-100, which is a recombinant human enzyme for the treatment of
cancers that are dependent on arginine for growth.
Phase Ia single dose clinical evaluation in liver cancer patients,
approved by the Department of Health of the Hong Kong SAR, has been completed in 2006
at the University of Hong Kong. Its safety profile has been ratified by PPD,
a leading global research organization. The trial showed exceptionally low toxicity and the expected dose response.
We have received explicit permission from the US FDA in our Pre-IND meeting in Washington.
In collaboration with Loma Linda University Clinical trial Centre, University of Hong Kong
and Kinexum, we have designed our phase Ib clinical trial protocol to specifically address the issue of
single agent and combination efficacy of BCT-100 with various chemotherapeutic agents in patients with liver
cancer, melanoma and prostate cancers. We are working towards IND approval. We worked closely with our CRO in Beijing (Joinn Laboratories) on preclinical studies and have just witnessed an US FDA GLP inspection in July 2009 with high commendations.
Our Phase Ib/II clinical study in Hong Kong has shown encouraging results and we are expanding our study to confirm our preliminary findings of promising safety profile, indication of stabilizing effect as well as potential overall survival of in BCT-100.
BCT scientists have also developed our own PRC patentable
proprietary chemical synthetic technology to produce Polyethylene Glycol (PEG).
A GMP-compliant manufacturing unit at the Hong Kong Science Park in Tai Po is now producing mSPA-PEG,
a bio-polymer used in the production of BCT-100 and potentially other protein therapeutics.
The USP quality GMP-compliant PEG is used in-house for our clinical drug. Local institution has acquired a trial order of our PEG in pegylating small molecule product, and we are collaborating with drug development companies in China in pegylating their proteins with our PEG.
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