NCCS Takes Lead in Clinical Trial for New Drug to Treat Head and Neck Cancer
Friday, 02 January 2009
|
Singapore investigators initiate and lead worldwide, multi-centre pivotal trial |
|
Three-to-five year project to further test new targeted therapy drug Nimotuzumab |
|
Clinical trial involves over 700 patients |
Singapore, 2 Jan, Friday – The National Cancer Centre Singapore (NCCS) announced today the launch of a new Phase III clinical trial on a new targeted therapy drug to treat locally advanced squamous cell cancers of the head and neck.
NCCS formalised its collaboration with Innogene Kalbiotech Pte Ltd, a Singapore based company that develops and commercialises innovative drugs , at a signing ceremony held at the centre today. The clinical trial to be completed in three to five years will involve at least 22 institutions from 12 countries worldwide. NCCS is taking the lead role as the main cancer centre coordinating this trial. The centre aims to have the first results reported in about five years’ time.
The countries involved in this trial span from Japan, South Korea, Taiwan, Thailand, Indonesia, India, Pakistan, Saudi Arabia, Israel to South Africa and Cuba. Participation of Australia, Canada, Philippines, and The United Kingdom is also under consideration.
This trial will include patients with locally advanced squamous cell cancers of the head and neck and who have had surgery. Half of the patients will be treated with the new targeted drug, Nimotuzumab. The drug will be administered weekly for an eight-week period, and will be given together with standard chemotherapy and radiotherapy. The trial is expected to offer an assessment of the drug’s efficacy, tolerability and influence on disease-free and progression-free survival for this particular indication.
NCCS Director, Prof Soo Khee Chee said: “Each year we see on average 200 patients who suffer from this form of head and neck cancer. We are hopeful that this trial on a larger group of patients will improve survival for this aggressive cancer.”
“We are working with 22 cancer centres and institutions in 12 countries. The trial will involve over 700 patients.”
Dr Rikrik Ilyas, Director of Innogene Kalbiotech Pte Ltd, said: “The efficacy of Nimotuzumab as an epidermal growth factor receptor-directed, targeted therapy is likely to be comparable to drugs of the same class. However, what is likely to set Nimotuzumab apart is its low toxicity and favourable safety profile.”
“Patients are spared the discomfort of severe skin rashes and may benefit from an enhanced quality of life. Both patients and physicians may also benefit from lack of hypomagnesemia often related to treatment with other anti-EGFR targeted drugs. Innogene is pleased to support NCCS in this investigator-initiated trial on Nimotuzumab, which would be the 2 nd trial on Nimotuzumab with NCCS.
Nimotuzumab has been tested in previous and ongoing trials globally, for other cancers such as non-small-cell lung (Canada, South Korea), gastric (Japan, South Korea) nasopharyngeal (China), head and neck (Canada), pancreas (Germany), breast (Cuba), brain (USA, Canada, Germany), colorectal (Canada), according to Dr Ilyas.
Explaining why Singapore is taking the lead in this research project, Prof Soo said, “The geographical location of Singapore makes us easily accessible from the other parts of the world. We are also backed by well-established transport, technology and medical infrastructure with stringent guidelines and auditing processes, which makes it a safe and conducive environment for patients. We have also significant experience in leading large multi-institutional trials.”
The trial is targeted to begin in March 2009 and patients who wish to take part in this trial should first seek consultation and assessment by their primary physician.
How Nimotuzumab works
Nimotuzumab is a humanised monoclonal antibody that targets a protein known as epidermal growth factor receptor (EGFR). Nimotuzumab, was selected by NCCS for the clinical trial because of its reported preferential safety profile. It deters tumour growth by binding to and disabling the EGFR, a protein that spurs the spread of cancerous cells. Because Nimotuzumab is a form of targeted therapy that binds to tumour cells with high specificity, the drug is thought to minimally affect normal tissues, hence likely to have less toxic side effects.
====================================
About National Cancer Centre Singapore
The National Cancer Centre Singapore (NCCS) is the premier cancer research and treatment facility in Singapore and in the region. It was established in 1997 and sees over 60 percent of the public sector medical oncology cases and about 70 percent of radiation oncology cases. NCCS not only houses the most number of oncologists in Singapore but is also equipped with the largest number of equipment to provide the latest radiation oncology care in Singapore. For more information, visit NCCS website at www.nccs.com.sg.
About Innogene Kalbiotech
Established in Singapore in July 2003, Innogene Kalbiotech Pte Ltd (Innogene) develops and commercialises biopharmaceuticals and medical diagnostics, specialising in oncology, intensive care and therapeutic and preventive vaccines. It coordinates clinical trials and research activities, and manages the application and commercialisation of patents worldwide. A wholly owned subsidiary of Jakarta-listed pharmaceutical company PT Kalbe Farma Tbk., Innogene spearheads the innovation and globalisation for Kalbe with research-based products. For more information, visit www.theracim.com and www.innogene-kalbiotech.com.
====================================
|
