Dated: 6/1/2008
Singapore has launched a two-year investigator-initiated clinical trial to determine the efficacy and safety of cancer therapy drug nimotuzumab when used in combination with chemoradiation to treat locally advanced squamous cell cancers of the head and neck (SCCHN).
Nimotuzumab, a humanized monoclonal antibody, targets a protein known as epidermal growth factor receptor (EGFR). It was selected by the National Cancer Centre Singapore (NCCS) for a clinical trial because of its reported preferential safety profile.
The study will evaluate anti-cancer activity in terms of response rates (number of people whose tumors respond to the treatment by shrinking or disappearing), progression-free survival, and the degree of toxicities experienced by patients.
Innogene Kalbiotech (Innogene) has been working with NCCS on a Phase II clinical trial on the cancer therapy drug. Up to 37 patients with locally advanced and unresectable SCCHN who have not received prior treatment with other anti-EGFR drugs, chemotherapy or radiotherapy will have nimotuzumab administered weekly, for eight weeks, in combination with chemoradiation.
Out of an initial 23 patients to undergo the combined treatment, at least 13 patients need to respond positively to the combination therapy for the remaining 14 patients to be enrolled and the trial to progress.
Nimotuzumab deters tumor growth by binding to and disabling the EGFR, a protein that spurs the spread of cancerous cells. As nimotuzumab is a form of targeted therapy that binds to tumor cells with high specificity, the drug is thought to minimally affect normal tissues, hence, it is likely to have less toxic side effects.
The targeted nature of nimotuzumab, coupled with its reduced toxicity and immunogenicity, has been reported in previous clinical trials in some countries. In more than 2,500 patients treated worldwide, repeated administration of nimotuzumab have not shown severe reactions such as the usual skin rash that frequently arises with anti-EGFR treatments.
While the focus of the Phase II clinical trial in Singapore is on treating SCCHN, nimotuzumab has been tested in previous and ongoing trials globally, including the US, Canada and Europe, for other cancers such as colorectal, non-small-cell lung, nasopharyngeal, pancreas, breast and brain cancer.
SCCHN pose an important health issue in Singapore, which sees an annual incidence of about 500 new cases. Most SCCHN begin in cells in the head and neck region such as the oral cavity, salivary glands, paranasal sinuses, nasal cavity, pharynx, larynx and lymph nodes in the upper part of the neck.
Nimotuzumab is approved for use in head and neck cancer and glioma in Argentina, China, Columbia, Cuba, India, Peru and the Ukraine. Applications for marketing approval are being made in Europe, Indonesia and the Philippines. Innogene, a licensee of YM BioSciences, holds the licensing and marketing rights for nimotuzumab in 13 countries in Asia and Africa.
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