YM, BioScience a company engaged in the acquisition, development and commercialisation of oncology and acute care products, has announced that the Office of Foreign Assets Control (OFAC) of the US Treasury Department has approved a license that allows YM BioSciences' wholly-owned US subsidiary to import nimotuzumab into the US for the purpose of clinical trials in paediatric patients with pontine glioma.
Nimotuzumab is a monoclonal antibody that targets the Epidermal Growth Factor Receptor (known as EGFR) and was developed at the Centre for Molecular Immunology affiliated with the University of Havana.
As a result of the OFAC license, YM BioSciences plans to submit an IND to the FDA to allow the investigation of nimotuzumab for the treatment of children with intrinsic diffuse pontine glioma. Upon FDA granting permission for the IND to proceed nimotuzumab, to the knowledge of the company, would be the first anti-cancer drug from Cuba to be used in clinical trials in the US.
"Diffuse pontine glioma is an inoperable malignant brain cancer that only affects children and, furthermore, it is a treatment resistant tumour so that children currently suffering from it have few treatment options," said David Allan, Chairman and CEO of YM BioSciences. "With this license from OFAC, we propose to submit an IND to the FDA to investigate nimotuzumab, thus potentially allowing US children access to the drug through a controlled clinical trial setting while collecting efficacy and safety data. Nimotuzumab has been available to children in other countries through their participation in clinical trials since 2004. At present median survival following diagnosis and treatment with radiation or chemoradiation is approximately 8.5 months, and median survival after recurrence following treatment is approximately three months."
Preliminary data from a phase II nimotuzumab monotherapy study in Germany in paediatric high-grade glioma were presented at SIOP in 2005 and at ASCO in 2006. Data from this study formed the basis for a currently ongoing phase III trial, combining nimotuzumab with radiation, in Europe through YM BioSciences' licensee OncoScience AG. Final results of that phase II trial were presented at the 38th Congress of the International Society of Paediatric Oncology, Geneva, Switzerland, September 18, 2006.
The OFAC license permitting the import of nimotuzumab is an important first step towards preparing to initiate US clinical trials, and provided that the FDA concurs with the design a trial in diffuse intrinsic pontine glioma will be undertaken in numerous US and Canadian hospitals with the principal investigational site being the Hospital for Sick Children in Toronto, Canada. The current OFAC license allows the import of nimotuzumab for use in clinical trials only. The commercialisation of the drug would require an additional license from OFAC.
Nimotuzumab, which is currently approved in India, China, Argentina, and Columbia as well as Cuba, was recently licensed by YM to Daiichi Pharmaceutical Co. for the Japanese market. In Europe and Canada, the drug is in numerous clinical trials including non-small cell lung cancer, paediatric glioma and refractory solid tumours (principally colorectal). That latter study evaluated nimotuzumab as monotherapy. The study was conducted at The Princess Margaret Hospital in Canada in 2006 and demonstrated significant clinical benefit in this highly refractory patient population. Data from this study will be submitted to upcoming medical meetings in 2007.