ImClone Systems’ share price surged by more than 18% on the Nasdaq Stock Exchange yesterday after clinical data showed that the firm’s oncology drug, Erbitux (cetuximab), used in combination with radiation, was more effective than radiation alone in preventing the spread of head and neck cancer.
The Phase III study included 424 patients with cancer either in area of the throat at the back of the mouth, the voice box, or the cavity at the back of the mouth that opens into the oesophagus that had spread through the head and neck region. Patients receiving first line treatment of Erbitux together with radiation had significant improvement. Overall survival and progression-free survival, secondary endpoints of the study, also demonstrated statistically significant improvements with the addition of Erbitux to radiation.
The company says that it will now discuss the next steps towards making a regulatory filing with the US Food and Drug Administration in this indication.
According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with oral, head and neck cancer this year, including cancers of the tongue, mouth, pharynx, and larynx. More than 11,000 Americans died from the disease in 2004.
Erbitux, which found itself at the centre of an insider trading scandal at ImClone [[22/01/02a]], [[13/06/02a]], [[10/04/03a]], won its first US green light in February last year in the treatment of colorectal cancer [[13/02/04b]].
- Meanwhile, billionaire investor, Carl Icahn, who is currently bidding to take over generics firm, Mylan Laboratories [[03/06/05d]], has made a filing with the US authorities to acquire “more than $100 million, but less than $500 million” of ImClone’s shares. According to Reuters, this could up Mr Icahn’s stake in ImClone to as much as 18%.