Advexin lung cancer program and head and neck cancer trials to be initiated
Introgen Therapeutics announced that it will move ahead with the development of registration plans for a non-small cell lung cancer indication for its Advexin gene drug. The company also announced it is able to streamline its phase 3 clinical trials for head and neck cancer to reduce spending, achieve efficiencies and re-allocate resources. In addition, Introgen will realign its research and development operations to reduce operating expenses and is cutting its current work force by about a third.
The company plans to reduce its quarterly operating expenses to about $4 million per quarter from its current level of over $6 million per quarter. The reductions are expected to be realized over the next two quarters. By controlling its cash burn rate, Introgen expects to have approximately 5 quarters of cash available.
"Lung cancer, with several hundred thousand new patients each year, represents a large medical need and large market opportunity for Advexin," said David Nance, president & CEO of Introgen. "After the recent publication of positive phase 2 trial results in 'Clinical Cancer Research,' lung cancer has been of considerable interest to prospective marketing partners," Nance added.
Nance continued, "It is now clear we should consider a lung cancer registration program in addition to our head & neck cancer program and we are now including support for lung cancer registration in our partnering discussions. Our first small molecule candidate INGN 601 (mebendozole) is also the subject of partnering discussions after positive data were recently reported in 'Molecular Cancer Therapeutics.' With difficult capital markets and limited resources, management felt it was prudent to conserve cash."
Max Talbott, senior vice president of worldwide commercial development, commented, "As part of the ongoing review announced in our July 2002 conference call, we have analyzed and reviewed operations and the enrollment process at about eighty phase 3 head and neck cancer trial sites. We have decided to decrease the number of clinical trial sites and to focus on fewer sites with larger numbers of potential clinical trial subjects. As a result, our monitoring and patient recruitment efforts can be concentrated and made more efficient to reduce phase 3 expenses to save money and allocate resources to other programs, including lung cancer."